• Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for medical management of otitis media with effusion in children 2 months to 13 years of age. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2004 Oct. 11 p. [67 references]

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence-based clinical practice guideline for medical management of otitis media in children 2 months to 6 years of age. Cincinnati (OH): Children's Hospital Medical Center (CHMC); 1999. 8 p.

Each recommendation is followed by evidence grades (A-X) identifying the type of supporting evidence. Definitions for the types of evidence are presented at the end of the "Major Recommendations" field.

Assessment and Diagnosis

General

Signs and symptoms of otitis media with effusion (OME) are often only identified upon follow-up to acute otitis media (AOM) or at an unrelated office visit.

History and Physical Examination

1. It is recommended that a focused history and physical of the child with OME includes assessment and documentation of:
   • Intermittent ear pain, fullness, or popping
   • Hearing/speech concerns (Roberts, Rosenfeld, & Zeisel, 2004 [M])
   • Balance (Golz, Angel-Yaeger, & Parush, 1998 [C]; Casselbrant et al.,1995 [C])
   • Bilaterality
   • Duration of effusion
   • Recurrent AOM
   • Presence of any craniofacial anomalies (American Academy of Family Physicians [AAFP], American Academy of Otolaryngology-Head and Neck Surgery [AAO-HNS], American Academy of Pediatrics [AAP] Subcommittee on Otitis Media with Effusion, 2004 [S])
2. It is recommended that OME be diagnosed by the presence of middle ear effusion (MEE), as assessed by pneumatic otoscopy, without signs and symptoms of acute inflammation (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]).

   Note: Adequate illumination for OME diagnosis requires appropriate maintenance of pneumatic otoscopes in the office, including changing the light bulb and battery (Barriga, Schwartz, & Hayden, 1986 [O]).

3. It is recommended that tympanometry may be used to enhance accuracy when diagnosing OME (Karma et al., 1989 [D]; Shekelle et al., 2003 [S]; Brookhouser, 1998 [S]; Jones and Kaleida, 2003 [O]; Pichichero, 2002 [O]; Pichichero & Poole, 2001 [O]).

   Note 1: Pneumatic otoscopy and tympanometry measure the degree of mobility of tympanic membrane as an indication of the presence of MEE (Palmu et al., 1999 [C]; van Balen, Aarts, & De Melker, 1999 [C]; Jerger, 1970 [C]; Jones and Kaleida, 2003 [O]; Pichichero, 2002 [O]; Barriga, Schwartz, & Hayden, 1986 [O]).

   Note 2: Acoustic reflectometry is not often used nor readily available in the Cincinnati area, though the procedure is acceptable for determining the presence of MEE (Block et al., 1999 [C]; Barnett et al., 1998 [C]; Block et al., 1998 [C]; Kimball, 1998 [S]).

4. It is recommended that the child with OME who is at risk for developmental difficulties be identified early. These children include those with sensory, physical, cognitive, or behavioral factors listed in the table below (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]).

   Note: Children with Down syndrome (Shott, Joseph, & Heithaus, 2001 [C]; Whiteman, Simpson, & Compton, 1986 [C]), cranial facial dysostosis (Corey, Caldarelli, & Gould, 1987 [C]), cleft palate (Paradise & Bluestone, 1974 [C]) and autism (Rosenhall et al., 1999 [C]) have been shown to be at higher risk for OME and/or its associated outcomes of developmental delay in hearing, speech or language.

   Table: Risk Factors for Developmental Difficulties (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S])

   Permanent hearing loss independent of OME

   Suspected or diagnosed speech and language delay or disorder

   Autism-spectrum disorder and other pervasive developmental disorders

   Syndromes (e.g., Down) or craniofacial disorders that include cognitive, speech, and language delays

   Blindness or uncorrectable visual impairment

   Cleft palate with or without associated syndrome

   Developmental delay

   Management

   The foundation of OME management is follow-up and monitoring of the presence or resolution of effusion. This monitoring is clinically important for the early identification of the child at risk for developmental difficulties and for the appropriate timing for referral of the child with persistent OME.

