AUTHOR AND EDITOR INFORMATION

Section 1 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

INTRODUCTION

Section 2 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Background

Otitis media with effusion (OME) is characterized by a nonpurulent effusion of the middle ear that may be either mucoid or serous. Symptoms usually involve hearing loss or aural fullness but typically do not involve pain or fever. In children, hearing loss is generally mild and is often detected only with an audiogram. Serous otitis media is a specific type of OME caused by transudate formation as a result of a rapid decrease in middle ear pressure relative to the atmospheric pressure. The fluid in this case is watery and clear.

Understanding the difference between OME and other forms of middle ear infections is important. Otitis media is a generic term defined as an inflammation of the middle ear without reference to a specific etiology or pathogenesis. Because all pneumatized spaces of the temporal bone are contiguous, inflammation of the middle ear may involve inflammation in the other 3 spaces: the mastoid, perilabyrinthine air cells, and the petrous apex. The term otitis media is often used to describe any of a continuum of related diseases: acute otitis media (AOM), recurrent acute otitis media (RAOM), OME, and chronic otitis media with effusion (COME).

AOM is a viral or bacterial infection of the middle ear that causes a rapid onset of signs and symptoms such as pain, fever, irritability, anorexia, and vomiting. Significant inflammation is present on physical examination, both on the tympanic membrane and in the middle ear effusion (MEE) in the form of purulence.

For further information, please also see the eMedicine articles Middle Ear, Inflammatory Diseases; Complications of Otitis Media; Middle Ear, Acute Otitis Media, Medical Treatment; and Middle Ear, Acute Otitis Media, Surgical Treatment

Pathophysiology

OME can occur during the resolution of AOM once the acute inflammation has resolved. Among children who have had an episode of AOM, as many as 45% have persistent effusion after 1 month, but this number decreases to 10% after 3 months.

Two main theories of the cause of AOM exist. The classic explanation proposes that eustachian tube dysfunction is the necessary precursor. The eustachian tube has been traditionally described to provide 3 main functions: equilibration of pressure between the middle and external ears, clearance of secretions, and protection of the middle ear. Its dysfunction can be caused by any number of circumstances from anatomic blockage to inflammation secondary to allergies, upper respiratory tract infection (URTI), or trauma.

If eustachian tube dysfunction is persistent, a negative pressure develops within the middle ear from the absorption and/or diffusion of nitrogen and oxygen into the middle ear mucosal cells. If present for long enough and with appropriate magnitude, the negative pressure elicits a transudate from the mucosa, leading to the eventual accumulation of a serous, essentially sterile effusion. Because the eustachian tube is dysfunctional, the effusion becomes a sessile medium ideal for the proliferation of bacteria and resultant AOM. This classic model is somewhat incorrect, since multiple studies have revealed that the same pathogenic bacteria are present in OME as in AOM.

The newer models describe the primary event as inflammation of the middle ear mucosa caused by a reaction to bacteria already present in the middle ear. Indeed, Bluestone and others have shown (using radiographic evidence) that reflux up the eustachian tube is demonstrable in children prone to otitis media. Furthermore, in 2007, Crapko et al demonstrated the presence of pepsin in the middle ear space of 60% of children with OME.¹ This reflux certainly may also occur in otherwise healthy individuals. The inflammatory mediators released as a result of bacterial antigenic challenge induce the up-regulation of mucin genes. The production of a mucin-rich effusion then provides an ample medium for the proliferation of bacteria and resultant AOM.

Yilmaz et al published a study in 2004 that documented significant changes in oxidative stress in patients with OME.² They demonstrated a significantly improved but not normalized level of oxidants following the placement of ventilation tubes. However, the role of antioxidants in the treatment of OME has yet to be fully investigated.

Regardless of the cause of AOM, eustachian tube dysfunction is nearly universal in OME. As further evidence, ligation of the eustachian tube in animals invariably leads to the formation of a persistent MEE. Once the acute inflammation and bacterial infection have resolved, a failure of the middle ear clearance mechanism allows MEE to persist. Many factors have been implicated in the failure of the clearance mechanism, including ciliary dysfunction; mucosal edema; hyperviscosity of the effusion; and, possibly, an unfavorable pressure gradient.

OME does not necessarily follow AOM. Theories to explain the development of MEE in this case include the secretion of fluid from inflamed middle ear mucosa. This theory proposes that the middle ear mucosa is sensitized by previous exposure to bacteria, and continued antigenic challenge from occasional reflux induces the production of the effusion. Again, multiple studies have revealed that the same flora of bacteria is present in OME as in AOM; these findings indicate that this effusion is not sterile, as was once believed.

