Otitis Media With Effusion

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

Classic theory

Two main theories of the cause of acute otitis media 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 acute otitis media. This classic model is somewhat incorrect, as multiple studies have revealed that the same pathogenic bacteria are present in otitis media with effusion as in acute otitis media.

Newer theories

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.[7] Furthermore, Crapko et al demonstrated the presence of pepsin in the middle ear space of 60% of children with otitis media with effusion,[8] although this reflux certainly may also occur in otherwise healthy individuals.

Similarly, in a prospective study of 129 pediatric patients with otitis media who underwent myringotomy with tympanostomy tube placement, O’Reilly et al found that ear samples from 64 patients tested positive for pepsin A, evidence that these children had aspirated gastric contents into the nasopharynx. The investigators suggested that this may in turn have initiated inflammation or exacerbated a preexisting condition.[9]

The inflammatory mediators released as a result of bacterial antigenic challenge induce the upregulation of mucin genes. The production of a mucin-rich effusion then provides an ample medium for the proliferation of bacteria and resultant acute otitis media.

Yilmaz et al published a study that documented significant changes in oxidative stress in patients with otitis media with effusion.[10] The investigators 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 otitis media with effusion has yet to be fully investigated.

Middle ear effusion

Regardless of the cause of acute otitis media, eustachian tube dysfunction is nearly universal in otitis media with effusion. As further evidence, ligation of the eustachian tube in animals invariably leads to the formation of a persistent middle ear effusion (MEE). Once the acute inflammation and bacterial infection have resolved, a failure of the middle ear clearance mechanism allows middle ear effusion 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.

Otitis media with effusion does not necessarily follow acute otitis media. Theories to explain the development of middle ear effusion 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 otitis media with effusion as in acute otitis media; these findings indicate that this effusion is not sterile, as was once believed.

Cleft palate

Otitis media with effusion 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.[11]

The same flora found in acute otitis media can be isolated in otitis media with effusion.[12] With otitis media with effusion, the inflammatory process has clearly resolved, and the volume of bacteria has decreased. However, because of the similarity of these 2 conditions, reviewing the pathogenic organisms in acute otitis media is worthwhile.

Common pathogens

The most common bacteria in acute otitis media, 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, as follows:

• 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 acute otitis media, 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 acute otitis media from the early 1990s, 29 (4.4%) of 663 patients had a virus that could be isolated. In other more recent studies, viruses have been isolated in conjunction with bacteria in 15-20% of cases of acute otitis media. Respiratory syncytial virus (RSV) 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 acute otitis media, viruses may promote bacterial superinfection by impairing eustachian tube function.

The only difference with the pathogens in otitis media with effusion compared with acute otitis media is that the frequency of S pneumoniae is not as high, and H influenzae and M catarrhalis are moderately more common.

Predisposing factors

Environmental factors, age, and disruption of the eustachian tube have been associated with otitis media with effusion.

Environmental factors

Besides the actual pathogens, environmental factors have been shown in numerous epidemiologic studies to be strongly associated with increased prevalence of otitis media with effusion. These factors include bottle feeding, feeding while supine, having a sibling with otitis media, 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 otitis media with effusion.[13, 14]

Age

Age is clearly another predisposing factor in the development of otitis media with effusion. 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, whereas worsening was more common in the winter. Type B tympanograms peaked in children aged 2-4 years, and, as expected with the prevalence of otitis media with effusion, decreased in children older than 6 years.

In adults, recognizing unilateral otitis media with effusion is crucial.[15] This entity must be considered a nasopharyngeal mass until definitively proven otherwise.

Eustachian tube disruption

Disruptions in the normal opening of the eustachian tube orifice in the nasopharynx are also associated with an increased prevalence of otitis media with effusion. 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 otitis media with effusion in patients with these conditions.