   1. It is recommended that observation without antibiotics be the first line management option for at least 3 months for the child with OME (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]).

      Note: Data on spontaneous resolution rates in the literature are extremely variable, but generally range from 20 to 80% by 3 months. Inclusion criteria, resolution criteria, duration of diagnosis, month of diagnosis, and transient improvement followed by relapse contribute to the reported variability (Rosenfeld & Kay, 2003 [M]).

   2. It is recommended that all children with OME who have a positive assessment for pain be treated with an appropriate analgesic, though ear pain in OME is not common (AAP Subcommittee on Management of Acute Otitis Media, 2004 [S]; The assessment and management of acute pain, 2001 [S]).
   3. It is recommended, for the otherwise healthy child with persistent OME, that no medication be given (Williamson, 2002 [S]).

      Note 1: Meta-analyses reviewing the benefit of antibiotics for persistent OME have been equivocal. One review published prior to current concern for judicious use of antibiotics found short-term benefit (Rosenfeld & Post, 1992 [M]). A more recent review raised questions about selection bias and concluded studies do not support the use of antibiotics for OME (Cantekin & McGuire, 1998 [M]).

      Note 2: A small randomized controlled trial demonstrated more rapid improvement in a nasal beclomethasone intervention group as compared to controls over a 12 week treatment period. Both groups were treated with antibiotics (Tracy et al., 1998 [B]).

      Note 3: Two weeks of systemic steroid therapy demonstrated better resolution of effusion at the end of therapy as compared to a control group (p = 0.03). However, two weeks after finishing treatment there was no difference between groups (p = 0.12) (Mandel et al., 2002 [A]).

   4. It is recommended that the child with OME who is at risk for developmental difficulties (see table above entitled "Risk Factors for Developmental Difficulties") be aggressively managed as appropriate to his/her condition. This individualized management may include:
      • Earlier referral for audiologic evaluation (Friel-Patti & Finitzo, 1990 [C]; Carney & Moeller, 1998 [S])
      • Shorter intervals between visits
      • Antibiotic therapy
      • Referral for speech/language assessment
      • Referral for pressure equalization (PE) tubes, and/or
      • Referral for other otolaryngological evaluation

        Note 1: A 5-year study of 48 children with Down syndrome found that the previously reported incidence of 38 to 78% hearing loss in children with Down syndrome can be reduced to 3% with aggressive management of otitis media (Shott, Joseph, & Heithaus, 2001 [C]).

        Note 2: Preventive strategies may be helpful to children with special populations, from poor socioeconomic environments, or with development delays who are at risk for language and learning delay and who are experiencing hearing loss due to OME (Roberts et al., 2003 [M], 1998 [C], 1995 [C]; Roberts, Burchinel, & Zeisel, 2002 [C]). See table below:

   Table: Strategies for Optimizing the Listening-Learning Environment for Children with OME and Hearing Loss (Roberts, Rosenfeld, & Zeisel, 2004 [M]; (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S])

   Get within 3 feet of the child before speaking

   Turn off competing audio signals such as unnecessary music and television in the background

   Face the child and speak clearly, using visual clues (hands, pictures) in addition to speech

   Slow the rate, raise the level, and enunciate speech directed at the child

   Read to or with the child, explaining pictures and asking questions

   Repeat words, phrases, and questions when misunderstood

   Assign preferential seating in the classroom near the teacher

   Use a frequency-modulated (FM) personal- or sound-field amplification system in the classroom

   5. It is recommended that the otherwise healthy child with OME be evaluated at 1 to 2 months after diagnosis and then again at 3 months after diagnosis, or until either spontaneous, medical, or surgical resolution of the effusion is achieved or until basis for a referral is identified (See Consults and Referrals section below) (Paradise et al., Otitis media, 2003 [A], Early versus delayed insertion, 2003 [A], 2001 [A]; AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]; Paradise, 2002 [X]).
   6. It is not recommended that other therapies be used in the treatment of OME.

