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Otitis media with effusion (serous otitis media) in children: Management

Otitis media with effusion (serous otitis media) in children: Management
Authors:
Stephen I Pelton, MD
Tal Marom, MD
Section Editors:
Sheldon L Kaplan, MD
Glenn C Isaacson, MD, FAAP
Deputy Editor:
Mary M Torchia, MD
Literature review current through: Dec 2022. | This topic last updated: Mar 09, 2022.

INTRODUCTION — Otitis media with effusion (OME (picture 1)), also called serous otitis media or "glue ear," is defined as the presence of middle ear fluid without signs of acute infection [1]. OME often occurs after acute otitis media (AOM), but it also may occur as a result of Eustachian tube dysfunction in young children in the absence of a preceding AOM.

In general, OME is a spontaneously resolving condition, and watchful observation is the preferred strategy, except for children with hearing impairment, developmental delay, or specific conditions (such as cleft palate) in whom OME is often persistent and needs to be addressed. The management of OME will be reviewed here. The clinical features and diagnosis of OME and the clinical features, diagnosis, treatment, and prevention of AOM are discussed separately:

(See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis".)

(See "Acute otitis media in children: Epidemiology, microbiology, and complications".)

(See "Acute otitis media in children: Clinical manifestations and diagnosis".)

(See "Acute otitis media in children: Treatment".)

(See "Acute otitis media in children: Prevention of recurrence".)

DEFINITIONS

Otitis media with effusion (OME) or serous otitis media – Presence of middle ear fluid without acute signs of infection (picture 1) [1].

Chronic OME – OME that persists for ≥3 months on otoscopic examination (with or without pneumatic otoscopy), tympanometry, or both. (See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis", section on 'Diagnosis'.)

"Glue ear" – Long-standing OME in which the middle ear fluid has become thick, yellowish, and glue-like (as seen during myringotomy) [2]; sometimes used synonymously with OME but should be reserved for the subset with thick middle ear fluid.

Tympanometry – An examination used to evaluate the condition of the middle ear and the mobility of the tympanic membrane and the ossicles by measuring the transmission of sound energy through the tympanic membrane over a range of air pressures in the external canal (figure 1). Type "A" is considered normal; Type "B" indicates OME, tympanic membrane perforation, or cerumen impaction; and Type "C" indicates Eustachian tube dysfunction.

"Tympanostomy tube," "ventilating tube," "grommet," or "pressure equalizer" – A small tube inserted into the tympanic membrane to keep the middle ear aerated for a prolonged period of time and to prevent the accumulation of fluid in the middle ear. Long-term tubes such as silicon T-tubes are not self-extruding and are usually kept for approximately two years in patients with recurrent OME, after at least one previous tympanostomy tube insertion. (See "Overview of tympanostomy tube placement, postoperative care, and complications in children".)

NATURAL HISTORY — OME usually resolves spontaneously [3-6]. Approximately 30 to 40 percent of children have recurrent episodes [7,8]. Although OME associated with acute otitis media (AOM) usually persists beyond the resolution of the acute symptoms of AOM, it also generally resolves spontaneously within several weeks, often less than four to six weeks (figure 2) [9-11]. (See "Acute otitis media in children: Treatment", section on 'Clinical course without antibiotics'.)

Some children develop chronic OME, defined as OME that persists for three months or longer. Patients with chronic OME may have problems related to the associated, often fluctuating, conductive hearing loss. Rarely, the chronic Eustachian tube dysfunction that results in OME persists for years, and the patient may develop long-term sequelae due to retraction (also known as atelectasis) of the tympanic membrane including retraction pockets, ossicular erosion, chronic tympanic membrane perforation, or cholesteatoma. (See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis", section on 'Complications and sequelae'.)

OME-ASSOCIATED HEARING LOSS — OME causes an average hearing loss of 20 to 28 dB [12-14]. Although OME-associated hearing loss is seldom >50 dB, approximately 20 percent of children with OME have hearing thresholds >35 dB [12].

APPROACH TO MANAGEMENT

Choice of intervention — The goals of management are to clear the middle ear fluid and restore normal middle ear pressure and hearing. The primary management options are "watchful waiting" and myringotomy with tympanostomy tube placement (with or without adenoidectomy). Myringotomy alone – without the insertion of a tympanostomy tube – is ineffective in the management of OME. Although it appears promising, additional information about endoscopic balloon dilation of the Eustachian tube is necessary before its effectiveness and adverse event profile are fully appreciated. (See 'Primary interventions' below and 'Myringotomy' below and 'Balloon dilation of the Eustachian tube' below.)