Diet

A study by Choi et al suggested that a high-fat diet is a risk factor for otitis media with effusion in children but that body mass index category; protein, water, and sodium intake; and distribution of carbohydrate intake are not.[16]

Other

In contrast to the Choi study, however, a study by Kaya et al suggested that in children, a link exists between chronic otitis media with effusion (OME) and the presence of overweight or obesity. The report, which looked at weight-for-height percentiles in 60 children with chronic otitis media with effusion (OME) and 86 controls, aged 2-10 years, found a higher prevalence of overweight and obesity in the otitis media group, indicating that overweight and obesity may increase the risk for chronic otitis media with effusion (OME), or vice versa.[17]

A study by Walker et al found that preschool children with chronic otitis media with effusion tended to be characterized by nasal obstruction, snoring (always or often), a greater number of hours per week in daycare, frequent colds, siblings in whom tympanostomy tube placement had been performed, long labor, and early introduction of cow’s milk. However, Asian ethnicity and the existence of older siblings were associated with a lower risk of the condition.[18]

In the 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 age 5 years show a 15-40% point prevalence in middle ear effusion (MEE). Furthermore, among children examined at regular intervals for 1 year, 50-60% of child care attendees and 25% of school-aged children were found to have a middle ear effusion 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 acute otitis media (AOM). Furthermore, approximately 80% of children have had an episode of otitis media with effusion (OME) when younger than 10 years. At any given time, 5% of children aged 2-4 years have hearing loss due to a middle ear effusion that lasts 3 months or longer. The prevalence of otitis media with effusion is highest in those aged 2 years or younger, and it sharply declines in children older than 6 years.

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

In another study, 12.8 million episodes of otitis media occurred in children younger than 5 years. Of children younger than 2 years, 17% had recurrent disease. Because at least 30% and as many as 45% of children with acute otitis media had otitis media with effusion after 30 days, and 10% had otitis media with effusion after 90 days, at least 3.84 million episodes of otitis media with effusion occurred the year studied; of these, 1.28 million episodes persisted at least 3 months.

Racial and sexual differences in incidence

The prevalence of otitis media with effusion 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.

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

Otitis media with effusion (OME) is the leading cause of hearing loss in children. This condition is associated with delayed language development in children younger than 10 years, and the loss is usually conductive, with an average air conduction threshold of 27.5 decibels (dB), but otitis media with effusion has also been associated with sensorineural hearing loss. Both prostaglandins and leukotrienes have been found in high concentrations in middle ear effusions (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.

In general, the prognosis for otitis media with effusion is good. Most episodes spontaneously resolve without intervention, and many resolve undiagnosed. Still, 5% of children who are not treated surgically have persistent otitis media with effusion at 1 year. Surgical intervention significantly improves the clearance of middle ear effusion 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 otitis media with effusion, potentially requiring the replacement of pressure equalization tubes (PETs) and, in most cases, simultaneous adenoidectomy.

Complications

Because otitis media with effusion lacks the inflammation found in acute otitis media, it has few complications. As noted above, the most important complications and reasons for treatment are hearing loss and potential language development delay. Nonetheless, persistent effusion provides an exceptional environment for the proliferation of bacteria. Therefore, recurrent acute otitis media (RAOM) with its potential complications is also a threat.

The complications of the various surgical interventions are discussed in Treatment.

On a primary care level, ongoing education of primary care providers (PCPs) and pediatricians is important and often falls into the responsibility of the otolaryngologists (ENTs). 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.

Prevention

The following modifications may help decrease the frequency of otitis media with effusion (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

Dietary and activity considerations

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

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

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

Neither the affected children nor their parents describe reports referable to a middle ear effusion in 40-50% of documented cases of otitis media with effusion. 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 middle ear effusion.

Adults with otitis media with effusion 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 upper respiratory tract infection (URTI), a recent plane trip or scuba diving trip, or current environmental allergies.

Otoscopic findings of inflammation in acute otitis media (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 middle ear effusion (MEE), and, occasionally, bullae. This appearance clearly contrasts with that of otitis media with effusion.

Findings that suggest the presence of otitis media with effusion 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 middle ear effusion should not be evident.

Otitis media with effusion can also be associated with negative pressure in the middle ear. This 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 otitis media with effusion. More commonly, adenoid hypertrophy is present, especially in patients with prolonged or recurrent condition.

