Otitis Media Treatment & Management

Updated: Jun 07, 2023
  • Author: Muhammad Waseem, MBBS, MS, FAAP, FACEP, FAHA; Chief Editor: Ravindhra G Elluru, MD, PhD  more...
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Medical Care

Medical management of otitis media (OM) is actively debated in the medical literature, primarily because of a dramatic increase in acute OM (AOM) prevalence over the past 10 years caused by drug-resistant S pneumoniae (DRSP) and beta-lactamase–producing H influenzae or M catarrhalis.

Beta-lactamases are enzymes that hydrolyze amoxicillin and some, but not all, oral cephalosporins, leading to in-vitro resistance to these drugs. Currently, 90% of M catarrhalis isolates and 40-50% of H influenzae isolates in the United States produce beta-lactamases. As a result, empiric antibiotic therapy for this disease has become more complex. Many opinions have been expressed regarding which drugs are best for first- and second-line therapy or whether antibiotics should be prescribed in all patients with AOM.

Medical therapy for acute otitis media

In 1999, the Centers for Disease Control and Prevention (CDC) therapeutic working group on DRSP published consensus recommendations for AOM management. [23] The recommendations supported the use of amoxicillin as the first-line antimicrobial agent of choice in patients with AOM. The group recommended increasing the dose used for empiric treatment from 40-45 mg/kg/day to 80-90 mg/kg/day because of concerns about increasingly resistant strains of S pneumoniae, which are theoretically susceptible to this higher dose.

The recommendations for second-line therapy were more controversial, despite their reasonableness from a scientific viewpoint. Stressing the importance of documenting true clinical failure of therapy after at least 3 days of treatment with high-dose amoxicillin, the working group suggested tympanocentesis for identification and susceptibility testing of the etiologic bacteria to guide alternate antibiotic therapy.

In cases where second-line therapy is empirically chosen (a common occurrence, because few primary care physicians routinely perform tympanocentesis in the office), the recommendations suggested administering the following three preparations:

  • High-dose oral amoxicillin-clavulanate (80-90 mg/kg/day of amoxicillin component, 6.4 mg/kg/day of clavulanate component)
  • Oral cefuroxime axetil (suspension, 30 mg/kg/day in divided doses; tablet, 250 mg twice daily)
  • Intramuscular (IM) ceftriaxone (administered as a single IM injection of 50 mg/kg on 3 consecutive days)

The choice of these three preparations from among the 16 antimicrobials currently approved by the US Food and Drug Administration (FDA) for OM therapy was based on studies that reported that these drugs achieve sufficient concentrations in middle ear fluid for bactericidal action against the common pathogens in AOM, including DRSP and beta-lactamase–producing H influenzae. Similar studies for the other 13 approved agents either have not been completed or failed to show similar efficacy against resistant bacteria.

These recommendations relied heavily on the pharmacodynamics model of drug efficacy. In this model, clinical cure is believed to correlate with demonstrated penetrance of the antibiotic into the middle ear at a level believed to be sufficient to kill the bacterial pathogens that cause AOM. Nevertheless, this model had the following shortcomings:

  • Although bacteriologic eradication correlates with a successful clinical outcome, clinical success occurs in more than 60% of patients, even when bacteriologic eradication is not achieved; eventually, almost all patients improve
  • Validation of the pharmacodynamic model relies on tympanocentesis to identify the causative bacteria and to measure antibiotic levels in middle ear fluid; some antibiotics (eg, azithromycin and clarithromycin) concentrate intracellularly, not in middle ear fluid, and are bacteriostatic rather than bactericidal; a model predicated on certain drug levels and bacterial eradication may underestimate the efficacy of these agents
  • The drug levels used by the CDC to define bacterial killing were based on standards that changed 6 months after the CDC publication

The following crucial issues in AOM treatment were not clearly addressed by the CDC recommendations:

