Clinical Practice Guideline

Clinical Practice Guideline:
Otitis Media with Effusion

(Update)
Show all authors
Richard M. Rosenfeld, MD, MPH, Jennifer J. Shin, MD, SM, Seth R.
Schwartz, MD, MPH, ...
First Published February 1, 2016 Research Article

Article information
Abstract
Objective
This update of a 2004 guideline codeveloped by the American Academy of
Otolaryngology—Head and Neck Surgery Foundation, the American Academy of
Pediatrics, and the American Academy of Family Physicians, provides evidence-based
recommendations to manage otitis media with effusion (OME), defined as the
presence of fluid in the middle ear without signs or symptoms of acute ear infection.
Changes from the prior guideline include consumer advocates added to the update
group, evidence from 4 new clinical practice guidelines, 20 new systematic reviews,
and 49 randomized control trials, enhanced emphasis on patient education and shared
decision making, a new algorithm to clarify action statement relationships, and new
and expanded recommendations for the diagnosis and management of OME.
Purpose
The purpose of this multidisciplinary guideline is to identify quality improvement
opportunities in managing OME and to create explicit and actionable
recommendations to implement these opportunities in clinical practice. Specifically,
the goals are to improve diagnostic accuracy, identify children who are most
susceptible to developmental sequelae from OME, and educate clinicians and patients
regarding the favorable natural history of most OME and the clinical benefits for
medical therapy (eg, steroids, antihistamines, decongestants). Additional goals relate
to OME surveillance, hearing and language evaluation, and management of OME
detected by newborn screening. The target patient for the guideline is a child aged 2
months through 12 years with OME, with or without developmental disabilities or
underlying conditions that predispose to OME and its sequelae. The guideline is
intended for all clinicians who are likely to diagnose and manage children with OME,
and it applies to any setting in which OME would be identified, monitored, or
managed. This guideline, however, does not apply to patients <2 months or >12 years
old.
Action Statements
The update group made strong recommendations that clinicians (1) should document
the presence of middle ear effusion with pneumatic otoscopy when diagnosing OME
in a child; (2) should perform pneumatic otoscopy to assess for OME in a child with
otalgia, hearing loss, or both; (3) should obtain tympanometry in children with
suspected OME for whom the diagnosis is uncertain after performing (or attempting)
pneumatic otoscopy; (4) should manage the child with OME who is not at risk with
watchful waiting for 3 months from the date of effusion onset (if known) or 3 months
from the date of diagnosis (if onset is unknown); (5) should recommend against using
intranasal or systemic steroids for treating OME; (6) should recommend against using
systemic antibiotics for treating OME; and (7) should recommend against using
antihistamines, decongestants, or both for treating OME.
The update group made recommendations that clinicians (1) should document in the
medical record counseling of parents of infants with OME who fail a newborn
screening regarding the importance of follow-up to ensure that hearing is normal
when OME resolves and to exclude an underlying sensorineural hearing loss; (2)
should determine if a child with OME is at increased risk for speech, language, or
learning problems from middle ear effusion because of baseline sensory, physical,
cognitive, or behavioral factors; (3) should evaluate at-risk children for OME at the
time of diagnosis of an at-risk condition and at 12 to 18 months of age (if diagnosed
as being at risk prior to this time); (4) should not routinely screen children for OME
who are not at risk and do not have symptoms that may be attributable to OME, such
as hearing difficulties, balance (vestibular) problems, poor school performance,
behavioral problems, or ear discomfort; (5) should educate children with OME and
their families regarding the natural history of OME, need for follow-up, and the
possible sequelae; (6) should obtain an age-appropriate hearing test if OME persists
for 3 months or longer OR for OME of any duration in an at-risk child; (7) should
counsel families of children with bilateral OME and documented hearing loss about
the potential impact on speech and language development; (8) should reevaluate, at 3-
to 6-month intervals, children with chronic OME until the effusion is no longer
present, significant hearing loss is identified, or structural abnormalities of the
eardrum or middle ear are suspected; (9) should recommend tympanostomy tubes
when surgery is performed for OME in a child <4 years old; adenoidectomy should
not be performed unless a distinct indication exists (nasal obstruction, chronic
adenoiditis); (10) should recommend tympanostomy tubes, adenoidectomy, or both
when surgery is performed for OME in a child ≥4 years old; and (11) should
document resolution of OME, improved hearing, or improved quality of life when
managing a child with OME.
Keywords otitis media with effusion, middle ear effusion,

tympanostomy tubes, adenoidectomy, clinical practice guideline
Differences from Prior Guideline
This clinical practice guideline is an update and replacement for an earlier guideline
codeveloped in 2004 by the American Academy of Otolaryngology—Head and Neck
Surgery Foundation (AAO-HNSF), the American Academy of Pediatrics (AAP), and
the American Academy of Family Physicians (AAFP).1 An update was necessitated by
new primary studies and systematic reviews that might modify clinically important
recommendations. Changes in content and methodology from the prior guideline
include
Addition of consumer advocates to the guideline development group


New evidence from 4 clinical practice guidelines, 20 systematic reviews, and

49 randomized controlled trials (RCTs)


Emphasis on patient education and shared decision making with an option grid
for surgery and new tables of counseling opportunities and frequently asked
questions


Expanded action statement profiles to explicitly state quality improvement

opportunities, confidence in the evidence, intentional vagueness, and
differences of opinion


Enhanced external review process to include public comment and journal peer
review


Additional information on pneumatic otoscopy and tympanometry to improve

diagnostic certainty for otitis media with effusion (OME)


Expanded information on speech and language assessment for children with

OME


New recommendations for managing OME in children who fail a newborn

hearing screen, for evaluating at-risk children for OME, and for educating and
counseling parents


A new recommendation against using topical intranasal steroids for treating

OME


A new recommendation against adenoidectomy for a primary indication of

OME in children <4 years old, including those with prior tympanostomy
tubes, unless a distinct indication exists (nasal obstruction, chronic
adenoiditis).


A new recommendation for assessing OME outcomes by documenting OME

resolution, improved hearing, or improved quality of life (QOL)


New algorithm to clarify decision making and action statement relationships
Introduction
OME is defined as the presence of fluid in the middle ear (Figure 1, Table 1) without
signs or symptoms of acute ear infection.2,3 The condition is common enough to be
called an “occupational hazard of early childhood”4 because about 90% of children
have OME before school age5 and they develop, on average, 4 episodes of OME
every year.6 Synonyms for OME include ear fluid and serous, secretory, or
nonsuppurative otitis media.
Figure 1. Location of the middle ear space. Otitis media with effusion occurs when
fluid builds up in the middle ear space, which normally is air filled and lies just
behind the eardrum. With permission from Rosenfeld 2005.
Table 1. Abbreviations and Definitions of Common
Terms.
Table 1. Abbreviations and Definitions of Common Terms.
View larger version
About 2.2 million diagnosed episodes of OME occur annually in the United States at
a cost of $4.0 billion.7 The indirect costs are likely much higher since OME is largely
asymptomatic and many episodes are therefore undetected, including those in children
with hearing difficulties or school performance issues. In contrast, acute otitis media
(AOM) is the rapid onset of signs and symptoms of inflammation in the middle ear,8
most often with ear pain and a bulging eardrum. In lay terms, OME is often called ear
fluid and AOM ear infection (Figure 2). The lay language in Table 2 can help parents
and families better understand OME, why it occurs, and how it differs from ear
infections.
Figure 2. Comparison of otitis media with effusion (top) and acute otitis media
(bottom). The left images show the appearance of the eardrum on otoscopy, and the
right images depict the middle ear space. For otitis media with effusion, the middle
ear space is filled with mucus or liquid (top right). For acute otitis media, the middle
ear space is filled with pus, and the pressure causes the eardrum to bulge outward
(bottom right). With permission from Rosenfeld 2005.
Table 2. Frequently Asked Questions: Understanding
Ear Fluid.
Table 2. Frequently Asked Questions: Understanding Ear Fluid.
View larger version
OME may occur during an upper respiratory infection, spontaneously because of poor
eustachian tube function (Figure 3), or as an inflammatory response following AOM,
most often between the ages of 6 months and 4 years.9 In the first year of life, >50%
of children will experience OME, increasing to >60% by age 2 years.10 When children
aged 5 to 6 years in primary school are screened for OME, about 1 in 8 are found to
have fluid in one or both ears.11 The prevalence of OME in children with Down
syndrome or cleft palate, however, is much higher, ranging from 60% to 85%.12,13
Figure 3. Position of the eustachian tube (red) as it connects the middle ear space to
the back of the nose, or nasopharynx. The child’s eustachian tube (right) is shorter,
more floppy, and more horizontal, which makes it less effective in ventilating and
protecting the middle ear than the eustachian tube in the adult (left).
Most episodes of OME resolve spontaneously within 3 months, but about 30% to 40%
of children have repeated OME episodes and 5% to 10% of episodes last ≥1 year.2,5,14
Persistent middle ear fluid from OME results in decreased mobility of the tympanic
membrane and serves as a barrier to sound conduction.15 At least 25% of OME
episodes persist for ≥3 months16 and may be associated with hearing loss, balance
(vestibular) problems, poor school performance, behavioral problems, ear discomfort,
recurrent AOM, or reduced QOL.17 Less often, OME may cause structural damage to
the tympanic membrane that requires surgical intervention.16
The high prevalence of OME—along with many issues, including difficulties in

diagnosis and assessing its duration, associated conductive hearing loss, potential
impact on child development, and significant practice variations in management—
makes OME an important condition for up-to-date clinical practice guidelines.
Purpose
The purpose of this multidisciplinary guideline is to identify quality improvement
opportunities in managing OME and to create explicit and actionable
recommendations to implement these opportunities in clinical practice. Specifically,
the goals are to improve diagnostic accuracy, identify children who are most
susceptible to developmental sequelae from OME (Table 3), and educate clinicians
and patients regarding the favorable natural history of most OME and the lack of
clinical benefits for medical therapy (eg, steroids, antihistamines, decongestants).
Additional goals relate to OME surveillance, hearing and language evaluation, and
management of OME detected by newborn screening.
Table 3. Risk Factors for Developmental Difficulties in

Children with Otitis Media with Effusion.a
Table 3. Risk Factors for Developmental Difficulties in Children with Otitis Media
with Effusion.a
View larger version
The target patient for the guideline is a child aged 2 months through 12 years with
OME, with or without developmental disabilities or underlying conditions that
predispose to OME and its sequelae. The age range was chosen for consistency with
the precursor guideline1 and to correspond with inclusion criteria in many OME
studies. The guideline is intended for all clinicians who are likely to diagnose and
manage children with OME, and it applies to any setting in which OME would be
identified, monitored, or managed. This guideline, however, does not apply to patients
<2 months or >12 years of age.
The guideline does not explicitly discuss indications for tympanostomy tubes, even
though OME is the leading indication for tympanostomy tube insertion, because
indications are thoroughly explained in a companion clinical practice guideline from
the AAO-HNSF.17 Rather, discussions of surgery focus on adjuvant procedures (eg,
adenoidectomy, myringotomy) and sequelae of OME (eg, retraction pockets,
atelectasis of the middle ear) that were excluded from the tympanostomy tube
guideline.
Health Care Burden
Incidence and Prevalence
Approximately 2.2 million new cases of OME are diagnosed annually in the United
States,1 with 50% to 90% of children affected by 5 years of age.5,10,18-21 The point
prevalence is 7% to 13%, with a peak in the first year of life and a per-year period
prevalence of 15% to 30%.5 About 4 episodes of new-onset OME occur annually in
young children with a mean duration of 17 days per episode.6 Longitudinal evaluation
with weekly otoscopy suggests that 25% of observed days in children 0 to 9 years of
age show evidence of otitis media (OME and AOM), with 13% to 21% having
bilateral involvement.6
Otitis media is a common reason for outpatient visits to pediatricians, accounting for 1
in 9 (11.4%) office encounters in primary care practices.22 Of these otitis media visits,
about 1 in 3 are for OME, which can present as the primary diagnosis (17%), in
conjunction with AOM (6.5%), or under the general heading of nonspecific otitis
media (13%). The prevalence of OME and the associated physician visits vary with
geography and season, affecting up to 84% of observed children in some studies.6,20,23-
27
Despite the frequency of OME, surveillance data from pediatric practice networks
suggest that a minority of clinicians follow clinical practice guidelines. For example,
only 7% to 33% of pediatricians use pneumatic otoscopy for diagnosis, and only 29%
obtain an age-appropriate hearing test when the effusion persists for ≥3 months.22,28
Moreover, 32% treat OME inappropriately with antibiotics,28 which results in
unnecessary adverse events and bacterial resistance.
Impact on Children and Families
OME is the most common cause of hearing impairment in children in developed

nations,29 and permanent hearing loss related to otitis media has a prevalence of 2 to
35 per 10,000.30 Otitis media may be related to difficulties in speech and reading,
delayed response to auditory input, limited vocabulary, and disturbances in attention.31
It may also be associated with being less task oriented and less capable of independent
classroom work.32 Observational studies measuring caregiver reports suggest that
school performance may improve after OME has been identified and treated.33
The impact of OME on disease-specific QOL and functional health status may be
substantial, affecting children and caregivers.34,35 According to a prospectively
measured parental report, 76% of children with OME suffer from otalgia, 64% from
sleep disruption, 49% from behavioral problems, 33% to 62% from speech and
hearing concerns, and 15% from balance symptoms.35,36 In addition, parent-child
interaction may be poorer than in healthy children, and caregiver concerns (eg, worry,
concern, or inconvenience because of ear problems) are often high.35,37,38 OME can
affect the vestibular system and gross motor skills, and these problems may be
reversible once the effusion has been addressed.39-42
OME has a substantial impact on child QOL, both from direct effects of persistent
effusion and from a rate of AOM that is up to 5 times higher than when effusion is
absent.37,43,44 The primary domains affected by OME and recurrent AOM are physical
suffering, emotional distress, and caregiver concerns.45 Less often, OME and the
attendant eustachian tube dysfunction may result in sequelae that include tympanic
membrane retraction/atelectasis, ossicular erosion, cholesteatoma formation, and
tympanic membrane perforation.46 The impact of OME is increased in children with
comorbidities such as Down syndrome or cleft palate.12,47
Direct and Indirect Costs
Direct costs related to otitis media, which includes OME and AOM, are $3 billion to
$5 billion annually,48-51 and the true economic impact is likely higher, because indirect
costs are sizable yet difficult to estimate.37,52 Studies of AOM suggest that the indirect
cost of lost caregiver productivity may far exceed that of the direct cost of medical
treatment.52 In addition, the estimated net cost of impaired well-being from otitis
media is $1.1 billion to $2.6 billion.53,54
The direct costs of managing OME include medical therapy, which is largely
ineffective. Antibiotics, for example, have short-term efficacy, but long-term use
cannot be justified because of concerns over adverse events and induced bacterial
resistance.55 Although several studies have shown an association between
gastroesophageal reflux and OME, the limited evidence regarding antireflux therapy
does not show significant benefits.56 Similarly, despite a high prevalence of atopic
conditions, such as allergic rhinitis, in children with OME,57-59 there are no benefits to
routinely treating with antihistamines, decongestants, or steroids (systemic or topical
intranasal).3,60,61 Most studies, however, do not consider the allergy status of children,
and it is unknown if those with proven allergies might respond differently.
Methods
General Methods and Literature Search
In developing this update of the evidence-based clinical practice guideline, the

methods outlined in the third edition of the AAO-HNSF’s guideline development
manual were followed explicitly.62
An executive summary of the original OME guideline1 was sent to a panel of expert
reviewers from the fields of general otolaryngology, pediatric otolaryngology,
otology, family practice, pediatrics, nursing, audiology, and speech language
pathology who assessed the key action statements to decide if they should be kept in
their current form, revised, or removed and to identify new research that might affect
the guideline recommendations. The reviewers concluded that the original guideline
action statements remained valid but should be updated with major modifications.
Suggestions were also made for new key action statements.
An information specialist conducted 2 systematic literature searches using a validated

filter strategy to identify clinical practice guidelines, systematic reviews, and RCTs
published since the prior guideline (2004). Search terms used were “Otitis Media with
Effusion”[Mesh] OR “otitis media with effusion”[tiab] OR (OME[tiab] AND otitis)
OR “middle ear effusion”[tiab] OR “glue ear”[tiab]; otitis/exp OR otitis AND media
AND (effusion/exp OR effusion); MH “Otitis Media with Effusion” OR TI (OME and
effusion) OR TI “otitis media with effusion”; and (DE “OTITIS MEDIA”) OR “otitis
media with effusion” OR (OME AND otitis) OR “middle ear effusion” OR “glue ear.”
In certain instances, targeted searches for lower-level evidence were performed to
address gaps from the systematic searches identified in writing the guideline. The
original MEDLINE search was updated from January 2004 to January 2015 to include
Medline, National Guidelines Clearinghouse, Cochrane Database of Systematic
Reviews, Excerpta Medica database, Cumulative Index to Nursing and Allied Health,
and the Allied and Complimentary Medicine Database.
1.
The initial search for clinical practice guidelines identified 13 guidelines.

Quality criteria for including guidelines were (a) an explicit scope and
purpose, (b) multidisciplinary stakeholder involvement, (c) systematic
literature review, (d) explicit system for ranking evidence, and (e) explicit
system for linking evidence to recommendations. The final data set retained 4
guidelines that met inclusion criteria.
2.
3.
The initial search for systematic reviews identified 138 systematic reviews or
meta-analyses that were distributed to the panel members. Quality criteria for
including reviews were (a) relevance to the guideline topic, (b) clear objective
and methodology, (c) explicit search strategy, and (d) valid data extraction
methods. The final data set retained was 20 systematic reviews or meta-
analyses that met inclusion criteria.
4.
5.
The initial search for RCTs identified 86 RCTs that were distributed to panel
members for review. Quality criteria for including RCTs were (a) relevance to
the guideline topic, (b) publication in a peer-reviewed journal, and (c) clear
methodology with randomized allocation to treatment groups. The total final
data set retained 49 RCTs that met inclusion criteria.
6.
The AAO-HNSF assembled a guideline update group (GUG) representing the

disciplines of otolaryngology–head and neck surgery, pediatric otolaryngology,
otology, pediatrics, allergy and immunology, family medicine, audiology, speech-
language pathology, advanced practice nursing, and consumer advocacy. The GUG
had several conference calls and one in-person meeting during which it defined the
scope and objectives of updating the guideline, reviewed comments from the expert
panel review for each key action statement, identified other quality improvement
opportunities, and reviewed the literature search results.
The evidence profile for each statement in the earlier guideline was then converted
into an expanded action statement profile for consistency with our current
development standards.62 Information was added to the action statement profiles
regarding the quality improvement opportunity, level of confidence in the evidence,
differences of opinion, intentional vagueness, and any exclusion to which the action
statement does not apply. New key action statements were developed with an explicit
and transparent a priori protocol for creating actionable statements based on
supporting evidence and the associated balance of benefit and harm. Electronic
decision support software (BRIDGE-Wiz; Yale Center for Medical Informatics, New
Haven, Connecticut) was used to facilitate creating actionable recommendations and
evidence profiles.63
The updated guideline then underwent GuideLine Implementability Appraisal to

appraise adherence to methodologic standards, improve clarity of recommendations,
and predict potential obstacles to implementation.64 The GUG received summary
appraisals and modified an advanced draft of the guideline based on the appraisal. The
final draft of the updated clinical practice guideline was revised based on comments
received during multidisciplinary peer review, open public comment, and journal
editorial peer review. A scheduled review process will occur at 5 years from
publication or sooner if new, compelling evidence warrants earlier consideration.
Classification of Evidence-Based Statements
Guidelines are intended to reduce inappropriate variations in clinical care, produce

optimal health outcomes for patients, and minimize harm. The evidence-based
approach to guideline development requires that the evidence supporting a policy be
identified, appraised, and summarized and that an explicit link between evidence and
statements be defined. Evidence-based statements reflect both the quality of evidence
and the balance of benefit and harm that is anticipated when the statement is
followed. The definitions for evidence-based statements are listed in Tables 4 and 5.
Table 4. Strength of Action Terms in Guideline

Statements and Implied Levels of Obligation.
Table 4. Strength of Action Terms in Guideline Statements and Implied Levels of