OME is ubiquitous in children who have a cleft palate. The cause is simply the lack of proper insertion of the tensor veli palatini muscle in the soft palate. The muscle is, therefore, unable to open the eustachian tube on swallowing or wide mouth opening. A functional obstruction of the tube results.

Frequency

United States

Middle ear infections are the most common medical problem in infants and children of preschool age, and they are the most frequent primary diagnoses in children younger than 15 years who are examined at physicians' offices.

Clinical guidelines from a joint commission of specialties document that screening surveys of healthy children between infancy and 5 years show a 15-40% point prevalence in MEE. Furthermore, among children examined at regular intervals for a year, 50-60% of child care attendees and 25% of school-aged children were found to have a MEE at some point during the examination period, with peak incidence during the winter months.

Between 84% and 93% of all children experience at least 1 episode of AOM. Furthermore, approximately 80% of children have had an episode of OME when younger than 10 years. At any given time, 5% of children aged 2-4 years have hearing loss due to MEE that lasts 3 months or longer. The prevalence of OME is highest in those aged 2 years or younger, and it sharply declines in children older than 6 years.

In 1989, a 7-year study of otitis media conducted in the greater Boston area revealed the frequency of AOM. In children younger than 1 year, 62% had at least 1 episode of AOM, and 17% had 3 or more episodes. In children younger than 3 years, 83% had at least 1 episode of AOM, and 46% had 3 or more episodes.

In 1990, 12.8 million episodes of otitis media occurred in children younger than 5 years. Of children younger than 2 years, 17% had recurrent disease. Since at least 30% and as many as 45% of children with AOM had OME after 30 days, and 10% had OME after 90 days, at least 3.84 million episodes of OME occurred that year; 1.28 million episodes persisted at least 3 months.

Mortality/Morbidity

OME is the leading cause of hearing loss in children. It is associated with delayed language development in children younger than 10 years. The loss is usually conductive, with an average air conduction threshold of 27.5 dB, but OME has also been associated with sensorineural hearing loss. Both prostaglandins and leukotrienes have been found in high concentrations in MEE, and their ability to cross the round window membrane has been demonstrated. Chronic exposure to these metabolites of arachidonic acid may cause a temporary and sometimes permanent sensorineural hearing loss.

Race

The prevalence of OME is higher in Native Americans, particularly Navajo and Eskimo peoples, than in other races. The reason for the higher frequency in these populations has been attributed to a number of factors, but no findings have confirmed the most likely etiologies. No difference in prevalence rates between white and black populations exists.

Sex

No statistically significant difference exists between the sexes in terms of incidence or prevalence, although some findings suggest that males may have a slightly higher frequency.

Age

As mentioned above, the highest incidence of OME occurs in children younger than 2 years, and incidence decreases dramatically in those older than 6 years. The reasons for this age predilection are discussed in Causes.

CLINICAL

Section 3 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

History

Otitis media with effusion (OME) nearly always follows AOM as it resolves. However, MEE can be present without preceding AOM, as in the case of serous otitis media after barotrauma.

• Neither the affected children nor their parents describe reports referable to a MEE in 40-50% of documented cases of OME. The most common report involving children comes from parents who are concerned with signs consistent with decreased hearing. Parents may notice that the television volume is too loud and that the child sits close to the television, does not respond when called (new onset), and often asks "what?" However, these signs are not consistent and do not reliably indicate potential MEE.
• Adults with OME report aural fullness and/or pressure, an ear being plugged, or decreased hearing. Reports of pain are rare.
• Associated findings during history taking may include a recent URTI, a recent plane trip or scuba diving trip, or current environmental allergies.

Physical

• Otoscopic findings of inflammation in AOM may include decreased mobility of the tympanic membrane (which has a bulging contour) that is manifested by difficulty in assessing the ossicular landmarks, yellowness and/or redness with hypervascularity, purulent MEE, and, occasionally, bullae. This appearance clearly contrasts with that of OME.
• Findings that suggest the presence of OME include observable air-fluid levels (which may be vertically oriented), serous middle ear fluid, and a translucent membrane with diminished mobility.
• Extensive inflammation and purulent MEE should not be evident.
• OME can also be associated with negative pressure in the middle ear. Negative pressure is suggested by the prominence of the lateral process, a more horizontal orientation of the malleus, and movement only with negative pneumatoscopy.
• Occasionally, tonsillar hypertrophy can accompany findings of OME. More commonly, adenoid hypertrophy is present, especially in patients with prolonged or recurrent OME.
• Additional findings may include turbinate bogginess, postnasal drip, rhinorrhea, and watery and/or erythematous eyes consistent with a concurrent URTI or environmental allergies.

