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their habits of critical inquiry and balanced judgement, and to contribute to better patient care. Disclosures: Kathleen R. Billings, MD, current author

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Otitis Media with Effusion View online at http://pier.acponline.org/physicians/diseases/d485/d485.html

Module Updated: 2012-11-28

CME Expiration: 2015-11-28

Author

Kathleen R. Billings, MD

Table of Contents

1. Prevention .........................................................................................................................2

2. Screening ..........................................................................................................................5

3. Diagnosis ..........................................................................................................................6

4. Consultation ......................................................................................................................10

5. Hospitalization ...................................................................................................................12

6. Therapy ............................................................................................................................13

7. Patient Education ...............................................................................................................18

8. Follow-up ..........................................................................................................................19

References ............................................................................................................................21

Glossary................................................................................................................................25

Tables ...................................................................................................................................26

http://pier.acponline.org/physicians/diseases/d485/d485.html

Otitis Media with Effusion


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1. Prevention Top

Advise parents about factors that may increase or decrease risk for developing OME.

1.1 Inform parents that breast-feeding may reduce episodes of OME in the child.

Recommendations

• When counseling about breast-feeding, consider mentioning evidence for an association between

exclusive breast-feeding beyond age 6 months and reduction in episodes of OME.

Evidence

• A prospective cohort of 306 infants in two suburban practices in the U.S. found that incidence of

OME was inversely related to rates of breast-feeding beyond age 3 months. Logistic regression

found that formula feeding was the most significant predictor of OME episodes. Age of colonization

with middle-ear pathogens and day-care attendance outside the home were less significant

predictors (1).

• A cohort of 1439 preschool children in the Netherlands 2 years of age were followed at 3-month

intervals to their fourth birthday. Breast-feeding protected against OME (2).

• A 2007 panel report from the Recent Advances in Otitis Media Research Conference reviewed

studies of children around the world and found OME prevalence to be linked to lack of breast-

feeding and to parental smoking (3).

• A secondary analysis of data collected on children aged 6 to 24 months showed that exclusive

breast-feeding for ≤4 to 6 months compared with >6 months increased the risk for having ≥3 otitis

media episodes in the previous 12 months (OR 1.95 [CI, 1.06 to 3.59]) (4).

Rationale

• Breast-feeding may reduce incidence of atopic symptoms and reduce incidence of upper respiratory

tract infections.

• Upper respiratory tract infections and eustachian-tube congestion are associated with OME.

Comments

• Studies of this kind (prospective cohort) are more prone to risk of bias from confounding than are

randomized, controlled trials; however, a trial randomly assigning women to either breast-feed or

formula-feed would not be possible. Regression analysis attempted to account for known

confounding variables in these studies.

1.2 Advise parents that day-care attendance outside the home may be associated with OME.

Recommendations

• Advise parents or caregivers to consider selecting small rather than large day-care groups for

children prone to OME.

Evidence

• A prospective cohort of 252 Australian children attending day care found that OME was detected

4.4 times in 12 2-week periods (37% of all examinations conducted) (5).

• A 6-week prospective study of 386 children who had had three or more recent episodes of acute

OM found that day-care attendance predicted chronic OME. Children with one or more of the

following factors need special attention for prevention of the sequelae of persistent OME: no history

of adenoidectomy, acute OM in the first year of life, and the presence of bilateral OME in the period

between June and November (6).



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• A cohort of 1439 preschool children in the Netherlands 2 years of age were followed at 3-monthly

intervals to their fourth birthday. Day-care attendance was a risk factor for OME (2).

• A Swedish cohort of 1306 children followed from birth to age 7 years found that day-care

attendance of 12 or more months during the first 4 years of life increased the risk for protracted

OME by 2.6 times (7).

• A U.S. prospective cohort study of 2253 infants found that repeated exposure to large numbers of

other children, either in the home or at day care, was the most significant sociodemographic risk

factor for OME (8).

• A multivariate logistic regression analysis of more than 11,000 infants at two urban and one

suburban location in the United States showed that day-care attendance was associated with OM. A

dose-response relationship with day-care size predicting risk for otitis media was observed;

compared with no day care, the odds ratio for OM was 1.5 for day-care facilities with 1 to 3

children, 2.0 for day-care facilities with 4 to 6 children, 3.0 for day-care facilities with 7 to 12

children, and 3.8 for day-care facilities with more than 12 children (9).

• A randomized, controlled trial of 143 children aged 6 months to 3.5 years looked at day-care type.

Mothers and children randomly assigned to intervention were provided high-quality day care at an

assigned center, while controls used whatever means of child care they could arrange. Children in

the intervention group had more OME and used more health services than those in the control

group (10).

Rationale

• Upper respiratory tract infections are associated with OME, and OME is more common in children

who attend day care.

Comments

• Small rather than large day-care centers may be preferable because smaller numbers of children

may be associated with fewer circulating pathogens.

1.3 Advise parents that exposure to environmental tobacco smoke may be

associated with increased risk for OME in their children.

Recommendations

• Provide appropriate interventions for smoking cessation in parents.

Evidence

• A 1998 systematic review of five studies found that parental smoking was associated with middle-

ear disease, with an OR of 1.38 (CI, 1.23 to 1.55) for middle-ear effusion, an OR of 1.48 (CI, 1.08

to 2.04) for recurrent OM, and an OR of 1.21 (CI, 0.95 to 1.53) for referral for OM with effusion

(11).