Which option is undertaken and when depends upon the presence or absence of comorbid conditions that increase the impact of conductive hearing loss on speech, language, or learning problems; the severity of OME-associated hearing loss; the duration of the effusion; and whether it is unilateral or bilateral (algorithm 1) [1,2]. Seasonality also may play a role. Onset in the summer or fall is associated with lack of spontaneous resolution [1,15,16]. When all factors are considered, the balance of risks and benefits will favor watchful waiting for most children and placement of tympanostomy tubes in some.

Hearing aids (worn and implantable) are reserved for the rare cases of children with chronic OME who cannot undergo or benefit from tympanostomy tube placement (ie, aural atresia, ossicular dysfunction). (See 'Hearing aids' below.)

Unproven and/or ineffective interventions that are not recommended and discussed below include antibiotics, antihistamines, oral and intranasal glucocorticoids, nasal balloon autoinflation, and complementary and alternative therapies. (See 'Unproven or ineffective interventions' below.)

The recommendations provided in this topic review are generally consistent with those of professional society guidelines [1,2].

Children at risk for speech, language, or learning issues — "At-risk" children are those who have or are at risk for speech, language, or learning problems. This includes children with hearing loss independent of OME and children with neurodevelopmental or genetic disorders (eg, Down syndrome, 22q11.2 deletion syndrome, autism spectrum disorder, intellectual disability, learning disorder, attention deficit hyperactivity disorder), craniofacial abnormalities (eg, cleft palate), and uncorrectable visual impairment (who depend on hearing more than children with normal vision) [1,2,17].

We perform hearing evaluation in children who are at risk for speech, language, or learning disorders if OME persists for >4 weeks. The conductive hearing loss associated with OME has a more significant impact in children with disabilities. The type of testing depends upon the age of the child and their ability to cooperate with testing. If hearing impairment is significant, surgery is recommended. In addition, children with speech delay should be referred for speech and language evaluation. (See "Hearing loss in children: Screening and evaluation" and "Evaluation and treatment of speech and language disorders in children".)

We agree with professional society recommendations for early surgical referral (ie, within three months) for children with OME who are at risk for speech, language, or learning problems (algorithm 1) [1,17]. These at-risk children typically have been excluded from most studies evaluating the short- and long-term consequences of OME [18]. However, it is reasonable to assume that the conductive hearing loss associated with chronic middle ear effusion presence may increase the risk of speech, language, or learning problems in children with baseline risk factors [19]. (See 'Tympanostomy tubes' below.)

At-risk children also may be candidates for hearing aids or amplification devices for hearing loss independent of OME [1]. They also may require speech and language therapy independent of OME. (See "Evaluation and treatment of speech and language disorders in children", section on 'Treatment' and "Hearing loss in children: Treatment".)

Children not at risk for speech, language, or learning issues — Children with OME who are not at risk for speech, language, or learning problems typically undergo hearing evaluation if OME has persisted for three months or longer (ie, chronic OME) [1,17]. Waiting for three months to evaluate the hearing of these children allows sufficient time for spontaneous resolution in many cases [2]. Speech and language evaluation also may be warranted, particularly if hearing loss with hearing threshold of ≥16 dB is detected. (See "Evaluation and treatment of speech and language disorders in children".)

The management strategy for children who are not at risk depends upon the condition of the tympanic membrane and middle ear, the results of the hearing evaluation (audiometry and tympanometry), the duration of the effusion, whether the fluid is unilateral or bilateral, and the preferences of the parents or caregivers (algorithm 1).

Structural damage to tympanic membrane or middle ear — Prompt surgical referral is warranted for children with structural changes of the tympanic membrane or middle ear (eg, retraction [also known as atelectasis], retraction pocket (picture 2A-B)), tympanic membrane perforation, otorrhea, or cholesteatoma (picture 3A-B) [1]. Such children may require surgery independent of OME. (See "Cholesteatoma in children", section on 'Surgical treatment'.)

Hearing threshold ≥41 dB — We recommend that children with persistent OME-associated conductive hearing loss with a hearing threshold of ≥41 dB be referred for surgical evaluation. (See 'Tympanostomy tubes' below.)

There are few studies evaluating the long-term outcome of children with OME-associated hearing loss at this level. However, as permanent hearing loss of this magnitude may affect speech, language, and academic performance, we recommend referral to otolaryngology [20-22].