Causes

The same flora found in AOM can be isolated in OME. With OME, the inflammatory process has clearly resolved, and the volume of bacteria has decreased. However, because of the similarity of AOM and OME, reviewing the pathogenic organisms in AOM is worthwhile.

• The most common bacteria in AOM, in order of frequency, are Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. These pathogens are also the most frequent organisms associated with sinusitis and pneumonia. Together, these pathogens account for 85% of acute ear infections.
• • S pneumoniae is found in 35% of cases, and the prevalence does not seem to vary with age. The serotypes most commonly isolated, in order of frequency, are 19, 23, 6, 14, and 3.
  • H influenzae is found in 20% of cases. Of these cases, 25-45% involve beta-lactamase production, with a clear trend of increasing resistance.
  • M catarrhalis is found in 4-13% of cases of AOM, with a great frequency in winter and autumn. Of these cases, 70-100% involve beta-lactamase production.
  • Additional bacterial pathogens include Streptococcus pyogenes, Staphylococcus aureus, gram-negative enteric bacteria, and anaerobes. When an effusion is present for longer than 3 months, Pseudomonas species predominate.
  • In 30% of examined tympanocentesis specimens, microorganisms are not found. In a meta-analysis of results from 10 studies of tympanocentesis in AOM from the early 1990s, 29 (4.4%) of 663 patients had a virus that could be isolated. In other recent studies, viruses have been isolated in conjunction with bacteria in 15-20% of cases of AOM. Respiratory syncytial virus and influenza virus were the most frequent. The relation between viral and bacterial infection is controversial. Because viruses have been identified as the sole infective agents in only 4-6% of middle ear aspirates obtained from children with AOM, viruses may promote bacterial superinfection by impairing eustachian tube function.
• The only difference with the pathogens in OME compared with AOM is that the frequency of S pneumoniae is not as high, and H influenzae and M catarrhalis are moderately more common.
• Besides the actual pathogens, environmental factors have been shown in numerous epidemiologic studies to be strongly associated with increased prevalence of OME. These factors include bottle feeding, feeding while supine, having a sibling with OM, attending daycare, having allergies to common environmental entities, having a lower socioeconomic status, living in a home in which people smoke, and having a parental history of OME.
• Age is clearly another predisposing factor in the development of OME. In infants, the eustachian tube has a nearly horizontal orientation (relative to the ground) and develops the 45° angle (as in adults) after several years. In addition, the size and shape of the eustachian tube at birth, unlike those in adults, are unfavorable for ventilation of the middle ear. Multiple studies of children in Denmark revealed that by the time children were aged 1 year, tympanograms were either type B (flat) or type C (negative pressure) in 24% of their ears. Improvement occurred in the spring and summer, while worsening was more common in the winter. Type B tympanograms peaked in children aged 2-4 years, and, as expected with the prevalence of OME, decreased in children older than 6 years.
• Disruptions in the normal opening of the eustachian tube orifice in the nasopharynx are also associated with an increased prevalence of OME. These commonly occur in patients who have a cleft palate and in children with Down syndrome and other disorders affecting the palate. In addition, the decreased mucociliary clearance and higher viscosity of mucus in cystic fibrosis have been hypothesized to account for a higher prevalence of OME in patients with these conditions.
• In adults, recognizing unilateral OME is crucial. This entity must be considered a nasopharyngeal mass until definitively proven otherwise.

DIFFERENTIALS

Section 4 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Other Problems to be Considered

Benign nasopharyngeal masses
Nasopharyngeal carcinoma
Adenoid hypertrophy
Congenital defects affecting the eustachian tube and its egress
Ciliary dyskinesia
Immunoglobulin G (IgG) subclass deficiencies

WORKUP

Section 5 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Lab Studies

• Traditionally, laboratory tests have rarely been used in the workup and diagnosis of otitis media with effusion (OME) unless another process is suspected. History taking and physical examination are sensitive and specific enough to facilitate accurate diagnosis and treatment of the disease. Obtaining cultures is not routine for OME but is discussed below with tympanocentesis in Procedures.
• In rare cases, the erythrocyte sedimentation rate is determined to rule out bony destruction, or the CBC count is assessed to rule out active infection.