  • Patient compliance and the associated factors of dosing frequency, duration of therapy, palatability, and drug cost
  • Guidance for special situations (eg, allergy to penicillins, beta-lactam drugs, or both)
  • Discussion of the option of withholding antibiotic therapy for 2-3 days in a subset of patients with AOM who are likely to experience spontaneous resolution of disease with only supportive care and analgesic therapy (a practice that is widespread in the Netherlands and Scandinavia but that has few proponents in the United States)

Compliance, duration of therapy, and cost are important issues in treating children with AOM. The primary determinants of compliance appear to be the following:

  • Frequency of dosing
  • Palatability of the agent
  • Duration of therapy

Less frequent dosing (ie, once or twice daily) is more desirable than more frequent dosing, which interferes with daily routines. Shorter duration of therapy (ie, 5-7 days vs 10-14 days) increases compliance but should be used only when equal clinical efficacy can be assured. In many instances, palatability ultimately determines compliance in children.

In 2013, the American Academy of Pediatrics (AAP) and the American Academy of Family Practice (AAFP) published updated guidelines for the medical management of AOM (see Guidelines). [24]  Among other recommendations, these guidelines recommended antibiotics for bilateral or unilateral AOM in children aged at least 6 months with severe signs or symptoms and for nonsevere bilateral AOM in children aged 6-23 months. Amoxicillin was cited as the antibiotic of choice unless the child has received it within the previous 30 days, has concurrent purulent conjunctivitis, or is allergic to penicillin.

For children who are allergic to penicillin or beta-lactam, the only currently available products are cephalosporins, trimethoprim-sulfamethoxazole, and macrolides. Patients who are allergic to penicillin show 10-15% cross-reactivity when treated with cephalosporins. Levofloxacin has demonstrated higher efficacy in the treatment of AOM than amoxicillin-clavulanate has and can be used in patients who are allergic to penicillin. [25]

Pneumococcal resistance to trimethoprim-sulfamethoxazole is increasing and has become more common than penicillin resistance in some areas. Use this drug to treat AOM only in regions where it remains effective.

Of the macrolides, erythromycin-sulfisoxazole is a good choice, but many children refuse it because of its taste; a 5-day course of azithromycin or 10-day course of clarithromycin may be preferred. If DRSP is the suspected etiologic bacterium, do not use macrolides, because pneumococcal resistance is absolute with macrolides and, unlike the resistance seen with some beta-lactam antibiotics, cannot be overcome by increasing the dose.

Many children with AOM do not benefit from antimicrobial therapy, either because the illness is not of bacterial origin or because their immune system clears the infection without use of a drug. No clinical criteria currently distinguish which children do not require antibiotic therapy for AOM.

Until such criteria are available, many practitioners are unlikely to withhold initial antimicrobial therapy for proven cases of AOM. Increasing awareness of the pathophysiology of the disease among parents and healthcare providers has resulted in an increase in an observation-only approach in emergency departments with less parental anxiety. [26]

Medical therapy for otitis media with effusion

Most cases of OM with effusion (OME) occur after an episode of AOM, and 67% of patients develop a middle-ear effusion (MEE). The mean duration of the effusions is 23 days, but many persist much longer. Most cases of OME spontaneously resolve. Studies of the natural history of this disease report the following:

  • An MEE is harbored in 50% of ears 1 month after an episode of acute OME
  • An MEE is harbored in 20% of ears after 2 months
  • An MEE continues to be harbored in 10-15% of ears after 3 months
  • OMEs that persist longer than 3 months have spontaneous resolution rates of only 20-30%, even after years of observation

Most cases of chronic OME are associated with conductive hearing loss, averaging approximately 25 dB. Complications of hearing loss (eg, language delay, behavioral problems, poor academic performance) have led to investigations of multiple medical and surgical treatments for OME. The following are among the many strategies advocated for medical treatment in patients with OME:

  • Antimicrobials
  • Antihistamine-decongestants
  • Intranasal and systemic steroids
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Mucolytics
  • Aggressive management of allergic symptoms

Of these options, only antimicrobial therapy has provided measurable benefits. Steroid therapy (when administered in combination with a beta-lactam antimicrobial) has shown benefit in some studies and no benefit in others. All other medical therapies (ie, decongestants, antihistamines, mucolytics, and NSAIDs) have not provided measurable short- or long-term improvements in patients with OME.