A systematic review of randomized trials in children with OME found that the benefit of tympanostomy tubes on hearing appears modest and short lived and diminishes after six to nine months (similar to the duration of natural resolution) [18]. Although no effect was found on speech, language, or cognitive outcomes, data for these outcomes were sparse. Studies in children with established speech, language, developmental, or learning problems are lacking.

Hearing threshold 16 to 40 dB — The management of children without speech, language, or learning problems and OME-associated conductive hearing loss with a hearing threshold of 16 to 40 dB (ie, slight/mild hearing loss) is determined on a case-by-case basis, after a discussion of the risks and benefits of watchful waiting versus tympanostomy tube placement with the parents/caregivers and/or the patient [1,2,17]. In most cases, there is no need for surgery and a "wait-and-see" approach is sufficient. Follow-up is usually recommended with repeat hearing evaluation within three to six months. (See 'Tympanostomy tubes' below and 'Watchful waiting' below.)

The balance of risks and benefits is determined largely by the auditory deprivation associated with mild hearing loss for six to nine months (the period during which the primary benefit of tympanostomy tubes is expected); however, systematic reviews of randomized trials and other controlled studies have found no compelling evidence that early insertion of tympanostomy tubes impacts speech and language development in children with mild conductive hearing loss [9,18,23,24]. Tympanostomy tubes may be warranted for children with unilateral or bilateral OME for three months or longer (chronic OME) and symptoms that are likely attributable to OME (including poor school performance, behavioral problems, or reduced quality of life) [17].

Definitive long-term evidence of improvement for most outcomes following tympanostomy tube placement is lacking. Tympanostomy tube insertion is associated with short- and intermediate-term resolution of hearing loss, and caregivers have reported postoperative improvements in language skills. However, long-term benefits have not been established because resolution of middle ear effusion usually occurs spontaneously within six to nine months. Another potential benefit may be small reduction in recurrent acute otitis media (AOM) episodes [25]. (See 'Potential benefits' below and "Acute otitis media in children: Prevention of recurrence", section on 'Potential benefits'.)

Factors that should be considered in the decision include [1,2,17,26]:

Delayed or abnormal language in the young child or poor school performance associated with behavioral abnormalities in the older child.

Bilateral OME of ≥3 months' duration; in observational studies, bilateral OME has been associated with more severe hearing loss and decreased rates of spontaneous resolution (approximately 25 percent at 6 months and 30 percent at 12 months) [1,2,27].

Unilateral or bilateral OME for three months or longer (chronic OME) and symptoms that are likely attributable to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life (eg disturbed sleep, behavior change) as perceived by the parents or caregivers [28-30].

Prolonged duration (eg, unilateral OME for ≥6 months or cumulative duration of OME for ≥6 of the past 12 months); prolonged duration is associated with a diminished likelihood of spontaneous resolution [5] and increased risk of structural damage to the tympanic membrane [22].

Age <3 years (a critical time for speech and language development) [31].

Recurrent AOM episodes, defined as ≥3 episodes in 6 months or ≥4 episodes in 12 months if middle ear fluid is present at the time of assessment for tympanostomy tube placement in at least one ear [17]; recurrent AOM episodes increase the cumulative duration of middle ear effusion.

Season; onset in the summer or fall is associated with lack of spontaneous resolution [1,15,16].

Home environment that is not conducive to language development (eg, does not provide academic and language stimulation) [32].

Normal hearing — We recommend that children without speech, language, or developmental problems and normal hearing (ie, hearing loss with a threshold of ≤15 dB) be managed with watchful waiting for an additional three months (the first three months of watchful waiting typically occur before the hearing evaluation) [1,2]. OME is likely to resolve spontaneously in such children, and there is no demonstrated risk to watchful waiting. (See 'Natural history' above and 'Watchful waiting' below.)

Recurrence after tympanostomy tube extrusion — Recurrence of OME is common after tympanostomy tube extrusion. In observational and randomized trials, up to 50 percent of children who have undergone tympanostomy tube placement for persistent OME required a second procedure [33-36].

The preferred procedure(s) depend on age [1]:

<4 years – For children <4 years who develop recurrent persistent OME after extrusion of tympanostomy tubes and require repeat surgery, repeat tympanostomy tube placement without adenoidectomy is preferred unless there is a separate and distinct indication for adenoidectomy (eg, nasal obstruction, obstructive sleep apnea). (See "Tonsillectomy and/or adenoidectomy in children: Indications and contraindications", section on 'Adenoidectomy'.)