Imaging Studies

• Plain radiography of the mastoid was once used effectively to screen for OME but is rarely used today given the sensitivity of history and physical examination in helping diagnose the disease.
• CT scanning is extremely sensitive and not needed for diagnosis. However, CT is important in attempting to rule out potential complications of otitis media (eg, mastoiditis, sigmoid sinus thrombosis, erosion of bone with intracranial extension) or unusual lesions (eg, cholesteatoma). CT scanning is particularly important in unilateral OME when a nasopharyngeal or eustachian tube mass must be ruled out.
• MRI is particularly useful in the workup for soft tissue masses that may be contributing to middle ear effusions because of its superior ability to delineate borders within soft tissues and help determine the extent of potential intracranial extension (often helpful in nasopharyngeal masses). In addition, MRI and its closely associated variants of magnetic resonance venography (MRV) and magnetic resonance arteriography (MRA) demonstrate complications such as thrombosis of the intracranial sinuses very well. However, when intracranial extension is present, either from invasion from the nasopharynx or the temporal bone, CT scanning helps define the bony anatomy more specifically and should be used in conjunction with MRI.

Other Tests

• Tympanometry is perhaps the most useful of all tests in association with OME.
• • Tympanometry reveals a type B result in 43% of cases of OME and a type C result in 47% of cases.

    A type B tympanogram is an imperfect measure of OME with 81% sensitivity and 74% specificity versus myringotomy. More recent studies (after 2001) have shown a higher rate of sensitivity and specificity, both around 90%. This is likely because of improvements in the technology used.

  • 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. However, in those younger than 7 months, tympanometry is unreliable because of excessive compliance of the external auditory canal. The 2003 Agency for Healthcare Research and Quality (AHRQ) evidence report states that tympanometry results in children older than 4 years are reliable.
  • This test is a cost-effective adjunct to physical examination. Several studies have compared tympanometry with pneumatic otoscopy in terms of accuracy in detecting MEE when compared with the criterion standard of myringotomy. Nearly all studies show that pneumatic otoscopy is slightly more sensitive, at around 93%, but they differ on specificity, showing rates from 50-88%. Many of the conclusions in these protocols stated that the greatest use for tympanometry is in aiding the clinician in ruling out MEE for what appears to be an immobile tympanic membrane on examination.
• According to an updated clinical practice guideline on OME published in May 2004 by the joint efforts of the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on Otitis Media with Effusion, audiology is a necessary component of the evaluation of certain patients with OME.³
• • The guidelines refer to recent randomized trials that have sought to determine if any long-term detrimental effects of OME are observed in children who have no hearing loss or risk factors for speech and language delay. When these children were followed for several years, no long-term detrimental effects were identified. Such results have shifted the paradigm for treatment so that chronic OME without hearing loss is no longer an absolute indication for the placement of tubes in children who are not at risk for language delays.
  • Studies examining hearing sensitivity in children with OME report that average pure tone hearing loss at 4 frequencies (500, 1000, 2000, and 4000 Hz) ranges from normal hearing to moderate hearing loss (0–55 dB). The 50th percentile is about 25 dB hearing level (HL), and approximately 20% of ears exceed 35 dB HL.
  • The committee stated that initial hearing testing can be done in a primary care setting for children aged 4 years or older but also stated that conventional audiometry with earphones is performed with a fail criterion of more than 20 dB HL at 1 or more frequencies (500, 1000, 2000, 4000 Hz) in either ear.
• Language testing has also been advocated in the clinical practice guidelines for children with hearing loss (pure tone average greater than 20 dB HL on comprehensive audiometric evaluation). Testing for language delays is important because communication is integral to all aspects of human functioning. Young children with speech and language delays during the preschool years are at risk for continued communication problems and later delays in reading and writing.

Procedures

• Tympanocentesis involves the aspiration of effusion from the middle ear.
• • This procedure can be performed as an office procedure, even in small children if necessary.
  • It can serve as both a therapeutic procedure and a diagnostic procedure.
  • The therapy consists of the removal of an MEE that can impair hearing or cause a sensation of aural fullness. Moreover, if performed in AOM, it may relieve a significant amount of pain.
  • The usefulness of tympanocentesis as a diagnostic procedure is greater with AOM that does not respond to antibiotics than in other conditions.
  • Tympanocentesis is useful to acquire specimens for culture in cases of AOM resistant to standard antibiotics and in immunocompromised hosts.
  • In RAOM, it may be used to obtain cultures and determine sensitivities.
• The criterion standard for documentation of a MEE is myringotomy, which has the advantage of increased exposure and better suctioning when compared to tympanocentesis. The primary disadvantage is a larger incision with a greater, albeit small, chance of persistent perforation or otorrhea.