Patients in whom OME is unresponsive to medical therapy and with an MEE that persists more than 12 weeks should be referred to an otolaryngologist to discuss surgical options in conjunction with further medical therapies.

Antimicrobial therapy

No clinical guidelines or consensus recommendations suggest which antimicrobials to use as first-line agents for OME. In this era of increasing antibiotic resistance, selection of an antibiotic agent should be individualized to the patient.

In each patient, consider prior experience with antibiotics, age, sex, and daycare attendance.

If penicillin allergy is not a concern and if the patient has no recent exposure to antibiotics, a reasonable choice for initial therapy is amoxicillin, administered at the same high dose recommended by the CDC for AOM (ie, 80-90 mg/kg/day). A reasonable first choice in a patient with antibiotic exposure during the prior month is trial administration of a beta-lactamase–stable agent (eg, amoxicillin-clavulanate) or a second- or third-generation cephalosporin.

As with antimicrobial selection, no recommendations have been made regarding duration of therapy; 10 days is reasonable for amoxicillin, amoxicillin-clavulanate, and cephalosporins. Studies of prolonged treatment in patients with OME show no advantage in therapies that last longer than 10 days.

Steroid therapy

The literature on steroid therapy is inconclusive. In 1994, the Agency for Health Care Policy and Research (AHCPR) reviewed more than 5000 articles on OME management and published a clinical practice guideline. [27] Although the review found that a combination of steroids and antibiotics improved MEE clearance in 25.1% of patients, the difference was not statistically significant, and the risks of steroids were felt to outweigh their potential benefits. The guideline stated that steroids were not recommended for OME treatment in children of any age.

After the publication of the AHCPR guideline, another investigation of steroids plus antibiotics to treat OME was published by Rosenfeld, [28] who reported that surgery was avoided or postponed for 6 months in 1 of 4 children treated with steroids. Therefore, steroid administration may have a role in patients who are not good surgical candidates.

The steroid regimen should be oral prednisone or prednisolone at a dosage of 1 mg/kg/day for 5-7 days, administered in combination with a beta-lactam antibiotic.

Steroids are contraindicated in patients with exposure to varicella who have not received the varicella vaccine because of the possibility of life-threatening disseminated disease.

Controversy continues over the optimal management of OME. The AHCPR guideline, although criticized for having a narrow scope, for favoring medical rather than surgical management of OME, and for minimizing the problem of drug-resistant bacteria, provides a framework within which to consider management options.

In 2016, the American Academy of Otolaryngology–Head and Neck Surgery Foundation, the AAP, and the AAFP issued updated guidelines for OME, including recommendations on the use of pneumatic otoscopy, tympanometry, routine screening, steroids, systemic antibiotics, antihistamines or decongestants, hearing tests, tympanostomy tubes, and adenoidectomy (see Guidelines). [29]


Surgical Care

From the beginning, it is essential to integrate surgical management of AOM and OME with medical treatment. Early surgical interventions (eg, tympanocentesis) may be performed by primary care providers, but more invasive procedures (eg, myringotomy, TT insertion, and adenoidectomy) require an otolaryngologist.

In patients with intratemporal or intracranial complications of OM, surgical consultation is critical. Certain special patient populations, such as those with cleft palate, Down syndrome, or other craniofacial abnormalities, may require early surgical intervention to prevent OM.