≥4 years – For children ≥4 years who develop recurrent persistent OME after extrusion of tympanostomy tubes and require repeat surgery, tympanostomy tube placement, with or without adenoidectomy, has been demonstrated to be of value.

In systematic reviews and meta-analyses of randomized trials, the addition of adenoidectomy was associated with improved rates of resolution and decreased rates of additional surgery in children ≥4 years [37,38]. Information regarding the additive effect on OME when adenoidectomy was also performed in children <4 years was limited, and the potential risks (eg, velopharyngeal insufficiency, more complex anesthesia) outweighed the uncertain benefits [1,37,38]. (See 'Adenoidectomy' below and "Tonsillectomy and/or adenoidectomy in children: Indications and contraindications".)

PRIMARY INTERVENTIONS

Watchful waiting

Potential indications — "Watchful waiting" for three months from the onset of the effusion (or the diagnosis of effusion if the date of onset is not known) is recommended for children who have OME; are not at risk for speech, language, or learning problems; and otherwise have normal hearing (ie, hearing threshold ≤15 dB) [1,2,17]. Watchful waiting is also an option for children who have OME; are not at risk for speech, language, or learning problems; and whose OME-associated conductive hearing loss is slight/mild (ie, hearing threshold of 16 to 40 dB). The recommendation for watchful waiting is based upon the high likelihood of spontaneous resolution of OME during the first three to six months [5]. (See 'Natural history' above.)

During the period of watchful waiting, slight/mild conductive hearing loss (ie, hearing threshold of 16 to 40 dB) can be addressed by speaking in close proximity to the child, facing the child and speaking clearly, repeating phrases when misunderstood, providing preferential classroom seating, and/or having the teacher use a frequency modulated (FM) system in the classroom [39].

Systematic reviews, randomized trials, and other controlled studies of the use of tympanostomy tubes for OME-associated hearing loss supports a strategy of watchful waiting rather than immediate placement of tympanostomy tubes [18,24]. Children who received tympanostomy tubes spent 32 percent less time with effusion during the first postoperative year (a mean of 128 days in individual studies). However, mean improvements in hearing were modest and diminished after six to nine months. The benefits diminish because the hearing of children treated with watchful waiting improves as the effusion resolves over time. In otherwise healthy children, there were no proven short-term benefits in language development or cognition. (See 'Tympanostomy tubes' below.)

One of the included trials, in which children (younger than three years) with persistent middle ear effusion were randomly assigned to prompt or delayed insertion of tympanostomy tubes, provides additional support for an initial period of watchful waiting in children who are not at risk for speech, language, or learning problems [40]. Delayed insertion of tympanostomy tubes occurred up to nine months later if the effusion had not cleared spontaneously; by the 9- to 11-year follow-up, 55 percent had not received tubes [41]. Developmental (speech, language, cognition, and psychosocial) outcomes were assessed at 3, 4, 6, and 9 to 11 years of age and were the same between groups [40-43]. (See 'Tympanostomy tubes' below.)

Follow-up — For the majority of children with OME who are managed with watchful waiting, clinical evaluation (including pneumatic otoscopy and developmental surveillance) and hearing tests (including tympanometry) should be repeated every three to six months [17]. Developmental surveillance and hearing evaluation are discussed separately. (See "Hearing loss in children: Screening and evaluation", section on 'Formal audiology' and "Developmental-behavioral surveillance and screening in primary care", section on 'Approach to surveillance'.)

Observation should continue until the effusion has resolved or the child develops an indication for surgical referral. (See 'Potential indications' below.)

Tympanostomy tubes

Potential indications — The decision regarding the placement of tympanostomy tubes should involve the otolaryngologist, parent(s) or caregiver(s), and the primary care provider.

Potential indications for tympanostomy tubes include [1,2,17]:

OME in children who are at risk for speech, language, or learning problems, regardless of hearing status; referral within three months is recommended (see 'Children at risk for speech, language, or learning issues' above)

Tympanic membrane changes (eg, retraction pockets (picture 2A-B)) (see 'Structural damage to tympanic membrane or middle ear' above)

Persistent OME-associated hearing loss with a hearing threshold of ≥41 dB (see 'Hearing threshold ≥41 dB' above)

Bilateral OME for ≥3 months, unilateral OME for ≥6 months, or recurrent episodes of AOM with cumulative duration of OME for ≥6 of the previous 12 months

Potential benefits — Myringotomy and placement of a tympanostomy tube is a definitive means of clearing middle ear fluid, improving effusion-associated conductive hearing loss, and maintaining an air-filled middle ear cavity as long as the tympanostomy tubes remain patent [33,34]. Tympanostomy tubes help to reduce the symptoms of OME (including associated conductive hearing loss) during the natural course of resolution [2,23,44]. However, recurrence of OME after extrusion of the tympanostomy tubes occurs in as many as 50 percent of patients, and repeat surgery may be required. (See "Overview of tympanostomy tube placement, postoperative care, and complications in children".)