Histologic Findings

In AOM, temporal bone studies reveal vascular dilatation and hyperplasia, inflammation and metaplasia of the mucosa, gland formation, edema, and infiltration with a mononuclear cell population. These same findings may be present, to a lesser degree, in OME.

TREATMENT

Section 6 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Medical Care

A number of medical interventions have been suggested for the treatment of otitis media with effusion (OME), all with controversial but overall poor results. Historically, if MEE persists for 3 months, surgical intervention was indicated. This dogma has recently been revised and is discussed below.

• Modification of risk factors for OME: To the authors' knowledge, no randomized controlled trials have been performed to assess whether a modification of risk factors for OME decreases its prevalence. However, massive amounts of epidemiologic evidence suggest that modification of these risk factors is a reasonable primary care intervention. The following modifications may help:
• • Avoiding secondhand smoke
  • Breastfeeding whenever possible
  • Avoiding feeding, either by breast or bottle, while completely supine
  • Avoiding exposure to a large number of children, particularly in daycare centers
  • Avoiding exposure to children who are known to be affected
  • Avoiding known allergens
  • Kouwen and Dejonckere published a study in 2007 that demonstrated a 40% reduction in the prevalence of OME in children from the Netherlands who routinely (at least weekly) chew gum.⁴ Presumably, one hypothesis is that this is caused by the increased eustachian tube function secondary to palatal muscle action.
• Antimicrobial agents: Because OME demonstrates viable pathogenic bacteria, treatment with appropriate antibiotics is reasonable, albeit with evidence showing only short-term benefit.
• • Studies of erythromycin, sulfisoxazole, amoxicillin, amoxicillin-clavulanate, and trimethoprim-sulfamethoxazole have demonstrated clearance rates faster than those of a placebo, although the difference is barely statistically significant in most of these trials.
  • In 1992, a large meta-analysis of findings from 10 blinded randomized controlled trials involving 1041 children with OME revealed that resolution of MEE was significantly more likely in the patients treated with antimicrobials than in those treated with placebo or those receiving no treatment. The difference was noted at short-term (2- to 5-wk) follow-up. The findings of 2 other meta-analyses in 1993 and 1998 did not demonstrate a difference between antimicrobials and placebo with 6- to 11-week follow-up period.
  • When the OME becomes chronic (3 mo), the effectiveness of antimicrobials diminishes, although this finding is controversial.
  • Studies published between 2002 and 2004 and cited by the clinical practice guidelines for OME also demonstrate clearance of MEE with antibiotics; however, they also show rapid and frequent recurrence.
• Steroids: In 3 placebo-controlled randomized clinical trials, oral steroids alone did not improve OME clearance within 2 weeks of treatment. When oral steroids are combined with antibiotics, the rate of clearance of MEE does not improve compared with the rate with antibiotics alone. A couple of small studies of topical nasal steroid sprays (versus placebo) have demonstrated fewer effusions at 4 and 8 weeks, as well as improved middle ear pressure at 12 weeks. Empirical evidence indicates that these medications show promise. To the authors' knowledge, only one randomized study has been published comparing intranasal steroids (beclomethasone) and antibiotics to antibiotics alone. This study demonstrated no statistically significant difference between the 2 arms.
• Antihistamines and decongestants: In the largest study to date, Cantekin and others randomly assigned 553 children with COME to receive an antihistamine/decongestant or placebo. The clearance rates of the effusion did not differ. That antihistamines increase the viscosity of secretions may account for this finding. The viscosity of COME is often substantial; thus, it is aptly termed glue ear in these cases. COME can also manifest as a serous effusion as well. However, nasal obstruction, rhinorrhea, and sinusitis often accompany otitis media, and antihistamines and decongestants may be considered for the relief of these associated symptoms. This is particularly true if the inciting cause is allergies. Antihistamines, as the name suggests, prevent the degranulation of mast cells and subsequent release of histamine, which can lead to mucosal engorgement with resultant increase in nasal obstruction and an increase in the production of mucus.
• Mucolytics: In 1993, a large randomized controlled study of 430 children revealed that clearance rates for OME did not significantly improve with mucolytics versus placebo. Findings of 2 smaller trials of other mucolytics confirmed this result.
• Autoinflation: Several investigators have reported mixed results when attempting to determine if autoinflation, compared with no intervention, improves effusion clearance rates. The ambiguity in the data may be a result of great variability in autoinflation methods and/or noncompliance in patients. In 1999, a meta-analysis of findings from 6 randomized controlled studies did reveal a benefit with the use of nasal balloons for autoinflation in children.