Indications for tympanocentesis are as follows:

  • OM in patients who have severe otalgia, who are seriously ill, or who appear toxic
  • Unsatisfactory response to antimicrobial therapy
  • Onset of AOM in a patient receiving antimicrobial therapy
  • OM associated with a confirmed or potential suppurative complication
  • OM in a newborn, sick neonate, or patient who is immunologically deficient, any of whom may harbor an unusual organism

Tympanostomy tubes

In July 2013, the American Academy of Otolaryngology–Head and Neck Surgery Foundation (AAO-HNSF) issued the first evidence-based, multidisciplinary clinical practice guideline on the use of TTs in children aged 6 months to 12 years who have OM. [30]  These guidelines were subsequently updated in February 2022 (see Guidelines). [31]

Adenoidectomy and tonsillectomy

The performance of adenoidectomy, tonsillectomy, or both to treat patients with OM (in addition to myringotomy and TT placement) has generated extensive discussion and research, though potential benefits are controversial. Current literature supports the following recommendations from Bluestone [32] :

  • Initial surgery - Myringotomy and TT placement are the initial surgical techniques (withhold adenoidectomy unless the patient has a nasal obstruction); some experts advocate simultaneous adenoidectomy in patients older than 3 years because this has been shown to improve eustachian tube (ET) function
  • Repeat surgery (following extrusion of tubes and recurrence of chronic MEE unresponsive to antimicrobial therapy) - Myringotomy, with or without TT placement, and adenoidectomy, irrespective of adenoid size, are the techniques used
  • Tonsillectomy - Although tonsillectomy is not indicated for treatment of OM (because it has not been shown to benefit ET function), it may be performed concurrently with surgery for OM if indications are present (eg, frequently recurrent tonsillitis, pharyngeal obstruction)

Surgery for children with cleft palate

Myringotomy and TT placement are warranted in most children with cleft palate because of inherent ET dysfunction (ETD) and increased risk of OM. In patients who also have a cleft lip, the TT may be placed at the time of initial lip repair, many months prior to palate repair. Consider performing TT placement or replacement at the time of palate repair.

Surgery for children with Down syndrome

Children with Down syndrome often exhibit ETD, conductive and sensorineural hearing loss, external auditory canal (EAC) stenosis, and subtle immunologic deficiencies. These conditions create a high risk for OM, make diagnosis of MEE difficult, and can lead to profound language and learning difficulties. The essential elements of care in these patients include close monitoring, appropriate surgical interventions for EAC enlargement, and repetitive TT placements.

Tube selection is a critical issue. These patients may require prolonged external ventilation with TTs because of prolonged ETD. Unfortunately, TTs labeled as long-acting or permanent cause the greatest damage to the tympanic membrane (TM). These patients often require repeated TT insertions, even when long-acting or permanent TTs are used. The best procedure may be to anticipate early extrusion and reinsertion and to avoid these tubes in favor of ultrasmall TTs to prevent long-term TM damage.



Medical strategies to prevent OM include eliminating risk factors for AOM, immunologic interventions, and antibiotic prophylaxis. Surgical strategies to prevent recurrent OM include prophylactic myringotomy and TT insertion.

Elimination of risk factors

Risk factors include daycare attendance, secondary exposure to tobacco smoke, pacifier use, and breastfeeding for less than 3 months (breastfeeding for >3 months decreases risk).

Daycare attendance

A meta-analysis of studies of risk factors for AOM reported that care outside the home leads to an approximately 2.5-fold increase in the relative risk of recurrent AOM, probably because of greater exposure to respiratory infections. Children in daycare have an increased frequency of URIs, and their infections are often more prolonged.

AOM risk correlates with the number of contacts with other children rather than the absolute number of children enrolled in a center. Rates of respiratory infections, including AOM, are higher among children in daycare centers than among those receiving family care.

The risk of increased infection associated with group daycare is greatest in the first 2 years of life and particularly in the first year.

Tobacco smoke exposure

Tobacco smoke is an upper respiratory irritant, and multiple studies have shown that passive smoke exposure places children at increased risk for pneumonia, bronchitis, bronchiolitis, chronic MEE, and more frequent and severe asthma.