      Systemic steroids, antihistamines, decongestants, and complementary or alternative treatments have not been documented to be efficacious in the treatment of OME, and some herbal preparations may have harmful side effects (Ernst, 2003 [M]; Mandel et al., 1987 [A]; Harrison, Fixsen, & Vickers, 1999 [B]; Fallon, 1997 [C]; Williamson, 2002 [S]; Miller et al., 2000 [S]).

      Note: It is recognized that use of complementary and alternative medicine (CAM) is common and its use is often not reported to the primary care physician (Eisenberg et al., 1998 [O]; Spigelblatt et al., 1994 [O]). The physician may take the OME visit as an opportunity to begin a respectful discussion regarding the safety and efficacy of complementary and alternative medicine with families who report its use.

   Consults and Referrals

   Evaluation for placement of pressure-equalizing (PE) tubes is the most common reason children with OME are referred to an otolaryngologist. The discussion of alternatives, risks, benefits, and expected outcomes associated with tube placement begins with the primary care clinician and is continued with the otolaryngologist if the patient is referred.

   Reestablishing ventilation to the middle ear by tube placement may be helpful for the following reasons:

   • To decrease the frequency of recurrent AOM for families burdened by repeated infections or in cases affected by antibiotic resistance
   • To maximize hearing potential for children at risk for poor school performance, behavior problems, or speech/language delay
   • To prevent chronic changes to the tympanic membrane (TM) or to the middle ear space
   • To prevent or treat acute complications of AOM

   Delaying insertion of tube placement will allow many cases to resolve spontaneously and may be elected for the following reasons:

   • To delay or avoid surgery and anesthesia
   • To decrease risk of TM abnormalities caused by surgery
   • To reduce unnecessary use of resources
   1. It is recommended that a child be referred for audiologic evaluation (see table below entitled "Hearing Loss Definitions and Expected Auditory Behaviors in Children with OME"):
      • If OME persists for at least 3 months
      • If concerns are noted for hearing, speech, or language, by parents, teachers, or healthcare providers, or
      • 3 months after a prior audiologic evaluation in a child being observed with OME

      (Johnston et al., 2004 [A]; Brody et al., 1999 [C]; Rosenfeld, Goldsmith, & Madell, 1998 [C]; AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]; Local Expert Consensus [E])

      Table: Hearing Loss Definitions and Expected Auditory Behaviors in Children with OME

      Level of Hearing Loss/Hearing Levels (decibels [dB])
      Moderate/>40 Communication, learning, and socialization significantly affected Understands conversational speech only within a distance of 3 to 5 feet (face-to-face)
      Mild/26 to 39 Has difficulty with selective hearing and background noise Has significant difficulty with faint or distant speakers May mimic attention problems
      Normal to Slight/<25 May exhibit fatigue due to listening effort May have difficulty with faint or distant speakers

      Adapted from (Martin & Clark, 1996 [S]; Anderson & Matkin, 1991 [S])

   2. It is recommended that an introduction and a discussion be initiated by the primary care clinician with the parents of children with documented OME of the procedure, alternatives, risks, benefits, and expected outcomes of PE tube insertion being considered for otolaryngological referral (Local Expert Consensus [E]).

      Note: It has been shown that insertion of tympanostomy tubes will reduce the total amount of time with effusions that a child will experience, but has not been shown to affect important speech/language development, behavior, or cognitive outcomes up to 4 years of age. Furthermore, prompt insertion of PE tubes (compared to delaying insertion 6 to 9 months) in otherwise healthy children with persistent (>3 months) OME in the first 3 years of life results in increased TM abnormalities compared to children selectively managed; however, this finding is of questionable clinical significance (Johnston et al., 2004 [A]; Paradise et al., 2001 [A]).