• Several studies have found no association with caregiver smoking and OME in children, including a

cohort study of 1439 children in the Netherlands (2). In addition, a Swedish cohort of 1306

children followed from birth to age 7 years found no association with caregiver smoking and the

incidence of protracted OME (7).

• A case-controlled study from Mozambique examined OME risk factors in children less than 6 years.

Exposure to tobacco, wood and charcoal smoke, short-term breast-feeding, and overcrowding were

associated with otitis media (12).

Rationale

• Exposure to secondhand smoke may increase upper respiratory tract congestion and reduce

resistance to infections in children.

Comments

• Caregiver smoking is likely to account for a small part of the variance in incidence of OME.

1.4 Perform standard immunizations to prevent OME.



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Recommendations

• Ensure that children receive standard schedule pneumococcal, influenza, and H. influenzae

vaccines.

Evidence

• A 2009 Cochrane review of pneumococcal vaccine to prevent otitis media included 7 trials.

Vaccination in infancy with a 7-valent vaccine was associated with a small (6% to 7%) relative risk

reduction in OM, which was statistically significant in only 1 study; in an additional study, an 11-

valent vaccine resulted in a larger reduction in OM (relative risk reduction, 34% [CI, 21% to 44%),

but a 9-valent vaccine in toddlers did not lead to a significant reduction in OM (relative risk

reduction, 17% [CI, -2% to 33%) (13).

• S. pneumoniae accounted for 38% of positive cultures and H. influenzae accounted for 27% of

positive cultures in a large series of bacterial cultures of middle-ear fluids in 2807 children (14).

Vaccination against these organisms might reduce episodes of acute OM and OME.

• A “before and after” (interrupted time series) U.S. study evaluating the effect of a conjugate

vaccine against pneumococci on OME involved 37,000 children and found an 8.9% reduction in all

visits for OM and a 20.3% reduction in ventilation-tube placement (15).

• The effect of influenza vaccine on prevention of acute OM has been studied. A 2-year placebo-

controlled trial (1602 children in year 1 and 1358 children in year 2) found that the overall vaccine

efficacy was 96% against acute OM associated with culture-confirmed influenza (16). Each of 288

children were vaccinated with a live, attenuated vaccine or placebo given by intranasal spray (17).

The vaccinated children had 30% [CI, 18 to 45%] fewer episodes of acute OM. An efficacy trial (n

= 133) of inactivated virosomal subunit influenza vaccine in children with recurrent OM found a

positive effect for the vaccine in preventing recurrent acute OM (18). In a 6-month period, 24

vaccine recipients had 32 episodes of acute OME while 42 control subjects had 64 episodes. Two

trials on children attending day care have been reported, and both showed a reduction in culture-

positive acute OM (19; 20).

• A randomized, double-blind, placebo-controlled trial examining the effectiveness of the inactivated

influenza vaccine in preventing acute OM in children aged 6 to 14 months found that the vaccine

did not reduce rates of acute OM or the amount of time with middle-ear effusion (21).

• A comparative study on the national impact of vaccinations showed a decline in otitis media rates

among children under 2 years when comparing the years 1994 to 1999 with 2002 to 2003. A 20%

decline was observed (22).

Rationale

• Inflammation in the middle ear during acute OM may become chronic resulting in OME, and

vaccination against certain organisms causing acute infection might reduce episodes of acute OM

and the subsequent development of OME.

Comments

• Influenza as a cause of acute OM is relatively rare. In the Houston family study, a little over 4% of

children during the first year of life developed influenza-related acute OM (23).

• Although antiviral drugs have shown efficacy in treating influenza (24), the effect on acute OM and

subsequent development of OME has not been evaluated.



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2. Screening Top

Recognize that the general population of asymptomatic children should not be screened for OME.

2.1 Do not screen asymptomatic patients for OME.

Recommendations

• Do not attempt earlier diagnosis of OME in asymptomatic patients.

• Recognize that programs for population screening for OME are not indicated.

Evidence

• One hundred eighty-seven children 1 to 2 years old with persisting OME identified by screening in

The Netherlands were randomly assigned to immediate treatment with ventilation tubes or a period

of “watchful waiting” (25). No differences were found in expressive or comprehensive language

between the two treatment groups. Both groups improved on measures of quality of life, but there

was no difference between groups.

• A 2003 systematic review confirmed that there was no advantage to screening children to undergo

early treatment for OME with ventilation tubes (26).

• OME has been associated with problematic behavior; the hypothesis is that reduced hearing affects

concentration, which affects behavior (27).

Rationale

• OME spontaneously resolves in many cases.

• Without a clinical problem, such as hearing loss or speech delay, OME may not affect a child's

general health.

Comments

• OME is not a suitable condition for screening because it has a high rate of spontaneous remission,

it may not cause significant hearing loss, and the effect of treatment of OME on language

development appears temporary for most young patients.

• The 2004 clinical practice guideline for OME from the American Academy of Pediatrics, the

American Academy of Family Physicians, and the American Academy of Otolaryngology—Head and

Neck Surgery states that screening for OME is not inherently harmful, but potential risks include

inaccurate diagnosis, overtreating self-limited disease, potential anxiety, and the costs of screening

and unnecessary treatment (28).

http://oto.sagepub.com/content/130/5_suppl/S95.long



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3. Diagnosis Top

Consider the diagnosis of OME in patients with hearing loss over time rather than in patients with presence of fluid in the middle ear at a single visit.

3.1 Obtain a history of risk factors for OM and of hearing problems over time.

Recommendations

• Obtain a history of hearing loss over time (months rather than weeks) or where there is concern

about hearing and language.