Obligation.
View larger version
Table 5. Aggregate Grades of Evidence by Question

Type.62
Table 5. Aggregate Grades of Evidence by Question Type.62
View larger version
Guidelines are never intended to supersede professional judgment; rather, they may be
viewed as a relative constraint on individual clinician discretion in a particular clinical
circumstance. Less frequent variation in practice is expected for a strong
recommendation than what might be expected with a recommendation. Options offer
the most opportunity for practice variability.65 Clinicians should always act and decide
in a way that they believe will best serve their individual patients’ interests and needs,
regardless of guideline recommendations. Guidelines represent the best judgment of a
team of experienced clinicians and methodologists addressing the scientific evidence
for a particular topic.66
Making recommendations about health practices involves value judgments on the

desirability of various outcomes associated with management options. Values applied
by the GUG sought to minimize harm, diminish unnecessary and inappropriate
therapy, and reduce the unnecessary use of systemic antibiotics. A major goal of the
panel was to be transparent and explicit about how values were applied and to
document the process.
Financial Disclosure and Conflicts of Interest

The cost of developing this guideline, including travel expenses of all panel members,
was covered in full by the AAO-HNSF. Potential conflicts of interest for all panel
members in the past 5 years were compiled and distributed before the first conference
call and were updated at each subsequent call and in-person meeting. After review and
discussion of these disclosures,67 the panel concluded that individuals with potential
conflicts could remain on the panel if they (1) reminded the panel of potential
conflicts before any related discussion, (2) recused themselves from a related
discussion if asked by the panel, and (3) agreed to not discuss any aspect of the
guideline with industry before publication. Last, panelists were reminded that
conflicts of interest extend beyond financial relationships and may include personal
experiences, how a participant earns a living, and the participant’s previously
established “stake” in an issue.68
Guideline Key Action Statements

Each evidence-based statement is organized in a similar fashion: a key action
statement in bold, followed by the strength of the recommendation in italics. Each key
action statement is followed by an “action statement profile” that explicitly states the
quality improvement opportunity (and corresponding National Quality Strategy
domain based on the original priorities),69 aggregate evidence quality, level of
confidence in evidence (high, medium, low), benefit, risks, harms, costs and a
benefits-harm assessment. Additionally, there are statements of any value judgments,
the role of patient preferences, clarification of any intentional vagueness by the panel,
exceptions to the statement, any differences of opinion, and a repeat statement of the
strength of the recommendation. Several paragraphs subsequently discuss the
evidence base supporting the statement. An overview of each evidence-based
statement in this guideline can be found in Table 6.
Table 6. Summary of Guideline Key Action Statements.
Table 6. Summary of Guideline Key Action Statements.
View larger version
The role of patient, parent, and/or caregiver preferences in making decisions deserves
further clarification. For some statements, where the evidence base demonstrates clear
benefit, the role of patient preference for a range of treatments may not be relevant
(eg, intraoperative decision making), but clinicians should provide patients with clear
and comprehensible information on the benefits. This will facilitate patient
understanding and shared decision making, which in turn leads to better patient
adherence and outcomes. In cases where evidence is weak or benefits unclear, the
practice of shared decision making—again where the management decision is made
by a collaborative effort between the clinician and an informed patient—is extremely
useful. Factors related to patient preference include (but are not limited to) absolute
benefits (number needed to treat), adverse effects (number needed to harm), cost of
drugs or procedures, and frequency and duration of treatment.
STATEMENT 1a. PNEUMATIC OTOSCOPY: The clinician should

document the presence of middle ear effusion with pneumatic otoscopy
when diagnosing OME in a child.Strong recommendation based on
systematic review of diagnostic studies with a preponderance of benefit over
harm.


STATEMENT 1b. PNEUMATIC OTOSCOPY: The clinician should

perform pneumatic otoscopy to assess for OME in a child with otalgia,
hearing loss, or both.Strong recommendation based on systematic review of
diagnostic studies with a preponderance of benefit over harm.
Action Statement Profile for Statement 1a and 1b


Quality improvement opportunity: To improve diagnostic accuracy for OME

with a readily available but underutilized means of assessing middle ear status
(National Quality Strategy domain: clinical process/effectiveness)


Aggregate evidence quality: Grade A, systematic review of cross-sectional

studies with a consistent reference standard


Level of confidence in evidence: High


Benefit: Improve diagnostic certainty; reduce false-negative diagnoses caused

by effusions that do not have obvious air bubbles or an air-fluid level; reduce
false-positive diagnoses that lead to unnecessary tests and costs; readily
available equipment; document mobility of the tympanic membrane; efficient;
cost-effective


Risks, harms, costs: Costs of training clinicians in pneumatic otoscopy; false-
positive diagnoses from nonintact tympanic membrane; minor procedural
discomfort


Benefit-harm assessment: Preponderance of benefit


Value judgments: Pneumatic otoscopy is underutilized for diagnosing OME,

especially in primary care settings; accurate diagnosis of OME using
pneumatic otoscopy is a prerequisite for managing children with OME.


Intentional vagueness: None


Role of patient preferences: Very limited


Exceptions: None


Policy level: Strong recommendation


Differences of opinion: None
Supporting Text
The purpose of this statement is to improve diagnostic accuracy for OME by

encouraging pneumatic otoscopy as the primary diagnostic method. Accurate
diagnosis is important to avoid false-negative findings because OME can be relatively
asymptomatic and have a normal-appearing tympanic membrane. Conversely,
pneumatic otoscopy can help avoid false-positive diagnoses caused by surface
changes or abnormalities in the tympanic membrane without middle ear effusion.
Prior guidelines on managing OME1,2 have emphasized the need to accurately
diagnose OME and differentiate OME from AOM. The hallmark of both conditions is
fluid in the middle ear cavity; however, AOM is associated with a bulging tympanic
membrane and acute inflammation (pain, fever, erythema, otorrhea), whereas in OME
the tympanic membrane may appear normal, and there are no signs or symptoms of
acute inflammation. Pneumatic otoscopy is especially useful in diagnosing OME
because the tympanic membrane can be in a neutral or retracted position and the only
sign of effusion can be reduced mobility.
Pneumatic otoscopy has been recommended as the primary method for diagnosing
OME because reduced tympanic membrane mobility correlates most closely with the
presence of fluid in the middle ear.1 Even if bubbles or an air-fluid level are seen
behind the tympanic membrane on initial examination, pneumatic otoscopy is
confirmatory and can differentiate surface abnormalities from true middle ear
effusion. A systematic review of 9 methods for diagnosing OME7 showed that
pneumatic otoscopy had the best balance of sensitivity (94%) and specificity (80%)
when compared with myringotomy as the gold standard. An additional study70 found
that pneumatic otoscopy can improve diagnostic accuracy for OME, even in
experienced observers, but this study utilized video presentations and did not assess
the observer’s skill in performing the examination.
Despite well-documented benefits of pneumatic otoscopy in diagnosing OME7 and

the existence of prior guidelines1 recommending its use, the technique is often not
utilized by physicians in making the diagnosis of OME. In one study of primary care
practice networks,28 pneumatic otoscopy was used to diagnose OME in 33% of
patients. Similarly, a randomized trial of clinical decision support found that only 7%
of OME seen in a large primary care practice network was diagnosed with pneumatic
otoscopy.22
Interobserver variability may be a factor in the accuracy of diagnosis by pneumatic

otoscopy, given the variability of training and experience among clinicians.71,72 The
practical tips in Table 7 may help increase success in performing pneumatic otoscopy
and making the procedure comfortable for children. When pneumatic otoscopy is
inconclusive, tympanometry can be used to improve diagnostic accuracy, as outlined
in the next key action statement.
STATEMENT 2. TYMPANOMETRY. Clinicians should obtain

tympanometry in children with suspected OME for whom the diagnosis is
uncertain after performing (or attempting) pneumatic otoscopy.Strong
recommendation based on extrapolation of systematic reviews of diagnostic
studies with a preponderance of benefit over harm.

Table 7. Practical Tips for Performing Pneumatic
Otoscopy.
Table 7. Practical Tips for Performing Pneumatic Otoscopy.
View larger version

Action Statement Profile for Statement 2

Quality improvement opportunity: Improve diagnostic accuracy for OME and

raise awareness regarding the value of tympanometry as an objective measure
of middle ear status (National Quality Strategy domain: clinical
process/effectiveness)


Aggregate evidence quality: Grade B, extrapolation from systematic review of

cross-sectional studies with a consistent reference standard for tympanometry
as a primary diagnostic method


Level of confidence in evidence: High regarding the value of tympanometry

for primary diagnosis; medium regarding the value as an adjunct to pneumatic
otoscopy


Benefit: Improved diagnostic accuracy; confirm a suspected diagnosis of

OME; obtain objective information regarding middle ear status; differentiate
OME (normal equivalent ear canal volume) vs tympanic membrane
perforation (high equivalent ear canal volume); obtain prognostic information
on likelihood of timely spontaneous resolution (eg, a flat, or type B, tracing
has the poorest prognosis); educational value in confirming pneumatic
otoscopy findings


Risks, harms, costs: Cost; lack of access; equipment calibration and

maintenance; misinterpretation of findings




Value judgments: None


Intentional vagueness: The individual who performs tympanometry is not

specified and could be the clinician or another health professional; whether to
use portable or tabletop tympanometry is at the discretion of the clinician


Role of patient preferences: Limited


Exceptions: Patients with recent ear surgery or trauma




Supporting Text
The purpose of this statement is to promote tympanometry as an objective tool in

diagnosing OME, both for confirming pneumatic otoscopy findings and as an
alternative to otoscopy when visualization of the membrane is limited. Tympanometry
can also objectively assess tympanic membrane mobility for patients who are difficult
to examine or do not tolerate insufflation.
Understanding Tympanometry
Tympanometry provides an objective assessment of tympanic membrane mobility,

eustachian tube function, and middle ear function by measuring the amount of sound
energy reflected back when a small probe is placed in the ear canal.73 The procedure is
usually painless, is relatively simple to perform, and can be done with a portable
screening unit or a diagnostic desktop machine. A tympanogram (Figure 4) is a graph
of energy admitted to the tympanic membrane and middle ear in response to air
pressure introduced to the ear canal. Acoustic energy is transmitted to the ear canal,
and an internal microphone measures the reflected sound while the pressure is varied
from negative to positive. The effect on middle ear function can then be recorded
graphically.
Figure 4. Normal, type A tympanogram result. The height of the tracing may vary but
is normal when the peak falls within the 2 stacked rectangles. The AD tracing (upper)
indicates an abnormally flexible tympanic membrane, and the AS tracing (lower)
indicates an abnormally stiff tympanic membrane; the presence of a well-defined
peak, however, makes the likelihood of effusion low. With permission from Onusko.73
Tympanometric curves, or tracings, are classified into 3 main types: type A (low
probability of effusion) with a sharp peak and normal middle ear pressure, type B
(high probability of effusion; Figure 5) with no discernible peak and a flat tracing,
and type C (intermediate probability of effusion) with a discernible peak and negative
middle ear pressure. While subjective typing of tympanograms is often used (eg, A, B,
and C), measuring static admittance and peak pressure is more objective (Figure 4).
Static admittance (Y) is the amount of energy absorbed by the tympanic membrane
and middle ear, measured in mmho or mL. Peak tympanometric air pressure estimates
the middle ear pressure, which is normally around zero and is expressed in
decapascals (daPa) or mmH20.
Figure 5. Abnormal, type B, tympanogram results: A, a normal equivalent ear canal

volume usually indicates middle ear effusion; B, a low volume indicates probe
obstruction by cerumen or contact with the ear canal; C, a high volume indicates a
patent tympanostomy tube or a tympanic membrane perforation. With permission
from Onusko 2004.
Prior to performing tympanometry, the ear canal should be examined with otoscopy to
assess for cerumen blockage, foreign bodies, drainage, tympanic membrane
perforation, or a collapsed canal. This will help the examiner correlate the findings
with the tympanometry results. Proper calibration of the tympanometer is essential for
accurate results.
Tympanometry as an Adjunct to Pneumatic Otoscopy
Tympanometry is a useful adjunct to pneumatic otoscopy because it provides

objective evidence of middle ear status. Although recommended as a first-line
diagnostic test for OME, pneumatic otoscopy has varying degrees of validity and
accuracy in routine clinical practice. All studies examining test performance of
pneumatic otoscopy have used experienced otoscopists with special training,
validation, or both. In contrast, OME is most often diagnosed by primary care
providers who are not validated against experienced otoscopists and do not often use a
pneumatic attachment.22,28
There are no specific studies that validate the performance characteristics of

tympanometry as a confirmatory, or adjunctive, test with pneumatic otoscopy. We
therefore recommend tympanometry when the diagnosis of OME is uncertain after
pneumatic otoscopy is used or attempted. Specific situations for which tympanometry
is recommended include
Child intolerance of pneumatic otoscopy


Inability to reliably perform pneumatic otoscopy because of training or

equipment considerations (eg, inability to obtain an air-tight seal)


Difficulty visualizing the tympanic membrane because of partially obstructing

cerumen that cannot be readily removed by the clinician


Difficulty visualizing the tympanic membrane because of a very narrow or

stenotic external auditory canal (eg, Down syndrome)


Uncertainty about the presence or absence of OME because of equivocal

findings on pneumatic otoscopy


Need or desire to rule out OME in an at-risk (Table 3) child


Need or desire for objective confirmation of OME before surgery
Interpretation of Tympanometry and Limitations

Proper interpretation of a type B result must consider the equivalent ear canal volume
(Figure 5), which is displayed on the tympanogram printout and estimates the amount
of air in front of the probe. A normal ear canal volume for children is between 0.3 and
0.9 cm74 and usually indicates OME when combined with a type B result. A low
equivalent ear canal volume can be caused by improper placement of the probe (eg,
pressing against the ear canal) or by obstructing cerumen. A high equivalent ear canal
volume occurs when the tympanic membrane is not intact because of a perforation or
tympanostomy tube. When a patent tympanostomy tube is present, the volume is
typically between 1.0 and 5.5 mL.74
A systematic review of 52 diagnostic studies against the gold standard of

myringotomy found that tympanometry, with either portable or professional (desktop)
units, had sensitivity equivalent to pneumatic otoscopy for detecting OME (90% to
94%) but substantially lower specificity (50% to 75% for tympanometry, 80% for
otoscopy).75 Adding width measurement (type B, or broad tympanogram) to peak
admittance (type AS, or shallow tympanogram) improves sensitivity, but using peak
admittance alone results in lower sensitivity (67%). Abnormal tympanometric width
(250 daPa or greater) combined with low peak admittance had a sensitivity of 83%
and a specificity of 87% when compared with a myringotomy gold standard.76
In infants <6 months of age, tympanometry based on a standard 226-Hz probe tone is
insensitive to middle ear effusion77-79; thus, a higher-frequency probe tone (1000 Hz)
is recommended.80 In neonate ears with confirmed middle ear disease, 226-Hz
tympanograms are not reliably different from those obtained from normal ears.
Current evidence from comparative studies based on computed tomography scanning
and auditory brainstem response testing shows that tympanometry with higher probe-
tone frequencies (eg, 1000 Hz) is more sensitive to OME in infants <6 months old.81,82
STATEMENT 3. FAILED NEWBORN HEARING SCREEN: Clinicians

should document in the medical record counseling of parents of infants
with OME who fail a newborn hearing screen regarding the importance
of follow-up to ensure that hearing is normal when OME resolves and to
exclude an underlying sensorineural hearing loss
(SNHL).Recommendation based on observational studies with a
predominance of benefit over harm.


Quality improvement opportunity: Increase adherence to follow-up and ensure

that an underlying SNHL is not missed (National Quality Strategy domains:
care coordination, patient and family engagement)


Aggregate evidence quality: Grade C, indirect observational evidence on the
benefits of longitudinal follow-up for effusions in newborn screening
programs and the prevalence of SNHL in newborn screening failures with
OME


Level of confidence in evidence: Medium


Benefit: More prompt diagnosis of SNHL; earlier intervention for hearing

loss; reduce loss to follow-up; reassure parents


Risks, harms, costs: Time spent in counseling; parental anxiety from increased
focus on child hearing issues






Intentional vagueness: The method and specifics of follow-up are at the

discretion of the clinician but should seek resolution of OME within 3 months
of onset or, if not known, diagnosis


Role of patient preferences: Minimal role regarding the need for counseling
but a large role for shared decision making in the specifics of how follow-up is
implemented and in what specific care settings


Exceptions: None


Policy level: Recommendation


Supporting Text
The purpose of this statement is to reduce the chance of a missed or delayed diagnosis
of SNHL because a failed newborn hearing test result is attributed to OME without
further investigation. We stress the importance of patient follow-up after a failed
newborn screening and the need to educate parents and caregivers regarding the
reasons for failure and the potential causes of hearing loss. Universal newborn
screening for hearing loss is based on the premise that intervention before age 6
months can reduce the potential detrimental effects of hearing loss on speech and
language acquisition.83-85
OME is an important cause of transient moderate hearing loss in newborns that can
result in a failed newborn hearing screen. In a prospective study of screening failures
referred for further testing, 55% of children had OME, of which 23% had spontaneous
resolution of effusion.86 In the remaining infants, hearing normalized after
tympanocentesis or placement of ventilation tubes, but only 69% of children had
immediate return. Conversely, 31% had delayed return of hearing over several
months, with a median of 4.8 months for all children combined. This study highlights
that persistent hearing loss after surgery for OME does not necessarily imply SNHL
but may be the result of residual (or recurrent) OME or delayed normalization of
middle ear function.
Although many infants who fail screening because of transient OME will normalize
within several months of effusion resolution,86 some will be diagnosed with an
underlying SNHL. A cohort study of screening failures with OME found that 11% had
SNHL in addition to the transient conductive hearing loss from the effusion.87 About
two-thirds of failures were initially attributed to OME, and one-third of children
required tympanostomy tubes to resolve the fluid.
Since the 1993 National Institutes of Health consensus88 and the Joint Commission on
Infant Hearing 2000 position statement on infants with hearing loss that was updated
in 2007,80 a concerted effort has been made to identify newborns with hearing loss,
and all newborns are routinely screened for hearing loss before leaving the hospital.
Despite universal hearing screening programs, delays in follow-up of >2 months do
occur between a failed newborn hearing screen and the first diagnostic auditory
brainstem response.89 Some of the reasons cited by parents are as follows: there were
too many screenings; the family chose to wait; or the family was assured that the
failed screening was likely caused by something other than permanent hearing loss
(eg, OME). This last reason highlights the importance of not assuming that OME, if
present, is always the cause of hearing loss.
Barriers to follow-up after a failed newborn hearing screen have been widely
studied90-94 and include limited access to pediatric audiologists and/or centers, the
presence of other medical comorbidities that may delay ability to follow-up, the
presence of mild or unilateral hearing loss, and the family’s belief that the child is
hearing adequately after observing his or her response to sounds in one’s own
environment. Clinicians who manage children who fail newborn screening should be
aware that in one study about two-thirds did not return for follow-up testing.95
Involving parents in shared decision making to emphasize the importance of follow-
up, to review the options for follow-up, and to discuss the barriers to follow-up may
improve adherence to follow-up recommendations.
The following considerations apply to managing infants with OME that persists after
a failed newborn hearing screen:
Referral to an otolaryngologist is appropriate for all infants with documented

persistent hearing loss after a failed newborn hearing screen, even if the cause
is presumed to be secondary to OME.


For those infants aged ≥6 months with documented bilateral OME for ≥3
months and documented hearing difficulties, clinicians should offer
tympanostomy tubes.17


Insertion of tympanostomy tubes to resolve effusion and facilitate better

assessment of hearing status may also be appropriate on an individualized
basis for children with severe hearing loss (which cannot be attributed
completely to OME), a history of congenital SNHL in the immediate family,
or an at-risk status as defined in Table 3.


The decision of whether or not to insert tympanostomy tubes should be shared

with, and explained to, patients and their families.
The list of frequently asked questions in Table 8 can be distributed to parents and
caregivers to fulfill the obligation of counseling regarding the importance of follow-
up to ensure that hearing is normal when OME resolves and to exclude an underlying
SNHL.

