Watchful waiting
Clinicians should manage OME in a child who is not at risk of developmental sequelae with watchful waiting for 3 months (from the date of onset of effusion, if known, or else from the date of diagnosis).[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
Children who have the following conditions are considered to be at risk of developmental sequelae as a result of OME:[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Permanent non-OME related hearing loss
Speech and language delay or disorder
Autism-spectrum disorder
Genetic syndromes or craniofacial disorders associated with cognitive or language delays
Blindness or uncorrectable visual impairment
Cleft palate
Developmental delay
Intellectual disability, learning disorders, or attention deficit/hyperactivity disorder.
OME is common in childhood and most cases resolve spontaneously within 3 months.[69]Tos M. Epidemiology and spontaneous improvement of secretory otitis. Acta Otorhinolaryngol Belg. 1983;37(1):31-43.
http://www.ncbi.nlm.nih.gov/pubmed/6684381?tool=bestpractice.com
OME related to acute otitis media (AOM) has a high rate of spontaneous resolution, with 90% resolving by 3 months.[70]Teele DW, Klein JO, Rosner BA. Epidemiology of otitis media in children. Ann Otol Rhinol Laryngol Suppl. 1980 May-Jun;89(3 pt 2):5-6.
http://www.ncbi.nlm.nih.gov/pubmed/6778349?tool=bestpractice.com
OME that is not preceded by AOM has a resolution rate of 28% to 52% within 3-4 months of diagnosis.[71]Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope. 2003 Oct;113(10):1645-57.
https://onlinelibrary.wiley.com/doi/full/10.1097/00005537-200310000-00004
http://www.ncbi.nlm.nih.gov/pubmed/14520089?tool=bestpractice.com
[72]Williamson IG, Dunleavey J, Bain J, et al. The natural history of otitis media with effusion-a three-year study of the incidence and prevalence of abnormal tympanograms in four South West Hampshire infant and first schools. J Laryngol Otol. 1994 Nov;108(11):930-4.
http://www.ncbi.nlm.nih.gov/pubmed/7829943?tool=bestpractice.com
However, 30% to 40% of children in whom OME spontaneously clears will have repeated episodes of OME.[73]Stool SE, Berg AO, Berman S, et al. Otitis media with effusion in young children: clinical practice guideline no. 12. Rockville, MD: Agency for Healthcare Research and Quality; 1994. AHCPR publication 94-0622.[74]Tos M. Epidemiology and natural history of secretory otitis. Am J Otol. 1984 Oct;5(6):459-62.[72]Williamson IG, Dunleavey J, Bain J, et al. The natural history of otitis media with effusion-a three-year study of the incidence and prevalence of abnormal tympanograms in four South West Hampshire infant and first schools. J Laryngol Otol. 1994 Nov;108(11):930-4.
http://www.ncbi.nlm.nih.gov/pubmed/7829943?tool=bestpractice.com
[71]Rosenfeld RM, Kay D. Natural history of untreated otitis media. Laryngoscope. 2003 Oct;113(10):1645-57.
https://onlinelibrary.wiley.com/doi/full/10.1097/00005537-200310000-00004
http://www.ncbi.nlm.nih.gov/pubmed/14520089?tool=bestpractice.com
Adults with OME have similar rates of spontaneous resolution to that of children, especially if the effusion is associated with an upper respiratory tract infection.[75]Mills R, Vaughan-Jones R. A prospective study of otitis media with effusion in adults and children. Clin Otolaryngol Allied Sci. 1992 Jun;17(3):271-4.
http://www.ncbi.nlm.nih.gov/pubmed/1505097?tool=bestpractice.com
As such, watchful waiting is an acceptable option for patients with a first-time diagnosis of OME. However, keep a high index of suspicion in adults with persistent OME, especially if unilateral, to evaluate for nasopharyngeal carcinoma.
Patients with OME undergoing a watchful waiting approach should be reassessed every 3-6 months with otoscopy and audiologic testing.[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
See Monitoring.