• Ask caregivers about behavioral problems in children.

• Consider risk factors, such as whether the child

Was breast-fed

Has older siblings

Attends day care outside the home

Is exposed to environmental tobacco smoke

Is considered to be at high risk for speech, language, or learning problems

Evidence

• OME is common and has a prevalence of about 20% at age 2 years (29).

• At least 80% of children had OME at least once before age 4 years, and for many, this is probably a

physiologic response (30).

• In a prospective study of 1328 children examined at 3-month intervals, there was a fairly constant

rate of improvement of 50% every 3 months (31).

• A U.K. case-control study evaluated risk factors for OM with effusion in children. Having a mother

who smokes 10 or more cigarettes a day (OR, 1.7 [CI, 1.1 to 2.8]), a sibling with OME (OR, 1.6),

multiple upper respiratory symptoms (OR, 2.2 [CI, 1.5 to 3.2]), and referral between July and

December (OR, 1.7 [CI, 1.1 to 2.8]) were associated with OME (32).

• Eight hundred fifty schoolchildren in the U.K., ages 5 to 8 years, were examined over a 3-year

period. Although 27% had evidence of effusion, in only 10% of the children did it persist for a year

or more (33).

• Secondary analysis of a randomized, controlled trial identified children with a mother who smokes,

referral between July and September, multiple upper airway symptoms, and siblings with a history

of OME as at high risk for OME (34).

• A cohort study in the Netherlands included children less than 13 years. Among children aged 2 to

6, the acute OM and OME rates declined by 15% and 41%, respectively, and for children aged 6 to

13, rates declined by 40% and 48% (35).

Rationale

• Although OME is common, there is a high rate of spontaneous recovery.

Comments

• Because of the high rate of spontaneous recovery, OME is transient in most cases. Only OME that

causes hearing or behavioral problems should be considered clinically significant.

3.2 Use pneumatic otoscopy to evaluate the eardrum for evidence of OME.

Recommendations

• Look for fluid in the middle ear and a retracted tympanic membrane, which is dull and cloudy and

exhibits decreased mobility.



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• Use pneumatic otoscopy where possible to make the clinical diagnosis of OME.

Evidence

• A 2003 systematic review of diagnostic methods in children included 52 studies and found

pneumatic otoscopy when performed by experienced clinicians to have a sensitivity of 93.8% (CI,

91.4% to 96.3%) and a specificity of 80.5% (CI, 75.1% to 86.0%) for the detection of middle-ear

effusions (36).

Rationale

• Fluid in the middle ear and a retracted tympanic membrane are associated with OME.

• Pneumatic otoscopy gives additional information about the mobility of the tympanic membrane.

Comments

• Pneumatic otoscopy is a clinical examination maneuver that performs reasonably well in diagnosing

OME. Patients must be warned of the slight discomfort associated with blowing air against the

tympanic membrane. Clinicians may wish to avoid blowing air onto the tympanic membrane in

children in whom cooperation is borderline or absent.

3.3 Use tympanometry to confirm the diagnosis of OME.

Recommendations

• Confirm findings on history and pneumatic otoscopy with tympanometry.

• See table Laboratory and Other Studies for Otitis Media with Effusion.

Evidence

• A 2003 systematic review of diagnostic methods in children included 52 studies and found that the

best results are obtained when B curves (flat tympanograms) are used as the cutoff for middle-ear

effusion (81% sensitivity, 75% specificity) (36).

• A 2010 Cochrane analysis of ventilation-tube use for OME-related hearing loss deemed OME to be

present when tympanometry results in a flat curve (type B), when mobility of the tympanic

membrane is absent or reduced, or when fluid or air bubbles are present behind the drum and

there are no infectious symptoms (37).

Rationale

• Tympanometry measures the changes in acoustic impedance of the tympanic membrane-middle

ear system with changes in air pressure in the external auditory canal.

• OME causes the tympanic membrane to become less mobile, and a tympanogram appears flat in

the presence of OME rather than a peak that represents compliance in response to a pressure

gradient.

• Microtympanometry compares well with tympanometry; the performance of newer acoustic

reflectometers approaches that of tympanometer (acoustic reflectometry records the sound

reflected from the tympanic membrane).

Comments

• When interpreting microtympanometry results, 74% of family physicians had a satisfactory or

perfect agreement with a “gold standard” (38). An international study found that primary care

clinicians could interpret tympanograms effectively (39).

• Tympanometry, microtympanometry, and acoustic reflectometry are useful instruments for

obtaining “objective” measure to indicate OME. A printout is usually available from these machines

that can be useful as part of the patient record; however, most evaluations of the performance of

these instruments have been conducted with patients about to undergo tympanostomy.

• In children aged 7 months or younger, tympanometry has not been found to be reliable due to the

very compliant ear canals in infants (40).

• There is no relatively noninvasive and credible gold standard for evaluating the performance of

these instruments in diagnosing OME in community settings in which prevalence and severity is



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lower. Not all children with evidence of OME on tympanometry will have significant hearing loss;

however, these tests can be done in clinicians' offices, and handheld devices are particularly

convenient.

3.4 Evaluate hearing in patients with persistent OME for more than 3 months.

Recommendations

• Do a hearing test in cases of persistent OME.

• Perform language testing in children with sustained hearing loss.

• Do not use distraction tests for screening or diagnosis of OME.

• See table Laboratory and Other Studies for Otitis Media with Effusion.