Additional findings may include turbinate bogginess, postnasal drip, rhinorrhea, and watery and/or erythematous eyes consistent with a concurrent upper respiratory tract infection (URTI) or environmental allergies.

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 this condition but is in tympanocentesis.

In rare cases, the erythrocyte sedimentation rate (ESR) is obtained to rule out bony destruction, or the complete blood cell (CBC) count is assessed to rule out active infection.

In acute otitis media (AOM) histologic studies of the temporal bone 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 otitis media with effusion.

Plain radiography of the mastoid was once used effectively to screen for otitis media with effusion (OME), but this imaging study is now rarely used for this purpose, given the sensitivity of history and physical examination in helping diagnose the disease.

CT scanning

Computed tomography (CT) scanning is extremely sensitive and not needed for diagnosis. However, CT scanning 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). This imaging modality is particularly important in unilateral otitis media with effusion when a nasopharyngeal or eustachian tube mass must be ruled out.

MRI

Magnetic resonance imaging (MRI) is particularly useful in the workup for soft-tissue masses that may be contributing to middle ear effusions (MEE) because of its superior ability to delineate borders within soft tissues and to help determine the extent of potential intracranial extension (often useful in nasopharyngeal masses). In addition, MRI and its closely associated variants 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 to define the bony anatomy more specifically and should be used in conjunction with MRI.

Tympanometry is perhaps the most useful of all tests in association with otitis media with effusion (OME). This test reveals a type B result in 43% of cases of otitis media with effusion and a type C result in 47% of cases.

Previously, compared with myringotomy, a type B tympanogram was an imperfect measure of otitis media with effusion, with 81% sensitivity and 74% specificity. Studies later than 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.

Tympanometry is a cost-effective adjunct to physical examination. Several studies have compared this test with pneumatic otoscopy in terms of accuracy in detecting middle ear effusion 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% to 88%. Many of the conclusions in these protocols stated that the greatest use for tympanometry is in aiding the clinician in ruling out middle ear effusion (MEE) for what appears to be an immobile tympanic membrane on examination.

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.

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. Tympanocentesis can serve as both a therapeutic procedure and a diagnostic procedure.[4] The therapy consists of the removal of a middle ear effusion (MEE) that can impair hearing or cause a sensation of aural fullness.

The criterion standard for documentation of a middle ear effusion is myringotomy, which has the advantage of increased exposure and better suctioning relative to tympanocentesis.[5] The primary disadvantage is a larger incision with a greater, albeit small, chance of persistent perforation or otorrhea.

In general, inpatient care for otitis media with effusion (OME) is not required unless complications that threaten the stability of the patient's condition are suspected. Even surgical intervention with pressure equalization tubes (PETs) and adenoidectomy is typically completed in ambulatory surgery settings.

A number of medical interventions have been suggested for the treatment of otitis media with effusion, all with controversial but overall poor results. Historically, if a middle ear effusion (MEE) persisted for 3 months, surgical intervention was indicated. This dogma has been revised.

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 a meta-analysis of findings from 6 randomized controlled studies, results did reveal a benefit with the use of nasal balloons for autoinflation in children.

An open, pragmatic, randomized trial by Williamson et al also supported the efficacy of autoinflation, finding that in children with otitis media with effusion, it cleared effusions and improved symptoms.  The study included 320 children aged 4-11 years, who were treated either with a combination of autoinflation (three times per day for 1-3 months) and usual care or with usual care alone. The investigators reported that at 1 and 3 months, the rate of normal tympanograms was higher in children in the autoinflation group.  The study also found greater improvement in ear-related quality of life, in children and parents, in the autoinflation group.[19]

Consultations

An otolaryngologist should be consulted whenever the primary care physician (PCP) is concerned about persistent conductive hearing loss in children, especially those with signs of language development delay.

In addition, an otolaryngologist (ENT) 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.