   3. It is recommended that a child with MEE of at least 3 months duration be referred for evaluation for PE tube insertion for:
      • Recurrent AOM (history of 6 episodes over a 12 month period taking into account the severity of episodes, clustering of episodes, and persistence of OME)
      • Moderate hearing loss (see table above titled Hearing Loss Definitions and Expected Auditory Behaviors in Children with OME)
      • Anatomic changes developing secondary to OME or AOM
      • Clinical symptoms of severe retraction pockets in the tympanic membrane; otalgia; tinnitus; or if neurologic problems related to balance are evident
      • Complications from AOM or chronic OME (such as mastoiditis, facial nerve paralysis, disturbance in balance, or meningitis) (Paradise et al., 2001 [A]; Engel-Yeger, Golz, & Parush, 2004 [C]; Paradise, 2002 [X]).
   4. It is recommended that a child with MEE for at least 3 months duration with mild hearing loss (see table above entitled "Hearing Loss Definitions and Expected Auditory Behaviors in Children with OME") be considered for evaluation for PE tube insertion based upon risk factors (Teele, Klein, & Rosner, 1989 [C]) which may include:
      • Developmental disorders (Shott, Joseph, & Heithaus, 2001 [C])
      • Previous PE tubes
      • Sibling history of ear infection
      • Male gender
      • Fall and winter season (Gordon, Grunstein, & Burton, 2004 [C])

        Note 1: Regardless of the laterality, continuity of OME, or degree of hearing loss (pure tone average loss of up to 40 decibels), delay of tube insertion for 6 to 9 months in children <3 years of age in one large randomized controlled trial did not result in significant differences, up to age 4, on any measure of speech, language production, cognition, child behavior, or parental stress (Paradise et al., Otitis media, 2003 [A], Early versus delayed insertion, 2003 [A], 2001 [A]).

        Note 2: The decision to refer earlier or later for evaluation for PE tube insertion rests on the advantages of avoiding surgery due to resolution of OME during the period of delay versus the added advantage the surgery provides by being performed sooner rather than later in the cases which do not resolve. The value placed on these uncertain variables by clinicians, combined with the patient biology and family preferences may result in different decisions for different patient:clinician dyads.

        Note 3: In a large randomized controlled trial, in the group randomized to delay tube insertion for 6 to 9 months, 66% did not receive tubes by age 3 (Paradise et al., 2001 [A]). Secondary analysis of observational studies have shown the spontaneous rate of clinical resolution of OME to be 31% at 12 months (95% confidence interval [CI]: 0.19, 0.43) (Rosenfeld & Kay, 2003 [M]).

   5. It is recommended that a child with signs of speech delay be referred for a speech and language evaluation (AAFP, AAO-HNS, AAP Subcommittee on Otitis Media with Effusion, 2004 [S]).
   6. It is recommended that appropriate and complete documentation, including what is expected from the specialist, accompany referrals to otolaryngologist, audiologist, or speech pathologist (Kuyvenhoven & De Melker, 1990 [D]; AAP Subcommittee on Management of Acute Otitis Media, 2004 [S]).

   Education

   1. It is recommended that the family be counseled regarding the expected length of time the child may continue to have OME as well as the importance of follow-up for unresolved OME.
   2. It is recommended that the family be educated about preventable risk factors. These include:
      • Parental smoking or other sources of second-hand smoke (Uhari, Mantysaari, & Niemela, 1996 [M]; Ilicali et al., 1999 [C])
      • Exposure to others (especially family members) with upper respiratory infections (Uhari, Mantysaari, & Niemela, 1996 [M])
      • Excessive pacifier use, limiting use to when the child is falling asleep (Uhari, Mantysaari, & Niemela, 1996 [M]; Niemela et al., 2000 [A])
   3. It is recommended that the family of the child at risk for speech or language delay be educated regarding preventive strategies. See table above entitled "Strategies for Optimizing the Listening-Learning Environment for Children with OME and Hearing Loss."

   Definitions:

   Evidence Based Grading Scale:

   A: Randomized controlled trial: large sample
   B: Randomized controlled trial: small sample
   C: Prospective trial or large case series
   D: Retrospective analysis
   E: Expert opinion or consensus
   F: Basic laboratory research
   S: Review article
   M: Meta-analysis
   Q: Decision analysis
   L: Legal requirement
   O: Other evidence
   X: No evidence

An algorithm is provided in the original guideline document for the evaluation and management of otitis media with effusion (OME) in children 2 months to 13 years of age.

