OTITIS MEDIA WITH EFFUSION IN CHILDREN

SCOPE OF THE PRACTICE GUIDELINE

This clinical practice guideline is for use by the Philippine Society of Otolaryngology-Head and
Neck Surgery. It covers the diagnosis and management of otitis media with effusion in children
between 2 months and 12 years without developmental disabilities or underlying conditions that
1
predispose to OME and its sequelae.

OBJECTIVES
The objectives of the guideline are (1) to emphasize the requisites of diagnosis of otitis media
with effusion; (2) to evaluate current diagnostic techniques; and (3) to describe treatment
2
options.

LITERATURE SEARCH
This guideline is mainly based on the 1997 Philippine Society of Otolaryngology-Head and Neck
Surgery Clinical Practice Guidelines and the American Academy of Pediatrics (AAP), American
Academy of Family Physicians (AAFP) and American Academy of Otolaryngology- Head and
Neck Surgery (AAO-HNS) Subcommittee on Management on Otitis Media with Effusion Practice
Guideline and supplemented by additional research on the topic. The literature search strategy
used MEDLINE, Cochrane Database, National Library of Medicine’s PubMed database and
Agency for Healthcare Research and Quality (AHRQ) Evidence Report and Technology
Assessment were searched using the keyword otitis media, exploded to include otitis media with
effusion with the subheadings regarding prevalence, diagnosis, and therapy. The search was
limited to articles involving humans and those published in English in the last fifteen years. The
search yielded 4020 articles (4013 PUBMED and 7 cochrane). Thirty (30) abstracts were chosen
and results were further assessed for relevance. Full text articles were obtained when possible.
The chosen articles were divided as follows:
Meta-analysis 7
Randomized controlled trials 7
Non-randomized controlled study 10
Descriptive study 1
Committee report 2
Clinical Practice Guidelines 4

DEFINITION
Otitis media with effusion (OME) is defined as the presence of fluid in the middle ear with intact
tympanic membrane without signs or symptoms of acute infection. The following were
considered synonymous and were partly taken from the work of Lim (1983): glue ear, non-
suppurative otitis media, serous otitis media, mucoid otitis media, catarrhal otitis media, secretory
otitis media, aerotitis with effusion. OME is differentiated from acute otitis media, which is defined
as an infection of the middle ear with acute onset of signs and symptoms of middle ear
inflammation. Under the ICD-10 classification, the diagnosis of OME will fall under Classification
1,3,4
H65 (Nonsuppurative otitis media) and its subclassifications.

PREVALENCE
Approximately 90% of children (80% of individual ears) have OME at some time before school
age, most often between ages 6 months and 4 years. In the first year of life, >50% of children will
experience OME, increasing to >60% by 2 years. Many episodes resolve spontaneously within 3
months, but approximately 30-40% of children have recurrent OME, and 5% to 10% of episodes
1
last 1 year or longer.

In the Philippines, no published data on prevalence of OME is available at this time. Multicenter
studies are therefore recommended to address this issue.

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RECOMMENDATIONS ON THE DIAGNOSIS OF OTITIS MEDIA WITH EFFUSION

1. The diagnosis of OME is made by thorough history and otolaryngologic examination.

Pneumatic otoscopy should be used as the primary diagnostic method for OME.
Otoscopy alone may not be sufficient.

Grade A Recommendation

Pneumatic otoscopy when validated by myringotomy, yielded (1) a sensitivity of 85-90% and
a specificity of 70-79% (Kaleida and Stool, 1992); and (2) a positive predictive value of 91%
and a negative predictive value of 84% (Toner and Mains 1990).

In the AAFP, AAP and AAO-HNS guideline, pneumatic otoscopy is recommended for
assessment of the middle ear because it combines visualization of the tympanic membrane
1
(otoscopy) with a test of membrane mobility (pneumatic otoscopy).

On pneumatic otoscopy, the following maybe seen through an intact tympanic membrane: (1)
air-fluid level, and/ or (2) air bubbles (3) limited or absent mobility of the tympanic membrane
3
maybe demonstrated.

2. Tympanometry may be used to confirm the diagnosis of OME.

Grade A Recommendation

When the diagnosis of OME is uncertain, tympanometry should be considered as an adjunct

to pneumatic otoscopy.

Tympanometry provides an indirect measure of tympanic membrane compliance and an

estimate of middle ear air pressure. The positive predictive value of an abnormal (type B, flat)
tympanogram is between 49% and 99%. The negative predictive value (64-93%) of this test
1
is better since the majority of middle ears have normal tympanograms.