Evidence

• Hearing loss from OME ranges from a few decibels to as much as 50 dB, with a mean hearing level

of 20 to 30 dB (41; 42). At this level, hearing loss is often considered to be sufficient to warrant

intervention; a hearing loss of 30 dB can mean that a normal conversation sounds like a soft

whisper (42).

• A 2004 meta-analysis evaluated the effect of OME on language acquisition and included 14

prospective studies. There was no significant effect of OME on expressive or receptive language

(43).

• With milder hearing loss, problems may become significant in the presence of background noise,

such as may be present in a classroom (44).

• Positive predictive values ranged from 49% to 66% for a hearing loss ≥25 dB of an abnormal

tympanogram in referred populations (45; 46).

• Distraction tests are not sufficiently sensitive. The Health Visitor Distraction Test was found to have

a sensitivity of 38% (47).

• The 2004 clinical practice guideline for OME from the American Academy of Pediatrics, the


Neck Surgery recommends that clinicians determine whether other conditions coexist that put a

child at risk for developmental delay and then take these conditions into consideration when

planning assessment and management (28).

Rationale

• Not all OME is associated with important hearing loss; sometimes there may be minimal fluid in the

middle ear or its quality may not hinder the condition in the middle ear to a significant extent.

Comments

• OME on its own does not warrant treatment unless there is associated hearing loss. Some patients

hear adequately with OME; however, milder hearing loss may become significant in the presence of

background noise as is sometimes present in a classroom.

• Hearing tests are difficult in children under age 4 years and are resource intensive; however, age-

appropriate hearing tests exist. Hearing tests are the “gold standard”; therefore, it is not possible

to calculate their sensitivity and specificity.

• Tympanometry, pneumatic otoscopy, speech audiometry, tuning forks, observation of behavior, or

caregivers' opinions regarding levels of hearing loss are no substitute for hearing tests.

3.5 Consider other causes of hearing loss.

Recommendations

• If the eardrum is mobile and tympanometry is negative, consider other causes of hearing loss.

• See table Differential Diagnosis of Otitis Media with Effusion.

Evidence

• Consensus.




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Rationale

• Without fluid in the middle ear, OME is not present and other causes of hearing loss, such as inner

ear or neurologic causes of hearing loss, should be considered.

• Chronic suppurative OM usually presents with a discharging ear, and a central perforation is seen

on examining the eardrum.

• Cholesteatoma and other conditions involving the eardrum are rare causes of hearing loss that may

be confused with OME unless a proper visual examination of the eardrum is undertaken.

• In adults with persistent unilateral OME, consider a structural lesion of the nasopharynx and do a

full examination of the nasopharynx and sinuses.

Comments

• OME is especially common in children, and hearing loss from other causes is rare but should be

considered if evidence of OME is questionable and hearing loss is present. The eardrum and

mastoid must be carefully examined. Rhabdomyosarcoma, lymphoma, and squamous carcinoma of

the nasopharynx may rarely cause OME.



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4. Consultation Top

Confirm hearing loss associated with OME by referring to appropriate specialists who can perform hearing tests that involve special equipment and skills. Consider consulting an appropriate specialist for help in managing patients with OME.

4.1 Refer children with OME and suspected hearing loss for hearing tests.

Recommendations

• Refer children with persistent OME for hearing tests to an audiologist, ENT surgeon, or a clinician

trained in performing the age-appropriate hearing test; refer sooner for children at high risk.

• Evaluate adults with persistent unilateral OME earlier for sinusitis and possible structural lesions.

Evidence

• The 2004 clinical practice guidelines for OME from the American Academy of Pediatrics, the


Neck Surgery recommend that clinicians distinguish the child with OME who is at risk for speech,

language, and learning problems and promptly evaluate hearing, speech, language, and need for

intervention (28).

• Positive predictive values ranged from 49% to 66% for a hearing loss ≥25 dB of an abnormal

tympanogram in referred populations (45; 46).

• A 2003 systematic review and meta-analysis using data from prospective cohort groups and

untreated groups in randomized, controlled trials concluded that the natural history of OME is

generally favorable, although this varies with the population and outcome under examination. Fifty-

six percent of children with OME will improve at 3 months, 72% at 6 months, and 87% by 1 year.

In otherwise healthy children, observation is recommended for 3 to 6 months before surgery,

although this must be considered in light of possible negative effects of OME on speech, hearing,

educational achievements, and general development (54).

Rationale

• It is difficult to conduct hearing tests in children younger than 4 years in the primary care setting.

• Not all OME is associated with hearing loss, and OME without associated hearing loss does not

normally warrant treatment.

• Structural lesions should be considered in adults with unilateral OME as these can cause

eustachian-tube dysfunction.

Comments

• Earlier referral may be considered at any time if there is concern about hearing, speech, or

behavior. Secondary care evaluation is more urgent if an underlying sensorineural hearing loss is

suspected. Unilateral OME in an adult should prompt consideration of a structural nasopharyngeal

lesion.

• “Watchful” waiting, involving ongoing monitoring without active treatment, will allow spontaneous

recovery without lasting effects in most children. However, children with severe hearing loss will

need to be identified for early intervention.

4.2 Consider early consultation with an otolaryngologist for complex cases of OME.

Recommendations

• Refer patients with OME to an otolaryngology or audiology consultant when there is

Significant hearing loss, language delay, or learning problems




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Special situations, such as Down syndrome or cleft palate

Structural ear abnormalities, such as chronic OM, tympanic membrane retraction pockets, or erosion of portions of the ossicular chain and cholesteatoma

Language delays and behavioral problems

• Refer patients with underlying craniofacial abnormalities, such as Down syndrome or cleft palate,

and developmental or behavioral concerns earlier.