STATEMENT 4a. IDENTIFYING AT-RISK CHILDREN: Clinicians

should determine if a child with OME is at increased risk for speech,
language, or learning problems from middle ear effusion because of
baseline sensory, physical, cognitive, or behavioral factors (Table
3).Recommendation based on observational studies with a preponderance of
benefit over harm.


STATEMENT 4b. EVALUATING AT-RISK CHILDREN: Clinicians

should evaluate at-risk children (Table 3) for OME at the time of
diagnosis of an at-risk condition and at 12 to 18 months of age (if
diagnosed as being at risk prior to this time).Recommendation based on
observational studies with a preponderance of benefit over harm.
Table 8. Frequently Asked Questions: Ear Fluid and

Newborn Hearing Screening.
Table 8. Frequently Asked Questions: Ear Fluid and Newborn Hearing Screening.
View larger version

Action Statement Profile for Statements 4a and 4b

Quality improvement opportunity: Raise awareness of a subset of children

with OME (Table 3) who are disproportionately affected by middle ear
effusion as compared with otherwise healthy children and to detect OME in at-
risk children that might have been missed without explicit screening but could
affect their developmental progress (National Quality Strategy domain:
population/public health)


Aggregate evidence quality: Grade C, observational studies regarding the high

prevalence of OME in at-risk children and the known impact of hearing loss
on child development; D, expert opinion on the ability of prompt diagnosis to
alter outcomes


Level of confidence in the evidence: Medium


Benefit: Identify at-risk children who might benefit from early intervention for
OME (including tympanostomy tubes) and from more active and accurate
surveillance of middle ear status; identify unsuspected OME and reduce the
impact of OME and associated hearing loss on child development


Risks, harms, costs: Direct costs of evaluating for OME (eg, tympanometry),
identifying self-limited effusions, parental anxiety, potential for overtreatment




Value judgments: The GUG assumed that at-risk children (Table 3) are less
likely to tolerate OME than would the otherwise healthy child and that
persistent OME could limit the benefit of ongoing therapies and education
interventions for at-risk children with special needs; assumption that early
identification of OME in at-risk children could improve developmental
outcomes


Intentional vagueness: The method of evaluating for OME is not specified but
should follow recommendations in this guideline regarding pneumatic
otoscopy and tympanometry; an interval of 12 to 18 months is stated to give
the clinician flexibility and to ensure that evaluation takes place at a critical
time in the child’s development


Role of patient preferences: None


Exceptions: None




Supporting Text
The purpose of these statements are (1) to highlight the importance of identifying
children with comorbid conditions (Table 3) that warrant prompt intervention for
OME and (2) to ensure that OME is not overlooked or underdiagnosed in a
susceptible population. Recognizing “at risk” children allows for individualized
intervention to reduce the potential negative impact of OME with associated hearing
loss on the development of speech, language, and cognition.
As recommended in statement 4a, a clinician can “determine” if the child has an at-
risk condition from the medical history and review of systems. There is no
expectation that clinicians examine all children for these conditions nor order
specialized tests or consults on every child with OME.
Identifying At-Risk Children
Although definitive studies are lacking,1,96 children who are at risk for developmental
difficulties (Table 3) would likely be disproportionately affected by hearing problems
from OME. In addition, children with permanent hearing loss, independent of OME,
may have added difficulty hearing due to the OME, which could worsen existing
speech and/or language delays.97,98 Similarly, children with blindness or uncorrectable
visual impairment depend on hearing more than their normal-vision counterparts,99
making them further susceptible to OME sequelae, including imbalance, difficulty
with sound localization, communication difficulties including delayed speech and/or
language development, and impaired ability to interact and communicate with others.1
Developmental, behavioral, and sensory disorders are not uncommon among children
<17 years old in the United States.100 Hearing loss may significantly worsen outcomes
for affected children, making detection of OME and management of chronic effusion
of utmost importance. Frequent middle ear effusion caused by recurrent AOM or
chronic OME (unilateral or bilateral) can degrade the auditory signal and cause
difficulties with speech recognition, higher-order speech processing, speech
perception in noise, and sound localization.101
Children with Down syndrome have an increased rate of recurrent AOM, chronic
OME, poor eustachian tube function, and stenotic ear canals that can impede the
assessment of tympanic membrane and middle ear status. They also have a risk of
mixed or SNHL.102-106 Such risks may persist throughout childhood and may require
multiple tympanostomy tube placements. Hearing assessments are recommended
every 6 months starting at birth, and evaluation by an otolaryngologist is
recommended if middle ear status is uncertain or when hearing loss is found.107
Children with stenotic ear canals are best assessed with an otologic microscope every
3 to 6 months to remove cerumen and detect OME.106
Cleft palate is a common malformation, with a prevalence of 1 in 700 live births.108

OME occurs in nearly all infants and children with cleft palate109,110 because of
abnormal insertions of the tensor veli palatini, which causes limited ability of the
eustachian tube to open actively.12 Chronic OME in children with cleft palate is
almost always associated with conductive hearing loss.12 Monitoring for OME and
hearing loss should continue throughout childhood, including after palate repair,
because of a continued high prevalence.111,112
Eustachian tube dysfunction not only affects children with Down syndrome and cleft
palate but is commonly associated with other craniofacial syndromes and
malformations involving the head and neck.
Evaluating At-Risk Children
A corollary to identifying children with OME who are at risk for developmental
problems is to also focus on the larger population of at-risk children who may have
OME that is unsuspected or overlooked. Several of the at-risk conditions in Table 3
are associated with a higher prevalence of OME, including cleft palate and Down
syndrome or other craniofacial syndromes, but for the other listed conditions, the
prevalence of OME may not be elevated (eg, autism spectrum disorder, general
developmental delays). The impact of effusion on a child’s QOL and developmental
progress, however, is still disproportionately higher than for a child without additional
risk factor.33
Explicit efforts to evaluate at-risk children with OME are important because OME, by
definition, is not associated with acute inflammation. Therefore, pain, discomfort, and
other ear-specific or localized symptoms may not be present. Symptoms of OME may
be subtle or absent and manifest only through poor balance, behavioral problems,
school performance issues, or limited progress with ongoing speech therapy.
When OME is detected in an at-risk child, tympanostomy tubes should be offered

when the likelihood of spontaneous resolution is low (eg, type B tympanogram or
persistence for ≥3 months).17 For children who do not receive tympanostomy tubes, a
follow-up schedule to monitor OME and hearing levels (HLs) should be determined
based on the specific needs of the child. This may be more frequent than the 3- to 6-
month intervals recommended later in this guideline for children with OME who do
not have any of the risk factors in Table 3. Children should be monitored until OME
resolves in all affected ears.
The GUG recommends assessing for OME at 12 to 18 months of age because this is
an especially critical period for language, speech, balance, and coordination
development. Children progress from single words to multiple-word combinations,
are able to understand many types of words, and can follow simple instructions. By 18
months of age, language and speech delays are easily discerned at office
examinations, and delays beyond 2.5 years of age negatively affect performance in
school.113 Mild to moderate hearing loss, unilateral or bilateral, may cause academic,
social, and behavioral difficulties,114,115 making this time frame a critical period for
identifying OME and, when warranted, intervening.
Pneumatic otoscopy, tympanometry, or both may be used to evaluate at-risk children

for OME (see statements 1a, 1b, and 2). The choice of diagnostic modality depends
largely on the level of cooperation of the patient and the ability to adequately
visualize the tympanic membrane. Children with Down syndrome or autism spectrum
disorder may be unable to cooperate for pneumatic otoscopy, especially if the pressure
applied to assess movement startles or distresses them sufficiently. Tympanometry is
often better tolerated and provides a printed result for reference. For children with
stenotic ear canals, the binocular microscope is useful for removing cerumen and
visualizing the tympanic membrane. Children may rarely need to be restrained (eg, a
papoose board) or sedated for satisfactory examination.
Evaluation for OME when a child is first diagnosed as being at risk and again
between the ages of 12 and 18 months constitutes the minimum surveillance for these
patients. The GUG agreed that ideal practice would entail surveillance every 3 to 6
months for the presence of OME or hearing loss, but this could also lead to
unnecessary tests or anxiety since not all at-risk children have a higher incidence of
OME. Caregivers should be made aware that changes in behavior, deteriorating
balance and coordination, and poorer attention spans and increased irritability should
all prompt an evaluation for OME and hearing loss.
STATEMENT 5. SCREENING HEALTHY CHILDREN: Clinicians

should not routinely screen children for OME who are not at risk and do
not have symptoms that may be attributable to OME, such as hearing
difficulties, balance (vestibular) problems, poor school performance,
behavioral problems, or ear discomfort.Recommendation against based on
RCTs and cohort studies with a preponderance of harm over benefit.


Quality improvement opportunity: Avoid unnecessary tests and treatment for a

highly prevalent and usually self-limited condition (National Quality Strategy
domains: efficient use of health care resources, population/public health)


Aggregate evidence quality: Grade A, systematic review of RCTs


Level of confidence in the evidence: High



Benefit: Avoid unnecessary tests, avoid unnecessary treatment, limit parent

anxiety


Risks, harms, costs: Potential to miss clinically relevant OME in some

children


Benefit-harm assessment: Preponderance of benefit over harm




Role of patient preferences: Limited but a parent can request screening if

desired


Intentional vagueness: The word “routine” is used to indicate that there may
be specific circumstances where screening is appropriate—for example, a
child with a strong family history of otitis media or a child who is suspected to
be at risk but does not yet have a formal at-risk diagnosis


Exceptions: None


Policy level: Recommendation against


Difference of opinions: None

Supporting Text
The purpose of this statement is to prevent unnecessary testing, subsequent visits,

parental or child anxiety, and expenditure for a highly prevalent, often asymptomatic
condition that is usually self-limited. This statement is directed at large-scale,
population-based screening programs in which all children, regardless of symptoms,
comorbidities, or other concerning factors, are screened with tympanometry or related
methods. This statement does not apply to at-risk children (Table 3) or those with
factors placing them at higher risk for otitis media, hearing loss, or both, as discussed
in the supporting text for statements 4a and 4b.
Effective screening programs reduce disease sequelae through opportunities for early
intervention. Population-based screening for OME, however, does not have benefits to
justify the time, expense, and potential worries raised in children and their
caregivers.18,116 A systematic review116 found no significant differences in
comprehensive language development or expressive language in children screened for
OME who underwent early intervention. In addition, screening does not improve
intelligence scores, behavioral problems, or strain on the parental-child
relationship.116,117
A recommendation against population-based screening does not mean that children

should not be evaluated for OME in general. Whereas normal, healthy, asymptomatic
children should not be subjected to additional time, travel, and time away from school
for screening, assessing the child for OME is appropriate during routine well child
visits and whenever ear-specific symptoms exist (eg, hearing loss, ear discomfort). In
addition, if a child has a history suggestive of worrisome school performance,
behavioral problems, or imbalance, then evaluation for OME is beneficial.17
Screening programs are most beneficial when sensitivity and specificity are high such
that results indicate true absence or presence of disease that will benefit from early
intervention. For OME, the disease state of concern is not asymptomatic fluid but
previously undetected hearing loss or other OME-induced symptoms that would
benefit from treatment. For instance, OME may occur with or without hearing
sequelae, and among screened children 3 to 7 years of age, a type B (flat)
tympanogram has a sensitivity of 65% to 92% and a specificity of 43% to 80% for
associated hearing loss.118 Moreover, the positive predictive value of a type B
tympanogram for pure tone hearing loss worse than 25 to 30 dB is only 33% to
49%.118 Thus, it is not uncommon for OME to occur without related hearing loss, and
if asymptomatic OME is identified, then the initial management is watchful waiting,
not early intervention.
Screening programs should also be considered with regard to implications for the
population as a whole. OME is highly prevalent condition that is found in 15% to
40% of healthy preschool children.9,14,18,19,119-123 Therefore, a screening program could
send up to 40% of children for additional assessment, regardless of whether
symptoms might prompt intervention. Such a program would potentially result in a
widely felt strain on children, families, and physicians, all without evidence of proven
benefit, and is therefore not recommended.

STATEMENT 6. PATIENT EDUCATION: Clinicians should educate
families of children with OME regarding the natural history of OME,
need for follow-up, and the possible sequelae.Recommendation based on
observational studies and preponderance of benefit over harm.


Quality improvement opportunity: Provide clear, patient-friendly education

regarding OME, its natural history, and possible sequelae to empower families
for shared decisions (National Quality Strategy domain: patient and family
engagement)


Aggregate evidence quality: Grade C, observational studies




Benefits: Reduce anxiety; facilitate shared decisions; provide parents with a

fuller understanding of their child’s condition; emphasize the importance of
follow-up; educate families about risk factors and coping strategies


Risks, harms, costs: Time for education









Role of patient preferences: Limited


Exceptions: None




Supporting Text
The purpose of this statement is to emphasize the importance of patient and family
education to improve outcomes through shared decision making. Education should
take the form of verbal and written information that addresses the common questions
or concerns that family members and/or caregivers of children with OME may have.
This can be readily accomplished by providing a list of frequently asked questions
(Table 9) and supplementing with brief discussion. Information should be provided in
a way that is sensitive to the family’s language, literacy, and cultural needs.
Table 9. Frequently Asked Questions: Treating and

Managing Ear Fluid.
Table 9. Frequently Asked Questions: Treating and Managing Ear Fluid.
View larger version
Appropriate follow-up and monitoring are important for children with OME, as
disease progression can lead to complications with a negative impact on long-term
outcomes. Providing information to patients and families and including them in the
decision-making process improves patient satisfaction and compliance in AOM,124 and
it is reasonable to generalize this to OME. Important points that should be discussed
with the family of a child with OME include details regarding risk factors for
developing OME, the natural history of the disease, risk of damage to the eardrum and
hearing, and options for minimizing the effect of OME.
Risk Factors for Developing OME
OME is a common problem affecting >60% of children before 2 years of age.10 The
rate is even higher in children with developmental issues such as Down syndrome or
cleft palate.12,13 OME may occur during or after an upper respiratory tract infection,
spontaneously due to poor eustachian tube function, or as a result of AOM.9 A major
risk factor for developing OME is age because of its direct correlation with angulation
of the eustachian tube. Other factors that increase the risk of developing OME include
passive smoking, male sex, and attending day care.125 There is also a major genetic
component up to age 5 years.126 In contrast, the risk of OME is less when infants have
been breast-fed, and this risk continues to decrease the longer the duration of breast-
feeding.127
Natural History of OME
The spontaneous resolution of OME is likely but depends on the cause and onset.16
About 75% of children with OME resolve by 3 months when it follows an episode of
AOM. If the OME is spontaneous and the date of onset is unknown, the 3-month
resolution rate is lower, at 56%. When the date of onset is known, however, this rate
increases to 90%.
Resolution rates also depend on how a successful outcome is defined. In the preceding
paragraph, resolution is defined broadly as any improvement in tympanogram curve,
from a type B to anything else (eg, type A or type C). Complete resolution, defined as
only a type A tympanogram, is much lower, only 42% at 3 months, when the date of
onset is unknown. Episode duration is similar regardless of whether it is an initial or
recurrent episode. Children who have onset during the summer or fall months, a >30-
dB HL hearing loss, or a history of prior tubes are less likely to resolve the effusion
spontaneously.118,128
Options for Minimizing Effects of OME
Several options exist for minimizing the effects of OME in terms of hearing loss,
speech and language development, and classroom learning (Table 10). Clinicians
should discuss these strategies for optimizing the listening and learning environment
until the effusion resolves. Speaking with the child should be done in close proximity,
with clear but natural enunciation and while facing the child directly. Additional
communication strategies may include gaining the child’s attention before speaking to
them, reducing background noise when possible, and rephrasing or repeating
information when clarification is needed. Additionally, preferential classroom seating
should be provided, with children moved closer to the front and with the better-
hearing ear directed toward the instructor.129,130
Table 10. Strategies for Improving the Listening and
Learning Environment for Children with Otitis Media
with Effusion and Hearing Loss.a
Table 10. Strategies for Improving the Listening and Learning Environment for
Children with Otitis Media with Effusion and Hearing Loss.a
View larger version

Risk Factors in Managing or Preventing OME
As noted above, a variety of factors can lead to an increased risk of OME and
recurrence of AOM. Numerous studies indicate that breast-feeding can decrease this
risk127 by transmitting antibodies from mother to child and reducing environmental
allergies. Additionally, removing tobacco smoke from the child’s environment is
recommended, as the duration of exposure appears to be linked to OME risk.125 Good
hand hygiene and pneumococcal vaccination may reduce the development of AOM in
this population as well.131
Limiting pacifier use in children <18 months old decreases the incidence of AOM by
about 30%,132 which would also reduce the prevalence of OME that routinely follows
these episodes. Despite common advice to avoid supine bottle-feeding in infants to
prevent otitis media, there are no well-designed studies to justify this claim beyond
one small observational study that showed more abnormal tympanograms when
children were fed supine.133 Similarly, feeding infants with nonventilated or
underventilated bottles can generate negative pressure in the middle ear, but whether
this leads to increased prevalence of OME is unknown.134
Medical Therapy for OME
Medical therapy is discussed in more detail later in this guideline, but for purposes of
counseling parents, the clinician should convey that drugs and medications are not
recommended for managing OME. Antihistamines, decongestants, antireflux therapy,
and topical nasal steroids are ineffective.3,56,60,61 Orally administered steroids have
short-term efficacy, but after 1 or 2 months the benefit is no longer significant.3,61
Antibiotics have a small benefit in resolving OME, but they have significant adverse
effects and do not improve HLs or reduce the need for future surgery.55 Last, despite
the popularity of complementary and alternative therapy, there are no RCTs to show
benefits in managing OME.3

STATEMENT 7. WATCHFUL WAITING: Clinicians should manage the

child with OME who is not at risk with watchful waiting for 3 months
from the date of effusion onset (if known) or 3 months from the date of
diagnosis (if onset is unknown).Strong recommendation based on systematic
review of cohort studies and preponderance of benefit over harm.


Quality improvement opportunity: Avoid interventions with potential adverse

events and cost for a condition that is usually self-limited (National Quality
Strategy domains: patient safety, efficient use of health care resources)


Aggregate evidence quality: Grade A, systematic review of cohort studies




Benefit: Avoid unnecessary referrals, evaluations, and interventions; take

advantage of favorable natural history


Risks, harms, costs: Delays in therapy for OME that persists for >3 months,
prolongation of hearing loss




Value judgments: Importance of avoiding interventions in an often self-limited

condition




Role of patient preferences: Small


Exceptions: At-risk children (Table 3) who may be offered tympanostomy

tubes earlier than 3 months if there is a type B tympanogram in one or both
ears




Supporting Text
The purpose of this statement is to avoid unnecessary referral, evaluation, and surgery
in children with a short duration of OME. This recommendation is based on the self-
limited nature of most OME, which has been well documented in cohort studies and
in control groups of randomized trials.7,16 Although the likelihood of spontaneous
resolution of OME is determined by the cause and duration of effusion,16 it is often
self-limited when preceded by common risk factors such as upper respiratory
infection or AOM.135
The natural history of OME has been well described with relation to the 3-month time
frame. OME occurring after an episode of AOM resolves in 75% to 90% of cases by
the third month.136-138 Among 100 children with newly diagnosed OME and a type B
(flat curve) tympanogram, 56 will improve to a non-B (nonflat curve) by 3 months; 72
will have improved at 6 months; and 87 will no longer have a flat tracing at 12
months.16 In contrast, among 100 children with chronic OME, 19 will resolve by 3
months, 25 by 6 months, 31 by 12 months, and 33 will no longer have a flat tracing at
24 months.16 Although a type B tympanogram is an imperfect measure of OME (81%
to 94% sensitivity and 74% to 94% specificity vs myringotomy), it is the most widely
reported measure suitable for deriving pooled resolution rates.7,16,75
There is little potential harm associated with a specified period of observation in the
child who is not at risk for speech, language, or learning problems. When observing a
child with OME, clinicians should inform the parent or caregiver that the child may
experience reduced hearing until the effusion resolves, especially if bilateral.
Clinicians may discuss strategies for optimizing the listening and learning
environment until the effusion resolves (see Table 10). These strategies include
speaking in close proximity to the child, facing the child and speaking clearly,
repeating phrases when misunderstood, and providing preferential classroom
seating.129,130
The recommendation for a 3-month period of observation is based on a clear

preponderance of benefit over harm and remains consistent with previous guidelines
and the goal of avoiding unnecessary surgery.1,2 Factors to consider when determining
the optimal intervals for follow-up include clinical judgment, parental comfort level,
unique characteristics of the child and/or his or her environment, access to a health
care system, and HLs if known.
STATEMENT 8a. STEROIDS: Clinicians should recommend against

using intranasal steroids or systemic steroids for treating OME.Strong
recommendation against based on systematic review of RCTs and
preponderance of harm over benefit.


