The Subcommittee on Otitis Media with Effusion, which was convened by the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP), and the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), has released evidence-based clinical practice guidelines on the diagnosis and management of otitis media with effusion (OME). The guideline applies to children between two months and 12 years of age with or without developmental disabilities or underlying conditions that predispose to OME. The subcommittee included experts in the fields of primary care, otolaryngology, epidemiology, infectious diseases, hearing, speech and language, and advance practice nursing. This guideline is an update of the 1994 clinical practice guideline developed by the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality [AHRQ]) which was limited to children one year to three years of age with no craniofacial or neurologic abnormalities, or sensory deficits. The full report was published in the May 1, 2004, issue of Pediatrics.

The authors note that these guidelines are a framework for clinical decision-making and are not intended to replace clinical judgment or to establish a protocol for all children with this condition.

In this guideline, OME is defined as the presence of fluid in the middle ear without signs or symptoms of acute ear infection. OME is differentiated from acute otitis media, which is defined as: (1) a history of acute onset of signs and symptoms, (2) the presence of middle ear effusion, and (3) signs and symptoms of middle ear inflammation. The presence of persistent middle-ear fluid from OME results in decreased mobility of the tympanic membrane and is a barrier to sound conduction.

Recommendation 1a

Clinicians should use pneumatic otoscopy as the primary diagnostic method for OME. OME should be distinguished from acute otitis media (AOM). (This recommendation is based on a systematic review of cohort studies and a preponderance of benefit over harm.)

The correct diagnosis of OME is essential to proper management. Differentiating OME from AOM will avoid the use of unnecessary antimicrobial agents. In patients with OME, the tympanic membrane is often cloudy with distinctly impaired mobility, and an air-fluid level or bubble may be visible in the middle ear. Pneumatic otoscopy is the primary method of diagnosing OME because it is readily available in practice settings, is cost effective, and is accurate. Nonpneumatic otoscopy is not recommended for primary diagnosis.

Recommendation 1b

Tympanometry can be used to confirm the diagnosis of OME. (This option is based on cohort studies and a balance of benefit and harm.)

In cases where the diagnosis of OME is uncertain, tympanometry or acoustic reflectometry should be considered as an adjunct to pneumatic otoscopy. For children at least four months of age, tympanometry with a standard 226 Hz probe tone is reliable. Infants younger than four months require specialized equipment with a higher probe tone frequency.

Recommendation 1c

Population-based screening programs for OME are not recommended in healthy, asymptomatic children. (This recommendation is based on randomized controlled trials and cohort studies with a preponderance of harm over benefit.)

The authors state that population-based screening has not been found to influence short-term language outcomes. Although screening for OME is not inherently harmful, potential risks include inaccurate diagnosis, over treating self-limited disease, parental anxiety, and the costs of screening and unnecessary treatment. This recommendation concerns population-based screening programs of all children in a school or community without regard to any preexisting symptoms or history of disease; it does not apply to hearing screening or monitoring of specific children with previous or recurrent OME.

Recommendation 2

Clinicians should document the laterality and duration of effusion, and the presence and severity of associated symptoms at each assessment of the child with OME. (This recommendation is based on observational studies and a strong preponderance of benefit over harm.)

At each assessment of the child with OME, the clinician should document in the medical record the laterality (unilateral or bilateral), duration of effusion, and presence and severity of associated symptoms. When the duration of OME is uncertain, the clinician must use all available evidence to make a reasonable estimate. Documentation facilitates diagnosis and treatment, ensures patient safety, and reduces medical errors.

Recommendation 3

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. (This recommendation is based on case series, preponderance of benefit over harm, and ethical limitations in studying at-risk children with OME.)

The authors defined an at-risk child as one who is at increased risk for developmental difficulties (delay or disorder) because of physical, sensory, cognitive, or behavioral factors that are not caused by OME but can make the child less tolerant of hearing loss or vestibular problems secondary to middle-ear effusion. Management of the child with OME who is at increased risk for developmental delays should include: (1) speech and language therapy concurrent with managing OME, (2) hearing aids or other amplification device for hearing loss independent of OME, (3) insertion of tympanostomy tube, and (4) hearing testing after resolution of OME to document improvement.

Recommendation 4

Clinicians should manage the child with OME who is 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). (This recommendation is based on a systematic review of cohort studies and a preponderance of benefit over harm.)