To the author's knowledge, no randomized controlled trials have been performed to assess whether a modification of risk factors for otitis media with effusion 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 that demonstrated a 40% reduction in the prevalence of otitis media with effusion in children from the Netherlands who routinely (at least weekly) chewed gum.[20] Presumably, one hypothesis is that otitis media with effusion is caused by the increased eustachian tube function secondary to palatal muscle action.

Pharmacologic management of otitis media with effusion (OME) includes administration of antimicrobial agents, steroids, antihistamines and decongestants, and mucolytics. However, an international consensus conference of the 2017 International Federation of Oto-rhino-laryngological Societies Congress recommended against the treatment of otitis media with effusion (OME) with steroids, antibiotics, decongestants, or antihistamines, citing concerns regarding side effects and cost, as well as a lack of evidence for long-term therapeutic effectiveness.[6]

Antimicrobial agents

Because otitis media with effusion demonstrates viable pathogenic bacteria, treatment with appropriate antibiotics has been considered reasonable, albeit with evidence showing only short-term benefit.[21]

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.

A large meta-analysis of findings from 10 blinded, randomized controlled trials involving 1041 children with otitis media with effusion revealed that resolution of middle ear effusion (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 did not demonstrate a difference between antimicrobials and placebo with 6- to 11-week follow-up period.

When the otitis media with effusion 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 otitis media with effusion also demonstrate clearance of middle ear effusion with antibiotics; however, they also show rapid and frequent recurrence.

A study by Roditi et al indicated that in the United States, 32% of pediatric ambulatory visits for otitis media with effusion resulted in administration of oral antibiotics, even when patients had no acute infection, with antibiotics being given most often in emergency departments.[22]

Steroids

In 3 placebo-controlled randomized clinical trials, oral steroids alone did not improve otitis media with effusion clearance within 2 weeks of treatment. When oral steroids are combined with antibiotics, the rate of clearance of middle ear effusion does not improve compared with the rate with antibiotics alone. A couple of small studies of topical nasal steroid sprays (vs 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 author's knowledge, only one randomized study has been published comparing intranasal steroids (beclomethasone) and antibiotics to antibiotics alone.[23] This study demonstrated no statistically significant difference between the 2 arms. A 2011 meta-analysis confirmed these findings.[24]

Another study found that topical intranasal steroids, alone or in combination with antibiotics, have no long- or short-term benefit in the management of children with otitis media with effusion.[25]

Williamson et al found that topical intranasal corticosteroids are very unlikely to be effective for treating otitis media with effusion.[26] In a double-blind, randomized, placebo-controlled trial in 207 children aged 4-11 years with persistent bilateral otitis media with effusion, children received either mometasone, 50 mcg in each nostril, or placebo spray once daily for 3 months. Tympanometric clearance in one or both ears at 1, 3, and 9 months was 40.6%, 58.1%, and 55.6%, respectively, in the steroid group; in the placebo group, it was 44.9%, 52.3%, and 65.3%, respectively.[26] Absolute risk reduction at 1 month was -4.3.

Antihistamines and decongestants

In the largest study to date, Cantekin and others randomly assigned 553 children with chronic otitis media with effusion (COME) to receive an antihistamine/decongestant or placebo and found no difference in the clearance rates of the effusion.[27] A 2011 meta-analysis confirmed these findings.[28] That antihistamines increase the viscosity of secretions may account for this finding. The viscosity of chronic otitis media with effusion is often substantial; thus, it is aptly termed glue ear in these cases. This condition can also manifest as a serous effusion.

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

A large, randomized, controlled study of 430 children revealed that clearance rates for otitis media with effusion did not significantly improve with mucolytics versus placebo. Findings of 2 smaller trials of other mucolytics confirmed this result.

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 otitis media with effusion.

The indications for surgical intervention remain controversial.  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 tubes (PETs) 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. However, only 30% of patients who have otitis media with effusion after 3 months duration will clear that effusion over the next 12 months; therefore, ongoing monitoring of hearing levels is required.

Again, most cases of otitis media with effusion 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.