Most of the prior controversy regarding the relationship between tobacco smoke exposure and OM resulted from faulty study design and a failure to objectively quantify tobacco smoke exposure. Studies have controlled for confounding factors more carefully, and many have measured serum or urine concentrations of cotinine, a nicotine metabolite, to objectively determine exposure to passive tobacco smoke. These studies consistently establish a direct relationship between parental smoking and increasing risk of AOM.

A meta-analysis of risk factors determined that parental smoking increases the risk of AOM by 66%. The average duration of MEE in children with elevated cotinine levels was 28 days, compared with 19 days' duration in children without elevated levels.

Pacifier use

This clearly increases the risk for AOM in infants and small children, although the reason for this predisposition is uncertain. In one study, the relative risk for recurrent AOM was 1.6 in children younger than 2 years who used a pacifier and 2.9 in children aged 2 and 3 years who used a pacifier. According to one theory, the constant sucking action associated with pacifier use exacerbates ETD, leading to inoculation of the middle ear with pathogenic bacteria.

Breastfeeding for less than 3 months

Breastfeeding protects young infants from OM and GI tract illness. A meta-analysis reported that breastfeeding for at least 3 months resulted in a relative AOM risk of 0.87 and a relative risk of recurrent AOM of 0.69. Breastfeeding for at least 6 months reduced the risk of AOM even further. The risk reduction probably results from transferred immunoglobulins, cellular elements, and many nonspecific components in mother's milk that, collectively, exhibit antibacterial, antiviral, and antiparasitic properties.


Pneumococcal vaccine

In February 2000, the FDA approved use of heptavalent pneumococcal CRM197 conjugate vaccine (PCV7), composed of seven pneumococcal antigens (ie, polysaccharide serotypes 4, 6B, 9V, 14, 19F, 23F; oligosaccharide serotype 18C) conjugated to 20 μg of CRM197 by reductive amination. PCV7 has been replaced by vaccines with broader coverage and is no longer used. 

At the time, PCV7 provided potential serotype and serogroup cross-protection (eg, 6A) in 88% of cases of bacteremia, 82% of cases of meningitis, and 71% of cases of pneumococcal OM episodes in children younger than 6 years in the United States. It had decreased the number of episodes of S pneumoniae AOM caused by the serotypes included in the vaccine. It had reduced the nasopharyngeal carriage of vaccine-type S pneumoniae, particularly antibacterial-resistant organisms, and had also prevented the spread to contacts in the community.

After the introduction of the heptavalent pneumococcal vaccine in 2000, researchers found that nearly two thirds of invasive pneumococcal disease cases in young children were caused by six serotypes not covered by that vaccine. Those serotypes, along with the original seven, were incorporated into a 13-valent pneumococcal vaccine, which was approved in February 2010 and which supplanted PCV7.

As of 2023, the 13-valent and 20-valent pneumococcal vaccines are approved by the FDA for children aged 6 weeks through 5 years to prevent OM caused by S pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. 

Since 1985, pneumococcal polysaccharide vaccines have been recommended for children older than 2 years who are at high risk for invasive disease, but they were not recommended for younger children and infants, because of poor antibody response in children younger than 2 years.

Prymula et al described the effectiveness of a newer vaccine that contained pneumococcal capsular polysaccharides conjugated to H influenzae–derived protein D in the prevention of a first episode of AOM. [33] According to the data from this study, the full effectiveness of the vaccine in treating children was questionable, even in high-risk children.

Pneumococcal conjugate vaccines induce proposed protective antibody responses (>0.15 μg/mL) in more than 90% of infants after a series of three doses administered at ages 2, 4, and 6 months. Following the priming doses, significant booster responses (ie, immunologic memory) are apparent when additional doses are administered in patients aged 12-15 months. In efficacy trials, such vaccines were associated with a 7% decrease in OM and a 15-20% decrease in TT placement.

