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Am Fam Physician. 2004;69(12):2776-2779

See related "Practice Guidelines" on page 2929.

In 1994, a clinical practice guideline1 on the diagnosis and management of otitis media with effusion (OME) was developed by the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality [AHRQ]). An update2 to this clinical practice guideline, developed by a committee with representatives from the American Academy of Pediatricians (AAP), the American Academy of Family Physicians (AAFP), the American Academy of Otolaryngology–Head & Neck Surgery (AAO–HNS), and other organizations, recently was issued. This updated guideline informs clinicians of evidence-based methods to identify, monitor, and manage OME in children ages two months through 12 years with or without developmental disabilities or underlying conditions that predispose to OME. A summary of this clinical practice guideline appears in this issue of American Family Physician.3 The 1994 guideline1 was limited to children ages one to three years with no craniofacial or neurologic abnormalities or sensory deficits.

Recommendations in this practice guideline2 are based on the best available published data, primarily the AHRQ report on OME from the Southern California Evidence-Based Practice Center,4 through April 2003. Evidence-based statements follow AAP definitions reflecting both the quality of evidence and the balance of benefit and harm.5

Consistent with the 1994 guideline1 and the AHRQ evidence report,4 this updated 2004 clinical practice guideline2 emphasizes making an accurate diagnosis of OME. Differentiating OME from acute otitis media (AOM) can avoid unnecessary antimicrobial use.6

  • Clinicians should use pneumatic otoscopy as the primary diagnostic method for distinguishing OME from AOM. [Strong recommendation] Tympanometry may be used to confirm diagnosis of OME. [Option]

The updated guideline2 is distinct from the 1994 guideline1 in areas relating to risk stratification, management, and monitoring.

  • Clinicians should distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME, and should more promptly evaluate hearing, speech, language, and need for intervention in these at-risk children. [Recommendation]

As defined in this updated guideline,2 an at-risk child “is at increased risk for developmental difficulties (delay or disorder) because of sensory, physical, cognitive, or behavioral factors” that “make the child less tolerant of hearing loss or vestibular problems secondary to middle-ear effusion.” Evaluation of at-risk children with OME should include hearing testing and evaluation of speech and language. Repeat hearing testing should be performed after OME resolves to document improvement, because OME may mask a permanent underlying hearing loss and cause a delay in detection.

  • Clinicians should manage children with OME who are not at risk with watchful waiting for three months from the date of effusion onset (if known), or from the date of diagnosis (if onset is unknown). [Recommendation]

This recommendation is based on the self-limited nature of most cases of OME as documented in cohort studies and in control groups of randomized trials.4,7 About 75 to 90 percent of residual cases of OME after an AOM episode resolve spontaneously within three months,7 and the three-month period of observation is consistent with avoiding unnecessary intervention or surgery.1 At the discretion of the clinician, watchful waiting may include interval examinations.

  • Hearing testing should be conducted when OME persists for three months or longer, or at any time that language delay, learning problems, or a significant hearing loss is suspected in a child with OME. [Recommendation]

Hearing testing for children aged four years or older can be done in a quiet area of the physician’s office. Conventional audiometry with earphones is performed with a fail criterion of greater than 20 decibels (dB) hearing loss at one or more frequencies (500; 1,000; 2,000; 4,000 Hz) in either ear. Comprehensive audiologic evaluation is indicated for children who fail office testing, are younger than four years of age, or cannot be tested in the primary care setting. Language testing should be conducted for children with hearing loss greater than 20 dB on comprehensive audiometric evaluation.

  • Children with persistent OME who are not at risk should be re-examined at three- to six-month intervals until the effusion clears, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected. [Recommendation]

If OME is asymptomatic and likely to resolve spontaneously, intervention is unnecessary even if OME persists for more than three months. In contrast, the 1994 OME guideline1 recommended surgery for OME persisting four to six months with hearing loss greater than 20 dB. The current updated guideline2 recommends surgery if a bilateral hearing loss of 40 dB or greater persists; otherwise, the decision to pursue surgery should be individualized. As long as OME persists, the child should be evaluated periodically for hearing loss or structural abnormality to determine the need for intervention.

  • When a child becomes a candidate for surgery, tympanostomy tube insertion is the preferred initial procedure; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis). Tonsillectomy alone or myringotomy alone should not be used. [Recommendation]

  • Antihistamines and decongestants are ineffective in the treatment of OME and are not recommended. [Continued negative recommendation] While antimicrobials and corticosteroids may yield short-term improvements, there is no demonstrated long-term efficacy, and neither should be used for routine management. [Continued negative recommendation]

  • The 2004 guideline2 makes “no recommendation” regarding the use of complementary and alternative medicine for OME because of the lack of evidence documenting therapeutic efficacy.

  • Similar to the 1994 guidelines,1 the 2004 guideline2 reached no conclusion regarding allergy management as treatment for OME based on insufficient evidence of therapeutic efficacy and the lack of a distinct causal associated between allergy and OME. [No recommendation]

  • The updated guideline2 recommends against population-based screening programs for OME among healthy, asymptomatic children. [Negative recommendation] Given the favorable natural history, there is no demonstrable benefit to such screening. Family physicians involved in school health programs should not allow OME screening on every child.

Updating this guideline serves to identify research issues relating to OME diagnosis, management, and surveillance that would be appropriate for family medicine researchers and primary care practice-based research networks to address. The complete OME guideline can be found at

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