Certain changes to the tympanic membrane may mandate pressure equalization 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 otitis media with effusion, a loss of 40 dB or greater is felt to be an absolute indication for pressure equalization tube insertion. A loss in the range of 21-40 dB is a relative indication with a very low threshold for placement.

Coronavirus disease 2019 (COVID-19)

Bann et al compiled a set of recommendations for best pediatric otolaryngology practices with regard to the coronavirus disease 2019 (COVID-19) pandemic. These included the following for procedures involving the oral cavity, oropharynx, nasal cavity, or nasopharynx[29] :

• Whenever possible, defer procedures involving the nasal cavity, nasopharynx, oral cavity, or oropharynx, as these pose a high risk for COVID-19 owing to the high viral burden in these locations
• Whenever possible, preoperative COVID-19 testing should be administered to patients and caregivers prior to surgical intervention
• Employment of enhanced personal protective equipment (PPE), with a strong recommendation for the use of a powered air-purifying respirator (PAPR), should be undertaken with any patient with unknown, suspected, or positive COVID-19 status
• Limit the use of powered instrumentation, including microdebriders, to reduce aerosol generation

With regard to audiologic evaluation and otologic surgery, the recommendations include the following[29] :

• Perform routine newborn hearing screening and early intervention as indicated in the Joint Committee on Infant Hearing (JCIH) recommendations
• Defer tympanostomy tube placement for unilateral otitis media with effusion
• Although it should be prioritized, intervention for bilateral otitis media with effusion and hearing loss may be deferred based on the availability of COVID-19 testing
• Surgery involving the middle ear and mastoid, owing to their continuity with the upper aerodigestive tract, should be considered high risk for COVID-19 transmission
• Whenever possible, defer mastoidectomy, but if the surgery is required, employ enhanced PPE and avoid the use of high-speed drills
• Employment of a PAPR is strongly recommended when, in patients with unknown, suspected, or positive COVID-19 status, high-speed drills are required for otologic procedures

With regard to head and neck surgery and deep neck space infections, the recommendations include the following[29] :

• Defer surgical excision of benign neck masses
• A multidisciplinary tumor board should decide the most appropriate treatment modality for pediatric patients with solid tumors of the head and neck, including thyroid cancer, with the availability of local resources taken into account
• Prior to surgical intervention, medical management of infectious conditions should, whenever possible, be attempted; on admission, patients and caregivers should be tested for COVID-19 and strictly quarantined pending test results

With regard to craniomaxillofacial trauma, the guidelines include the following[29] :

• When urgent or emergent bedside procedures, including closure of facial lacerations, are required, patients should be presumed positive for COVID-19, even if they are asymptomatic; carry out procedures in a negative-pressure room using enhanced PPE
• Employ closed-reduction techniques, when possible, until preoperative COVID-19 testing is available
• Avoid the use of high-speed drills, to reduce aerosol formation
• When urgent or emergent surgical intervention is required, patients should be presumed positive for COVID-19, even if they are asymptomatic

This section will briefly review myringotomy and aspiration of effusion and myringotomy with pressure equalization tube (PET) insertion.

Myringotomy and aspiration of effusion

When performed alone without the placement of pressure equalization tubes, this procedure has proved disappointing in long-term follow-up in children. Gates and others have shown that when myringotomy is performed with placement of pressure equalization tubes, there was improvement hearing, duration of middle ear effusion (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 1 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 PET insertion

Introduced in 1954 by Armstrong, this intervention has become the criterion standard and most common therapy for chronic otitis media with effusion (COME). Improved hearing and decreased rates of acute otitis media (AOM) are absolute benefits of myringotomy with placement of pressure equalization tubes; these have been documented multiple times. Typically, the tubes self-extrude 9-12 months after placement.

Pressure equalization tubes 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 otitis media with effusion.

Complications

The overall complication rate after placement of pressure equalization tubes 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. Although its exact frequency is unknown (estimates approximate 2%), persistent perforation increases markedly if the pressure equalization tubes remain in place longer than 18 months. This complication is also known to increase with the placement of tympanostomy tubes (T-tubes) that are designed to stay in the tympanic membrane longer than the typical grommet tube.[30, 31, 32] They can stay in place for years and are more commonly used for the patient with recurrent or chronic otitis media 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.