The likelihood of spontaneous resolution of OME is determined by the cause and duration of effusion. Approximately 75 to 90 percent of residual OME after an episode of AOM resolves spontaneously within three months. Any intervention for OME (medical or surgical) other than observation has the potential for harm. A specified period of observation in children who are not at risk for speech, language, or learning problems is associated with little harm. During this three-month period of watchful waiting, the clinician may choose to include interval visits to monitor OME using pneumatic otoscopy, tympanometry, or both.

Recommendation 5

Antihistamines and decongestants are ineffective for OME and are not recommended for treatment. Antimicrobials and corticosteroids do not have long-term efficacy and are not recommended for routine management. (This recommendation is based on a systematic review of randomized controlled trials and a preponderance of harm over benefit.)

The use of antimicrobials, with or without steroids, has not been shown to be effective in the long-term resolution of OME; in some cases this therapy may be an option, such as when the parent or caregiver has a strong aversion to impending surgery. The authors state that the likelihood of OME resolving long-term with these medications is small and strongly recommend against prolonged or repetitive courses of antimicrobials.

Recommendation 6

Hearing testing is recommended 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. Language testing should be conducted for children with hearing loss. (This recommendation is based on cohort studies and a preponderance of benefit over risk.)

Hearing testing is recommended for children in whom OME persists for three months or longer, or language delay, learning problems, or a significant hearing loss is suspected. Initial hearing testing for children at least four years of age can be conducted in the primary care setting in a quiet environment. The use of tympanometry, pneumatic otoscopy, caregiver judgment regarding hearing loss, speech audiometry, tuning forks, acoustic reflectometry, and behavioral observation are not recommended as substitutes for primary care hearing testing. Comprehensive audiologic examination is recommended for children who fail primary care testing, are younger than four years, or cannot be tested in the primary care setting.

Language testing should be conducted in children with hearing loss. Intervention can improve communications and other functional outcomes in children with a history of otitis media.

Recommendation 7

Children with persistent OME who are not at risk should be re-examined at three- to six-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. (This recommendation is based on randomized controlled trials and observational studies with a preponderance of benefit over harm.)

If OME is asymptomatic and likely to resolve spontaneously, intervention is unnecessary even if OME persists for more than three months. The clinician should determine if risk factors exist that would predispose the child to undesirable sequelae or predict nonresolution of the effusion. The child must be periodically reevaluated for factors that would prompt intervention as long as OME persists.

Recommendation 8

When children with OME are referred by the primary care clinician for evaluation by an otolaryngologist, audiologist, or speech-language pathologist, the referring clinician should document the effusion duration and the specific reason for referral (evaluation, surgery), and provide additional relevant information such as history of AOM and developmental status of the child. (This option is based on panel consensus and a preponderance of benefit over harm.)

When referring a child for evaluation to an otolaryngologist, the primary care physician should explain to the parent or caregiver the following information: the reason for referral, the possibility of the need for surgery, and alternatives to management and surgery. When referring a child to an otolaryngologist, audiologist, or speech-language pathologist, the following is the minimum information that should be conveyed in writing: the duration of OME, the laterality of OME, results of previous hearing testing or tympanometry, suspected speech or language problems, conditions that might exacerbate the deleterious effects of OME, and history of AOM. The primary care physician also may provide the otolaryngologist with the parents’ or caregivers’ attitude toward surgery, related conditions that might require concomitant surgery, and the child’s general health status. After evaluating the child, the otolaryngologist, audiologist, or speech-language pathologist should inform the referring physician of diagnostic impressions, plans for further assessment, and recommendations for monitoring and management.

Recommendation 9

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. Tonsillectomy alone or myringotomy alone should not be used to treat OME. (This recommendation is based on randomized controlled trials with a preponderance of benefit over harm.)

Determining candidacy for surgery for OME is based 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 (1) OME lasting four months or longer with persistent hearing loss or other signs and symptoms; (2) recurrent or persistent OME in at-risk children regardless of hearing status; and (3) OME and structural damage to the tympanic membrane or middle ear. A recommendation of surgery should be based on the individual.

Recommendation 10

No recommendation is made regarding complementary and alternative medicine as a treatment for OME. (No recommendation is based on a lack of scientific evidence documenting efficacy and an uncertain balance of harm and benefit.)

The authors state that there is insufficient evidence concerning complementary and alternative medicine to determine if the outcomes achieved for OME differ from those achieved with watchful waiting and spontaneous resolution.

Recommendation 11

No recommendation is made regarding allergy management as a treatment for OME. (No recommendation is based on insufficient evidence of therapeutic efficacy or a causal relationship between allergy and OME.)

The correlation between OME and allergy has been widely reported, but there are no prospective studies that have examined the effects of immunotherapy compared with observation only or other management options.