Summary of Medical Intervention

The American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on Otitis Media with Effusion published clinical guidelines in 2004 with the following verbatim nonsurgical recommendations for OME:

1. Document the laterality, duration of effusion, and presence and severity of associated symptoms at each assessment of the child with OME.
2. Distinguish the child with OME who is at risk for speech, language, or learning problems from other children with OME and more promptly evaluate hearing, speech, language, and need for intervention in children at risk.
3. Manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known), or from the date of diagnosis (if onset is unknown).
4. Hearing testing should 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.
5. Children with persistent OME who are not at risk should be re-examined at 3-6 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.

Surgical Care

Surgery has become the most widely accepted therapeutic intervention for persistent otitis media with effusion (OME), and it is clearly effective. The interventions include myringotomy with or without tube insertion, adenoidectomy, or both. Tonsillectomy has been shown to be of little benefit as a primary treatment of OME.

The indications for surgical intervention remain controversial but have changed with the practice guidelines published in 2004. As with all surgery, the benefits of intervention must outweigh the risks.

Previously, surgical intervention was advocated if fluid persisted beyond 3 months. However, 2 well-conducted long-term studies showed that in the absence of a significant hearing loss, children who were only observed compared with those children who received pressure equalization (PE) tubes had no difference in quality of life or overall hearing, speech, and language abilities. Therefore, in the presence of hearing thresholds better than 20 dB, observation is an option. On the other hand, only 30% of patients who have OME after 3 months duration will clear that effusion over the next 12 months; therefore, ongoing monitoring of hearing levels is required.

According to clinical guidelines on OME, certain changes to the tympanic membrane may mandate PE tube insertion despite normal hearing. These conditions include posterosuperior retraction pockets, ossicular erosion, adhesive atelectasis, and retraction pockets that accumulate keratin debris. Ongoing surveillance is mandatory because the frequency of structural damage increases with effusion duration.

For patients with hearing loss and OME, a loss greater than or equal to 40 dB is felt to be an absolute indication for PE tube insertion. A loss in the range of 21-40 dB is a relative indication with a very low threshold for placement.

Moreover, the clinical guidelines suggest more aggressive therapy for children at risk for developmental delays, particularly in the areas of speech and language development. Children who may be at risk include any of the following:

• Children with permanent hearing loss independent of otitis media with effusion
• Those with suspected or diagnosed speech and language delay or disorder
• Those with autism spectrum disorder or other pervasive developmental disorders
• Children with syndromes (eg, Down syndrome) or craniofacial disorders that include cognitive, speech, and language delays
• Those who are blind or have uncorrectable visual impairment
• Children with cleft palate, with or without an associated syndrome
• Children with developmental delay

Again, most cases of OME resolve spontaneously, and such spontaneous resolution is more common in the spring and summer. Thus, a conservative approach is often warranted at these times of the year; whereas, in fall and winter, exacerbations are more common, and surgical intervention is likely to yield better control.

