OVERVIEW: What every practitioner needs to know

Are you sure your patient has acute otitis media? What are the typical findings for this disease?

Acute onset of signs and symptoms of middle ear effusion (MEE) and middle-ear inflammation, usually within the 48 hours preceding presentation, are required for the diagnosis of acute otitis media (AOM).

The 2013 AAP Guideline on the Diagnosis and Management of Acute Otitis Media emphasizes the need for accurate diagnosis, using strict otoscopic criteria for sound clinical decision-making.

  • AOM should be diagnosed in children with moderate to severe bulging of the tympanic membrane (TM) or new onset of otorrhea, not due to otitis externa

    Continue Reading

  • AOM should be diagnosed in children with mild bulging of the TM and recent onset of ear pain or intense erythema of the TM

  • AOM should not be diagnosed in children who do not have MEE based on pneumatic otoscopy and/or tympanometry

Middle-ear effusion signs

Signs of middle ear effusion include the following: 

  • Tympanic membrane (TM) bulging

  • Limited or absent mobility of the TM on pneumatic otoscopy

  • Air-fluid level behind TM 

The American Academy of Pediatrics and the American Academy of Family Physicians consensus guidelines for  the management of AOM (2004) recommend pneumatic otoscopy with or without supplementary tympanometry or acoustic reflectometry to confirm these findings or direct demonstration of fluid by tympanocentesis. The AAP 2013 Guideline reaffirms pneumatic otoscopy as the standard for diagnosis of OM.

Middle-ear inflammation signs and symptoms

Evidence of middle ear inflammation includes the following:

  • Distinct TM erythema and/or moderate to severe TM bulging

  • Otorrhea through a perforation or a tympanostomy tube

  • Distinct otalgia clearly related to the ear(s) interfering with normal activity or sleep

What other disease/condition shares some of these symptoms?

Viral upper respiratory infection may present with acute symptoms that overlap with AOM such as fever and apparent otalgia, i.e., ear pulling, but may not have MEE with signs/symptoms of middle-ear inflammation which are required for the diagnosis of AOM. Otitis media with effusion (OME) presents with MEE, and varying degress of hearing loss, without signs or symptoms of acute ear infection.

Bullous myringitis presents with blisters on the TM but lacks MEE which is required for the diagnosis of AOM.

Acute otitis externa is generalized inflammation of the external ear canal of rapid onset and may present with otalgia and otorrhea, but does not cause MEE or middle-ear inflammation, which are required for the diagnosis of AOM.

Diagnosis of AOM is challenging, because of difficulties in performing otoscopy in young children, who may be uncooperative or have cerumen in the ear canals. A crying child may have TM erythema, but no bulging or middle ear effusion, and AOM should not be diagnosed.

What caused this disease to develop at this time?

Infants and children less than 2 years of age are most likely to develop acute otitis media. Precipitating factors and underlying conditions that contribute to the likelihood of developing acute otitis media include the following:

  • Genetic predisposition: relative to mother, father, or sibling

  • Male gender

  • Native American/Inuit ethnicity

  • Family history of recurrent otitis media (rAOM) (three AOM episodes in 6 months, or four in 12 months, with at least one episode in the last 6 months)

  • Premature birth

  • Viral upper respiratory infection

  • Influenza infection

  • Bronchiolitis

  • Immunodeficiency

  • Craniofacial defect affecting the eustachian tube function and thus middle ear aeration, such as Down syndrome and cleft palate 

Environmental factors associated with an increased likelihood of developing acute otitis media include the following:

  • Low socioeconomic status

  • Siblings in the household

  • Day care or child center attendance

  • Tobacco smoke exposure

  • Supine bottle feeding

  • Not breast fed  

What laboratory studies should you request to help confirm the diagnosis? How should you interpret the results?

AOM is diagnosed clinically based on otoscopic findings and history. Children with AOM refractory to therapy, or who have overt or impending complications of OAM, may require tympanocentesis or myringotomy for drainage and culture of the middle ear.

Children with recurrent AOM or persistent OME may require comprehensive audiologic testing to assess hearing and to determine candidacy for tympanostomy tube replacement.

Would imaging studies be helpful? If so, which ones?

Imaging studies are not useful for diagnosis of AOM in children. Children with intratemporal or intracranial complications of AOM, require imaging with contrast-enhanced computed tomography and/or magnetic resonance imaging.