STATEMENT 8b. ANTIBIOTICS: Clinicians should recommend against

using systemic antibiotics for treating OME.Strong recommendation
against based on systematic review of RCTs and preponderance of harm over
benefit.


STATEMENT 8c. ANTIHISTAMINES OR DECONGESTANTS:

Clinicians should recommend against using antihistamines,
decongestants, or both for treating OME.Strong recommendation against
based on systematic review of RCTs and preponderance of harm over benefit.
Action Statement Profile for Statements 8a, 8b, and 8c


Quality improvement opportunity: Discourage medical therapy that does not

affect long-term outcomes for OME (resolution, HLs, or need for
tympanostomy tubes) but does have significant cost and potential adverse
events (National Quality Strategy domain: patient safety, efficient use of
health care resources).


Aggregate evidence quality: Grade A, systematic review of well-designed
RCTs




Benefit: Avoid side effects and reduce cost by not administering medications;
avoid delays in definitive therapy caused by short-term improvement then
relapse; avoid societal impact of inappropriate antibiotic prescribing on
bacterial resistance and transmission of resistant pathogens.


Risks, harms, costs: None


Benefit-harm assessment: Preponderance of benefit over harm (in

recommending against therapy)


Value judgments: Emphasis on long-term outcomes, based on high-quality

systematic reviews, even though some therapies (eg, antibiotics, systemic
steroids) have documented short-term benefits






Exceptions: Patients in whom any of these medications are indicated for

primary management of a coexisting condition with OME


Policy level: Strong recommendation (against therapy)


Supporting Text
The purpose of these statements is to reduce ineffective and potentially harmful

medical interventions in OME when there is no long-term benefit to be gained in the
majority of cases. Medications have long been used to treat OME, with the dual goals
of improving QOL and avoiding more invasive surgical interventions. Both the 1994
guidelines2 and the 2004 guidelines1 determined that the weight of evidence did not
support the routine use of steroids (either oral or intranasal), antimicrobials,
antihistamines, or decongestants as therapy for OME.
Oral and Topical Steroids
The Agency for Healthcare Research and Quality comparative effectiveness review on
the use of oral steroids in the treatment of OME showed steroids to be of no
significant benefit either in resolution of the effusion or in improvement of HLs,3 and
adding antibiotics further failed to improve outcomes in comparison with control
patients who were either untreated or treated with antibiotics alone.61,139 Many of the
studies cited in this review predate the prior guidelines, and additional RCTs are not
available to support contrary findings.
Topical (intranasal) steroids have limited side effects, especially when compared with
systemically administered steroids. In children aged 4 to 11 years, there was no
difference in the resolution of effusion or hearing loss over 3 months between children
treated with nasal mometasone or placebo140; in fact, there was an economic
disadvantage in the group treated with mometasone, considering the high rate of
spontaneous resolution in the placebo group. Furthermore, 7% to 22% of study group
patients experienced minor adverse effects.61,140
There may be a short-term benefit of topical intranasal steroids in children with

adenoidal hypertrophy, although the magnitude of the effect is small, and dosing in
one report was higher than recommended.141,142 In patients with concomitant OME and
allergic rhinitis, there may be a role for topical intranasal steroids, since they do target
the inflammatory component of allergic rhinitis, which may be a contributing factor to
OME.143
Antibiotics
A 2012 Cochrane review55 of 23 studies on the use of antibiotics, either for short- or
long-term use for the treatment of OME, showed a small benefit for complete
resolution of the effusion. In contrast, antibiotic therapy did not have any significant
impact on HLs or the rate of subsequent tympanostomy tube insertion. The authors
concluded that antibiotic therapy should not be used to treat OME, because of small
benefits that are offset by adverse events, bacterial resistance, and no impact on HLs
or future surgery. These findings would not preclude using antibiotic therapy when
associated illnesses are present that would benefit from antibiotics, such as acute
bacterial sinusitis or group A streptococcal infection.
Antihistamines and Decongestants
A systematic review of RCTs60 evaluating antihistamines and/or decongestants for

treating OME found good interstudy agreement on the lack of short- (<1 month),
intermediate- (1-3 months) or long- (>3 months) term benefit on OME resolution.
Furthermore, no evidence was found of beneficial effects on hearing, although there
may be some benefit in terms of improvement of nasal and ocular allergic
symptomatology.60 The well-recognized adverse effects of antihistamines and
decongestants in children also tend to favor the placebo group over the treatment
group in several analyses.60
Montelukast was not found to be effective in the clearance of middle ear effusion.144 A
smaller study on the use of leukotriene inhibitors with or without antihistamine
reported a statistically significant improvement in otoscopic sign scores for subjects
using both therapies; however, improvement in bilateral tympanometry findings was
not significant.145
Other Treatments
As in the prior guidelines,1 there remains insufficient evidence from which to

formulate a recommendation on the use of complementary and alternative medicine in
the treatment of OME in children. Randomized controlled studies are necessary to
adequately advise on the use of complementary and alternative medicine, but they do
not exist.3 These studies will necessarily have to be large, given the high rate of
spontaneous resolution of OME in children, and they may be difficult to perform.
STATEMENT 9. HEARING TEST: Clinicians should obtain an age-

appropriate hearing test if OME persists for ≥3 months OR for OME of
any duration in an at-risk child.Recommendation based on cohort studies
and preponderance of benefit over harm.


Quality improvement opportunity: Obtains objective information on hearing

status that could influence counseling and management of OME (National
Quality Strategy domain: clinical process/effectiveness)


Aggregate evidence quality: Grade C, systematic review of RCTs showing
hearing loss in about 50% of children with OME and improved hearing after
tympanostomy tube insertion; observational studies showing an impact of
hearing loss associated with OME on children’s auditory and language skills.




Benefit: Detect unsuspected hearing loss; quantify the severity and laterality of
hearing loss to assist in management and follow-up decisions; identify
children who are candidates for tympanostomy tubes


Risks, harms, costs: Access to audiology, cost of the audiology assessment




Value judgments: Knowledge of hearing status is important for counseling and

managing children with OME and optimizing their learning environment, even
if this information does not determine surgical candidacy


Intentional vagueness: The words age-appropriate audiologic testing are used

to recognize that the specific methods will vary with the age of the child, but a
full discussion of the specifics of testing is beyond the scope of this guideline


Role of patient preferences: Small; caregivers may decline testing


Exceptions: None




Difference of opinion: None
Supporting Text
The purpose of this statement is to promote hearing testing in infants and children as
an important factor in decision making when OME becomes chronic or when a child
becomes a candidate for tympanostomy tube insertion.17 Age-appropriate tests are
available to reliably assess hearing in all children, without requiring a minimum age
for participation. Chronic OME is unlikely to resolve promptly and is associated with
significant hearing loss in at least 50% of children. OME, on average, produces a 10-
to 15-dB decrease in HLs, which results in an average HL of 28 dB.146-148 Despite
recommendations in prior guidelines,1,17 hearing testing is infrequently performed for
children with OME in primary care settings.22,28
Unresolved OME and associated hearing loss may lead to language delay, auditory
problems, poor school performance, and behavioral problems in young
children.16,130,148-151 Therefore, knowledge of the child’s hearing status is an important
part of management and should prompt the clinician to ask questions about the child’s
daily functioning to identify any issues or concerns that may be attributable to OME
that might otherwise have been overlooked (statement 4).
Understanding Hearing Testing
Hearing testing by an audiologist is needed to determine the degree, type, and

laterality of hearing loss to assess the functional impact of OME on a child’s hearing.
The degree of hearing impairment is based primarily on the accurate measurement of
hearing thresholds and secondarily by parent and school (teacher) reports describing
the perceived hearing ability of the child. Objective assessment of hearing is
necessary because parent assessment is inaccurate152 and hearing loss cannot be
predicted based on factors such as Down syndrome or other craniofacial anomalies.153
The American Academy of Pediatrics154 identified several key points relevant to

hearing assessment in children that, although not related exclusively to OME, are
worthy of summary here:
Any parental concern about hearing loss should be taken seriously and
requires an objective hearing screening of the patient.


All providers of pediatric health care should be proficient with pneumatic
otoscopy and tympanometry; however, neither method assesses hearing.


Developmental abnormalities, level of functioning, and behavioral problems

may preclude accurate results on routine audiometric screening and testing. In
this situation, referral to an otolaryngologist and audiologist should be made.


The results of abnormal screening should be explained carefully to parents,

and the child’s medical record should be flagged to facilitate tracking and
follow-up.


Any abnormal objective screening result requires audiology referral and

definitive testing.
Impact of OME on HLs
Hearing is measured in decibels (Figure 6), with a mean response >20-dB HL

indicating some degree of hearing loss for children.155 OME impairs sound
transmission to the inner ear by reducing mobility of the tympanic membrane and
ossicles, thereby reflecting acoustic energy back into the ear canal instead of allowing
it to pass freely to the cochlea.156 The impact of OME on hearing ranges from normal
hearing to moderate hearing loss (HL, 0-55 dB).101,147 The average hearing loss
associated with OME in children is 28-dB HL, while a lesser proportion
(approximately 20%) exceed 35-dB HL.101,146
Figure 6. An average hearing level between 0 and 20 dB is normal (green), 21 to 40 is

a mild hearing loss (yellow), 41 to 60 is a moderate loss (red), and 61 dB or higher is
severe loss (purple). A child with average hearing loss from MEE in both ears (28dB)
would barely hear soft speech, with some children barely aware of normal speech or a
baby crying. With permission from Rosenfeld 2005.
Methods of Hearing Testing
The preferred method of hearing assessment is age-appropriate audiologic testing

through conventional audiometry, comprehensive audiologic assessment, and
frequency-specific auditory-evoked potentials (auditory brainstem response to tone
bursts or auditory steady-state response).154 Typically developing children aged ≥4
years may be sufficiently mature for conventional audiometry, where the child raises
his or her hand when a stimulus is heard. This can be done in the primary care setting
with a fail criterion >20-dB HL at ≥1 frequencies (500, 1000, 2000, 4000 Hz) in either
ear.
Comprehensive audiologic evaluation by a licensed audiologist is recommended for

children aged 6 months to 4 years and for any child who fails conventional
audiometry in a primary care setting.154 Visual response audiometry is typically used
to assess hearing in children aged 8 months to 2.5 years, and it has been shown to
provide reliable results in infants as young as 6 months when performed by
audiologists.101,157 It is performed by an audiologist, during which the child learns to
associate speech or frequency-specific stimuli with a reinforcer, such as a lighted toy
or video clips. Children aged 2.5 to 4 years are assessed with play audiometry, by
having the child perform a task (eg, placing a peg in a pegboard or dropping a block
in a box) in response to a stimulus tone.
Ear-specific information on hearing can usually be obtained by an audiologist using

play audiometry or visual response audiometry with earphones. Some children, under
developmental age 4 years, may not tolerate headphones or ear inserts during a
hearing test. As an alternative, the test can be performed with loudspeakers in the
audiology booth; thus, the result primarily reflects performance of the better-hearing
ear.
Clinicians should appreciate that HLs, as measured in decibels, are a logarithmic scale
of intensity. For every 3-dB increase, there is a doubling in sound-intensity levels.
Therefore, a child with OME and an average HL of 28 dB would experience nearly an
8-fold decrease in sound intensity when compared with a child with normal hearing of
20 dB. Therefore, any child with a detected hearing loss prior to tympanostomy tube
insertion should have postoperative testing to confirm resolution of hearing loss that
was attributed to OME and to assess for an underlying SNHL.
Management of Hearing Loss
Knowledge of HLs in each ear will influence management for unilateral OME—for
example, listening strategies, preferential seating in the classroom, and monitoring for
an increase in hearing loss or involvement of the better ear over time. HLs are also
important in assessing tube candidacy17 and in decision making during OME
surveillance (as defined later in this guideline).
At-Risk Infants and Children
At-risk children with OME (Table 3) require more frequent hearing assessment and
prompt management to prevent additional impact on developmental outcomes. This
category includes children with speech-language or academic delay and children with
developmental disability of any cause, especially Down syndrome and other
craniofacial anomalies in which OME is very common and persistent. Children in
these categories should receive otologic and hearing screening or assessment when
the speech-language delay is identified to allow prompt treatment for OME. Hearing
should be reassessed following medical or surgical treatment, at ongoing intervals (at
least annually), or as recommended in relevant clinical practice guidelines.

STATEMENT 10. SPEECH AND LANGUAGE: Clinicians should

counsel families of children with bilateral OME and documented hearing
loss about the potential impact on speech and language
development.Recommendation based on observational studies and
preponderance of benefit over harm.


Quality improvement opportunity: Raise awareness of the potential impact of

hearing loss secondary to OME on a child’s speech and language and facilitate
caregiver education (National Quality Strategy domains: patient and family
engagement, care coordination)


Aggregate evidence quality: Grade C, observational studies; extrapolation of

studies regarding the impact of permanent mild hearing loss on child speech
and language




Benefit: Raise awareness among clinicians and caregivers; educate caregivers;

identify and prioritize at-risk children for additional assessment


Risks, harms, costs: Time spent in counseling




Value judgments: Group consensus that there is likely an underappreciation of

the impact of bilateral hearing loss secondary to OME on speech and language
development




Role of patient preferences: None


Exceptions: None




Supporting Text
The purpose of this statement is to highlight the importance of counseling families

about the potential effect that hearing loss associated with OME can have on speech
and language development.130,158 The effect of OME is greatest when repeated or
persistent episodes occur during early childhood. Clinicians can use the information in
Table 11 to facilitate a discussion about how bilateral OME with hearing loss might
affect speech and language development.
Table 11. Counseling Information on Otitis Media with

Effusion, Speech, and Language Development.
Table 11. Counseling Information on Otitis Media with Effusion, Speech, and
Language Development.
View larger version
The effect of OME-related hearing loss on communication development presumably

depends on several factors, including severity, laterality, duration, and age of
identification. Environmental factors, such as the amount of language stimulation in
the home and the quality of the caregiving environment, can also affect speech and
language development. These factors can influence how OME affects speech and
language and may help to explain the inconclusive results of studies that do not
control for all of these variables. Moreover, if the primary predictor variable is OME,
per se, and not the degree of hearing loss, the degree of association may be reduced or
even nonsignificant.
A systematic review7 concluded that there is no evidence to suggest that OME during
the first 3 years of life is related to later receptive or expressive language. This report,
however, should be interpreted cautiously because the independent variable was OME
and not hearing loss. Other systematic reviews130,158 have suggested at most a small
negative effect of OME and hearing loss on receptive and expressive language of
children through the elementary school years. Any effect of hearing loss due to OME
on speech and language development in typically developing children will likely be
magnified in children who are at risk (Table 3) because of other developmental
concerns.
One randomized trial159 and 3 systematic reviews116,160,161 concluded that prompt

insertion of tympanostomy tubes for OME did not improve language development.
These studies should be viewed with caution because they evaluated the effect of
OME on development and did not focus on the hearing loss. Moreover, children in
these studies were identified by screening (which is not recommended for OME) and
did not have preexisting delays, which makes it difficult to generalize results to
children with OME in everyday clinical practice, especially those with ≥1 at-risk
criteria (Table 3). In contrast, the authors of another systematic review110 concluded
that tympanostomy tubes may improve speech and language development in patients
with cleft palate, and the authors of a randomized trial162 concluded that
tympanostomy tubes have small benefits for children with bilateral OME and hearing
loss.
Communication is an integral part of all aspects of human interaction and QOL.

Therefore, clinicians should be vigilant about identifying patients with speech and/or
language delays and patients who are at risk for delays, particularly if there is a
history of bilateral hearing loss (with or without OME).
For preschool children with OME and hearing loss, clinicians should ask the
parent or caregiver whether there are any concerns about the child’s
communication development.


The clinician should also ask basic questions about the child’s speech and
language abilities and compare the child’s abilities with what is considered
typical for the child’s chronological age. For information about normal
development and developmental milestones, go to the website of the American
Speech-Language-Hearing Association (www.asha.org).163,164


The clinician can use a parent questionnaire or a more formal screening test to
judge speech and language development.165 For information about parent
questionnaires and screening tests, go to the website of the Agency for
Healthcare Research and Quality (http://www.ahrq.gov/) and the American
Speech-Language-Hearing Association website (www.asha.org).163,164,166
When delays or disorders are identified through comprehensive testing, intervention

should begin promptly for the best long-term prognosis. Without intervention,
children with speech and language delays during the preschool years are at risk for
continued communication problems167 and later difficulties in reading and writing.167-
169
Conversely, providing optimal treatment during the preschool years can facilitate
both speech and literacy development.170,171 Language intervention can improve
communication and other functional outcomes for children with a history of OME and
bilateral hearing loss.172
STATEMENT 11. SURVEILLANCE OF CHRONIC OME: Clinicians

should reevaluate, at 3- to 6-month intervals, children with chronic OME
until the effusion is no longer present, significant hearing loss is identified,
or structural abnormalities of the eardrum or middle ear are suspected.
Recommendation based on observational studies with a preponderance of
benefit over harm.


Quality improvement opportunity: Emphasize that regular follow-up is an

important aspect of managing chronic OME that can help avoid sequelae by
identifying children who develop signs or symptoms that would prompt
intervention (National Quality Strategy domains: patient safety, clinical
process/effectiveness).


Aggregate evidence quality: Grade C, observational studies




Benefit: Detection of structural changes in the tympanic membrane that may

require intervention; detection of new hearing difficulties or symptoms that
would lead to reassessing the need for intervention, including tympanostomy
tubes; discussion of strategies for optimizing the listening-learning
environment for children with OME; as well as ongoing counseling and
education of parents/caregiver.


Risks, harms, costs: Cost of follow-up




Value judgments: Although it is uncommon, untreated OME can cause

progressive changes in the tympanic membrane that require surgical
intervention. There was an implicit assumption that surveillance and early
detection/intervention could prevent complications and would provide
opportunities for ongoing education and counseling of caregivers.