Systematic reviews of randomized trials and other comparison studies evaluating the effectiveness of tympanostomy tubes for children with OME have concluded that children with tubes spend less time with effusion during the first postoperative year but the improvements in hearing loss diminish over time [9,24]. In a network meta-analysis of 10 randomized trials, mean hearing thresholds improved (ie, decreased) by 9 dB (95% CI -14 to -3.4 dB) one to three months after insertion of tympanostomy tubes. However, by 12 to 24 months, there was no difference in hearing thresholds between children with tubes and those managed with watchful waiting (mean difference 0, 95% CI -4.0 to 3.4) [9]. Another systematic review concluded that children with tympanostomy tubes spent 32 percent less time with middle ear effusion during the first year of follow-up than children managed with watchful waiting (mean 128 fewer days) [24].

A systematic review of eight randomized and nonrandomized comparison studies including 1665 children found little evidence that tympanostomy tubes improved cognitive, language, behavioral, or quality-of-life outcomes, but heterogeneity precluded definitive conclusions [9].

These systematic review findings of modest and short-lived improvement are inconsistent with the parental and clinical observation that the effects of tympanostomy tubes are beneficial and often dramatic, with a rapid increase in speech following insertion, and observational studies suggesting improved quality of life [28-30,44-46]. As an example, in a prospective survey of parents of 123 children who underwent bilateral placement of tympanostomy tubes, with or without adenoidectomy, postoperative symptom scores decreased by 75 and 60 percent at one and six months, respectively [28]. Parents also reported decreased worry about ear problems at both time points.

Risks — The risks of tympanostomy tubes include persistent tympanic membrane perforation, postoperative tympanostomy tube otorrhea (often a result of biofilm formation on the tube), retained tympanostomy tubes requiring another operation for removal, accidental displacement of the tube into the middle ear cavity, focal atrophy of the tympanic membrane, and cholesteatoma. Biofilm colonization of tympanostomy tubes is a common cause of persistent postoperative discharge. They are discussed separately. (See "Overview of tympanostomy tube placement, postoperative care, and complications in children", section on 'Complications and sequelae'.)

Follow-up — Postoperative care and follow-up for children who have undergone tympanostomy tube placement is discussed separately. (See "Overview of tympanostomy tube placement, postoperative care, and complications in children", section on 'Postoperative care'.)

OTHER INTERVENTIONS

Balloon dilation of the Eustachian tube — Endoscopic balloon dilation of the Eustachian tube ("tuboplasty") is a minimally invasive procedure for treating chronic, obstructive Eustachian tube dysfunction in adults. Small observational studies indicate that it is also safe and moderately successful in improving OME in children [47-49]. Failure of balloon dilation may be related to thickened mucosa or adenoid tissue obstruction at the Eustachian tube orifice that acts as a barrier to middle ear ventilation and is unresponsive to balloon dilation [50]. Although balloon dilation of the Eustachian tube appears to be promising and experience in children is increasing, additional studies are necessary to determine which children with OME are most likely to benefit.

Hearing aids — Hearing aids may be warranted for children with OME-associated conductive hearing loss but are discouraged unless tympanostomy tubes cannot be placed [1]. The 2008 National Institute for Health and Care Excellence guidelines (United Kingdom) indicate that hearing aids should be offered to children with persistent bilateral hearing loss as an alternative to surgical intervention when surgery is contraindicated or unacceptable [2]. In observational studies, hearing aids were well accepted by children with OME and their parents and were associated with improvement in hearing, speech, and development (as perceived by parents and teachers) [51-53]. In a retrospective study, only one-half of children with OME who were referred for hearing aids actually received them [53]; for most of the other children, by the time of the appointment, hearing aids were no longer necessary because hearing loss had resolved or was asymptomatic.