• Myringotomy and aspiration of effusion
• • When performed alone without the placement of PE tubes, this procedure has proved disappointing in long-term follow-up in children. Gates and others have shown that when myringotomy is performed with PE tube placement, the following improved: hearing, duration of MEE, time to recurrence, and need for repeated procedures.
  • Myringotomy and aspiration may be more a reasonable treatment in adults who can undergo the procedure in the office. The benefit is that immediate improvement in hearing and symptoms of aural fullness and pressure are possible. The drawback is that the incision usually heals within a week, whereas the underlying problem of eustachian tube dysfunction takes longer to resolve (6 wk on average); therefore, recurrences are common.
  • Myringotomy and aspiration is useful to treat patients with moderate to severe hearing loss as they recover normal middle ear function. A 20-25 dB conductive hearing loss added to their underlying loss may render hearing aids or other coping devices or strategies inadequate.
• Myringotomy with pressure equalization tube (PET) insertion
• • Introduced in 1954 by Armstrong, this intervention has become the criterion standard and most common therapy for COME. Improved hearing and decreased rates of AOM are absolute benefits of this procedure; these have been documented multiple times. Typically, the tubes self-extrude 9-12 months after placement.
  • PETs are available in a variety of sizes, shapes, and materials. All are designed to permit ventilation of the middle ear and mastoid system. Prolonged aeration of the middle ear has been shown to reverse the mucosal hyperplasia and metaplasia that accompany OME.
  • The overall complication rate after PET placement is about 11%. Persistent otorrhea is the most common complication, occurring in 15% of patients and persisting as long as 1 year in 5%. Second in frequency is tympanosclerosis, which is not likely to be clinically significant unless it is extensive. Persistent perforation is the third most common complication. Its exact frequency is unknown (estimates approximate 2%), but it increases markedly if PETs remain in place longer than 18 months. It is also known to increase with the placement of T-tubes that are designed to stay in the tympanic membrane longer than the typical grommet tube. They can stay in place for years and are more commonly used for the patient with recurrent or chronic OM that has failed to improve after the placement of grommet tubes. Other potential complications include granulation tissue formation, cholesteatoma, and sensorineural hearing loss.
  • Clinical guidelines summarize a number of studies and state that tympanostomy tubes are recommended for initial surgery because randomized trials show a mean 62% relative decrease in effusion prevalence and an absolute decrease of 128 effusion days per child during the next year. Hearing levels improve by a mean of 6-12 dB while the tubes remain patent.
• Adenoidectomy
• • Although adenoidectomy was once the principal treatment for OME, easy and low-risk PET placement is now favored.
  • Three rationales exist for the removal of the adenoids in the treatment of OME.
  • • First is removal because of enlargement. This theory states that large adenoids occlude the nasopharynx and choanae and lead to excessive nasopharyngeal pressure during swallowing. This potentiates eustachian tube reflux. Multiple studies have revealed that the result of adenoidectomy, however, is independent of adenoid size. This finding suggests that processes other than simple adenoid mass are involved.
    • The second rationale is the improvement of eustachian tube function. Improvement in the equilibration of positive middle ear pressure after adenoidectomy has been documented. In addition, extremely large adenoids may physically occlude the eustachian tube orifice, although Bluestone and others have shown that this is rare. The obstruction is nearly always functional.
    • The third and most recent rationale for adenoidectomy is removal of a potential source of inflammation and infection at the eustachian tube orifice. When performed correctly, adenoidectomy can be used to create a smooth nasopharyngeal mucosa, which decreases the colonization of bacteria that can occur in the crypts of adenoid tissue.
  • Whatever the rationale used, adenoidectomy alone was found to be nearly as effective as PET placement for treatment of OME. When adenoidectomy is performed with PET placement, the frequency of recurrent disease, disease-free interval, and duration of disease all improved, compared with the use of either procedure alone.
  • Complications of adenoidectomy include bleeding (0.4%), velopalatal insufficiency (usually temporary), and a patulous eustachian tube. 

Summary of Surgical Intervention

Again, a verbatim summary of the recommendations of the American Academy of Family Physicians, the American Academy of Otolaryngology-Head and Neck Surgery, and the American Academy of Pediatrics Subcommittee on Otitis Media with Effusion (2004) clinical guidelines are as follows:

• 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 (eg, 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.

Consultations

• An otolaryngologist should be consulted whenever the primary care physician is concerned about persistent conductive hearing loss in children, especially those with signs of language development delay.
• In addition, an otolaryngologist should be consulted if the disease is recurrent, if the appropriate medical therapies available to the primary care physician are exhausted, and/or if the criteria for surgical intervention have been met.
• An allergist, audiologist, and/or a speech therapist may be consulted, when appropriate.
• In select cases, an immunologist may be consulted for the workup for a possible immunocompromised state.

Diet

Breastfed babies have a lower risk of AOM and OME. Moreover, placing a child in the supine position while bottle feeding substantially increases the risk of OME, presumably because it contributes to eustachian tube reflux during swallowing.

Activity

During active OME, activity need not be limited. However, because of potential hearing loss, children may wish to sit closer to the teacher in their classrooms.