This test is particularly useful in small children whose external auditory canals may be too
small or too collapsible to permit adequate visualization of the tympanic membrane. In those
<7 months of age, tympanometry is unreliable because of excessive compliance of the
1,15
external auditory canal.

3. Hearing testing is recommended when OME persists for 3 months or longer.

Grade B Recommendation

Recent randomized trials suggest no impact on children with OME who are not at risk as
identified by screening or surveillance.

Hearing testing is recommended when OME persists for 3 months or longer or at any time
that language delay, learning problems, or a significant hearing loss is suspected. Conductive
hearing loss often accompanies OME, and may adversely affect binaural processing, sound
5, 6, 7
localization, and speech perception in noise.

However, the panel agrees that if the patient was brought in for hearing loss, an initial hearing
test should be done.

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RECOMMENDATIONS ON THE TREATMENT OF OTITIS MEDIA WITH EFFUSION

1. A child with OME who is not at risk should be managed with watchful waiting for three
months from the date of effusion onset (if known) or diagnosis (if onset is unknown).

Grade B recommendation

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. Around 75% to 90%
of residual OME after an AOM episode resolves spontaneously by 3 months.

A child at risk is one who is at increased risk for developmental difficulties (delay or disorder)
because of sensory, physical, cognitive, or behavioral factors listed in Table 1. These factors
are not caused by OME but can make the child less tolerant of hearing loss or vestibular
problems secondary to middle-ear effusion. In contrast the child with OME who is not at risk
is otherwise healthy and does not have any of the factors.
1
TABLE 1. Risk Factors for Developmental Difficulties*
Permanent hearing loss independent of otitis media with effusion
Suspected or diagnosed speech and language delay or disorder
Autism-spectrum disorder and other pervasive developmental disorders
Syndromes (eg, Down) or craniofacial disorders that include cognitive, speech, and
language delays

Blindness or uncorrectable visual impairment

Cleft palate, with or without associated syndrome
Developmental delay

*Sensory, physical, cognitive, or behavioral factors that place children who have otitis media with effusion at
increased risk for developmental difficulties (delay or disorder).

At the discretion of the clinician, this 3-month period of watchful waiting may include interval
visits at which OME is monitored by using pneumatic otoscopy, tympanometry, or both.
Factors to consider in determining the optimal interval(s) for follow-up include clinical
judgment, parental comfort level, unique characteristics of the child and/or his environment,
access to a health care system, and hearing levels (HLs) if known. After documented
1, 8, 9
resolution of OME in all affected ears, additional follow-up is unnecessary.

2. Children with persistent OME who are not at risk should be re-examined at three- to
six- month intervals until this is no longer present.

Grade C Recommendation

If OME is asymptomatic and likely to resolve spontaneously, intervention is unnecessary

even if OME persists for more than three months. The child must be periodically reevaluated
for factors that would need intervention as long as OME persists.

The risks of continued observation of children with OME must be balanced against the risks
of surgery. Children with persistent OME examined regularly at 3- to 6-month intervals, or
sooner if OME-related symptoms develop, are most likely at low risk for physical, behavioral,
1, 6
or developmental sequelae of OME.

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2.1. Antimicrobials and corticosteroids do not have long-term efficacy and are not
recommended for routine management.

Grade A recommendation

Therapy for OME is appropriate only if persistent and clinically significant benefits
can be achieved beyond spontaneous resolution. Long-term benefits of antimicrobial
therapy for OME are not proven despite a modest short-term benefit for 2 to 8 weeks
in randomized trials.

Antimicrobial therapy with or without steroids has not been demonstrated to be

effective in long-term resolution of OME, but in some cases this therapy can be
considered an option because of short-term benefit in randomized trials, when the
parent or caregiver expresses a strong aversion to impending surgery. In this
circumstance, a single course of therapy for 10 to 14 days may be used. The
likelihood that the OME will resolve long-term with these regimens is small, and
prolonged or repetitive courses of antimicrobials or steroids are strongly not
1
recommended.

One meta-analysis showed no benefit for oral steroid versus placebo within 2 weeks
but did show a short-term benefit for oral steroid plus antimicrobial versus
antimicrobial alone in 1 of 3 children treated. This benefit became nonsignificant after
10
several weeks in a prior meta-analysis and in a large, randomized trial.