Confirming the diagnosis

The diagnosis of AOM requires (1) acute onset of signs and symptoms of (2) middle ear effusion (MEE) and (3) middle-ear inflammation, usually within the 48 hours preceding presentation.

Evidence is limited on clinician accuracy and precision in identifying the three required clinical criteria for the diagnosis of AOM. In one study, of those children with MEE diagnosed by tympanocentesis, 97% had a type B tympanogram and all had an otoscopic exam consistent with AOM. In another study, 78% of AOM cases diagnosed by a general practitioner were confirmed by an otolaryngologist.

Symptoms: in a systematic review of four studies, ear pain and ear rubbing were reported to be modestly associated with the diagnosis of AOM though a more recent study suggests severity of parent-reported symptoms, including ear rubbing, ear pain, and fever, were not associated with AOM diagnosis.

Otoscopic signs: a cloudy, bulging, immobile, or red tympanic membrane on otoscopy have been found to be positively associated with AOM.

If you are able to confirm that the patient has acute otitis media, what treatment should be initiated?

The child with AOM should be assessed for pain. The mainstay for treatment of pain from AOM is administration of acetaminophen and/or ibuprofen.

The American Academy of Pediatrics and the American Academy of Family Physicians published consensus guidelines for the management of AOM in 2004, and this was updated by the AAP in 2013. The guidelines in 2004, introduced the concept of observation without initial antibiotic therapy for some children with AOM, and the recommedations regarding observation versus prompt treatment were refined in the 2013 guideline. The differences in the recommendations of the 2004 and 2013 guidelines are listed in Table I (See Table I).

Table 1.n

Differences in the 2004 and 2013American Academy of Pediatrics Guidelines for the Diagnosis and Management of Acute Otitis Media

Table I.
Certain Diagnoses; Uncertain Diagnosis
Age Severe illness Nonsevere illness Severe illness Nonsevere illness
<6 months Antibacterial therapy Antibacterial therapy Antibacterial therapy Antibacterial therapy
6 months to 2 years Antibacterial therapy Antibacterial therapy Antibacterial therapy Observation option
>=2 years Antibacterial therapy Observation option Observation option Observation option

;Certain diagnosis: All 3 criteria met, i.e. rapid onset, MEE, middle-ear inflammation.

†Severe illness: moderate to severe otalgia and 339°C

‡Observation option: otherwise healthy children observed of antibacterial therapy with symptomatic relief measures, e.g. analgesia, with follow-up ensured either by family-initiated visit or phone call, scheduled follow-up appointment, phone follow-up, or antibiotic prescription filled by the family if symptoms persist or worsen; antibacterial therapy if symptoms persist 48-72 hours or worsen

The decision to use antibiotics at the time of initial diagnosis of AOM depends on the patient’s age, whether AOM is unilateral or bilateral, the severity of symptoms, and whether otorrhea is present. These issues are listed below.

The decision to treat AOM with antibiotics at the time of diagnosis OR to observe with close follow up (and treatment for persistent symtoms / signs) should include:

  • Parental / caregiver input for shared decision making.

  • Ability to clinically assess patients in follow up for improvement or worsening.

  • Understanding that children under 6 months of age, children with bilateral AOM, and children with AOM causing otorrhea should be treated with antbiotics at the time of diagnosis.

  • Understanding that children with severe symptoms, such as prolonged or severe pain, or high fever should be treated with antibiotics at the time of diagnosis.

  • Understanding the controversies about the need to use antibiotics initially in chidren between the ages of 6 and 24 months, who have AOM with mild or moderate symptoms.

If antibiotic therapy is selected for treatment of a child with AOM, the AAP 2013 Guidelines recommend:

  • First-line treatment: High dose amoxicillin (80-90mg/kg/day), with consideration of amoxicillin-clavulanate (amoxicillin 90 mg/kg/day-clavulanate 6.4mg/kg/day) for children who have received amoxicillin in the previous 30 days or who have the otitis-conjunctivitis syndrome.

  • Alternatives for penicillin allergic patients, include cephalosporins such as cefnidir or cefuroxime.

  • Antibiotic treatment for children with apparent treatment failure of initial antibiotic therapy after 48-72 hours include amoxicillin-clavulanate or ceftriaxone IM (three daily injections).

  • Alternative treatments for children who fail initial therapy, include ceftriaxone IM, combined therapy with clindamycin and a third-generation cephalosporin.

  • Tympanocentesis/myringotomy can be performed for treatment failures to obtain cultures to direct antimicrobial therapy.