• Refer adults and children immediately if a structural lesion of the paranasal sinuses or nasopharynx

is suspected.

Evidence

• Guidelines were released in 2004 by the American Academy of Pediatrics, American Academy of

Family Physicians, and American Academy of Otololaryngology—Head and Neck Surgery on

diagnosis and management of otitis media with effusion and otitis media with effusion (48; 49).

Rationale

• Patients with underlying craniofacial abnormalities are likely to require earlier intervention because

eustachian-tube dysfunction is very common in this setting.

• Serious concern about speech delay, school-related problems, cognitive deficits, developmental

delay, or attention disorders may influence earlier referral.

Comments

• For most people, OME is a self-limiting disease, and approximately 75% to 90% of residual OME

following an episode of acute OM resolves within 3 months. However, OME may require earlier

treatment when associated with craniofacial abnormalities and existing language, behavior, and

development problems. Occasionally, structural lesions are associated with unilateral OME.

http://www.aafp.org/afp/2004/0615/p2929.html

http://pediatrics.aappublications.org/cgi/content/full/113/5/1412



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5. Hospitalization Top

Hospitalize patients with OME for surgical procedures only when necessary.

5.1 Hospitalize patients with OME only when required procedures cannot be done in the ambulatory setting.

Recommendations

• Consider hospitalization for ventilation-tube insertion, adenoidectomy, or both when procedures are

not technically or logistically possible in the ambulatory setting.

Evidence

• Consensus.

Rationale

• Ventilation-tube insertion and adenoidectomy usually require general anesthesia and postoperative

observation.

Comments

• In most centers, ventilation-tube insertion, adenoidectomy, or both can be done on an outpatient

basis and do not require overnight hospitalization.

• Hospitalization may be needed for the medically complex patient. For example, patients with

craniofacial anomalies like Pierre Robin sequence, Goldenhar's syndrome, or Down syndrome may

require lengthier airway monitoring after their procedures. Strategies for postoperative

management should be reviewed with the family and anesthesia team.



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6. Therapy Top

Consider the role of drug therapy in the treatment of OME. Consider appropriate surgical procedures in selected patients with OME.

6.1 Refer patients for ventilation-tube insertion if they have chronic OME (>3

months) and moderate hearing loss. Consider ventilation tubes for patients with less hearing loss in those at high risk.

Recommendations

• Consider placement of ventilation tubes in patients with chronic OME and hearing loss to drain fluid

and potentially improve hearing.

• Consider placement of ventilation tubes in patients without OME-related hearing loss who have

chronic OME and are at increased risk based on

Hearing loss from other causes

Developmental delays, including language delay

Craniofacial abnormalities

Visual loss

Evidence

• A 2010 Cochrane review of ventilation-tube placement for hearing loss associated with OME found

that children with tubes have better hearing for the first 2 to 6 months after the procedure but not

for longer. No effect on speech and language development was found (37).

• A 2001 meta-analysis of sequelae from ventilation-tube insertion showed that 16% of children

experienced otorrhea in the postoperative period and 26% experienced otorrhea later. A total of

3.8% experienced chronic otorrhea. Ventilation tubes were associated with more common

incidence of obstruction (7% of ears) and granulation tissue (5%). Sequelae after extrusion

included tympanosclerosis (32%), focal atrophy (25%), retraction pockets (3.1%), cholesteatoma

(0.7%), and perforation (2.2% with short-term tubes, 16.6% with long-term tubes) (55).

• Trials in children identified with OME by screening found that initial improvements in language

developmental outcomes from ventilation-tube insertion compared with watchful waiting were lost

by about 18 months (25; 56).

• A trial comparing early surgery with watchful waiting found that early surgical intervention reduced

behavioral problems and improved language development in children with OME at 9 months (57;

58); however, after 18 months, differences were no longer statistically significant.

• A randomized trial of 98 subjects assigned to three groups (ventilation tube alone, adenoidectomy

plus ventilation tube, and adenoidectomy plus myringotomy) showed no difference in the number

of further surgical procedures for ear disease needed among the groups by 36 months (59).



Neck Surgery recommend tympanostomy tubes for patients with 3 months or more of OME with

hearing loss > 40 dB and consideration of tubes in those with milder hearing loss or associated

problems and those at high risk (28).

Rationale

• Patients with conductive hearing loss associated with OME may obtain improved hearing when the

middle-ear fluid is allowed to drain.

• Ventilation tubes are associated with complications, such as obstruction, granulation tissue, and

tympanosclerosis.

Comments




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• Myringotomy alone has not been found to be an effective treatment for OME (42; 60).

• Side effects from ventilation tubes are common but rarely serious.

6.2 Consider long-term antibiotics in children with recurrent acute OM.

Recommendations

• Consider prophylactic antibiotics in children with recurrent acute OM, generally amoxicillin once

daily.

• Take into account adverse effects, cost, and antimicrobial resistance when considering long-term

antibiotics for recurrent acute OM.

Evidence

• A 2006 Cochrane review evaluated the effect of long-term antibiotics to prevent OM in high-risk

children and included 16 studies of 1483 children. Daily or twice-daily antibiotics decreased rates of

acute OM with a risk ratio of 0.62 (CI, 0.52 to 0.75) and the number of episodes of acute OM (61).

