Sections

Treatment

Overview of Medical and Surgical Approaches

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.

Modification of OME Risk Factors

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.

Pharmacotherapy

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.

Indications for Surgical Intervention

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

Myringotomy

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]}

Adenoidectomy

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.

Long-Term Monitoring

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

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