A report on 248 pediatric patients who received tympanostomy tubes and postoperative otic drop therapy found that tube occlusion occurred most frequently in patients with middle ear fluid and in those with longer time to postsurgical follow-up. In the study, a retrospective medical record review, Conrad et al determined that at first follow-up, one or both tubes were occluded in 10.6% of patients. Children with no serous fluid were found to be 3 times more likely to have unobstructed tubes than were children with fluid. It was also found that the chance of occlusion increased in relation to the amount of time that existed between surgery and follow-up.[33, 34]

In December 2015, an otic suspension of ciprofloxacin was approved by the US Food and Drug Administration (FDA) for pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. In a double-blind, randomized, controlled clinical trial, 83 children (mean age 2.8 y) were administered intraprocedural otic ciprofloxacin drops or placebo or sham treatment, with significantly fewer treatment failures associated with ciprofloxacin than with either the placebo or sham therapies.[35, 36]

Although adenoidectomy was once the principal treatment for otitis media with effusion (OME), easy and low-risk placement of pressure equalization tubes (PETs) is now favored.

Three rationales exist for the removal of the adenoids in the treatment of otitis media with effusion and are discussed below. Whatever the rationale used, adenoidectomy alone was found to be nearly as effective as placement of pressure equalization tubes for treatment of otitis media with effusion. When adenoidectomy is performed with placement of pressure equalization tubes, 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.

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. However, multiple studies have revealed that the result of adenoidectomy is independent of adenoid size. This finding suggests that processes other than simple adenoid mass are involved.

Removal for 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.[7]

Removal of a potential source of inflammation and infection at the eustachian tube orifice

The third and most recent rationale for adenoidectomy is to remove a potential inflammatory source and the presence of infection at the orifice of the eustachian tube. 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.

No standard of care for the follow-up of patients with otitis media with effusion (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 (ENT) instead of or in addition to their primary care physician (PCP). The author recommends the removal of pressure equalization tubes (PETs) 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 the conditions 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.

Guidelines for the diagnosis and management of otitis media with effusion (OME) have been issued by the following organizations:

• American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) (2016)
• University of Michigan Health System (UMHS) (2013)
• National Institute for Health and Care Excellence (NICE) (2008)

In 2016, the AAO-HNSF released updated practice guidelines for the management of OME which have been endorsed by the American Academy of Family Physicians (AAFP).[37]  The UMHS published an update to its 2007 guidelines in 2013.[38]  The guidelines from the NICE, published in 2008 and reaffirmed in 2011, are primarily focused on surgical interventions.[39]

Screening and diagnosis

The 2016 AAO-HNSF recommendations for the diagnosis of OME include the following[37] :

• Document the presence of middle ear effusion with pneumatic otoscopy 
• Pneumatic otoscopy should be used to assess for OME in a child with otalgia and/or hearing loss
• If the diagnosis is uncertain after performing pneumatic otoscopy, tympanometry should be obtained
• Counsel parents of infants with OME who fail a newborn hearing screen regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss (SNHL)
• Determine if the child is at increased risk for speech, language, or learning problems because of baseline sensory, physical, cognitive, or behavioral factors
• Children at high risk for developing otitis media with effusion—ie, those with an increased likelihood due to developmental issues or a syndrome or condition—should be screened for OME when the risk factor is diagnosed and again between age 12 and 18 months
• Routine screening of children for OME who are not at risk and do not have symptoms that may be attributable to OME, such as hearing difficulties, balance (vestibular) problems, poor school performance, behavioral problems, or ear discomfort, is not recommended

The 2013 UMHS guidelines recommend the combined use of otoscopy, pneumatic otoscopy, and tympanometry when necessary to determine the presence of middle ear effusion.[38]

The NICE guidelines note that concerns from parents, caregivers, or professionals about features suggestive of OME should precipitate an initial assessment. In addition, all children with Down syndrome or cleft palate should be assessed regularly for OME. Features suggestive of OME include the following[39] :