Recurrent AOM (rAOM)

  • Some children diagnosed with AOM have a history recurrent AOM (rAOM) as previously defined.

  • Prophylactic or suppressive antibiotics are not recommended for children with rAOM. RCTs suggest that long-term antibiotics will decrease the episodes of AOM by only 0.09 episodes per month.

  • Tympanostomy tube placement has been used to prevent rAOM in some children. The benefits of tube placement for prevention of AOM episodes are small. A recent guideline on the use of tympanostomy tubes in children has recommended: 1) Otherwise healthy children with a history of rAOM who have normal ear examination at the time of assessment for tubes should NOT have tympanostomy tubes placed and 2) Otherwise healthy children with a history of rAOM who have middle ear effusions in one or both ears at the time of assessment can be offered tympanostomy tubes. This reflects the small benefit of tubes for rAOM, the favorable natural history of rAOM in children, and the uncertainties in diagnosis of AOM in general.

AOM with an indwelling tympanostomy tube will present with otorrhea

  • A recent guideline from the American Academy of Otolaryngology-Head and Neck Surgery strongly recommends use of ototopical antibiotic drops, and NOT oral antibiotics, for acute tube otorrhea. Antibiotic drops are effective and have fewer adverse reactions.

  • Systemic oral antibiotics can be considered for tube otorrhea in the following circumstances: persistent otorrhea despite treatment with drops, impaired delivery of drops by an obstructed ear canal or an uncooperative child, contralateral otitis media behind an intact TM, and concern for more severe disease (severe symptoms, immune compromise, other site of bacterial infection, etc.).

What are the adverse effects associated with each treatment option?

Various adverse effects with the use of antibacterial therapy for AOM have been reported dependent on the specific antibiotic, including:

  • Gastrointestinal: stomatitis, taste perversion, vomiting, abdominal pain, abdominal discomfort, abdominal distension, gastrointestinal distress, diarrhea, abnormal stool, constipation 

  • Dermatologic: rash, urticaria, erythema multiforme, moniliasis, pruritis, sweating

  • Respiratory: respiratory disorder, cough

  • Neurologic: headache, dizziness, otalgia, nervousness, somnolence, burning, crying, pain

  • Otolaryngologic: ear discomfort, ear irritation, ear discharge, ear debris, ear precipitate, eardrum edema, eardrum hyperemia, ear pruritis, tinnitus, rhinitis

  • Systemic: fever


The risks associated with antibiotic therapy depend on the specific antibiotic, but the evidence is incomplete. Based on the available literature, the following significant differences in antibiotic risks were identified:

  • With amoxicillin therapy 3 to 10 children out of 100 with uncomplicated AOM will develop a rash and 5 to 10 will develop diarrhea

  • Amoxicillin (14%) is associated with a lower rate of diarrhea than cefixime (21%)

  • Amoxicillin-clavulanate (20%) is associated with a higher rate of diarrhea than single-dose ceftriaxone (9%)

  • Amoxicillin-clavulanate (26%) is associated with a higher rate of any adverse event compared with 5 days of azithromycin (9%)

The adverse effects of tympanostomy tube placement, include adverse reaction to anesthetic agents, need for repeated tube placement, otorrhea, persistent tympanic membrane perforation, and long-term TM changes such as retraction/tympanosclerosis.

  • The risks of anesthesia in an otherwise healthy child is remote

  • The need for replacement of tympanostomy tubes post-extrusion can approach 25%

  • Tympanosclerosis has been seen in 32% of patients followed long-term after tube placement

  • TM perforation can occur in 2-18% of patients after tube extrusion, depending on the type of tube used and clinical circumstances

What are the possible outcomes of acute otitis media?

Prognosis: approximately 80 children out of 100 with uncomplicated AOM will get better in 3 days without antibiotics, while with immediate treatment with amoxicillin an additional 12 children would improve.

Two recent studies suggest that children 6-23 and 6-35 months of age respectively, with AOM, may have greater benefit with antibacterial therapy than placebo.  These RCTs used amoxicillin-clavulanate in the treatment arms and had strict criteria for diagnosis of AOM.

While resolution of AOM is the rule, some children will:

  • Develop intracranial or intratemporal suppurative complications (see below)

  • Experience recurrent AOM

  • Fail to clear middle ear effusion and develop OME with possible associated conductive hearing loss

What causes this disease and how frequent is it?