In a meta-analytic study by Williams et al in 1993 with the use of antibiotics in

preventing recurrent AOM and in treating OME, 12 studies of short-term patient
outcomes of OME with 1697 subjects had a rate difference favoring antibiotics of
0.16( 95% CI, 0.03 to 0.029), while eight studies using ear as the outcome measure
with 2052 ears studied had a rate difference of 0.25 (95% CI, 0.10 to 0.40). No
significant difference was shown between placebo and antibiotics in the eight studies
regarding longer-term outcome of OME. Subgroup analyses by antibiotic grouping,
11
duration of treatment, and duration of disease did not show significant differences.

2.2. Antihistamines and decongestants are ineffective for OME and are not
recommended for treatment.

Grade A recommendation

Meta-analysis of 4 randomized trials showed no significant benefit for antihistamines

or decongestants versus placebo. No additional studies have been published since
1994 to change this recommendation.

Other non-surgical therapies that are discussed in the OME literature include
autoinflation of the Eustachian tube, oral or intratympanic use of mucolytics, and
systemic use of pharmacologic agents other than antimicrobials, steroids, and
antihistamine-decongestants. Insufficient data exist for any of these therapies to be
1
recommended in treating OME.

However, the panel agrees that for patients with concomitant diseases which
warrants the use of antihistamines and decongestants (i.e. allergic rhinitis), these
medications may be used for the said diseases, and not for OME.

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3. Myringotomy and ventilation tube insertion is the preferred initial procedure when
OME persists after 3 months AND is associated with significant hearing loss.

Grade B Recommendation

Surgical candidacy for OME largely depends on hearing status, associated symptoms, the
child’s developmental risk and the anticipated chance of timely spontaneous resolution of the
effusion. Candidates for surgery include children with OME lasting 3 months or longer with
persistent hearing loss or other signs and symptoms, recurrent or persistent OME in children
at risk regardless of hearing status, and OME and structural damage to the tympanic
membrane or middle ear. Ultimately, the recommendation for surgery must be individualized
based on consensus between the otolaryngologist and parent or caregiver that particular
child would benefit from intervention. Children with OME of any duration who are at risk are
1,17
candidates for earlier surgery.

In the study of Paradise et al., hearing levels were defined with the use of data on auditory
brain-stem response in infants younger than 6 months and pure-tone data for children 6
months or older. On the basis of the data obtained in children who had no effusion, abnormal
results were defines as an auditory brain-stem response threshold more than 20 dB above
the normal hearing level or a pure-tone average more than 25 dB hearing level up to the age
of 10 months, more than 20 dB hearing level from 10-23 months, and more than 15 dB
12
hearing level from the age of 2 years onwards.

Tympanostomy tubes are recommended for initial surgery because randomized trials show a
mean of 62% relative decrease in effusion prevalence and an absolute decrease of 128
13,19
effusion days per child during the next year.

Myringotomy is performed concurrent with adenoidectomy. Myringotomy plus adenoidectomy

is effective for children 4 years old or older, but tube insertion is advised for younger children,
when potential relapse of effusion must be minimized (eg, children at risk) or pronounced
14
inflammation of the tympanic membrane and middle ear mucosa is present. Tonsillectomy
or myringotomy alone (without adenoidectomy) is not recommended to treat OME.
Myringotomy alone, without tube placement or adenoidectomy, is ineffective for chronic OME,
16,18,20
because the incision closes within several days.