Adenoidectomy — When the decision is made to manage OME in children ≥4 years of age with surgical intervention, surgical options include adenoidectomy alone, adenoidectomy and tympanostomy tube placement, or tympanostomy tube placement alone [1]. Concomitant adenoidectomy is recommended for children undergoing recurrent tympanostomy tube placement.

Decisions about adenoidectomy are made on a case-by-case basis. Adenoidectomy generally is not recommended as the initial approach for children <4 years with persistent OME unless they have a distinct indication for the adenoidectomy independent of OME (eg, nasal obstruction, chronic sinusitis, obstructive sleep apnea) [1,2]. The potential risks (eg, velopharyngeal insufficiency, bleeding, anesthesia necessitating endotracheal intubation) outweigh the uncertain benefits in this age group [1,37,38]. (See "Tonsillectomy and/or adenoidectomy in children: Indications and contraindications".)

In systematic reviews of heterogeneous randomized trials, adenoidectomy (with or without tympanostomy tube placement) was beneficial in resolving middle ear fluid compared with unilateral or bilateral tympanostomy tube placement (without adenoidectomy), myringotomy only, and nonsurgical treatment in children ≥4 years [24,37,38,54]. However, adenoidectomy had only a small effect (<5 dB) on hearing levels [54]. The effects of adenoidectomy on tympanic membrane changes or cholesteatoma were not studied.

UNPROVEN OR INEFFECTIVE INTERVENTIONS

Antibiotics — We suggest not using antibiotics for the treatment of persistent OME. Although biofilms appear to play an important role in the pathogenesis of OME, biofilm-associated pathogens generally are unresponsive to antibiotic therapy. (See "Otitis media with effusion (serous otitis media) in children: Clinical features and diagnosis", section on 'Pathogenesis'.)

A 2016 systematic review of randomized trials found evidence of modest, short-term benefits as well as potential adverse events associated with the use of antibiotics for the treatment of OME [55]. Potential benefits included resolution of OME within two to three months (risk ratio 2, 95% CI 1.6-2.5). Potential harms included increased risk of diarrhea, vomiting, or skin rash (risk ratio 2.2, 95% CI 1.3-3.6). Antibiotics did not reduce the rate of tympanostomy tube insertion or tympanic membrane sequelae. The effects on short-term hearing were inconsistent. Data regarding speech, language, cognitive development, and quality of life were lacking. It is possible that the antibiotic therapy administered in some of the studies included in the systematic review and meta-analysis was insufficient in duration, dose, or spectrum to eradicate bacteria in biofilms. Nonetheless, given the high likelihood of spontaneous resolution and the potential to contribute to antibiotic resistance, and the limited benefits, the risks of antibiotic therapy for persistent OME outweigh the benefits in most situations.

Professional society guidelines also recommend against the use of any antibiotics in the treatment of OME [1,2]. (See 'Society guideline links' below.)

Oral glucocorticoids — We do not suggest oral glucocorticoids for the treatment of OME in children. Although oral glucocorticoids may hasten the short-term resolution of OME, improvement in hearing and functional status is unproven, often transient, and questionable.

In a 2011 meta-analysis of heterogeneous randomized trials of glucocorticoids (with or without antibiotics) for the treatment of OME in children, oral glucocorticoids were associated with greater resolution of OME at two weeks (relative risk [RR] from three trials 4.4, 95% CI 1.5-13.2) but not thereafter [56]. The only study that assessed hearing did not find a benefit [57]. Long-term hearing and speech development were not assessed [56]. In a subsequent multicenter trial, 389 children age two to eight years with OME for ≥3 months and documented bilateral hearing loss were randomly assigned to a seven-day course of oral prednisolone or placebo [58]. After five weeks, the rates of audiometric resolution of hearing loss, measures of functional status, and measures of quality of life were similar between groups. In a subsequent open-label randomized trial, oral glucocorticoids had no discernable effect on resolution or duration of middle ear fluid in children with AOM [59].

In the systematic review and subsequent randomized trial, no serious adverse effects were reported, but the number of patients was insufficient to adequately assess safety [56,58]. Avoidance of oral glucocorticoids is sometimes used as a measure of quality performance in the care of children with OME [60,61].

Professional society guidelines and the international OME taskforce recommend against the use of oral glucocorticoids for the treatment of OME [1,2,62]. (See 'Society guideline links' below.)

Intranasal glucocorticoids — We do not suggest intranasal glucocorticoids in the treatment of OME unless they are necessary for the treatment of underlying allergic/chronic rhinitis. (See "Pharmacotherapy of allergic rhinitis", section on 'Approach to specific patient groups'.)