• One hundred ninety-four children from 3 months to 6 years of age with three documented acute

OM episodes in the previous 6 months were randomly assigned to receive amoxicillin prophylaxis

once daily, amoxicillin prophylaxis twice daily, or placebo. Thirty-six noncompliant subjects were

excluded. The proportion of subjects remaining otitis free was 63% for the placebo group, 64% for

the once-daily amoxicillin group, and 61% for the twice-daily amoxicillin group (62).

Rationale

• Long-term antibiotics may eliminate pathologic microbes in the middle ear and prevent new, acute

infections from becoming symptomatic.

• Acute OM is associated with OME.

Comments

• Although long-term antibiotics appear to prevent some recurrences of acute OM, consideration

must be given to adverse effects and antimicrobial resistance from long-term antimicrobial use.

6.3 Do not use antibiotic treatment routinely for acute OME.

Recommendations

• High-value care: Do not routinely use antibiotics to treat OME.

• Use antibiotics for OME with caution as short-term benefit is not sustained.

Evidence



Neck Surgery recommend against routine antibiotic use for OME, citing poor response and potential

harms (28).

• A 2012 Cochrane review evaluated the effect of antibiotics on the resolution of symptoms in

children with OME and included 23 studies with 3027 children. Results for 1- to 3-month symptom

resolution (the primary outcome) could not be pooled; resolution rates were higher in the antibiotic

groups by 1% to 45%. Results for symptom resolution at 6 months were pooled, and the antibiotic

group had higher rates of resolution (risk difference, 13% [CI, 6% to 19%]) (63).

Rationale

• Inflammation in the middle ear causing effusions may result from ongoing infection, but antibiotics

have not been shown to be highly beneficial.

Comments

• Antibiotics have side effects, and their overuse is associated with higher levels of antimicrobial

resistance that should be considered in conjunction with the lack of evidence for long-term benefit

for OME.




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6.4 Do not routinely prescribe antihistamines or decongestants to reduce

OME.

Recommendations

• Do not routinely recommend antihistamines or decongestants for children with OME.

• Consider mucoactive drugs for short-term therapy in OME.

Evidence



Neck Surgery recommend against the use of decongestants and antihistamines for OME, citing very

poor evidence of benefit and harms including behavioral changes and insomnia (28).

• A 2001 meta-analysis of the effect of S-carboxymethylcysteine on children with OME included 7

trials involving 283 patients. The end point was the need for surgery, which can be subjective. The

overall number needed to treat was 5.5 to prevent 1 surgery, but there was a trend toward higher-

quality evidence showing less effect (64).

Rationale

• Thickened mucous may prevent drainage from the middle ear. Drugs that reduce mucous

production or reduce viscosity may promote drainage from the middle ear.

Comments

• Properly conducted, adequately powered trials are needed assessing outcomes over the longer

term.

6.5 Do not routinely prescribe oral or nasal steroids.

Recommendations

• Do not use systemic steroid treatment for OME.

• Consider topical intranasal steroids for short-term benefit.

Evidence

• A 2011 Cochrane review of the effect of oral or nasal steroids in children with OME and hearing loss

included 12 studies with 945 participants. Oral steroids led to more symptom resolution at 1 month

(RR, 4.48 [CI, 1.52 to 13.23]) but no long-term benefit and no benefit in hearing loss (65).

• A 2001 systematic review of studies of systemic or topical intranasal steroids for OME with or

without an antibiotic included 10 randomized, controlled trials. Only 1 study evaluated nasal

steroids, and that study found no effect on OME (66).

• A randomized, double-blind trial compared a short course of prednisolone given with amoxicillin to

amoxicillin alone. The researchers found that, directly after 14 days of treatment with steroid and

amoxicillin, a significant number of children were effusion free as compared with the amoxicillin-

only group. However, within 2 weeks of the end of treatment, this difference was no longer

evident, regardless of whether amoxicillin was continued or not (67).

• A randomized, placebo-controlled trial of children aged 4 to 11 years with OME compared topical

steroid spray (mometasone) with placebo spray. There was no difference in cure rates between the

groups at 1 or 3 months. Symptoms did not differ in the two groups, and no harm was reported

(68).

• A 2010 study evaluated the cost-effectiveness of nasal steroids in children with OME and found that

the strategy is unlikely to be cost-effective (69).

• The clinical practice guideline from the American Academy of Family Physicians, American Academy

of Pediatrics, and American Academy of Otolaryngology—Head and Neck Surgery advisory

committee recommended against the routine use of corticosteroids (49).

Rationale

• Steroids may decrease inflammation in the eustachian tube and middle ear.





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• Intranasal steroids are likely to be safer than systemic steroids as blood levels after topical use are

lower than after systemic use.

Comments

• Some may wish to try intranasal steroids (with or without an antibiotic) with the aim of short-term

benefit. Intranasal steroids can be used with relative safety for extended periods and may be

useful for prophylaxis, but further studies are needed.

6.6 Be aware of the potential relationship between GERD and OME but do not

treat GERD to prevent OME.

Recommendations

• Treat GERD aggressively in children with symptomatic GERD and OME.

Evidence

• A 2012 systematic review of the association between OM and GERD and the effect of GERD

treatment on OM found a high prevalence of GERD in children with chronic OME (48.4% [CI, 17.6%

to 64%]). Two included randomized, controlled trials evaluated the effect of antireflux therapy on

OME and found little to no benefit after 3 months of treatment (70).

• In a prospective before and after study, children with OME, recurrent OM, or both with signs and

symptoms of GERD confirmed by survey and flexible scope were treated with antireflux medication

(ranitidine, lansoprazole, or nizatidine). Over two 8- to 12-week intervals, OM was clinically

improved in 76% after the first interval and in 60% after the second (71).