Most antibiotics are effective in treating AOM despite changed microbiology due to the use of PCV7. [34]

Influenza vaccine

Influenza is a highly infectious viral illness that is common during the winter months. A small proportion of AOM is directly caused by influenza viruses and may be directly prevented by immunization with influenza vaccine. In addition, any influenza infection of the upper respiratory tract leads to respiratory epithelial inflammation and associated ETD, which predisposes the host to bacterial AOM.

Influenza vaccine is strongly recommended for any person older than 6 months in whom age or an underlying medical condition creates increased risk for complications of influenza. It can be administered to any person who wishes to reduce the chance of infection by the virus. The vaccine can be administered to children as young as 6 months. Many experts recommend that children who are prone to OM receive the annual vaccine, particularly those in group daycare who have increased risk of upper respiratory infection (URI) and AOM.

A 2015 Cochrane review concluded that influenza vaccine yielded a small decrease in the incidence of AOM but noted that this benefit may not justify the use of the vaccine unless the vaccine's efficacy in reducing influenza and its safety data (limited at present) are taken into account. [35] Further research is warranted.

Antibiotic prophylaxis

Many studies in the 1970s and 1980s showed the effectiveness of antibiotic prophylaxis in children with recurrent AOM. The most common regimens were sulfisoxazole (35 mg/kg once or twice daily) or amoxicillin (20 mg/kg once or twice daily). These therapies were usually administered in patients who had three or more episodes of AOM within a 6-month period or four or more episodes within 12 months.

The use of antibiotic prophylaxis for AOM has become widely questioned because of the increasing antibiotic resistance among bacterial pathogens responsible for middle-ear infections. Even before the drastic rise in drug-resistant bacteria, the clinical effectiveness of antibiotic prophylaxis for AOM was unimpressive.

A meta-analysis of 1993 studies showed that a child must be treated for 9 months to prevent just one episode of AOM. [36] The meta-analysis was based on decade-old data that are almost irrelevant now because of the growing prevalence of drug-resistant bacteria. Most experts who once supported antibiotic prophylaxis no longer recommend routine antibiotic prophylaxis for all children with recurrent AOM.



Refer all patients who may require surgical interventions for complicated OM or who have recurrent AOM or chronic OME to an otolaryngologist. Primary care physicians who are uncomfortable performing tympanocentesis should refer patients who need this procedure to an otolaryngologist.

Children who present with subjective evidence of hearing loss should be referred to an otologist for a formal hearing test (ie, audiogram). Subjective evidence of hearing loss is often provided by a parent or caregiver in younger children or, possibly, by a school teacher in older children.

Referral to a speech therapist is indicated for patients in whom COM has caused speech and language delays because of hearing loss.


Long-Term Monitoring

Inpatient care is indicated only in patients with intratemporal or intracranial complications of OM.

Most AOM cases resolve with antibiotic therapy, but recurrences are frequent. By the time children are aged 7 years, more than one third have experienced 6 or more episodes of AOM. In addition, many patients who are treated for AOM subsequently develop asymptomatic OME. Monitoring by otoscopic examination, acoustic reflectometry, and/or tympanometry is necessary to determine which children require further follow-up care and therapy to prevent hearing loss and resultant speech and learning disabilities.

Although the precise timing of follow-up visits is a matter of debate, examination after 4-6 weeks is reasonable. At the 4-week to 6-week follow-up visit, children in whom OME has not resolved should be rescheduled for a second follow-up appointment 4-6 weeks after the first.

If effusion persists as long as 12 weeks, perform a hearing test. Refer any child in whom the hearing loss in both ears exceeds 20 dB for surgical treatment with a bilateral myringotomy and TT placement. Children with a hearing loss of less than 20 dB and an MEE that persists beyond 12 weeks can be monitored, with the understanding that significant spontaneous improvement of the MEE after 12 weeks is unlikely, or they can receive antibiotic therapy using a beta-lactam–stable agent.