MEDICATION

Section 7 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

A consensus statement published in August of 2000 defined an appropriate logarithm for the medical treatment of AOM and RAOM.⁵ Antimicrobials are the only medications that have been shown to increase the rate of clearance of OME in randomized controlled trials. However, these benefits are temporary at best. The clinical guidelines from 2004 recommend avoiding the use of antibiotics, decongestants, oral steroids, and antihistamines for the treatment of OME due to evidence that cites their lack of effectiveness. The guidelines did not make a recommendation for or against the use of intranasal steroids, nor were any recommendations made for alternative medicine treatments.

Drug Category: Topical nasal steroids

Results of small trials have shown that nasal steroids speed the clearance of OME and prevent its recurrence. However, to the authors' knowledge, no large randomized trials have been performed to confirm this finding.

FOLLOW-UP

Section 8 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Further Inpatient Care

• In general, inpatient care is not required unless complications that threaten the stability of the patient's condition are suspected.
• Even surgical intervention with PETs and adenoidectomy is typically completed in ambulatory surgery settings.

Further Outpatient Care

• No standard of care for the follow-up of patients with OME has been established.
• The author follows up with the patient 3 weeks after the placement of the tubes and then every 6 months thereafter until the tubes extrude or are removed. Additional appointments are made as needed.
• Patients are instructed that if more than 2 episodes of otorrhea occur before the 6-month follow-up is scheduled, they should see their otolaryngologist instead of or in addition to their primary care physician. The author recommends the removal of PE tubes that have not spontaneously extruded between 18-24 months after placement due to the increasing risk of persistent tympanic membrane perforation. That rule generally applies to the first set of grommet-style tubes. 
• Patients should see their primary care physician, at the physician's discretion, during times of active disease, at regular intervals for well visits, and on an as-needed basis for further problems or questions.
• The otolaryngologist should monitor patients until OME resolves with medical or surgical intervention. Thereafter, if the patient's hearing is normal, the primary physician can provide care. If a documented hearing loss is present, it should be reevaluated as the severity and type dictate.
• A multidisciplinary team should rigorously follow and aggressively treat language-related developmental delays. Interventions should include the use of hearing aids, if justified.

In/Out Patient Meds

The clinical guidelines of 2004 made the following recommendations regarding medicine administration for OME: Antihistamines and decongestants are ineffective for OME and should not be used for treatment; antimicrobials and corticosteroids do not have long-term efficacy and should not be used for routine management.

Deterrence/Prevention

• The following modifications may help decrease the frequency of OME:
• • Avoiding secondhand smoke
  • Breastfeeding whenever possible
  • Avoiding feeding, either by breast or bottle, while completely supine
  • Avoiding exposure to a large number of children, particularly in daycare centers
  • Avoiding exposure to children who are known to be affected

Complications

• Since OME lacks the inflammation found in AOM, it has few complications. The most important complications and reasons for treatment are hearing loss and potential language development delay.
• However, persistent effusion provides an exceptional environment for the proliferation of bacteria. Therefore, RAOM with its potential complications is also a threat.
• The complications of the various surgical interventions are discussed in Surgical Care.

Prognosis

• In general, the prognosis for OME is good. Most episodes spontaneously resolve without intervention, and many resolve undiagnosed.
• Still, 5% of children who are not treated surgically have persistent OME at 1 year. Surgical intervention significantly improves the clearance of MEE in this population, but the benefits for speech and language development as well as quality of life remain controversial.
• Following spontaneous tube extrusion, 20-50% of patients will have a recurrence of OME, potentially requiring the replacement of PE tubes and, in most cases, simultaneous adenoidectomy.

Patient Education

• On a primary care level, ongoing education of primary care providers and pediatricians is important and often falls into the responsibility of the otolaryngologists. Equally important is educating parents and teachers to be aware of the potential for delayed language development in affected children. These measures make early intervention possible if problems are noted.

MISCELLANEOUS

Section 9 of 10  

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

Medical/Legal Pitfalls

• The single greatest pitfall in OME is the failure to fully evaluate a potential nasopharyngeal mass in an adult patient who has recurrent unilateral OME. At minimum, indirect mirror examination or flexible nasopharyngoscopy should be performed. Imaging studies and possibly even biopsies may be indicated.
• Other pitfalls include the failure to note hearing loss and the failure to recognize a potential delay in language development in children; these failures could have a lasting effect in the patient.

REFERENCES

Section 10 of 10

• Authors and Editors
• Introduction
• Clinical
• Differentials
• Workup
• Treatment
• Medication
• Follow-up
• Miscellaneous
• References

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Article Last Updated: Nov 19, 2007