Rationale

• Reflux of gastric acid and pepsin into the middle ear and eustachian tube has potential to cause

mucosal inflammation.

Comments

• Although children with identified GERD and OME may see improvement in time with OME after

antireflux management, accurately establishing a diagnosis of GERD by survey instruments and

flexible scope is controversial. The gold standard of pH probe may be cost prohibitive and increase

the risk to the patient.

6.7 Avoid use of drug therapies that have not been shown to be effective in

OME.

Recommendations

• Recognize that there is insufficient evidence for use of the following in OME:

Nonsteroidal agents

Homeopathy

Leukotriene inhibitors

Evidence

• Two underpowered trials showed a trend in favor of nonsteroidal anti-inflammatory agents over

placebo in clearing OME (72; 73). Long-term outcomes from properly powered studies are lacking.

• A trial of azelastine hydrochloride, an oral antiallergic drug, found no benefit for OME associated

with allergic rhinitis (74).

• A prospective, randomized, placebo-controlled study to determine if the leukotriene inhibitor

montelukast was effective in eliminating middle-ear fluid showed no benefit, and the study was

terminated (75).



Neck Surgery recommend against these unproven therapies (28).




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Rationale

• Nonsteroidal anti-inflammatory agents may reduce middle-ear inflammation and thus help clear

OME.

• Homeopathy may reduce inflammation underlying OME.

• Leukotrienes have been implicated in the pathogenesis of eustachian-tube dysfunction.

Comments

• Although homeopathy may have a benign adverse-effect profile, it is resource intensive and should

not be promoted as a treatment for OME until long-term benefit has been proved.

6.8 Do not recommend autoinflation maneuvers for patients with OME.

Recommendations

• Do not recommend autoinflation, Valsalva, or Politzer maneuvers for OME.

Evidence

• Although some trials of autoinflation have shown beneficial short-term effects on OME (76; 77), a

1999 systematic review found that studies of autoinflation of the middle ear were of low quality,

results varied, and long-term benefit was not shown (78). There is insufficient evidence to promote

its use in clinical practice.

Rationale

• Increasing the pressure in the nasopharynx may cause the eustachian tube to open, allowing

effusions in the middle ear to drain.

Comments

• There are no trials of sufficient quality and with longer-term follow-up to support the use of

autoinflation for OME in clinical practice.



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7. Patient Education Top

Inform caregivers (and patients, when appropriate), about the course, treatment, sequelae, and prognosis of OME.

7.1 Advise patients about the importance of careful evaluation of different therapeutic modalities, including their indications and limitations.

Recommendations

• Inform patients and families that

The natural history of OME is one of improvement and clearing in most patients

Observation should be continued at 3-month intervals unless hearing loss persists or structural abnormalities are detected

• Inform parents of the recommendations of the American Academy of Family Physicians, American

Academy of Pediatrics, and American Academy of Otolaryngology—Head and Neck Surgery

advisory committee (see Evidence).

Evidence

• The American Academy of Family Physicians, American Academy of Pediatrics, and American

Academy of Otolaryngology—Head and Neck Surgery advisory committee recommends that

children with OME who have no other medical issues be observed for 3 months from the diagnosis

or onset; hearing testing be conducted when OME persists for 3 months or longer or at any time

that language delay, learning problems, or a significant hearing loss is suspected in a child with

OME; children with persistent OME who are not at risk be reexamined at 3- to 6-month intervals

until the effusion is no longer present, significant hearing loss is identified, or structural

abnormalities of the eardrum or middle ear are suspected; when a child becomes a surgical

candidate (tympanostomy tube insertion is the preferred initial procedure), adenoidectomy should

not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis), repeat

surgery consists of adenoidectomy plus myringotomy with or without tube insertion, and

tonsillectomy or myringotomy alone should not be used to treat OME; because antihistamines and

decongestants are ineffective for OME, they should not be used for treatment; antimicrobials and

corticosteroids do not have long-term efficacy and should not be used for routine management

(49).

• The American Academy of Otolaryngology—Head and Neck Surgery considers ventilation-tube

insertion appropriate after OME has been present for 3 months or more (79).

Rationale

• Watchful waiting is preferred to early intervention because most cases are self-limiting and neither

medical nor surgical treatment has been proven to have long-term benefits.




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8. Follow-up Top

Schedule follow-up to determine disease status, hearing level, and need for intervention.

8.1 Schedule follow-up based on the specific intervention chosen.

Recommendations

• Follow patients with OME according to the recommendations of the American Academy of Family

Physicians, American Academy of Pediatrics, and American Academy of Otolaryngology—Head and

Neck Surgery advisory committee:

Observe children with OME who have no other medical issues for 3 months from the diagnosis or onset

Obtain hearing testing when OME persists for 3 months or longer or at any time that language delay, learning problems, or a significant hearing loss is suspected in a child with OME

Reexamine children with persistent OME who are not at risk at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected

When a child becomes a surgical candidate,

o Refer for tympanostomy tube insertion as the preferred initial procedure

o Do not perform adenoidectomy unless a distinct indication exists, e.g., nasal obstruction, chronic

adenoiditis

o Consider adenoidectomy plus myringotomy with or without tube insertion if repeat surgery is needed

o Do not use tonsillectomy or myringotomy alone to treat OME

Do not use antihistamines and decongestants to treat OME

Do not use antimicrobials and corticosteroids for routine management, as they do not have long-term efficacy

• Note that it is not necessary to advise against swimming in patients with ventilation tubes in place.