In a 2011 systematic review of heterogeneous randomized trials of systemic and topical nasal glucocorticoids for the treatment of OME in children, intranasal glucocorticoids were not helpful in OME resolution or improving hearing in the short term [56]. Long-term hearing and speech development were not assessed. A subsequent randomized trial confirmed the lack of benefit of intranasal glucocorticoids for children with OME [63]. Avoidance of intranasal glucocorticoids (unless there is adequate documentation of the rationale) is sometimes used as a measure of quality performance in the care of children with OME [60,61]. Professional society guidelines also recommend against the use of nasal glucocorticoids for the treatment of OME [1,2].

Autoinflation — Autoinflation refers to the process of allegedly active opening the Eustachian tube by raising intranasal pressure (eg, by forced exhalation with closed mouth and nose, blowing up a balloon through each nostril, or using a specifically designed nasal balloon) [64,65]. It is typically performed at least twice a day for several weeks to three months. The long-term benefit is uncertain.

Although we do not recommend autoinflation, it may be an alternative to watchful waiting for the older child who has continued problems with OME and is able to perform the technique [2,65]. It should not be used in children with active nasal discharge. Autoinflation has minimal adverse effects, but the benefits are uncertain and some children may find it difficult to perform [64,66,67]; in one trial, 12 percent of children (3 to 12 years) were unable to use the balloon [68].

In a 2013 systematic review of eight heterogeneous randomized trials (702 participants), autoinflation appeared to improve tympanometry and/or audiometry in children with OME in the short term, but pooled estimates were not significant [64]. None of the trials assessed long-term outcomes or language development. A subsequent open randomized trial compared one to three months of autoinflation (three times per day) with a purpose-manufactured balloon with usual care in 320 children (age 4 to 11 years) with tympanometry-confirmed OME [65]. Autoinflation increased the rate of normal tympanograms at one month (47 versus 36 percent, adjusted RR 1.36, 95% CI 0.99-1.88) and at three months (50 versus 38 percent, adjusted RR 1.37, 95% CI 1.03-1.83) and improved ear symptoms and quality of life. Respiratory infections (15 versus 10 percent) and otalgia (4 versus 1 percent) were more common in the autoinflation group.

Antihistamines and decongestants — We do not recommend antihistamines and/or decongestants for the treatment of OME in children. In a 2011 systematic review of 16 randomized trials, treatment with antihistamines and/or decongestants neither reduced the duration of OME nor prevented complications (recurrent OME or acute otitis media) [69]. However, treatment with antihistamines and/or decongestants was associated with increased risk of side effects (17 versus 6 percent among placebo recipients). Avoidance of antihistamines and decongestants is sometimes used as a measure of quality performance in the care of children with OME [60,61].

Professional society guidelines also recommend against the use of antihistamines and decongestants in the management of OME in children [1,2].

Complementary and alternative therapies — We do not recommend homeopathic, probiotic, or other complementary and alternative therapies for the treatment of OME in children.

The few published studies of homeopathic remedies for middle ear infections or OME have defects in study design, including small sample size, lack of randomization or blinding, and lack of validation of the diagnosis [70,71]. In addition, there are no standardized homeopathic regimens for otitis media and no data on appropriate doses or schedules.

A systematic review of complementary and alternative medicine interventions for otitis media found some evidence that probiotics may be beneficial in the treatment of OME [72], but additional studies are necessary before probiotics can be recommended [73].

The 2008 National Institute for Health and Care Excellence guidelines recommend against homeopathy, cranial osteopathy, acupuncture, dietary modifications (including probiotics), immunostimulants, and massage [2]. The 2022 American Academy of Otolaryngology-Head and Neck Surgery guidelines indicate that no benefits have been shown for chiropractic therapy, special diets, herbal remedies, or other complementary or alternative therapies [1,17].

Myringotomy — Myringotomy alone (ie, without tympanostomy tube placement) is ineffective in the management of persistent OME because the incision closes within a few hours [33,34]. Laser-assisted myringotomy may extend the ventilation period to several weeks [74,75]. However, in randomized trials, patients treated with laser myringotomy alone had shorter duration of middle ear ventilation and fewer effusion-free follow-up visits than those who received tympanostomy tubes [76,77].

AIRPLANE TRAVEL — Airplane travel for children with otitis media (OME or acute otitis media) is discussed separately. (See "Acute otitis media in children: Treatment", section on 'Management of pain'.)