AOM is a viral or bacterial infection of the middle ear and is one of the most common childhood infections treated with antibiotics in the United States.

In a study done in 1991-1994, that followed children through the first 6 months of life, 39% of infants0 had an episode of AOM and 20% had recurrent otitis media (ROM) by 6 months of age.  Eight million, eight hundred thousand children (11.8%) under the age of 18 years were reported to have ear infections in the United States inn 2006, with an estimated total treatment cost of $2.8 billion.

Bacterial pathogens found in middle ear effusions of children with AOM include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Since the introduction of heptavalent pneumococcal conjugate vaccine non-type b H. influenzae has become more prevalent as a cause of AOM, though S. pneumoniae remains an important etiologic agent with a greater proportion of episodes caused by non-vaccine serotypes. The 13-valent pneumococcal vaccine was licensed in 2010, and may additonally shift the microbiology of AOM.

How do these pathogens/genes/exposures cause the disease?

Viral upper respiratory infections can cause functional impairment of Eustachian tube function, leading to middle ear effusion and bacterial infection.

Children with craniofacial defects affecting the Eustachian tube and the middle ear, such as children with Down Syndrome or cleft palate, and children with immunodeficiencies are predisposed to infection of the middle ear by these pathogens. One twin study found genetic predisposition for time with middle ear effusion and frequency of AOM.

What complications might you expect from the disease or treatment of the disease?

Serious complications of AOM are rare and include:

  • Systemic complications, such as bacteremia

  • Intratemporal complications, such as facial nerve paralysis, mastoiditis, lateral sinus thrombosis, labyrinthitis

  • Intracranial complications, such as meningitis, brain abscess, otitic hydrocephalus

AOM may cause a TM perforation, but healing is the rule with appropriate therapy for AOM. Other complications include hearing loss, tympanosclerosis, middle ear atelectasis, and cholesteatoma, when AOM is severe, recurrent, or accompanied by long-term Eustachian tube dysfunction.

The adverse effects of medical and surgical treatment of AOM are discussed in prior sections.

How can acute otitis media be prevented?

A variety of measures have been reported to reduce the frequency of AOM in childhood. They include the following: 


  • Influenza vaccines had more than 30% efficacy in AOM prevention in children older than 2 years.

  • The heptavalent pneumococcal conjugate vaccine was associated with an efficacy in preventing AOM from all causes of 5.8% and 8.3%.  A decrease in OM visits in children older than 2 years of age was associated with the introduction of the 13-valent pnuemococcal vaccine in 2010.

Behavioral factors:

  • Reduction or elimination of pacifier use in the second 6 months of life is postulated to reduce AOM in infancy.

Nutritional factors:

  • Breastfeeding for the first 6 months helps prevent early episodes of AOM.

  • Avoidance of supine bottle feeding is postulated to reduce AOM in infancy.

Environmental factors:

  • Alteration of child care center attendance patterns can reduce recurrent AOM incidence.

  • Elimination of exposure to tobacco smoke is postulated to reduce AOM in infancy.

What is the evidence?

Lieberthal, AS, Carroll, AE, Chonmaitree, T, Ganiats, TG. “The diagnosis and treatment of acute otitis media”. Pediatrics. vol. 131. 2013. pp. e964-999. (Updated clinical practice guideline on AOM from the American Academy of Pediatrics.)

Marom, T, Tan, A, Wilkinson, GS, Pierson, KS, Freeman, JL, Chonmaitree, T. “Trends in otitis media related health care use in the United States, 2001-2011”. JAMA Pediatr. vol. 168. 2014. pp. 68-75. (Analysis of an insurance claims database demonstrates a downward trend in OM-related healthcare use over the study period, with a decrease in OM-related use in children under 2 years associated with introduction of Prevnar-13.)

Rosenfeld, RM, Schwartz, SR, Pynonnen, MA, Tunkel, DE. “Clinical practice guideline: tympanostomy tubes in children”. Otolaryngol Head Neck Surg. vol. 149. 2013. pp. S-35. (AAOHNS published this guideline about evaluation and indications for tympanostomy tubes and after care for children with indwelling tubes.)

Rettig, E, Tunkel, DE. “Contemporary concepts in management of acute otitis media in children”. Otolaryngol Clin North Am. vol. ; 47. 2014. pp. 651-772. (Review of trends in AOM management based on recent evidenced based guidelines.)