Evidence

• The specific recommendations are derived from the 2004 American Academy of Family Physicians,

American Academy of Pediatrics, and American Academy of Otolaryngology—Head and Neck

Surgery advisory committee clinical practice guideline (49).

• A prospective study found that in children younger than 3 years with persistent middle-ear

effusion, the insertion of tympanostomy tubes did not measurably improve developmental

outcomes at 4 years (80). Subgroup analyses of the 3-year follow-up data found no noticeable

improvements in developmental outcomes, regardless of whether the middle-ear effusion was

unilateral or bilateral, continuous, or associated with hearing loss (81).

• A randomized, controlled trial compared bilateral ventilation tubes alone (n=124), bilateral tubes

and adenoidectomy (n=127), and nonsurgical management (n=119) in children. After using

otoscopy and tympanometry to establish that the tubes were working properly, the researchers

found that ventilation tubes only partially improve the conductive impairment associated with OME.

They concluded that children with ventilation tubes that are not working properly cannot be

deemed to have “normal hearing.” The addition of adenoidectomy did not have any impact on

ventilation-tube functioning or on hearing thresholds (82).

• Poor eustachian-tube functioning is known to be a causative factor in the development of OME. A

trial examining the effect of a topical decongestant on eustachian-tube function in children with

ventilation tubes because of persistent OME concluded that topical decongestants do not improve

eustachian-tube function; thus, they cannot be recommended to prevent or treat OME (83).

• A 2009 systematic review examining prospective cohort trials and controlled clinical trials of

children with ventilation tubes concluded that there is no difference in risk for acute OM in those

children with ventilation tubes who swim vs. those who do not. There is no evidence that the use of




of 27

ear plugs, swimming caps, or ear drops reduces the risk for acute OM. In fact, there is an increased

risk for developing OM when using ear drops (84).

Rationale

• Specific guidelines for following of patients with OME are available for optimal care.



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Glossary Top

bid twice daily

CI confidence interval

CT computed tomography

dB decibel

ENT

ear, nose, and throat

GERD

gastroesophageal reflux disease

OM otitis media

OME otitis media with effusion

OR

odds ratio

tid three times daily

Terms

Acute otitis media The rapid onset of signs and symptoms of inflammation in the middle ear is characteristic of acute OM. One or more

local or systemic signs are present: otalgia, otorrhea, fever, recent onset of irritability, anorexia, vomiting, or diarrhea. The tympanic membrane is full or bulging, is opaque, and has limited or no mobility to pneumatic otoscopy, all of which are indicative of middle-ear effusion.

Otitis media with effusion OME is a chronic inflammation of the middle ear in which a collection of liquid is present in the middle-ear space, but there is an absence of acute infection and no perforation of the tympanic membrane is present.

Recurrent acute otitis media

Recurrent acute OM has been defined as three episodes of acute OM in the preceding 6 months or four episodes in

the preceding year with at least one in the preceding 6 months.



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Tables Top

Laboratory and Other Studies for Otitis Media with Effusion

Test Sensitivity (%) Specificity (%) Notes

Tympanometry >80 >80 Tympanometry measures the changes in acoustic

impedance of the tympanic membrane-middle ear

system with changes in air pressure in the external auditory canal.

In children aged 4 months and older,

tympanometry with a standard 226-Hz probe tone

is reliable. For younger children (aged <4

months), specialized equipment with a higher

probe tone frequency is necessary (48; 49).

Positive predictive values ranged from 49% to

66% for a hearing loss ≥25 dB of an abnormal

tympanogram in referred populations (45; 46)

Microtympanometry Handheld version of tympanometer. Performance

characteristics similar to tympanometry (50)

Acoustic reflectometry Acoustic reflectometers measure the quality of sound reflected off the eardrum, which is

influenced by the presence of fluid in the middle

ear. Newer instruments have performance

characteristics similar to tympanometry (51; 52)

Hearing tests Essential component of diagnosing OME that

requires intervention.

For infants ages 6 months to 1 year: behavioral

observation audiometry.

For children ages 1-2 years: visual reinforcement

audiometry.

For children ages 2 years and older: play audiometry.

For most children ages 5 years and older:

conventional audiometry

OME = otitis media with effusion.



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Differential Diagnosis of Otitis Media with Effusion

Disease Characteristics

OME Can be acute or recurrent, risk factors present

Neurologic causes of deafness High-risk infant, previous meningitis, equivocal or no evidence of OME. If the hearing loss is

sensorineural (rather than conductive), consider causes for decreased hearing other than OME

Sinusitis Sinusitis and nasal polyps are associated with OME

Examine sinuses, particularly in adults (53)

Chronic suppurative OM Discharging ear, perforated ear drum

Eardrum must be visualized

Cholesteatoma Retraction pocket in tympanic membrane. Note that a dry crust on the upper part of the tympanic

membrane may cover a retraction pocket

Entire eardrum must be visualized. Also examine mastoid process

Tumors Nasopharyngeal and parasinus tumors should be considered in unilateral OME in adults and even more

rarely in children. Nasopharyngeal carcinoma is more common among Chinese

Consider CT scanning and/or biopsy of the nasopharynx

Barotrauma Air travel, diving, and other causes of unequal pressure between the middle ear and the outside can

cause hemotympanum

Eardrum may have purplish discoloration due to bleeding

Intubation and nasogastric tubes Intubation and nasogastric tubes are associated with OME that resolves once the foreign body is

removed

Radiation therapy OME is common after radiation therapy to the head

CT = computed tomography; OM = otitis media; OME = otitis media with effusion.

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