Intentional vagueness: The surveillance interval is broadly defined at 3 to 6

months to accommodate provider and patient preference; “significant” hearing
loss is broadly defined as that noticed by the caregiver, reported by the child,
or interfering with school performance or QOL


Role of patient preferences: Moderate; opportunity for shared decision making

regarding the surveillance interval


Exceptions: None





Supporting Text
The purpose of this statement is to avoid sequelae of chronic OME and to identify
children who develop signs or symptoms for which intervention may be
appropriate.16,17 Children with chronic OME may develop structural changes of the
tympanic membrane, hearing loss, and speech and language delays. Reevaluation with
otoscopy, audiologic testing, or both at 3- to 6-month intervals facilitates ongoing
counseling and education of parents and caregivers so that they can participate in
shared decision making during surveillance.
Randomized trials117,173-175 suggest that otherwise healthy children with persistent

OME who do not have any of the at-risk criteria in Table 3 can be safely observed for
6 to 12 months with a low risk for developing sequelae or reduced QOL. The impact
of longer observation periods is unknown, so active surveillance is required during
prolonged observation of OME. For children who are at risk for developmental
sequelae of OME (Table 3), prolonged surveillance is not advised, and tympanostomy
tubes may be performed when the OME is not likely to resolve promptly (type B
tympanogram or persistence for ≥3 months).17
Rationale for Chronic OME Surveillance
The natural history of OME is favorable in most cases. If OME is asymptomatic and
is likely to resolve spontaneously, intervention is usually unnecessary, even if OME
persists for >3 months. The clinician should determine if there are risk factors that
would predispose to undesirable sequelae or predict persistence of the effusion. The
longer the effusion is present, the more the rate of resolution decreases and relapse
becomes more common.176-181 The risk factors associated with reduced likelihood of
spontaneous resolution of OME include128,182
onset of OME in summer or fall season,


hearing loss >30-dB HL in the better-hearing ear,


history of prior tympanostomy tubes, and


not having a prior adenoidectomy.
An important reason for regular follow-up of children with OME is to ensure integrity
of the tympanic membrane. OME is associated with tympanic membrane
inflammation,183-185 which can induce epithelial migration, erode bone, or alter the
mucosecretory or mucociliary clearance, especially in the presence of bacterial
products.186,187 Adding to this problem is chronic underventilation of the middle ear,
which is common in young children and may cause progressive medialization of the
tympanic membrane, predisposing to focal retraction pockets, generalized atelectasis,
ossicular erosion, and cholesteatoma.188 The incidence of structural damage increases
with effusion duration.188
Careful examination of the tympanic membrane can be performed with a handheld

pneumatic otoscope to search for abnormalities such as retraction pockets, ossicular
erosion, areas of atelectasis or atrophy, accumulation of keratin, and focal signs of
infection such as granulations or aural polyp. If there is any uncertainty whether all
structures are normal (other than the mild retraction that might be expected from
negative middle ear pressure), further evaluation should be carried out with a
binocular microscope.17,189 All children with these tympanic membrane conditions,
regardless of OME duration, should have a comprehensive audiologic evaluation
(typically including air and bone conduction thresholds and speech audiometry).
Conditions of the tympanic membrane that generally benefit from tympanostomy tube
insertion are posterosuperior retraction pockets, ossicular erosion, adhesive
atelectasis, and retraction pockets that accumulate keratin debris.17,189
Managing Chronic OME During Surveillance
During the surveillance period, parents and clinicians may use autoinflation of the
eustachian tube (eg, Politzer devices), which is a safe intervention that may offer
some clinical benefit.3,190 Mild improvement in combined assessment of tympanogram
and audiometry results was seen at 1 month and with an increasing benefit up to 3
months, after which there is a lack of data. Although the cost and risk of adverse
effects are low, the inconveniences of the use of these devices could limit their
acceptability to children and families. Decisions on these procedures with marginal
evidence should be a part of the shared decision making between the physician and
the caregiver.
Periodic assessment of hearing status is an important aspect of OME surveillance. A

perception by caregivers, teachers, medical personnel, or others of suspected
deterioration in hearing, speech, language, school performance, or behavioral
problems should prompt audiologic testing.191-193 Hearing loss has been defined by
conventional audiometry as a loss >20-dB HL at ≥1 frequencies (500, 1000, 2000,
4000 Hz) and requires a comprehensive audiologic evaluation.1 If a child with OME
has HLs in the normal range (HL ≤20 dB), a repeat hearing test should be performed
in 3 to 6 months if OME persists. In cases of mild hearing loss (HL, 21-39 dB) or
moderate (or greater) hearing loss (HL ≥40 dB), a comprehensive audiologic
evaluation is indicated if one has not already been done.
Mild SNHL is associated with difficulties in speech, language, and academic

performance in school, and persistent mild conductive hearing loss with OME may
have a similar impact.194,195 Moderate or greater hearing loss has been shown to affect
speech, language, and school performance. For children with hearing loss who are
being observed—for reasons such as surgery having been declined or being
contraindicated or having previously failed surgery (eg, recurrent otorrhea with tubes)
—consideration for hearing enhancement should be made, including strategies for
optimizing the listening-learning environment for children with OME and hearing loss
(Table 10), assistive listening devices, or hearing aids.130
Education of the child and caregivers should begin at the first encounter and continue
as an ongoing process so that the caregivers can actively participate in shared decision
making, where there are choices, and be a better partner during the observation
period. Clinicians should aim to create in them an understanding of the natural history
of the disease as well as signs and symptoms of disease progression to facilitate
prompt medical attention when indicated and to reduce the unnecessary use of
antibiotics. Communication between parents and primary care providers should be
encouraged. Prompt referral to an otolaryngologist is recommended when otoscopy
suggests possible, or impending, structural damage of the tympanic membrane.
STATEMENT 12a. SURGERY FOR CHILDREN <4 YEARS OLD:

Clinicians should recommend tympanostomy tubes when surgery is
performed for OME in a child <4 years old; adenoidectomy should not be
performed unless a distinct indication (eg, nasal obstruction, chronic
adenoiditis) exists other than OME.Recommendation based on systematic
reviews of RCTs with a preponderance of benefit over harm.


STATEMENT 12b. SURGERY FOR CHILDREN ≥4 YEARS OLD:

Clinicians should recommend tympanostomy tubes, adenoidectomy, or
both when surgery is performed for OME in a child 4 years old or
older.Recommendation based on systematic reviews of RCTs and
observational studies with a preponderance of benefit over harm.
Action Statement Profile for Statements 12a and 12b


Quality improvement opportunity: Promote effective therapy for OME (tubes

at all ages; adenoidectomy age ≥4 years) and discourage therapy with limited
or no benefits (adenoidectomy <4 years old) (National Quality Strategy
domains: patient safety, clinical process/effectiveness)


Aggregate evidence quality: Grade B, systematic review of RCTs (tubes,

adenoidectomy) and observational studies (adenoidectomy)


Level of confidence in the evidence: Medium, because of limited data on long-

term benefits of these interventions and heterogeneity among RCTs included
in the systematic reviews


Benefit: promoting effective therapy; avoiding adenoidectomy in an age group

where benefits have not been shown as a primary intervention for OME;
benefits of surgery that include improved hearing reduced prevalence of OME,
and less need for additional tympanostomy tube insertion (after
adenoidectomy)


Risks, harms, costs: Risks of anesthesia and specific surgical procedures,

sequelae of tympanostomy tubes and adenoidectomy




Value judgments: Although some studies suggest benefits of adenoidectomy

for children <4 years old as primary therapy for OME, the data are
inconsistent and relatively sparse; the additional surgical risks of
adenoidectomy (eg, velopharyngeal insufficiency, more complex anesthesia)
were felt to outweigh the uncertain benefits in this group


Intentional vagueness: For children aged ≥4 years, the decision to offer

tympanostomy tubes, adenoidectomy, or both is based on shared decision
making


Role of patient preferences: Moderate role in the choice of surgical procedure
for children aged ≥4 years (tubes, adenoidectomy, or both)


Exceptions: Adenoidectomy may be contraindicated in children with cleft

palate or syndromes associated with a risk of velopharyngeal insufficiency




Supporting Text
The purpose of these statements is to promote tympanostomy tubes as the primary

surgical intervention for OME, reserving adenoidectomy for children aged ≥4 years or
those with a distinct indication for the procedure other than OME (eg, nasal
obstruction, chronic adenoiditis). These statements differ from recommendations in
the first version of this guideline,1 which did not stratify indications for
adenoidectomy by child age. For example, adenoidectomy was previously
recommended for repeat OME surgery in children as young as 2 years, but more
recent evidence and systematic reviews suggest that 4 years is a more appropriate cut
point (as discussed below).
Surgery for Children <4 Years Old
If a decision is reached to manage OME in a child <4 years old with surgery, then
tympanostomy tube insertion is the procedure of choice. This recommendation is
consistent with the initial version of the OME guideline1 and offers the potential
benefits of improved hearing, reduced prevalence of middle ear effusion, reduced
incidence of AOM, and improved patient and caregiver QOL.17,196,197 Specific
recommendations for tympanostomy tube insertion are summarized in Table 12 based
on the AAO-HNSF clinical practice guideline on tympanostomy tubes.17
Table 12. Evidence-Based Recommendations for

Tympanostomy Tube Insertion.a
Table 12. Evidence-Based Recommendations for Tympanostomy Tube Insertion.a

View larger version
Adenoidectomy is not recommended for a primary indication of OME in children <4

years old because benefits are limited and of questionable clinical significance.198,199
The original OME guideline1 suggested a role for adenoidectomy when repeat surgery
was needed for OME relapse after prior tympanostomy tubes in children as young as
2 years, but this was based on limited evidence that is challenged by later
publications.198-201 Therefore, we have raised the threshold for adenoidectomy as
repeat surgery to age 4 years. Adenoidectomy may be performed concurrent with
tympanostomy tube insertion when there is a distinct indication, such as chronic
adenoiditis or nasal obstruction (caused by adenoid hypertrophy).
Adverse events from tympanostomy tubes relate to the procedure and to general
anesthesia. Whereas no mortality has been reported in tympanostomy tube trials, the
incidence of anesthesia-related death for children undergoing diverse procedures
ranges from 1 in 10,000 to 1 in 45,000 anesthetics delivered.202 The most common
tube-related sequela is otorrhea, which is seen in approximately 16% of children
within 4 weeks of surgery and 26% of children at any time the tube remains in place
(mean, 12-14 months).203 Complications include an obstructed tube lumen in 7% of
intubated ears, premature extrusion of the tube in 4%, and tube displacement into the
middle ear in 0.5%.203
Longer-term sequelae of tympanostomy tubes include visible changes in the

appearance of the tympanic membrane (eg, atrophy, retraction, perforation,
myringosclerosis) and, in some studies, a decrease in hearing of a few decibels
(although HLs still remain in the normal range). These outcomes do not appear to be
clinically important or require intervention in the overwhelming majority of patients.17
The posttympanostomy tube sequela most likely to require intervention is persistent
perforation, which occurs in about 2% to 3% of children.17 Myringoplasty or
tympanoplasty has an 80% to 90% success rate for surgical closure of persistent
perforation with a single procedure.204
Surgery for Children ≥4 Years Old
If a decision is reached to manage OME in a child aged ≥4 years with surgical

intervention, then adenoidectomy, tympanostomy tube insertion, or both can be
recommended. The availability of at least 3 surgical options for this age group (tubes
alone, adenoidectomy alone, or adenoidectomy plus tubes) creates an opportunity for
shared decision making with caregivers.
The rationale for recommending adenoidectomy as a management option for OME in

children aged ≥4 years is based on systematic reviews that may be summarized as
follows:
Boonacker and colleagues198 performed an individual patient data meta-

analysis based on 1761 children from 10 randomized trials, 9 of which
compared adenoidectomy with or without tubes to no surgery or tubes alone.
For children <4 years old, no clinically important benefits were found for
adenoidectomy. Conversely, children aged ≥4 years old spent 50 fewer days
with OME over the next 12 months, had lower failure rates (51% vs 70%), and
a lower rate of future surgery (2% vs 19%). In this study, failure at 12 months
was defined as additional surgery, recurrent AOM, middle ear effusion at least
50% of the time, or average hearing improvement <10-dB HL.


Mikals and Brigger199 reviewed 15 randomized trials and observational studies

of tympanostomy tubes, with or without adenoidectomy, as primary therapy
for OM. Adenoidectomy reduced the rate of repeat tympanostomy tube
insertion (from 36% to 17%) for children ≥4 years old, but when only younger
children were studied, there was no significant effect.


Wallace and colleagues205 reviewed randomized trials and found that

adenoidectomy increased OME resolution as measured by otoscopy (27% at 6
months) and tympanometry (22% at 6 months, 29% at 12 months). Outcomes
were unchanged whether tubes were or were not performed concurrently. In
this analysis, the authors were unable to stratify results by child age.
The primary benefits of adenoidectomy are to reduce failure rates, reduce time with
middle ear effusion, and decrease the need for repeat surgery (eg, future tubes). These
benefits are independent of adenoid volume and may relate to improved microflora in
the nasopharynx when adenoid tissue and associated pathogenic bacteria (planktonic
and in biofilms) are removed. Additionally, contact of the adenoid with the torus
tubarius may be predictive of increased benefit from adenoidectomy.206 When
compared with tube insertion alone, these benefits are offset, in part, by additional
anesthetic time (intubation, intravenous fluids), a small potential for hemorrhage, and
a longer recovery period (24 to 48 hours). In addition, velopharyngeal insufficiency
occurs rarely after adenoidectomy.
Shared Decision Making for OME Surgery
There are 2 aspects of shared surgical decision making for treatment of OME:
deciding between surgery or additional observation and, if surgery is chosen, selecting
the appropriate procedure(s). Surgical candidacy for OME depends largely on hearing
status, associated symptoms, the child’s developmental risk (Table 3), and the
anticipated chance of timely spontaneous resolution of the effusion. The poorest rates
of spontaneous resolution for OME occur when the effusion is chronic (≥3 months) or
associated with a type B (flat curve) tympanogram.16 Indications for tubes
(summarized in Table 12) are fully discussed in the AAO-HNSF clinical practice
guideline on tympanostomy tubes.17 Ultimately the recommendation for surgery must
be individualized, based on discussion among the primary care physician,
otolaryngologist, and parent or caregiver that a particular child would benefit from
intervention.
Once a decision to proceed with surgery is reached, the role of shared decision
making is limited for children <4 years old (tympanostomy tubes are recommended)
but increases significantly for older children. Surgical options for managing OME in
children ≥4 years old include the following:
1.
Tympanostomy tube placement alone, which offers the most reliable short- and
intermediate-term resolution of hearing loss associated with OME,197,205,207 but
has minor complications as noted above. Caregivers of children with speech
and language delays and OME perceive large improvements after tube
placement,33 making tubes desirable for at-risk children.
2.
3.
Adenoidectomy alone, which offers comparable rates of OME control

compared with tympanostomy tubes at 6 and 12 months,205 but may have a less
reliable impact in the short term. Adenoidectomy also reduces the need for
repeat surgery199 but has more potential anesthetic- and procedure-related
complications than tubes alone (see above). Last, some children with
persistent OME despite adenoidectomy may need additional surgery for
tympanostomy tube insertion.
4.
5.
Adenoidectomy plus myringotomy (without tubes), which includes aspiration

of effusion and possible lavage of the middle ear space with saline solution,
has outcomes comparable to tubes with less otorrhea and tympanic membrane
sequelae.208 Tympanostomy tube insertion, however, offers more reliable short-
term effusion resolution and middle ear ventilation, making it preferable to
myringotomy when potential relapse of effusion must be minimized (eg, at-
risk children) or when pronounced inflammation of the tympanic membrane
and middle ear mucosa is present.1
6.
7.
Adenoidectomy plus tympanostomy tube placement, which offers the

combined benefits of both procedures, especially the ability to reduce repeat
surgery in children with a history of tympanostomy tube placement.209 This
dual approach may be of particular benefit in children with nasal obstruction
or recurrent sinonasal infections that are bothersome but insufficient on their
own to justify adenoidectomy.
8.
A shared decision grid (Table 13) can help caregivers and patients participate in
shared decision making because it summarizes frequently asked questions that can be
used during a clinical encounter to efficiently compare management options. The grid
benefits clinicians by standardizing information transfer, facilitating patients’
understanding of treatment options, and making consultations easier.210
Table 13. Shared Decision Grid for Parents and

Caregivers Regarding Surgical Options for Otitis Media
with Effusion.a
Table 13. Shared Decision Grid for Parents and Caregivers Regarding Surgical
Options for Otitis Media with Effusion.a
View larger version
Clinicians should inform patients, parents, and/or caregivers that the goal of the grid
is to initiate a conversation about options and ask if they wish to read it themselves or
have the comparisons vocalized. If the patient, parent, and/or caregiver wishes to read
the grid, it is best to create space by asking permission to perform other tasks so that
they do not feel observed or under pressure.210 Questions and discussion are
encouraged, and the patient, parent, and/or caregiver is given a copy of the grid for
future reference. Since surgery for OME is nearly always elective, patients, parents,
and/or caregivers who express uncertainty are often best managed by delaying the
management decision and readdressing the issue at a subsequent office visit.
In some situations, a decision regarding tympanostomy tube insertion is driven less by

patient choice and more by findings on physical examination. For example, children
with chronic OME should have prompt tympanostomy tube insertion when there is
real or impending structural damage to the tympanic membrane caused by retraction
(from negative middle ear pressure) or collapse (from atrophy or atelectasis).
Although there are no randomized trials to support this approach, inserting the tube
will equalize middle ear pressure and eliminate middle ear effusion, which may help
avoid more extensive otologic surgery for ears with retraction pockets, atelectasis, or
early signs of cholesteatoma.
STATEMENT 13. OUTCOME ASSESSMENT: When managing a child

with OME, clinicians should document in the medical record resolution of
OME, improved hearing, or improved QOL.Recommendation based on
randomized trials and cohort studies with a preponderance of benefit over
harm.


Quality improvement opportunity: Focus on patient-centered outcome

assessment when managing children with OME (National Quality Strategy
domain: clinical process/effectiveness)


Aggregate evidence quality: Grade C, randomized trials and before-and-after

studies showing resolution, improved hearing, or improved QOL after
management of OME




Benefit: Document favorable outcomes in management


Risks, harms, costs: Cost of follow-up visits and audiometry; administrative

burden for QOL surveys


Benefit-harm assessment: Predominance of benefit over harm




Intentional vagueness: The time frame for assessing outcome is not stated; the
method of demonstrating OME resolution (otoscopy or tympanometry) is at
the discretion of the clinician.





Exceptions: None




Supporting Text
The purpose of this statement is to encourage clinicians to document patient-centered

outcomes when managing children with OME, regardless of the management option
chosen (eg, surgery, watchful waiting, or surveillance). Common goals of managing
OME are to resolve effusion, restore optimal hearing, and improve disease-specific
QOL.16,35,205 Documenting these outcomes is important to ensure patient follow-up and
to assess the effectiveness of management strategies.
For children with an intact tympanic membrane, resolution of OME can be

documented by showing normal tympanic membrane mobility with pneumatic
otoscopy (statement 1) or by recording a sharp peak on tympanometry (key action
statement 2) with either normal middle ear pressure (type A curve) or negative
pressure (type C1 curve). For children with tympanostomy tubes, resolution of OME
can be documented by showing an intact and patent tube with otoscopy or by
recording a large ear canal volume with tympanometry. Improved hearing can be
documented through age-appropriate comprehensive audiometry (key action
statement 9).
Documenting improved QOL for children with OME can be accomplished through a
valid and reliable disease-specific survey that is able to measure clinical change. The
most appropriate instrument currently available for this purpose is the OM-6,35 which
has 6 brief questions reflecting the domains of physical suffering, hearing loss, speech
impairment, emotional distress, activity limitations, and caregiver concerns.211 The
child’s caregiver completes the survey at baseline and then again after a minimum
follow-up period of 1 month. A change score is calculated as the difference between
surveys and can be used to rate clinical change as trivial, small, moderate, or large.211
The time interval for assessing OME outcomes is at the discretion of the clinician. For
children managed with watchful waiting (statement 7) or surveillance (statement 11),
the outcome assessment can take place at a follow-up visit. For children managed
with surgery (statement 12), the outcome assessment can take place at the
postoperative visit or a subsequent follow-up visit.
If documentation of outcome is not possible because of loss to follow-up, this should
be noted in the medical record along with any attempts to contact the family. For
children who are seen only once (eg, a child referred by the primary care clinician to a
specialist for evaluation only), the clinician should document the specific
circumstance in the medical record regarding why follow-up was not possible.
Implementation Considerations
The complete guideline is published as a supplement to Otolaryngology–Head and
Neck Surgery, and an executive summary will be simultaneously published in the
main journal. A full-text version of the guideline will also be accessible free of charge
at www.entnet.org, the AAO-HNSF website. The guideline will be presented to AAO-
HNS members as a miniseminar at the 2015 annual meeting. Existing brochures,
publications, and patient information sheets from the AAO-HNSF will be updated to
reflect guideline recommendations.
Although pneumatic otoscopy and tympanometry were recommended for diagnosing