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 References

1. American Academy of Family Physicians, American Academy of Otolaryngology-Head

and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media
with Effusion Pediatrics. 2004.
2. Clinical Practice Guidelines 2003. Department of Otorhinolaryngology, Philippine General
Hospital.
3. Clinical Practice Guidelines 1997. Philippine Society of Otolaryngology.
4. ICD-10 Classification
5. Joint Committee on Infant Hearing. Year 2000 position statement: principles and
guidelines for early hearing detection and intervention programs. Am J Audiol. 2000;9:9–
29
6. Stool SE, Berg AO, Berman S, et al. Otitis Media With Effusion in Young Children.
Clinical Practice Guideline, Number 12. AHCPR Publication No. 94-0622. Rockville, MD:
Agency for Health Care Policy and Research, Public Health Service, US Department of
Health and Human Services; 1994
7. Paradise JL, Feldman HM, Campbell TF, et al. Early versus delayed insertion of
tympanostomy tubes for persistent otitis media: developmental outcomes at the age of
three years in relation to prerandomization illness patterns and hearing levels. Pediatr
Infect Dis J. 2003;22: 309–314
8. Shekelle P, Takata G, Chan LS, et al. Diagnosis, Natural History, and Late Effects of
Otitis Media with Effusion. Evidence Report/Technology Assessment No. 55 AHRQ
Publication No. 03-E023. Rockville, MD: Agency for Healthcare Research and Quality,
2003.
9. Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope.
2003;113:1645–1657
10. Butler CC, van der Voort JH. Oral or topical nasal steroids for hearing loss associated
with otitis media with effusion in children. CochraneDatabase Syst
Rev.2002;4:CD001935
11. Williams RL, Chalmers TC, Stange KC, Chalmers FT, Bowlin SJ. Use of antibiotics in
preventing recurrent otitis media and in treating otitis media with effusion. A meta-analytic
attempt to resolve the brouhaha.JAMA. 1993;270:1344–1351
12. Paradise JL, Feldman HM, Campbell TF, et al. Effect of early or delayed insertion of
tympanostomy tubes for persistent otitis media on developmental outcomes at the age of
three years. N Engl J Med.2001;344:1179–1187.
13. Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae.
Otolaryngol Head Neck Surg. 2001;124:374–380
14. Gates GA, Avery CA, Prihoda TJ, Cooper JC Jr. Effectiveness of adenoidectomy and
tympanostomy tubes in the treatment of chronic otitis media with effusion. N Engl J Med.
1987;317:1444–1451
15. Palmu A, Puhakka H, Rahko T, Takala AK. Diagnostic Value of Tympanometry in
infancts in clinical practice. Int J Pediatr Otorhinolaryngol. 1999;49:207-213.
16. Rovers MM, Krabble PF, Straatman H, Ingels K, van der Wilt GJ, Zielhuis GA.
Randomized controlled trial of the effect of ventilation tubes (grommets) on quality of life
at age 1–2 years. Arch Dis Child.2001;84:45–49
17. Roberts JE, Rosenfeld RM, Zeisel SA. Otitis media and speech and language: a meta-
analysis of prospective studies. Pediatrics. 2004;113(3). Available at:
www.pediatrics.org/cgi/content/full/113/3/e238
18. Rovers MM, Straatman H, Ingels K, van der Wilt GJ, van den Broek P, Zielhuis GA. The
effect of ventilation tubes on language development in infants with otitis media with
effusion: a randomized trial. Pediatrics. 2000;106(3). Available at:
www.pediatrics.org/cgi/content/full/106/3/e42
19. Mandel EM, Rockette HE, Bluestone CD, Paradise JL, Nozza RJ. Efficacy of
myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.
Pediatr Infect Dis J. 1992;11:270–277
20. Paradise JL, Bluestone CD, Colborn DK, et al. Adenoidectomy and adenotonsillectomy
for recurrent acute otitis media: parallel randomized clinical trials in children not
previously treated with tympanostomy tubes. JAMA. 1999;282:945–953

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21. Coyte PC, Croxford R, McIsaac W, Feldman W, Friedberg J. The role of adjuvant
adenoidectomy and tonsillectomy in the outcome of insertion of tympanostomy tubes. N
Engl J Med. 2001;344:1188–1195
22. Rovers MM, Straatman H, Ingels K, van der Wilt GJ, van den Broek P, Zielhuis GA. The
effect of short-term ventilation tubes versus watchful waiting on hearing in young children
with persistent otitis media with effusion: a randomized trial. Ear Hear. 2001;22:191–199

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ALGORITHM FOR THE DIAGNOSIS AND TREATMENT OF OTITIS MEDIA WITH EFFUSION
IN CHILDREN 2 MONTHS TO 12 YEARS OF AGE

Patient 2 mo to 12 years presents with

signs and symptoms suggestive of
OME without signs of acute infection

Assess presence of MEE using

pneumatic otoscopy and or
tympanometry

Assess child with N

OME for risk for Diagnosis of OME
developmental
difficulties

Y
Manage the child at risk more Observe for 3 months without
aggressively than the otherwise antibiotics or other medications.
healthy child During this observation period,
evaluate after 3 months of diagnosis

Hearing test

N
Y Clarify follow-up
Resolved? specifics with parents
Hearing loss?

Y Hearing test
End
Myringotomy with VT
insertion
Y Hearing
loss?

Observe for another 3

months

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