The type of evidence is identified and classified for each recommendation (see "Major Recommendations").

Evidence Based Grading Scale:

A: Randomized controlled trial: large sample
B: Randomized controlled trial: small sample
C: Prospective trial or large case series
D: Retrospective analysis
E: Expert opinion or consensus
F: Basic laboratory research
S: Review article
M: Meta-analysis
Q: Decision analysis
L: Legal requirement
O: Other evidence
X: No evidence

• Cincinnati Children's Hospital Medical Center. Evidence based clinical practice guideline for medical management of otitis media with effusion in children 2 months to 13 years of age. Cincinnati (OH): Cincinnati Children's Hospital Medical Center; 2004 Oct. 11 p. [67 references]

Not applicable: The guideline was not adapted from another source.

1999 (revised 2004 Oct)

Cincinnati Children's Hospital Medical Center - Hospital/Medical Center

Cincinnati Children's Hospital Medical Center

Otitis Media with Effusion Team Members 2004

Community Physicians: Stephen Pleatman, MD, Chair; Robert Siegel, MD

CCHMC Physicians and Practitioners: Kieran Phelan, MD (General Pediatrics); Mike Rutter, MD (Otolaryngology); Paul Willging, MD (Otolaryngology); Karen Zur, MD (Otolaryngology); Susan Wiley, MD (Developmental Disabilities); Stephanie Kennebeck, MD (Emergency Medicine); Rebecca Brady, MD (Infectious Diseases)

Residents: Elena Huang, MD, Chief; Derek Fletcher, MD; Sharlene Matthieu, MD

Patient Services: Michelle Widecan, RN, MSN, CPNP (Emergency Dept); Gayle Riemer, MA CCC-A (Audiology); Dawn Butler, PharmD (Pharmacy)

Parent Advisors: Melissa Kennedy; Lisa Bohman

Division of Health Policy Clinical Effectiveness Support: Eloise Clark, MPH (Facilitator); Angela Booth-Jones, PhD, MS (Sen. Outcomes Coordinator); Danette Stanko, MA, MPH (Epidemiologist); Pam Schoettker, MS, (Medical Writer); Judy Bush, RN (Education Coordinator); Kate Rich (Lead Decision Support Analyst); Carol Frese, RN (Medical Reviewer); Ed Donovan, MD (Clinical Effectiveness); Uma Kotagal, MBBS, MSc (VP, Division Director); Ed Mendez, RN, MPH (Dir. Evidence Based Practice)

All Team Members and Clinical Effectiveness support staff listed above have signed a conflict of interest declaration.

Ad hoc Advisors: Robin Cotton, MD (Otolaryngology, Director); Chris Cunha, MD (Community Pediatrician); Bridgitt C. Pauly MS CCC-SLP/A (Speech Pathology); Keith Mandel, MD (PHO); Paula Parker (Parent Advisor); Alison Moncayo (Resident); Michael Farrell, MD (Chief of Staff); Richard Ruddy, MD (Emergency Medicine, Director); Tom DeWitt, MD (Gen. & Community Pediatrics, Director); Mel Rutherford, Esq (VP, Legal Services); Dorine Sequist, RN (VP, Patient Services); Barbarie Hill (Pratt Library); Kim Collins (Medical Education)

The guideline was developed without external funding. All Team Members and Clinical Effectiveness support staff listed have signed a conflict of interest declaration.

This is the current release of the guideline.

This guideline updates a previous version: Cincinnati Children's Hospital Medical Center. Evidence-based clinical practice guideline for medical management of otitis media in children 2 months to 6 years of age. Cincinnati (OH): Children's Hospital Medical Center (CHMC); 1999. 8 p.

This summary was completed by ECRI on September 20, 1999. The information was verified by the guideline developer as of November 15, 1999. This NGC summary was updated by ECRI on December 7, 2004. The information was verified by the guideline developer on January 12, 2005.