OME in the first version of this guideline,1 pneumatic otoscopy in particular continues
to be underused in primary care settings. We provide expanded information on both
these diagnostic modalities in the new guideline, but enhanced efforts will still be
needed in primary care settings to teach and promote accurate OME diagnosis. The
degree to which specialists use pneumatic otoscopy has not been studied, but
educational efforts would likely be of benefit to this population as well.
OME is one of the most common reasons that infants fail a newborn hearing test, but
ensuring follow-up to assess for resolution of the effusion and to exclude an
underlying SNHL can be challenging. We provide counseling materials in this regard
that clinicians can distribute to families of children with OME, but continued
education of hospital providers who administer the newborn testing is an additional
challenge. We hope that the new attention focused on this issue by the guideline will
promote investigation and change in this area.
The new guideline reaffirms a prior recommendation against routine screening of

children for OME but adds a new recommendation that clinicians evaluate at-risk
children for OME when the at-risk condition is diagnosed and again at 12 to 18
months of age (if diagnosed as being at risk prior to this time). This new
recommendation imposes some additional burden on providers, in terms of both
remembering to do the assessment and performing the actual evaluation for OME.
The GUG showed strong consensus and support for this recommendation as a means
to improve quality of care for at-risk children. Implementing this in practice will
require continuing medical education strategies and integration into clinical decision
support systems.
Whereas antibiotics and oral steroids are used infrequently to treat OME, there is a
perception that topical intranasal steroids and antireflux medications are relatively
common interventions, despite a lack of evidence for their efficacy. We recommend
explicitly against using these for a primary indication of OME, but reinforcement will
be needed to implement this strategy, especially through performance measures. This
is especially important to avoid costly, ineffective, and potentially harmful care.
Last, we make a new recommendation that adenoidectomy should not be done for a
primary indication of OME in children <4 years old. This contradicts established
practice for many clinicians and some information in the prior guideline (eg, offering
adenoidectomy when repeat surgery is required for children ≥2 years old). Continuing
medical education will be needed to explicitly focus on the rationale for this change
(eg, new randomized trials and systematic reviews) to promote uptake in routine
clinical practice.
Research Needs
Diagnosis
1.
Further standardize the definition of OME and distinctions with regard to fluid
from varying etiologies.
2.
3.
Assess the performance characteristics of pneumatic otoscopy as a diagnostic

test for OME when performed by primary care physicians and advanced
practice nurses in the routine office setting.
4.
5.
Determine the optimal methods for teaching pneumatic otoscopy to residents

and clinicians.
6.
7.
Develop a brief, reliable, objective method for diagnosing OME, beyond

pneumatic otoscopy.
8.
9.
Develop cost-effective tympanometry that facilitates testing in nonaudiology

settings.
10.
11.
Develop a classification method for identifying the presence of OME for

practical use by clinicians that is based on quantifiable tympanometric
characteristics.
12.
13.
Assess the usefulness of algorithms combining pneumatic otoscopy and

tympanometry for detecting OME in clinical practice.
14.
15.
Conduct additional validating cohort studies of acoustic reflectometry as a

diagnostic method for OME, particularly in children <2 years old.
16.
Newborn Hearing Screen

1.
Determine whether neonatal middle ear fluid has a differential rate of

resolution or natural history than fluid in older infants and children
2.
3.
Optimization of counseling to maximize rates of return for follow-up for those

who fail neonatal hearing screening and have OME.
4.
At-Risk Children
1.
Better define the child with OME who is at risk for speech, language, and
learning problems.
2.
3.
Conduct large, multicenter observational cohort studies to identify the child at

risk who is most susceptible to potential adverse sequelae of OME.
4.
5.
Conduct large, multicenter observational cohort studies to analyze outcomes

achieved with alternative management strategies for OME in children at risk.
6.
Watchful Waiting
1.
Define the anticipated rate of spontaneous resolution of OME in infants and
young children (existing data are limited primarily to children aged ≥2 years).
2.
3.
Conduct large-scale prospective cohort studies to obtain current data on the

spontaneous resolution of newly diagnosed OME of unknown prior duration
(existing data are primarily from the late 1970s and early 1980s).
4.
5.
Develop prognostic indicators to identify the best candidates for watchful

waiting.
6.
7.
Determine if the lack of impact from prompt insertion of tympanostomy tubes

on speech and language outcomes seen in asymptomatic young children with
OME identified by screening or intense surveillance can be generalized to
older children with OME or to symptomatic children with OME referred for
evaluation.
8.
9.
Determine whether children with an OME duration exceeding 1 to 2 years

have an increased risk of hearing loss, balance problems, discomfort, or other
findings that would prompt intervention.
10.
11.
Define straightforward and efficient metrics to elucidate OME-related

vestibular disturbance in patients too young to articulate related symptoms.
Develop better tools for monitoring children with OME, suitable for routine
clinical care.
12.
13.
Assess the value of new strategies for monitoring OME, such as acoustic
reflectometry performed at home by the parent or caregiver.
14.
15.
Promote early detection of structural abnormalities in the tympanic membrane
associated with OME that may require surgery to prevent complications.
16.
17.
Clarify and quantify the role of parent or caregiver education, socioeconomic

status, and quality of the caregiving environment as modifiers of OME
developmental outcomes.
18.
19.
Develop methods for minimizing loss to follow-up during OME watchful

waiting.
20.
Medication
1.
Evaluate previously unstudied discrete patient subgroups that may have a

differential effect in response to antimicrobials, steroids, antihistamines, or a
combination thereof for OME.
2.
3.
Investigate the lack of efficacy of nasal steroids for OME in relation to their
demonstrated capacity to decrease adenoid size
4.
5.
Investigate the efficacy of adenoidectomy in children >4 years of age.
6.
7.
Investigate the role of mucosal surface biofilms in refractory or recurrent

OME and develop targeted interventions.
8.
Hearing, Speech, and Language

1.
Conduct longitudinal studies on the natural history of hearing loss

accompanying OME.
2.
3.
Develop improved methods for describing and quantifying the fluctuations in

hearing of children with OME over time.
4.
5.
Conduct prospective controlled studies on the relation of hearing loss

associated with OME to later auditory, speech, language, behavioral, and
academic sequelae.
6.
7.
Develop reliable, brief, objective methods for estimating hearing loss

associated with OME.
8.
9.
Develop reliable, brief, objective methods for estimating speech, language, or

literacy delay associated with OME.
10.
11.
Agree on the aspects of speech, language, and literacy that are vulnerable to,
or affected by, hearing loss caused by OME, and reach a consensus on the best
tools for measurement.
12.
13.
Determine if OME and associated hearing loss place children from special
populations at greater risk for speech and language delays.
14.
Surgery
1.
Define the role of adenoidectomy in children aged ≤3 years as a specific OME

therapy.
2.
3.
Conduct controlled trials on the efficacy of tympanostomy tubes for
developmental outcomes in children with hearing loss, other symptoms, or
speech and language delay.
4.
5.
Conduct RCTs of surgery versus no surgery that emphasize patient-based

outcome measures (QOL, functional health status) in addition to objective
measures (effusion prevalence, HLs, AOM incidence, reoperation).
6.
7.
Identify the optimal ways to incorporate parent or caregiver preference into

surgical decision making.
8.
Allergy Management
1.
Evaluate whether there is a causal role of atopy in OME.
2.
3.
Evaluate whether age affects any relationship between allergy and OME.
4.
5.
Conduct RCTs on the efficacy of immunotherapy and nonantihistamine allergy

therapy for OME that are generalizable to the primary care setting.
6.
7.
Determine whether the subgroup with active allergy manifestations and

positive allergy testing has a distinct natural history or response to
interventions, including immunotherapy, as compared with children without
allergy.
8.
Conclusion
This evidence-based practice guideline offers recommendations for identifying,
monitoring, and managing the child with OME. The key action statements are
summarized in Table 6, and their interrelationship is shown in Figure 7. The
guideline emphasizes appropriate diagnosis and provides options for various
management strategies, including observation, medical intervention, and referral for
surgical intervention. These recommendations should provide primary care physicians
and other health care providers with assistance in managing children with OME.
Figure 7. Algorithm showing the relationship of guideline key action statements.

OME, otitis media with effusion; QOL, quality of life.
Disclaimer
The clinical practice guideline is provided for information and educational purposes
only. It is not intended as a sole source of guidance in managing otitis media with
effusion. Rather, it is designed to assist clinicians by providing an evidence-based
framework for decision-making strategies. The guideline is not intended to replace
clinical judgment or establish a protocol for all individuals with this condition and
may not provide the only appropriate approach to diagnosing and managing this
program of care. As medical knowledge expands and technology advances, clinical
indicators and guidelines are promoted as conditional and provisional proposals of
what is recommended under specific conditions but are not absolute. Guidelines are
not mandates; these do not and should not purport to be a legal standard of care. The
responsible provider, in light of all circumstances presented by the individual patient,
must determine the appropriate treatment. Adherence to these guidelines will not
ensure successful patient outcomes in every situation. The American Academy of
Otolaryngology—Head and Neck Surgery Foundation emphasizes that these clinical
guidelines should not be deemed to include all proper treatment decisions or methods
of care or to exclude other treatment decisions or methods of care reasonably directed
to obtaining the same results.
Author Contributions
Richard M. Rosenfeld, writer, chair; Jennifer J. Shin, writer, assistant chair; Seth
R. Schwartz, writer, methodologist; Robyn Coggins, writer, panel member; Lisa
Gagnon, writer, panel member; Jesse M. Hackell, writer, panel member; David
Hoelting, writer, panel member; Lisa L. Hunter, writer, panel member; Ann W.
Kummer, writer, panel member; Spencer C. Payne, writer, panel member; Dennis S.
Poe, writer, panel member; Maria Veling, writer, panel member; Peter M. Vila,
writer, panel member; Sandra A. Walsh, writer, panel member; Maureen D.
Corrigan, writer, AAO-HNSF staff liaison.
Disclosures
Competing interests: Jennifer J. Shin, royalties from the publication of 2 books—
Evidence-Based Otolaryngology (Springer International), Otolaryngology Prep and
Practice (Plural Publishing)—and recipient of a Harvard Medical School Shore
Foundation Faculty Grant; Lisa L. Hunter, teaching/speaking honoraria from
Interacoustics Inc and Arizona Ear Foundation, research funding from National
Institute on Deafness and Other Communication Disorders and Centers for Disease
Control and Prevention, textbook royalties from Plural Publishing (Acoustic
Immittance Measures); Ann W. Kummer, textbook royalties from Engage Learning
(Cleft Palate and Craniofacial Anomalies); Spencer C. Payne, consulting fee from
Acclarent, Medtronic, Styker, and Cook; research funding from Acclarent; expert
witness (case-by-case basis); Dennis S. Poe, research funding from Acclarent for
eustachian tube dilation balloons, financial interest in nasal spray for OM (not yet in
phase I trials); Stockholder–Otodyne; Maureen D. Corrigan, salaried employee of
American Academy of Otolaryngology—Head and Neck Surgery Foundation.
Sponsorships: American Academy of Otolaryngology—Head and Neck Surgery

Foundation.
Funding source: American Academy of Otolaryngology—Head and Neck Surgery

Foundation.
Acknowledgements
We gratefully acknowledge the support of Jean C. Blackwell, MLS, for her assistance
with the literature searches. In addition, we acknowledge the work of the original
guideline development group, which includes Richard M. Rosenfeld, MD, MPH;
Larry Culpepper, MD, MPH; Karen J. Doyle, MD, PHD; Kenneth M. Grundfast, MD;
Alejandro Hoberman, MD; Margaret A. Kenna, MD; Allan S. Lieberthal, MD; Martin
Mahoney, MD, PHD; Richard A. Wahl, MD; Charles R. Woods Jr, MD, MS; and
Barbara Yawn, MSC.
Sponsorships or competing interests that may be relevant to content are disclosed at