• Hearing difficulty (for example, mishearing when not looking at the speaker, difficulty in a group, asking for things to be repeated)
• Indistinct speech or delayed language development
• Repeated ear infections or earache
• History of recurrent upper respiratory tract infections or frequent nasal obstruction
• Behavioral problems, particularly lack of concentration or attention, or being withdrawn
• Poor educational progress
• Less frequently, balance difficulties (for example, clumsiness), tinnitus, and intolerance of loud sounds

Treatment

Updated guidelines on the use of tympanostomy tubes in children were published in February 2022 by the AAO-HNSF. Action statements include the recommendation that a hearing evaluation be performed in children who have had otitis media with perfusion (OME) for at least 3 months or should be carried out prior to surgery in pediatric patients who have become candidates for tympanostomy tube insertion.[40]

The 2016 AAO-HNSF recommendations for treatment of OME include the following[37] :

• Watchful waiting for 3 months from the date of effusion onset or, if the onset date is unknown, 3 months from the date of diagnosis for children who are not at risk for speech, language, or learning problems 

• Medical therapy for OME—including systemic antibiotics, systemic steroids, intranasal steroids, antihistamines, and decongestants—should be employed only in exceptional circumstances

• An age-appropriate hearing test should be given if OME persists for more than 3 months or should be administered to any at-risk child with OME regardless of duration

• At 3- to 6-month intervals, reevaluate children with chronic OME until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected

• Tympanostomy tube insertion when surgery is performed in a child under age 4 years; adenoidectomy should not be performed unless an indication for adenoid removal, such as nasal obstruction or chronic adenoiditis, is present

• Tympanostomy tube insertion, adenoidectomy, or both when surgery is performed in a child aged 4 years or older

Children who, as mentioned above, may be at risk for speech, language, or learning problems, according to the AAO-HNSF, include the following:

• Children with permanent hearing loss independent of OME

• 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

In 2013, the AAO-HNSF released specific guidelines on use tympanostomy tube insertion for children with otitis media that included the following recommendations[41] :

• Tympanostomy tube insertion should not be performed in children with a single episode of OME of less than 3 months' duration
• Bilateral tympanostomy tube insertion should be offered to children with bilateral OME of more than 3 months' duration and documented hearing difficulties
• Tympanostomy tube insertion may be considered in children with unilateral or bilateral OME of more than 3 months' duration and symptoms that include balance problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life
• Children with chronic OME who do not receive tympanostomy tubes should be reevaluated at 3- to 6-month intervals until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected
• Tympanostomy tube insertion may be offered to at-risk children with unilateral or bilateral OME that is unlikely to resolve quickly, as reflected by a type B (flat) tympanogram or persistence of effusion for more than 3 months 
• Educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications
• Clinicians should prescribe topical antibiotic eardrops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea
• Encourage routine, prophylactic water precautions (use of earplugs or headbands; avoidance of swimming or water sports) for children with tympanostomy tubes

The NICE guidelines include the following recommendations[39] :

• Consider surgical intervention after bilateral OME and hearing loss have been confirmed over a 3-month period and the impact of the hearing loss on a child's developmental, social, or educational status is judged to be significant
• Insertion of ventilation tubes is recommended
• Adenoidectomy is not recommended in the absence of persistent and/or frequent upper respiratory tract symptoms
• Autoinflation may be considered during the active observation period for children with OME who are likely to cooperate with the procedure
• Hearing aids should be offered to children with persistent bilateral OME and hearing loss as an alternative to surgical intervention if surgery is contraindicated or not acceptable

The following treatments are not recommended for the management of OME, according to the NICE guidelines:

• Antibiotics
• Topical or systemic antihistamines
• Topical or systemic decongestants
• Topical or systemic steroids
• Homeopathy
• Cranial osteopathy
• Acupuncture
• Dietary modification, including probiotics
• Immunostimulants
• Massage