“American Academy of Pediatrics and American Academy of Family Physicians. Diagnosis and management of acute otitis media”. Pediatrics. vol. 113. 2004. pp. 1451-1465. (The AAP and AAFP published this consensus guideline on diagnosis and management of AOM based on the best evidence available through September 2003 and addressed issues related to diagnosis; pain assessment; management with and without antibiotics; prevention; and complementary and alternative medicine. This guideline advanced the concept of initial observation before antibiotic therapy for some with AOM.)

Shekelle, PG, Takata, G, Newberry, SJ, Coker, T, Limbos, M, Chan, LS. “Management of Acute Otitis Media: Update. Evidence Report/Technology Assessment No. 198. (Prepared by the Southern California Evidence-Based Practice Center under Contract No. 290 2007 10056 I)”. November 2010.

Coker, TR, Chan, LS, Newberry, SJ, Limbos, MA, Suttorp, MJ, Shekelle, PG, Takata, GS. “Diagnosis, microbial epidemiology, and antibiotic treatment of acute otitis media in children”. JAMA. vol. 304. 2010 Nov 17. pp. 2161-2169. (The technical report describes in detail and the article summarizes the systematic review requested by the AAP to serve as the evidence base for the AAP's update of the 2004 AAP/AAFP consensus guideline on diagnosis and management of AOM and addresses issues related to diagnosis; epidemiology; and management with and without antibiotics.)

Hoberman, A, Paradise, JL, Rockette, HE, Shaikh, N, Wald, ER, Kearney, DH. “Treatment of acute otitis media in children under 2 years of age”. N Engl J Med. vol. 364. 2011. pp. 105-15.

Tahtinen, PA, Laine, MK, Huovinen, P, Jalava, J, Ruuskanen, O, Ruohola, A. “A placebo-controlled trial of antimicrobial treatment for acute otitis media”. N Engl J Med. vol. 364. 2011. pp. 116-26.

The Hoberman and Tahtinen studies show small benefits of amoxicillin-clavulanate therapy for young children with AOM.

Ongoing controversies regarding etiology, diagnosis, treatment 

  • The 2013 AAP AOM guideline eliminated the “uncertain diagnosis” category contained in the 2004 AOM guideline. This brings to light difficulties in accurate diagnosis of AOM in a “real world” clinical setting, requiring experience with cerumen management and pneumatic otoscopy in young children.

  • Debate continues about initial observation, versus immediate antibiotics at the time of diagnosis for some children with AOM. Two recent studies referenced above showed measureable benefits for active treatment with antibiotics, but the clinical relevance of these benefits are debated in the background of favorable natural history of AOM, side effects of antibiotic therapy, and the concerns about bacterial resistance from widespread use of antibiotics.

  • The role of tympanostomy tubes for recurrent AOM is debated, as the impact is small, with some cost and risk. The benefits of tympanostomy tubes are more plausible in children with OME and hearing loss from middle ear effusion, and for children who have sensory, cognitive, or craniofacial/syndromic issues that put them at risk for the effects of prolonged middle ear disease.

Originally written by Drs. Glenn Takata and David Tunkel. Revised by Drs. Eleni Rettig and David Tunkel.

Table II.
At Diagnosis for Initial Antibacterial Therapy Observation Option Clinical Failure at 48-72 Hours Antibacterial Therapy Clinical Failure at 48-72 Hours
>=39°C and/or Severe Otalgia Recommended Penicillin Allergy Recommended Penicillin Allergy Recommended Penicillin Allergy
No Amoxicillin, 80-90 mg/kg per day Non-type 1: cefdinir, cefuroxime, cefpodoxime
type 1: azithromycin, clarithromycin
Amoxicillin, 80-90 mg/kg per day Non-type 1: cefdinir, cefuroxime, cefpodoxime
type 1: azithromycin, clarithromycin
Amoxicillin-clavulanate, 90 mg/kg per day of amoxicillin with 6/4 mg/kg per day of clavulanate Non-type 1: ceftriaxone, 3 days
type 1: clindamycin
Yes Amoxicillin-clavulanate, 90 mg/kg per day of amoxicillin with 6/4 mg/kg per day of clavulanate Ceftriaxone, 1 or 3 days Amoxicillin-clavulanate, 90 mg/kg per day of amoxicillin with 6/4 mg/kg per day of clavulanate Ceftriaxone, 1 or 3 days Ceftriaxone, 1 or 3 days Tympanocentesis, clindamycin