the end of this article.
References
Rosenfeld, RM, Culpepper, L, Doyle, KJ. Clinical practice
1. guideline: otitis media with effusion. Otolaryngol Head Neck
Surg. 2004;130(5):S95-S118. Google Scholar, SAGE Journals, ISI
Stool, SE, Berg, AO, Berman, S. Otitis Media with Effusion in
Young Children: Clinical Practice Guideline No. 12. Rockville,
2.
MD: Agency for Healthcare Research and Quality; 1994. AHCPR
publication 94-0622. Google Scholar
Berkman, ND, Wallace, IF, Steiner, MJ. Otitis Media with
Effusion: Comparative Effectiveness of Treatments. Comparative
3. Effectiveness Review No. 101. Rockville, MD: Agency for
Healthcare Research and Quality; 2013. AHRQ publication 13-
EHC091-EF. Google Scholar
Rosenfeld, RM. A Parent’s Guide to Ear Tubes. Hamilton, Canada:
4.
BC Decker Inc; 2005. Google Scholar
Tos, M. Epidemiology and natural history of secretory otitis. Am
5.
J Otol. 1984;5:459-462. Google Scholar, Medline
Mandel, EM, Doyle, WJ, Winther, B, Alper, CM. The incidence,
prevalence and burden of OM in unselected children aged 1-8 years
6. followed by weekly otoscopy through the “common cold” season.
Int J Pediatr Otorhinolaryngol. 2008;72:491-499. Google Scholar,
Crossref, Medline, ISI
Shekelle, P, Takata, G, Chan, LS. Diagnosis, Natural History and
Late Effects of Otitis Media with Effusion: Evidence
7. Report/Technology Assessment No. 55. Rockville, MD: Agency for
Healthcare Research and Quality; 2003. AHRQ publication 03-E023.
Google Scholar
Lieberthal, AS, Carroll, AE, Chonmaitree, T. The diagnosis and
8. management of acute otitis media. Pediatrics. 2013;131:e964-e999.
Google Scholar, Crossref, Medline, ISI
Paradise, JL, Rockette, HE, Colborn, DK. Otitis media in 2253
Pittsburgh-area infants: prevalence and risk factors during the
9.
first two years of life. Pediatrics. 1997;99:318-333. Google
Scholar, Crossref, Medline, ISI
Casselbrant, ML, Mandel, EM. Epidemiology. In: Rosenfeld, RM,
10. Bluestone, CD, eds. Evidence-Based Otitis Media. 2nd ed.
Hamilton, Canada: BC Decker Inc; 2003:147-162. Google Scholar
Martines, F, Bentivegna, D, Di Piazza, F, Martinciglio, G,
Sciacca, V, Martines, E. The point prevalence of otitis media
11. with effusion among primary school children in Western Sicily.
Eur Arch Otorhinolaryngol. 2010;267:709-714. Google Scholar,
Flynn, T, Möller, C, Jönsson, R, Lohmander, A. The high
prevalence of otitis media with effusion in children with cleft
12. lip and palate as compared to children without clefts. Int J
Pediatr Otorhinolaryngol. 2009;73:1441-1446. Google Scholar,
Maris, M, Wojciechowski, M, Van de Heyning, P, Boudewyns, A. A
cross-sectional analysis of otitis media with effusion in
13.
children with Down syndrome. Eur J Pediatr. 2014;173:1319-1325.
Williamson, IG, Dunleavey, J, Bain, J. The natural history of
otitis media with effusion: a three-year study of the incidence
14. and prevalence of abnormal tympanograms in four South West
Hampshire infant and first schools. J Laryngol Otol.
1994;108:930-934. Google Scholar, Crossref, Medline, ISI
Williamson, I. Otitis media with effusion. Clin Evid. 2002;7:469-
15.
476. Google Scholar
Rosenfeld, RM, Kay, D. Natural history of untreated otitis media.
16. Laryngoscope. 2003;113:1645-1657. Google Scholar, Crossref,
Medline, ISI
Rosenfeld, RM, Schwartz, SR, Pynnonen, MA. Clinical practice
17. guideline: tympanostomy tubes in children. Otolaryngol Head Neck
18. Zielhuis, GA, Rach, GH, van den Broek, P. Screening for otitis
media with effusion in preschool children. Lancet. 1989;1:311-
314. Google Scholar, Crossref, Medline, ISI
Casselbrant, ML, Brostoff, LM, Cantekin, EI. Otitis media with
19. effusion in preschool children. Laryngoscope. 1985;95:428-436.
Aydemir, G, Ozkurt, FE. Otitis media with effusion in primary
schools in Princes’ Islands, Istanbul: prevalence and risk
20.
factors. J Int Med Res. 2011;39:866-872. Google Scholar, SAGE
Journals, ISI
Martines, F, Martines, E, Sciacca, V, Bentivegna, D. Otitis media
with effusion with or without atopy: audiological findings on
21.
primary schoolchildren. Am J Otolaryngol. 2011;32:601-606. Google
Forrest, CB, Fiks, AG, Bailey, LC. Improving adherence to otitis
media guidelines with clinical decision support and physician
22.
feedback. Pediatrics. 2013;131:e1071-e1081. Google Scholar,
Daly, KA, Hoffman, HJ, Kvaerner, KJ. Epidemiology, natural
history, and risk factors: panel report from the Ninth
23. International Research Conference on Otitis Media. Int J Pediatr
Otorhinolaryngol. 2010;74:231-240. Google Scholar, Crossref,
Medline, ISI
Rushton, HC, Tong, MC, Yue, V, Wormald, PJ, van Hasselt, CA.
Prevalence of otitis media with effusion in multicultural schools
24.
in Hong Kong. J Laryngol Otol. 1997;111:804-806. Google Scholar,
Morris, PS, Leach, AJ, Silberberg, P. Otitis media in young
Aboriginal children from remote communities in Northern and
25.
Central Australia: a cross-sectional survey. BMC Pediatrics.
2005;5:27. Google Scholar, Crossref, Medline
Kiris, M, Muderris, T, Kara, T, Bercin, S, Cankaya, H, Sevil, E.
Prevalence and risk factors of otitis media with effusion in
26. school children in Eastern Anatolia. Int J Pediatr
Medline, ISI
Mahadevan, M, Navarro-Locsin, G, Tan, HKK. A review of the burden
of disease due to otitis media in the Asia-Pacific. Int J Pediatr
27.
Medline, ISI
Lannon, C, Peterson, LE, Goudie, A. Quality measures for the care
28. of children with otitis media with effusion. Pediatrics.
2011;127:e1490-e1497. Google Scholar, Crossref, Medline, ISI
Qureishi, A, Lee, Y, Belfield, K, Birchall, JP, Daniel, M. Update
29. on otitis media: prevention and treatment. Infect Drug Resist.
2014;7:15-24. Google Scholar, Medline, ISI
Monasta, L, Ronfani, L, Marchetti, F. Burden of disease caused by
30. otitis media: systematic review and global estimates. PLOS One.
2012;7:e36226. Google Scholar, Crossref, Medline, ISI
31. Bellussi, L, Mandalà, M, Passali, FM, Passali, GC, Lauriello, M,
Passali, D. Quality of life and psycho-social development in
children with otitis media with effusion. Acta Otorhinolaryngol
Ital. 2005;25:359-364. Google Scholar, Medline
Roberts, JE, Burchinal, MR, Collier, AM, Ramey, CT, Koch, MA,
Henderson, FW. Otitis media in early childhood and cognitive,
32.
academic, and classroom performance of the school-aged child.
Pediatrics. 1989;83:477-485. Google Scholar, Medline, ISI
Rosenfeld, RM, Jang, DW, Tarashansky, K. Tympanostomy tube
outcomes in children at-risk and not at-risk for developmental
33.
delays. Int J Pediatr Otorhinolaryngol. 2011;75:190-195. Google
Klein, JO. The burden of otitis media. Vaccine. 2000;19(suppl
34.
1):S2-S8. Google Scholar, Crossref, Medline, ISI
Brouwer, CN, Maillé, AR, Rovers, MM, Grobbee, DE, Sanders, EA,
Schilder, AG. Health-related quality of life in children with
35.
otitis media. Int J Pediatr Otorhinolaryngol. 2005;69:1031-1041.
Karkanevatos, A, Lesser, TH. Grommet insertion in children: a
36. survey of parental perceptions. J Laryngol Otol. 1998;112:732-
Rovers, MM. The burden of otitis media. Vaccine. 2008;26(suppl
37.
7):G2-G4. Google Scholar, Crossref, Medline, ISI
Timmerman, AA, Anteunis, LJC, Meesters, CMG. Response-shift bias
and parent-reported quality of life in children with otitis
38.
media. Arch Otolaryngol Head Neck Surg. 2003;129:987-991. Google
Scholar, Crossref, Medline
Casselbrant, ML, Furman, JM, Rubenstein, E, Mandel, EM. Effect of
otitis media on the vestibular system in children. Ann Otol
39.
Rhinol Laryngol Suppl. 1995;104:620-624. Google Scholar, SAGE
Journals
Casselbrant, ML, Redfern, MS, Furman, JM, Fall, PA, Mandel, EM.
Visual-induced postural sway in children with and without otitis
40.
media. Ann Otol Rhinol Laryngol Suppl. 1998;107:401-405. Google
Scholar, SAGE Journals
Golz, A, Netzer, A, Angel-Yeger, B, Westerman, ST, Gilbert, LM,
Joachims, HZ. Effects of middle ear effusion on the vestibular
41.
system in children. Otolaryngol Head Neck Surg. 1998;119:695-699.
Google Scholar, SAGE Journals, ISI
Orlin, MN, Effgen, SK, Handler, SD. Effect of otitis media with
effusion on gross motor ability in preschool-aged children:
42.
preliminary findings. Pediatrics. 1997;99:334-337. Google
Alho, OP, Oja, H, Koivu, M, Sorri, M. Chronic otitis media with
effusion in infancy: how frequent is it? How does it develop?
43.
Arch Otolaryngol Head Neck Surg. 1995;121:432-436. Google
44. Koopman, L, Hoes, AW, Glasziou, PP. Antibiotic therapy to prevent
the development of asymptomatic middle ear effusion in children
with acute otitis media: a meta-analysis of individual patient
data. Arch Otolaryngol Head Neck Surg. 2008;134:128-132. Google
Rosenfeld, RM, Bhaya, MH, Bower, CM. Impact of tympanostomy tubes
45. on hild quality of life. Arch Otolaryngol Head Neck Surg.
2000;126:585-592. Google Scholar, Crossref, Medline
Jung, TTK, Alper, CM, Hellstrom, SO. Panel 8: complications and
46. sequelae. Otolaryngol Head Neck Surg. 2013;148(4)(suppl):E122-
E143. Google Scholar, SAGE Journals, ISI
Austeng, ME, Akre, H, Øverland, B, Abdelnoor, M, Falkenberg, ES,
Kvaerner, KJ. Otitis media with effusion in children with in Down
47.
syndrome. Int J Pediatr Otorhinolaryngol. 2013;77:1329-1332.
Marom, T, Tan, A, Wilkinson, GS, Pierson, KS, Freeman, JL,
Chonmaitree, T. Trends in otitis media-related health care use in
48.
the United States, 2001-2011. JAMA Pediatrics. 2014;168:68-75.
O’Brien, MA, Prosser, LA, Paradise, JL. New vaccines against
otitis media: projected benefits and cost-effectiveness.
49.
Pediatrics. 2009;123:1452-1463. Google Scholar, Crossref,
Medline, ISI
Zhou, F, Shefer, A, Kong, Y, Nuorti, JP. Trends in acute otitis
media-related health care utilization by privately insured young
50.
children in the United States, 1997-2004. Pediatrics.
Schwartz, SR, Gates, GA. Economic costs. In: Rosenfeld, RM,
51. Bluestone, CD eds. Evidence-Based Otitis Media. 2nd ed. Hamilton,
Canada: BC Decker Inc; 2003. Google Scholar
Alsarraf, R, Jung, CJ, Perkins, J, Crowley, C, Alsarraf, NW,
Gates, GA. Measuring the indirect and direct costs of acute
52.
otitis media. Arch Otolaryngol Head Neck Surg. 1999;125:12-18.
Google Scholar, Crossref, Medline
Kong, K, Coates, HLC. Natural history, definitions, risk factors
53. and burden of otitis media. Med J Aust. 2009;191(9):S39-S43.
Google Scholar, Medline, ISI
Access-Economics. The cost burden of otitis media in Australia
2009.
54.
http://www.accesseconomics.com.au/publicationsreports/getreport.p
hp?report=190&id=244. Accessed September 2009. Google Scholar
van Zon, A, van der Heijden, GJ, van Dongen, TMA. Antibiotics for
55. otitis media with effusion in children. Cochrane Database Syst
Rev. 2012;9:CD009163. Google Scholar
Miura, MS, Mascaro, M, Rosenfeld, RM. Association between otitis
media and gastroesophageal reflux: a systematic review.
56.
Otolaryngol Head Neck Surg. 2012;146:345-352. Google Scholar,
SAGE Journals, ISI
Alles, R, Parikh, A, Hawk, L. The prevalence of atopic disorders
in children with chronic otitis media with effusion. Pediatr
57.
Allergy Immunol. 2001;12:102-106. Google Scholar, Crossref,
Medline, ISI
58. Caffarelli, C, Savini, E, Giordano, S. Atopy in children with
otitis media with effusion. Clin Exp Allergy. 1998;28:591-596.
Luong, A, Roland, PS. The link between allergic rhinitis and
chronic otitis media with effusion in atopic patients.
59.
Otolaryngol Clin North Am. 2008;41:311-323. Google Scholar,
Griffin, G, Flynn, CA. Antihistamines and/or decongestants for
60. otitis media with effusion (OME) in children. Cochrane Database
Syst Rev. 2011;9:CD003423. Google Scholar
Simpson, SA, Thomas, CL, van der Linden, M, MacMillan, H, van der
Wouden, JC, Butler, CC. Identification of children in the first
61. four years of life for early treatment for otitis media with
effusion. Cochrane Database Syst Rev. 2007;1:CD004163. Google
Scholar, Crossref, ISI
Rosenfeld, RM, Shiffman, RN, Robertson, P. Clinical practice
guideline development manual, third edition: a quality-driven
62.
approach for translating evidence into action. Otolaryngol Head
Neck Surg. 2013;148(1):S1-S55. Google Scholar, SAGE Journals, ISI
Shiffman, RN, Michel, G, Rosenfeld, RM, Davidson, C. Building
better guidelines with BRIDGE-Wiz: a software assistant to
63. promote quality, transparency, and implementability. J Amer Med
Inform Assoc. 2012;19:94-101. Google Scholar, Crossref, Medline,
ISI
Shiffman, RN, Dixon, J, Brandt, C. The guideline implementability
appraisal (GLIA): development of an instrument to identify
64.
obstacles to guideline implementation. BMC Med Inform Decis.
2005;5:23. Google Scholar, Crossref, Medline
Eddy, DM. Clinical decision making: from theory to practice.
65. Cost-effectiveness analysis: will it be accepted? JAMA.
American Academy of Pediatrics Steering Committee on Quality
Improvement and Management. Classifying recommendations for
66.
clinical practice guidelines. Pediatrics. 2004;114:874-877.
Choudhry, NK, Stelfox, HT, Detsky, AS. Relationships between
authors of clinical practice guidelines and the pharmaceutical
67.
industry. JAMA. 2002;287:612-617. Google Scholar, Crossref,
Medline, ISI
Detsky, AS. Sources of bias for authors of clinical practice
68. guidelines. Can Med Assoc J. 2006;175:1033, 1035. Google Scholar,
US Department of Health and Human Services. 2012 annual progress
report to congress: national strategy for quality improvement in
69. health care.
http://www.ahrq.gov/workingforquality/nqs/nqs2012annlrpt.pdf.
Published May 2014. Accessed August 8, 2015. Google Scholar
Jones, WS, Kaleida, PH. How helpful is pneumatic otoscopy in
70. improving diagnostic accuracy? Pediatrics. 2003;112:510-513.
Steinbach, WJ, Sectish, TC. Pediatric resident training in the
71. diagnosis and treatment of acute otitis media. Pediatrics.
Pichichero, ME, Poole, MD. Assessing diagnostic accuracy and
tympanocentesis skills in the management of otitis media. Arch
72.
Pediatr Adolesc Med. 2001;155:1137-1142. Google Scholar,
Crossref, Medline
Onusko, E. Tympanometry. Am Fam Physician. 2004;70:1713-1720.
73.
Google Scholar, Medline, ISI
American Speech-Language-Hearing Association. Guidelines for
screening infants and children for outer and middle ear
74. disorders, birth through 18 years. In: Guidelines for Audiologic
Screening. Rockville, MD: American Speech-Language-Hearing
Association; 1997:15-22. Google Scholar
Takata, GS, Chan, LS, Morphew, T, Mangione-Smith, R, Morton, SC,
Shekelle, P. Evidence assessment of the accuracy of methods of
75. diagnosing middle ear effusion in children with otitis media with
effusion. Pediatrics. 2003;112:1379-1387. Google Scholar,
Nozza, RJ, Bluestone, CD, Kardatzke, D, Bachman, R.
Identification of middle ear effusion by aural acoustic
76.
admittance and otoscopy. Ear Hear. 1994;15:310-323. Google
Paradise, JL, Smith, CG, Bluestone, CD. Tympanometric detection
77. of middle ear effusion in infants and young children. Pediatrics.
Marchant, CD, McMillan, PM, Shurin, PA, Johnson, CE, Turczyk, VA,
Feinstein, JC. Objective diagnosis of otitis media in early
78. infancy by tympanometry and ipsilateral acoustic reflex
thresholds. J Pediatr. 1986;109:590-595. Google Scholar,
Hunter, LL, Prieve, BA, Kei, J, Sanford, CA. Pediatric
79. applications of wideband acoustic immittance measures. Ear Hear.
2013;34(suppl 1):36S-42S. Google Scholar, Crossref, Medline, ISI
Joint Committee on Infant Hearing. Position statement: principles
and guidelines for early hearing detection and intervention
80.
programs. Pediatrics. 2007;120:898-921. Google Scholar, Crossref,
Medline, ISI
Baldwin, M. Choice of probe tone and classification of trace
patterns in tympanometry undertaken in early infancy. Int J
81.
Audiology. 2006;45:417-427. Google Scholar, Crossref, Medline,
ISI
Zhiqi, L, Kun, Y, Zhiwu, H. Tympanometry in infants with middle
ear effusion having been identified using spiral computerized
82.
tomography. Am J Otolaryngol. 2010;31:96-103. Google Scholar,
Wittman-Price, RA, Rope, KA. Universal newborn hearing screening.
83.
Am J Nurs. 2002;102:71-77. Google Scholar, Crossref, ISI
84. Calderon, R, Naidu, S. Further support of the benefits of early
identification and intervention with children with hearing loss.
Volta Rev. 1999;100:53-84. Google Scholar
Kennedy, CR, McCann, DC, Campbell, MJ. Language ability after
85. early detection of permanent childhood hearing impairment. N Engl
J Med. 2006;354:2131-2141. Google Scholar, Crossref, Medline, ISI
Boudewyns, A, Declau, F, Van den Ende, J. Otitis media with
effusion: an underestimated cause of hearing loss in infants.
86.
Otol Neurotol. 2011;32:799-804. Google Scholar, Crossref,
Medline, ISI
Boone, RT, Bower, CM, Martin, PF. Failed newborn hearing screens
as presentation for otitis media with effusion in the newborn
87.
population. Int J Pediatr Otorhinolaryngol. 2005;69:393-397.
National Institutes of Health. Early identification of hearing
88. impairment in infants and young children. NIH Consens Statement.
1993;11:1-24. Google Scholar
Holte, L, Walker, E, Oleson, J. Factors influencing follow-up to
89. newborn hearing screening for infants who are hard of hearing. Am
J Audiol. 2012;21:163-174. Google Scholar, Crossref, Medline, ISI
Moeller, MP, White, KR, Shisler, L. Primary care physicians’
knowledge, attitudes, and practices related to newborn hearing
90.
screening. Pediatrics. 2006;118:1357-1370. Google Scholar,
Harrison, M, Roush, J. Age of suspicion, identification, and
intervention for infants and young children with hearing loss: a
91.
national study. Ear Hear. 1996;17:55-62. Google Scholar,
Folsom, RC, Widen, JE, Vohr, BR. Identification of neonatal
92. hearing impairment: recruitment and follow-up. Ear Hear.
Coplan, J. Deafness: ever heard of it? Delayed recognition of
93. permanent hearing loss. Pediatrics. 1987;79:206-213. Google
Scholar, Medline, ISI
Dalzell, L, Orlando, M, MacDonald, M. The New York State
universal newborn hearing screening demonstration project: ages
94. of hearing loss identification, hearing aid fitting, and
enrollment in early intervention. Ear Hear. 2000;21:118-130.
Korres, S, Nikolopoulos, TP, Peraki, EE. Outcomes and efficacy of
newborn hearing screening: strengths and weaknesses (success or
95.
failure?). Laryngoscope. 2008;118:1253-1256. Google Scholar,
Ruben, RJ. Otitis media: the application of personalized
96. medicine. Otolaryngol Head Neck Surg. 2011;145:707-712. Google
Scholar, SAGE Journals, ISI
Ruben, RJ, Math, R. Serous otitis media associated with
97. sensorineural hearing loss in children. Laryngoscope.
98. Brookhouser, PE, Worthington, DW, Kelly, WJ. Middle ear disease
in young children with sensorineural hearing loss. Laryngoscope.
Ruben, R. Host susceptibility to otitis media sequelae. In:
Rosenfeld, RM, Bluestone, CD, eds. Evidence-Based Otitis Media.
99.
2nd ed. Hamilton, Canada: BC Decker Inc; 2003:505-514. Google
Scholar
Sices, L, Feudtner, C, McLaughlin, J, Drotar, D, Williams, M. How
do primary care physicians manage children with possible
100. developmental delays? A national survey with an experimental
design. Pediatrics. 2004;113:274-282. Google Scholar, Crossref,
Medline, ISI
Gravel, JS. Hearing and auditory function. In: Rosenfeld, RM,
101. Bluestone, CD, eds. Evidence-Based Otitis Media. 2nd ed.
Hamilton, Canada: BC Decker Inc; 2003:342-359. Google Scholar
Iino, Y, Imamura, Y, Harigai, S. Efficacy of tympanostomy tube
insertion for otitis media with effusion in children with Down
102.
syndrome. Int J Pediatr Otorhinolaryngol. 1999;49:143-149. Google
Selikowitz, M. Short-term efficacy of tympanostomy tubes for
secretory otitis media in children with Down syndrome. Dev Med
103.
Child Neurol. 1993;35:511-515. Google Scholar, Crossref, Medline,
ISI
Raut, P, Sriram, B, Yeoh, A, Hee, KY, Lim, SB, Daniel, ML. High
prevalence of hearing loss in Down syndrome at first year of
104.
life. Ann Acad Med Singapore. 2011;40:493-498. Google Scholar,
Medline, ISI
Park, AH, Wilson, MA, Stevens, PT, Harward, R, Hohler, N.
Identification of hearing loss in pediatric patients with Down
105.
syndrome. Otolaryngol Head Neck Surg. 2012;146:135-140. Google
Shott, SR. Down syndrome: common otolaryngologic manifestations.
106. Am J Med Genet. 2006;142C:131-140. Google Scholar, Crossref,
Medline, ISI
Bull, MJ; Committee on Genetics. Health supervision for children
107. with Down syndrome. Pediatrics. 2011;128:393-406. Google Scholar,
Vanderas, AP. Incidence of cleft lip, cleft palate, and cleft lip
108. and palate among races: a review. Cleft Palate J. 1987;24:216-
225. Google Scholar, Medline
Sheahan, P, Blayney, AW, Sheahan, JN, Earley, MJ. Sequelae of
otitis media with effusion among children with cleft lip and/or
109.
cleft palate. Clin Otolaryngol. 2002;27:494-500. Google Scholar,
Kuo, C-L, Tsao, Y-H, Cheng, H-M. Grommets for otitis media with
effusion in children with cleft palate: a systematic review.
110.
Pediatrics. 2014;134:983-994. Google Scholar, Crossref, Medline,
ISI
111. D’Mello, J, Kumar, S. Audiological findings in cleft palate
patients attending speech camp. Indian J Med Res. 2007;125:777-
782. Google Scholar, Medline, ISI
Ponduri, S, Bradley, R, Ellis, PE. The management of otitis media
with early routine insertion of grommets in children with cleft
112.
palate: a systematic review. Cleft Palate Craniofac J.
McLaughlin, MR. Speech and language delay in children. Am Fam
113.
Physician. 2011;83:1183-1188. Google Scholar, Medline, ISI
Bess, F, Tharpe, A. Case history data on unilateral hearing
114. injured children. Ear Hear. 1986;7:14-19. Google Scholar,
Bess, FH, Dodd-Murphy, J, Parker, RA. Children with minimal
sensorineural hearing loss: prevalence, educational performance,
115.
and functional status. Ear Hear. 1998;19:339-354. Google Scholar,
Simpson, SA, Thomas, CL, van der Linden, M, MacMillan, H, van der
Wouden, JC, Butler, CC. Identification of children in the first
116. four years of life for early treatment for otitis media with
effusion. Cochrane Database Syst Rev. 2007;1:CD004163. Google
Paradise, JL, Feldman, HM, Campbell, TF. Effect of early or
delayed insertion of tympanostomy tubes for persistent otitis
117.
media on developmental outcomes at the age of three years. N Engl
J Med. 2001;344:1179-1187. Google Scholar, Crossref, Medline, ISI
MRC Multicenter Otitis Media Study Group. Sensitivity,
specificity and predictive value of tympanometry in predicting a
118. hearing impairment in otitis media with effusion. Clin
Otolaryngol. 1999;24:294-300. Google Scholar, Crossref, Medline,
ISI
Sorenson, CH, Jensen, SH, Tos, M. The post-winter prevalence of
middle ear effusion in four-year-old children, judged by
119.
tympanometry. Int Otorhinolaryngol. 1981;3:119-128. Google
Fiellau-Nikolajsen, M. Epidemiology of secretory otitis media: a
120. descriptive cohort study. Ann Otol Rhinol Laryngol. 1983;92:172-
177. Google Scholar, SAGE Journals, ISI
Poulsen, G, Tos, M. Repetitive tympanometric screenings of two-
121. year-old children. Scand Audiol. 1980;9:21-28. Google Scholar,
Crossref, Medline
Tos, M, Holm-Jensen, S, Sørensen, CH. Changes in prevalence of
122. secretory otitis from summer to winter in four-year-old children.
Am J Otol. 1981;2:324-327. Google Scholar, Medline
Thomsen, J, Tos, M. Spontaneous improvement of secretory otitis:
123. a long-term study. Acta Otolaryngol. 1981;92:493-499. Google
Merenstein, D, Diener-West, M, Krist, A. An assessment of the
shared-decision model in parents of children with acute otitis
124.
media. Pediatrics. 2005;116:1267-1275. Google Scholar, Crossref,
Medline, ISI
125. Todberg, T, Koch, A, Andersson, M, Olsen, SF, Lous, J, Homoe, P.
Incidence of otitis media in a contemporary Danish National Birth
Cohort. PLOS One. 2014;9:e111732. Google Scholar, Crossref,
Medline, ISI
Casselbrant, ML, Mandel, EM, Rockette, HE. The genetic component
of middle ear disease in the first 5 years of life. Arch
126.
Otolaryngol Head Neck Surg. 2004;130:273-278. Google Scholar,
Crossref, Medline
Schilder, AGM, Lok, W, Rovers, MM. International perspectives on
management of acute otitis media: a qualitative review. Int J
127.
van Balen, FA, de Melker, RA. Persistent otitis media with
effusion: can it be predicted? A family practice follow-up study
128.
in children aged 6 months to 6 years. J Fam Pract. 2000;49:605-
611. Google Scholar, Medline, ISI
Roberts, JE, Burchinal, MR, Jackson, SC. Otitis media in
childhood in relation to preschool language and school readiness
129.
skills among black children. Pediatrics. 2000;106:725-735. Google
Roberts, JE, Rosenfeld, RM, Zeisel, SA. Otitis media and speech
130. and language: a meta-analysis of prospective studies. Pediatrics.
2004;113:e238-e248. Google Scholar, Crossref, Medline, ISI
Pavia, M, Bianco, A, Nobile, CGA. Efficacy of pneumococcal
vaccination in children younger than 24 months: a meta-analysis.
131.
Pediatrics. 2009;123:e1103-e1110. Google Scholar, Crossref,
Medline, ISI
Niemela, M, Pihakari, O, Pokka, T, Marinelli, P, Angelillo, IF.
Pacifier as a risk factor for acute otitis media: a randomized,
132.
controlled trial of parental counseling. Pediatrics.
Tully, SB, Bar-Haim, Y, Bradley, RL. Abnormal tympanography after
133. supine bottle feeding. J Pediatr. 1995;126:S105-S111. Google
Brown, CE, Magnuson, B. On the physics of the infant feeding
bottle and middle ear sequela: ear disease in infants can be
134.
associated with bottle feeding. Int J Pediatr Otorhinolaryngol.
Bhutta, MF. Epidemiology and pathogenesis of otitis media:
135. construction of a phenotype landscape. Audiol Neurootol.
Teele, DW, Klein, JO, Rosner, BA. Epidemiology of otitis media in
136. children. Ann Otol Rhinol Laryngol Suppl. 1980;89:5-6. Google
Scholar, SAGE Journals
Mygind, N, Meistrup-Larsen, KI, Thomsen, J. Penicillin in acute
137. otitis media: a double-blind placebo-controlled trial. Clin
Otolaryngol. 1981;6:5-13. Google Scholar, Crossref, Medline, ISI
Burke, P, Bain, J, Robinson, D. Acute red ear in children:
138. controlled trial of non-antibiotic treatment in general practice.
BMJ. 1991;303:558-562. Google Scholar, Crossref, Medline
Thomas, CL, Simpson, SA, Butler, CC. Oral or topical nasal
steroids for hearing loss associated with otitis media with
139.
effusion in children. Cochrane Database Syst Rev.
2006;3:CD001935. Google Scholar, Crossref, ISI
Williamson, I, Benge, S, Barton, S. A double-blind randomised
placebo-controlled trial of topical intranasal corticosteroids in
140. 4- to 11-year-old children with persistent bilateral otitis media
with effusion in primary care. Health Technol Assess (Winch Eng).
Bhargava, R, Chakravarti, A. A double-blind randomized placebo-
controlled trial of topical intranasal mometasone furoate nasal
141. spray in children of adenoidal hypertrophy with otitis media with
effusion. Am J Otolaryngol. 2014;35:766-770. Google Scholar,
Cengel, S, Akyol, MU. The role of topical nasal steroids in the
treatment of children with otitis media with effusion and/or
142.
adenoid hypertrophy. Int J Pediatr Otorhinolaryngol. 2006;70:639-
Lack, G, Caulfield, H, Penagos, M. The link between otitis media
with effusion and allergy: a potential role for intranasal
143.
corticosteroids. Pediatr Allergy Immunol. 2011;22:258-266. Google
Schoem, SR, Willard, A, Combs, JT. A prospective, randomized,
placebo-controlled, double-blind study of montelukast’s effect
144.
on persistent middle ear effusion. Ear Nose Throat J.
2010;89:434-437. Google Scholar, Medline
Ertugay, CK, Cingi, C, Yaz, A. Effect of combination of
montelukast and levocetirizine on otitis media with effusion: a
145.
prospective, placebo-controlled trial. Acta Otolaryngol.
Hunter, LL, Margolis, RH, Giebink, GS. Identification of hearing
146. loss in otitis media. Ann Otol Rhinol Laryngol Suppl.
1994;103:59-61. Google Scholar, SAGE Journals
Sabo, DL, Paradise, JL, Kurs-Lasky, M, Smith, CG. Hearing levels
in infants and young children in relation to testing technique,
147.
age group, and the presence or absence of middle-ear effusion.
Ear Hear. 2003;24:38-47. Google Scholar, Crossref, Medline
Gravel, JS, Roberts, JE, Roush, J. Early otitis media with
148. effusion, hearing loss, and auditory processes at school age. Ear
Hear. 2006;27:353-368. Google Scholar, Crossref, Medline, ISI
Hunter, LL, Margolis, RH, Rykken, JR, Le, CT, Daly, KA, Giebink,
149. GS. High frequency hearing loss associated with otitis media. Ear
Hear. 1996;17:1-11. Google Scholar, Crossref, Medline, ISI
Shriberg, LD, Friel-Patti, S, Flipsen, P, Brown, RL. Otitis
media, fluctuant hearing loss, and speech-language outcomes: a
150.
preliminary structural equation model. J Speech Lang Hear Res.
151. Lieu, JEC. Speech-language and educational consequences of
unilateral hearing loss in children. Arch Otolaryngol Head Neck
Surg. 2004;130:524-530. Google Scholar, Crossref, Medline
Brody, R, Rosenfeld, RM, Goldsmith, AJ, Madell, R. Parents cannot
152. detect mild hearing loss in children. Otolaryngol Head Neck Surg.
1999;121:681-686. Google Scholar, SAGE Journals, ISI
Sidell, D, Hunter, L, Lin, L, Arjmand, E. Risk factors for
hearing loss surrounding pressure equalization tube placement in
153.
children. Otolaryngol Head Neck Surg. 2014;150:1048-1055. Google
Harlor, AD, Bower, C; Committee on Practice and Ambulatory
Medicine, Section on Otolaryngology–Head and Neck Surgery,
American Academy of Pediatrics. Clinical report: hearing
154.
assessment in infants and children: recommendations beyond
neonatal screening. Pediatrics. 2009;124:1252-1263. Google
American Speech-Language-Hearing Association. Typical speech and
language development.
155.
http://www.asha.org/public/speech/development/. Accessed March
24, 2015. Google Scholar
Marsh, RR, Baranak, CC, Potsic, WP. Hearing loss and visco-
156. elasticity of middle ear fluid. Int J Pediatr Otorhinolaryngol.
Widen, JE, Folsom, RC, Cone-Wesson, B. Identification of neonatal
hearing impairment: hearing status at 8 to 12 months corrected
157.
age using a visual reinforcement audiometry protocol. Ear Hear.
Casby, MW. Otitis media and language development. Am J Speech
158.
Lang Path. 2001;10:65-80. Google Scholar, Crossref, ISI
Paradise, JL, Feldman, HM, Campbell, TF. Early versus delayed
insertion of tympanostomy tubes for persistent otitis media:
developmental outcomes at the age of three years in relation to
159.
prerandomization illness patterns and hearing levels. Pediatr
Infect Dis J. 2003;22:309-314. Google Scholar, Crossref, Medline,
ISI
Browning, GG, Rovers, MM, Williamson, I. Grommets (ventilation
tubes) for hearing loss associated with otitis media with
160.
Rovers, MM, Black, N, Browning, GG, Maw, R, Zelhuis, GA, Haggard,
MP. Grommets in otitis media with effusion: an individual patient
161.
data meta-analysis. Arch Dis Child. 2005;90:480-485. Google
Maw, AR, Bawden, R. The long term outcome of secretory otitis
media in children and the effects of surgical treatment: a ten
162.
year study. Acta Otorhinolaryngol Belg. 1994;48:317-324. Google
Scholar, Medline
American Speech-Language-Hearing Association. Directory of
speech-language pathology assessment onstruments.
163.
http://www.asha.org/assessments.aspx. Accessed March 24, 2015.
Google Scholar
American Speech-Language-Hearing Association. Typical speech and
language development.
164.
http://www.asha.org/public/speech/development/. Accessed March
24, 2015. Google Scholar
Klee, T, Pearce, K, Carson, DK. Improving the positive predictive
value of screening for developmental language disorder. J Speech
165.
Lang Hear Res. 2000;43:821-833. Google Scholar, Crossref,
Medline, ISI
Agency for Healthcare Research and Quality. Screening for Speech
and Language Delay in Preschool Children. Rockville, MD: Agency
166.
for Healthcare Research and Quality; 2015. Systematic evidence
review 41. Google Scholar
Johnson, CJ, Beitchman, JH, Young, A. Fourteen-year follow-up of
children with and without speech/language impairments:
167.
speech/language stability and outcomes. J Speech Lang Hear Res.
Catts, HW. The relationship between speech-language impairments
168. and reading disabilities. J Speech Hear Res. 1993;36:948-958.
Scarborough, HS, Dobrich, W. Development of children with early
169. language delay. J Speech Lang Hear Res. 1990;33:70-83. Google
Gillon, GT. Facilitating phoneme awareness development in 3- and
170. 4-year-old children with speech impairment. Lang Speech Hear Serv
Sch. 2005;36:308-324. Google Scholar, Crossref, Medline, ISI
Kirk, C, Gillon, GT. Integrated morphological awareness
171. intervention as a tool for improving literacy. Lang Speech Hear
Serv Sch. 2009;40:341-351. Google Scholar, Crossref, Medline, ISI
Glade, M. Diagnostic and Therapeutic Technology Assessment:
Speech Therapy in Patients with a Prior History of Recurrent
172.
Acute or Chronic Otitis Media with Effusion. Chicago, IL:
American Medical Association; 1996. Google Scholar
Paradise, JL, Campbell, TF, Dollaghan, CA. Developmental outcomes
173. after early or delayed insertion of tympanostomy tubes. N Engl J
Med. 2005;353:576-586. Google Scholar, Crossref, Medline, ISI
Rovers, MM, Straatman, H, Ingels, K. The effect of ventilation
tubes on language development in infants with otitis media with
174.
effusion: a randomized trial. Pediatrics. 2000;106:E42. Google
Rovers, MM, Straatman, H, Ingels, K. The effect of short-term
ventilation tubes versus watchful waiting on hearing in young
175. children with persistent otitis media with effusion: a randomized
trial. Ear Hear. 2001;22:191-199. Google Scholar, Crossref,
Medline, ISI
Rosenfeld, RM, Kay, D. Natural history of untreated otitis media.
176. Laryngoscope. 2003;113:1645-1657. Google Scholar, Crossref,
Medline, ISI
177. Thomsen, J, Tos, M. Spontaneous improvement of secretory otitis:
a long-term study. Acta Otolaryngol. 1981;92:493-499. Google
Anabousi, S, Bakowsky, U, Schneider, M, Huwer, H, Lehr, CM,
Ehrhardt, C. In vitro assessment of transferrin-conjugated
178. liposomes as drug delivery systems for inhalation therapy of lung
cancer. Eur J Pharm Sci. 2006;29:367-374. Google Scholar,
Tos, M. Spontaneous improvement of secretory otitis and impedance
179. screening. Arch Otolaryngol. 1980;106:345-349. Google Scholar,
Crossref, Medline
Tos, M, Holm-Jensen, S, Sorensen, CH, Mogensen, C. Spontaneous
course and frequency of secretory otitis in 4-year-old children.
180.
Arch Otolaryngol. 1982;108:4-10. Google Scholar, Crossref,
Medline
Zielhuis, GA, Rach, GH, van den Broek, P. The natural course of
otitis media with effusion in preschool children. Eur Arch
181.
Medline, ISI
MRC Multicentre Otitis Media Study Group. Surgery for persistent
otitis media with effusion: generalizability of results from the
182. UK trial (TARGET). Trial of alternative regimens in glue ear
treatment. Clin Otolaryngol Allied Sci. 2001;26:417-424. Google
Yellon, RF, Doyle, WJ, Whiteside, TL, Diven, WF, March, AR,
Fireman, P. Cytokines, immunoglobulins, and bacterial pathogens
183.
in middle ear effusions. Arch Otolaryngol Head Neck Surg.
1995;121:865-869. Google Scholar, Crossref, Medline
Samuel, EA, Burrows, A, Kerschner, JE. Cytokine regulation of
184. mucin secretion in a human middle ear epithelial model. Cytokine.
Kim, SH, Cha, SH, Kim, YI, Byun, JY, Park, MS, Yeo, SG. Age-
dependent changes in pattern recognition receptor and cytokine
185. mRNA expression in children with otitis media with effusion. Int
J Pediatr Otorhinolaryngol. 2015;79:229-234. Google Scholar,
de Ru, JA, Grote, JJ. Otitis media with effusion: disease or
defense? A review of the literature. Int J Pediatr
186.
Medline, ISI
Vonk, MJ, Hiemstra, PS, Grote, JJ. An antimicrobial peptide
modulates epithelial responses to bacterial products.
187.
Laryngoscope. 2008;118:816-820. Google Scholar, Crossref,
Medline, ISI
Maw, AR, Bawden, R. The long term outcome of secretory otitis
media in children and the effects of surgical treatment: a ten
188.
year study. Acta Otorhinolaryngol Belg. 1994;48:317-324. Google
Scholar, Medline
Rosenfeld, RM, Culpepper, L, Doyle, KJ. Clinical practice
189. guideline: otitis media with effusion. Otolaryngol Head Neck
Perera, R, Glasziou, PP, Heneghan, CJ, McLellan, J, Williamson,
I. Autoinflation for hearing loss associated with otitis media
190.
with effusion. Cochrane Database Syst Rev. 2013;5:CD006285.
Google Scholar
Haggard, MP, Birkin, JA, Browning, GG, Gatehouse, S, Lewis, S.
Behavior problems in otitis media. Pediatr Infect Dis J.
191.
1994;13(1)(suppl 1):S43-S50. Google Scholar, Crossref, Medline,
ISI
Bennett, KE, Haggard, MP. Behaviour and cognitive outcomes from
192. middle ear disease. Arch Dis Child. 1999;80:28-35. Google
Bennett, KE, Haggard, MP, Silva, PA, Stewart, IA. Behaviour and
developmental effects of otitis media with effusion into the
193.
teens. Arch Dis Child. 2001;85:91-95. Google Scholar, Crossref,
Medline, ISI
Davis, JM, Elfenbein, J, Schum, R, Bentler, RA. Effects of mild
and moderate hearing impairments on language, educational, and
194.
psychosocial behavior of children. J Speech Hear Dis. 1986;51:53-
62. Google Scholar, Crossref, Medline
Bess, FH, Dodd-Murphy, J, Parker, RA. Children with minimal
sensorineural hearing loss: prevalence, educational performance,
195.
and functional status. Ear Hear. 1998;19:339-354. Google Scholar,
Rovers, MM, Black, N, Browning, GG, Maw, R, Zelhuis, GA, Haggard,
MP. Grommets in otitis media with effusion: an individual patient
196.
data meta-analysis. Arch Dis Child. 2005;90:480-485. Google
Hellstrom, S, Groth, A, Jorgensen, F. Ventilation tube treatment:
197. a systematic review of the literature. Otolaryngol Head Neck
Surg. 2011;145:383-395. Google Scholar, SAGE Journals, ISI
Boonacker, CWB, Rovers, MM, Browning, GG. Adenoidectomy with or
without grommets for children with otitis media: an individual
198.
patient data meta-analysis. Health Technol Assess (Winch Eng).
Mikals, SJ, Brigger, MT. Adenoidectomy as an adjuvant to primary
tympanostomy tube placement: a systematic review and meta-
199.
analysis. JAMA Otolaryngol Head Neck Surg. 2014;140:95-101.
Casselbrant, ML, Mandel, EM, Rockette, HE. Adenoidectomy for
otitis media with effusion in 2-3-year-old children. Int J
200.
Hammaren-Malmi, S, Saxen, H, Tarkkanen, J, Mattila, PS.
Adenoidectomy does not significantly reduce the incidence of
otitis media in conjunction with the insertion of tubes in
201.
children who are younger than 4 years: a randomized trial.
Pediatrics. 2005;116:185-189. Google Scholar, Crossref, Medline,
ISI
202. van der Griend, BF, Lister, NA, McKenzie, IM. Postoperative
mortality in children after 101,885 anesthetics at a tertiary
pediatric hospital. Anesth Analg. 2011;112:1440-1447. Google
Kay, DJ, Nelson, M, Rosenfeld, RM. Meta-analysis of tympanostomy
203. tube sequelae. Otolaryngol Head Neck Surg. 2001;124:374-380.
Google Scholar, SAGE Journals, ISI
Mohamad, SH, Khan, I, Hussain, SSM. Is cartilage tympanoplasty
more effective than fascia tympanoplasty? A systematic review.
204.
Otol Neurotol. 2012;33:699-705. Google Scholar, Crossref,
Medline, ISI
Wallace, IF, Berkman, ND, Lohr, KN. Surgical treatments for
205. otitis media with effusion: a systematic review. Pediatrics.
Nguyen, LHP, Manoukian, JJ, Yoskovitch, A, Al-Sebeih, KH.
Adenoidectomy: selection criteria for surgical cases of otitis
206.
media. Laryngoscope. 2004;114:863-866. Google Scholar, Crossref,
Medline, ISI
Browning, GG, Rovers, MM, Williamson, I. Grommets (ventilation
tubes) for hearing loss associated with otitis media with
207.
Gates, GA, Avery, CA, Prihoda, TJ. Effectiveness of adenoidectomy
and tympanostomy tubes in the treatment of chronic otitis media
208.
with effusion. N Eng J Med. 1987;317:1444-1451. Google Scholar,
Paradise, JL, Bluestone, CD, Rogers, KD. Efficacy of
adenoidectomy for recurrent otitis media in children previously
209. treated with tympanostomy-tube placement: results of parallel
randomized and nonrandomized trials. JAMA. 1990;263:2066-2073.
Elwyn, G, Lloyd, A, Joseph-Williams, N. Option grids: shared
210. decision making made easier. Patient Educ Couns. 2013;90:207-212.
Rosenfeld, RM, Goldsmith, AJ, Tetlus, L, Balzano, A. Quality of
211. life for children with otitis media. Arch Otolaryngol Head Neck
Surg. 1997;123:1049-1054. Google Scholar, Crossref, Medline
Calkins, C, Cosway, B, Cochran, N, Venkatraman, G, Elwyn, G.
Option grid for fluid in the middle ear.
212.
http://www.optiongrid.org/resources/fluidinear_grid.pdf. Accessed
March 3, 2015. Google Scholar