SOCIETY GUIDELINE LINKS — Links to society and government-sponsored guidelines from selected countries and regions around the world are provided separately. (See "Society guideline links: Acute otitis media, otitis media with effusion, and external otitis".)

INFORMATION FOR PATIENTS — UpToDate offers two types of patient education materials, "The Basics" and "Beyond the Basics." The Basics patient education pieces are written in plain language, at the 5th to 6th grade reading level, and they answer the four or five key questions a patient might have about a given condition. These articles are best for patients who want a general overview and who prefer short, easy-to-read materials. Beyond the Basics patient education pieces are longer, more sophisticated, and more detailed. These articles are written at the 10th to 12th grade reading level and are best for patients who want in-depth information and are comfortable with some medical jargon.

Here are the patient education articles that are relevant to this topic. We encourage you to print or email these topics to your patients. (You can also locate patient education articles on a variety of subjects by searching on "patient education" and the keyword[s] of interest.)

Basics topic (see "Patient education: Ear tubes (The Basics)")

Beyond the Basics topic (see "Patient education: Ear infections (otitis media) in children (Beyond the Basics)")

SUMMARY AND RECOMMENDATIONS

Definitions and natural history – Otitis media with effusion (OME) is defined as middle ear fluid without acute signs of infection (picture 4). OME usually resolves spontaneously within six weeks. Approximately 30 to 40 percent of children with OME have recurrent episodes. (See 'Definitions' above and 'Natural history' above.)

Approach to management – The goals of management are to clear the middle ear fluid and restore normal hearing. The primary management options are "watchful waiting" and tympanostomy tube (ventilation tube, grommet) placement. Which option is undertaken and when depends upon coexisting conditions that increase the risk of hearing, speech, language, or learning problems; the severity of OME-associated hearing loss; the duration of the effusion; and whether the effusion is unilateral or bilateral (algorithm 1). (See 'Choice of intervention' above.)

Risk for speech, language, or learning problems – "At-risk" children are those who have or are at risk for speech, language, or learning problems. This includes children with hearing loss independent of OME, neurodevelopmental disorders, craniofacial disorders (eg cleft palate), and uncorrectable visual impairment.

For children with OME who are at risk for speech, language, or learning problems, we suggest early surgical referral (ie, within three months) for tympanostomy tube placement (Grade 2B). (See 'Children at risk for speech, language, or learning issues' above and 'Tympanostomy tubes' above.)

Structural damage to tympanic membrane or middle ear – Prompt surgical referral is warranted for children who have structural damage to the tympanic membrane or middle ear (eg, retraction pocket (picture 2A-B), cholesteatoma (picture 3A-B)). (See 'Structural damage to tympanic membrane or middle ear' above.)

Hearing threshold ≥41 dB – For children with persistent OME-associated hearing loss with a hearing threshold of ≥41 dB, we recommend prompt surgical referral for tympanostomy tube placement (Grade 1B). (See 'Hearing threshold ≥41 dB' above and 'Tympanostomy tubes' above.)

Hearing threshold 16 to 40 dB – The management of children without speech, language, or learning problems and OME-associated conductive hearing loss with a hearing threshold of 16 to 40 dB is determined on a case-by-case basis, after a discussion of the risks and benefits of watchful waiting versus tympanostomy tube placement. (See 'Hearing threshold 16 to 40 dB' above.)

Hearing threshold ≤15 dB – For children without speech, language, or developmental problems and with hearing threshold of ≤15 dB (ie, normal hearing), we recommend watchful waiting (Grade 1A). Children who are managed with watchful waiting should be reevaluated (with pneumatic otoscopy, developmental surveillance, and hearing testing) every three to six months until the effusion has resolved or the child develops an indication for surgical referral. (See 'Normal hearing' above and 'Watchful waiting' above.)

Unproven or ineffective interventions

We suggest not using antibiotics in the management of children with OME (Grade 2B); the benefits are generally transient. We suggest not using oral or intranasal glucocorticoids in the management of OME (Grade 2B); although they may hasten resolution of OME, improvement in hearing and functional status is unproven. (See 'Antibiotics' above and 'Oral glucocorticoids' above and 'Intranasal glucocorticoids' above.)

We recommend not using antihistamines or decongestants routinely in the management of OME in children, as no benefits have been observed. (Grade 1A). (See 'Antihistamines and decongestants' above.)

ACKNOWLEDGMENT — The UpToDate editorial staff acknowledges Jerome Klein, MD, who contributed to an earlier version of this topic review.

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