Coronavirus disease 2019 (COVID-19)

Bann et al compiled a set of recommendations for best pediatric otolaryngology practices with regard to the coronavirus disease 2019 (COVID-19) pandemic. These included the following for procedures involving the oral cavity, oropharynx, nasal cavity, or nasopharynx[29] :

• Whenever possible, defer procedures involving the nasal cavity, nasopharynx, oral cavity, or oropharynx, as these pose a high risk for COVID-19 owing to the high viral burden in these locations
• Whenever possible, preoperative COVID-19 testing should be administered to patients and caregivers prior to surgical intervention
• Employment of enhanced personal protective equipment (PPE), with a strong recommendation for the use of a powered air-purifying respirator (PAPR), should be undertaken with any patient with unknown, suspected, or positive COVID-19 status
• Limit the use of powered instrumentation, including microdebriders, to reduce aerosol generation

With regard to audiologic evaluation and otologic surgery, the recommendations include the following[29] :

• Perform routine newborn hearing screening and early intervention as indicated in the Joint Committee on Infant Hearing (JCIH) recommendations
• Defer tympanostomy tube placement for unilateral otitis media with effusion
• Although it should be prioritized, intervention for bilateral otitis media with effusion and hearing loss may be deferred based on the availability of COVID-19 testing
• Surgery involving the middle ear and mastoid, owing to their continuity with the upper aerodigestive tract, should be considered high risk for COVID-19 transmission
• Whenever possible, defer mastoidectomy, but if the surgery is required, employ enhanced PPE and avoid the use of high-speed drills
• Employment of a PAPR is strongly recommended when, in patients with unknown, suspected, or positive COVID-19 status, high-speed drills are required for otologic procedures

With regard to head and neck surgery and deep neck space infections, the recommendations include the following[29] :

• Defer surgical excision of benign neck masses
• A multidisciplinary tumor board should decide the most appropriate treatment modality for pediatric patients with solid tumors of the head and neck, including thyroid cancer, with the availability of local resources taken into account
• Prior to surgical intervention, medical management of infectious conditions should, whenever possible, be attempted; on admission, patients and caregivers should be tested for COVID-19 and strictly quarantined pending test results

With regard to craniomaxillofacial trauma, the guidelines include the following[29] :

• When urgent or emergent bedside procedures, including closure of facial lacerations, are required, patients should be presumed positive for COVID-19, even if they are asymptomatic; carry out procedures in a negative-pressure room using enhanced PPE
• Employ closed-reduction techniques, when possible, until preoperative COVID-19 testing is available
• Avoid the use of high-speed drills, to reduce aerosol formation
• When urgent or emergent surgical intervention is required, patients should be presumed positive for COVID-19, even if they are asymptomatic

A consensus statement published in August 2000 defined an appropriate logarithm for the medical treatment of acute otitis media (AOM) and recurrent acute otitis media (RAOM).[42] Antimicrobials are the only medications that have been shown to increase the rate of clearance of otitis media with effusion (OME) in randomized controlled trials. However, these benefits are temporary at best.

Class Summary

Results of small trials have shown that nasal steroids speed the clearance of otitis media with effusion (OME) and prevent its recurrence. A 2011 meta-analysis confirmed these findings.[24] However, to the author's knowledge, no large randomized trials have been performed to confirm this finding.

Fluticasone (Flonase)

Fluticasone is a topical corticosteroid spray that has anti-inflammatory effects on the nasal mucosa and, presumably, on the nasopharynx, where the eustachian tube orifice is located.

Class Summary

An otic suspension may be used intraoperatively.

Ciprofloxacin otic (Otiprio)

Ciprofloxacin is an ototopical fluoroquinolone. This class of antimicrobial has a broad spectrum of activity. Additionally, fluoroquinolones do not cause vestibular or cochlear toxicity, recognized with aminoglycosides. The sustained-exposure ciprofloxacin suspension (Otiprio) is indicated for pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. It is administered as a single intratympanic dose of 0.1 mL (6 mg) into each affected ear, following suctioning of the middle ear effusion.