Clinical Practice Guideline

Uploaded by

Copyright:

Available Formats

Clinical Practice Guideline

Uploaded by

Document Information

Original Description:

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Clinical Practice Guideline

Uploaded by

Copyright:

Available Formats

Clinical Practice Guideline:

Otitis Media with Effusion

First Published February 1, 2016 Research Article

Keywords otitis media with effusion, middle ear effusion,

Addition of consumer advocates to the guideline development group

New evidence from 4 clinical practice guidelines, 20 systematic reviews, and

Expanded action statement profiles to explicitly state quality improvement

Additional information on pneumatic otoscopy and tympanometry to improve

Expanded information on speech and language assessment for children with

New recommendations for managing OME in children who fail a newborn

A new recommendation against using topical intranasal steroids for treating

A new recommendation against adenoidectomy for a primary indication of

A new recommendation for assessing OME outcomes by documenting OME

New algorithm to clarify decision making and action statement relationships

Table 1. Abbreviations and Definitions of Common Terms.

View larger version

Table 2. Frequently Asked Questions: Understanding Ear Fluid.

View larger version

The high prevalence of OME—along with many issues, including difficulties in

Table 3. Risk Factors for Developmental Difficulties in

View larger version

Impact on Children and Families

OME is the most common cause of hearing impairment in children in developed

Direct and Indirect Costs

In developing this update of the evidence-based clinical practice guideline, the

An information specialist conducted 2 systematic literature searches using a validated

The initial search for clinical practice guidelines identified 13 guidelines.

The AAO-HNSF assembled a guideline update group (GUG) representing the

The updated guideline then underwent GuideLine Implementability Appraisal to

Classification of Evidence-Based Statements

Guidelines are intended to reduce inappropriate variations in clinical care, produce

Table 4. Strength of Action Terms in Guideline

Table 4. Strength of Action Terms in Guideline Statements and Implied Levels of

Table 5. Aggregate Grades of Evidence by Question

Table 5. Aggregate Grades of Evidence by Question Type.62

View larger version

Making recommendations about health practices involves value judgments on the

Financial Disclosure and Conflicts of Interest

Guideline Key Action Statements

Table 6. Summary of Guideline Key Action Statements.

Table 6. Summary of Guideline Key Action Statements.

View larger version

STATEMENT 1a. PNEUMATIC OTOSCOPY: The clinician should

STATEMENT 1b. PNEUMATIC OTOSCOPY: The clinician should

Action Statement Profile for Statement 1a and 1b

Quality improvement opportunity: To improve diagnostic accuracy for OME

Aggregate evidence quality: Grade A, systematic review of cross-sectional

Level of confidence in evidence: High

Benefit: Improve diagnostic certainty; reduce false-negative diagnoses caused

Benefit-harm assessment: Preponderance of benefit

Value judgments: Pneumatic otoscopy is underutilized for diagnosing OME,

Intentional vagueness: None

Role of patient preferences: Very limited

Policy level: Strong recommendation

Differences of opinion: None

The purpose of this statement is to improve diagnostic accuracy for OME by

Despite well-documented benefits of pneumatic otoscopy in diagnosing OME7 and

Interobserver variability may be a factor in the accuracy of diagnosis by pneumatic

STATEMENT 2. TYMPANOMETRY. Clinicians should obtain