Oral and nasal corticosteroids
Oral and nasal corticosteroids are not recommended for the treatment of OME.[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[1]Simon F, Haggard M, Rosenfeld RM, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1s):S33-9.
https://www.sciencedirect.com/science/article/pii/S187972961830005X
http://www.ncbi.nlm.nih.gov/pubmed/29398506?tool=bestpractice.com
The presence of nasal and nasopharyngeal inflammation may contribute to Eustachian tube dysfunction and subsequently OME. As such, anti-inflammatory treatment in the form of intranasal and systemic corticosteroids have been investigated for OME. One Cochrane review including 12 studies with a total of 945 participants (mainly children up to age 12 years) found that treatment with oral steroids and antibiotics was beneficial for 'a quicker resolution of OME in the short term' compared to antibiotics alone.[76]Simpson SA, Lewis R, van der Voort J, et al. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD001935.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001935.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/21563132?tool=bestpractice.com
However, the trials included in this review were mostly small and of poor quality. A subsequent trial found that oral steroids (alone or followed up with intranasal steroids) led to faster resolution of OME at 6 weeks than management with watchful waiting, but there was no difference at 3 months of follow-up.[77]Hussein A, Fathy H, Amin SM, et al. Oral steroids alone or followed by intranasal steroids versus watchful waiting in the management of otitis media with effusion. J Laryngol Otol. 2017 Oct;131(10):907-13.
http://www.ncbi.nlm.nih.gov/pubmed/28807086?tool=bestpractice.com
Another trial did not find any significant differences in hearing outcomes or quality of life with oral steroid treatment for OME.[78]Francis NA, Cannings-John R, Waldron CA, et al. Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial. Lancet. 2018 Aug 18;392(10147):557-68.
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0140673618314909
http://www.ncbi.nlm.nih.gov/pubmed/30152390?tool=bestpractice.com
Intranasal steroids have also not been found to lead to significant improvements in OME resolution, hearing loss, or other OME-related symptoms.[79]Williamson I, Benge S, Barton S, et al. Topical intranasal corticosteroids in 4-11 year old children with persistent bilateral otitis media with effusion in primary care: double blind randomised placebo controlled trial. BMJ. 2009 Dec 16;339:b4984.
https://www.bmj.com/content/339/bmj.b4984.long
http://www.ncbi.nlm.nih.gov/pubmed/20015903?tool=bestpractice.com
[76]Simpson SA, Lewis R, van der Voort J, et al. Oral or topical nasal steroids for hearing loss associated with otitis media with effusion in children. Cochrane Database Syst Rev. 2011 May 11;2011(5):CD001935.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001935.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/21563132?tool=bestpractice.com
In patients with concomitant intranasal findings such as inflammation, allergy, or adenoid hypertrophy, nasal steroids may be directed at these conditions.[80]Bhargava R, Chakravarti A. A double-blind randomized placebo-controlled trial of topical intranasal mometasone furoate nasal spray in children of adenoidal hypertrophy with otitis media with effusion. Am J Otolaryngol. 2014 Nov-Dec;35(6):766-70.
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0196070914001380
http://www.ncbi.nlm.nih.gov/pubmed/25151658?tool=bestpractice.com
[81]Cengel S, Akyol MU. The role of topical nasal steroids in the treatment of children with otitis media with effusion and/or adenoid hypertrophy. Int J Pediatr Otorhinolaryngol. 2006 Apr;70(4):639-45.
http://www.ncbi.nlm.nih.gov/pubmed/16169093?tool=bestpractice.com
[82]Lack G, Caulfield H, Penagos M. The link between otitis media with effusion and allergy: a potential role for intranasal corticosteroids. Pediatr Allergy Immunol. 2011 May;22(3):258-66.
http://www.ncbi.nlm.nih.gov/pubmed/21457332?tool=bestpractice.com
Antihistamines and decongestants
Antihistamines (with or without decongestants) and montelukast are not recommended for the treatment of OME.[1]Simon F, Haggard M, Rosenfeld RM, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1s):S33-9.
https://www.sciencedirect.com/science/article/pii/S187972961830005X
http://www.ncbi.nlm.nih.gov/pubmed/29398506?tool=bestpractice.com
[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
Given the possible association between allergy and OME, antihistamines and other allergy treatments have been examined. In a Cochrane review of 16 studies of children (aged 18 and under) with a diagnosis of OME, antihistamine treatment with or without nasal decongestants was found to offer no short- or long-term benefit for the resolution of OME. There was also no evidence for improved hearing outcomes. In the groups treated with antihistamines, decongestants, or a combination of both, there was a higher rate of side-effects such as irritability, sedation, and gastrointestinal upset.[83]Griffin G, Flynn CA. Antihistamines and/or decongestants for otitis media with effusion (OME) in children. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD003423.
https://www.doi.org/10.1002/14651858.CD003423.pub3
http://www.ncbi.nlm.nih.gov/pubmed/21901683?tool=bestpractice.com
Similarly, leukotriene inhibitors such as montelukast have not been found to lead to faster OME resolution.[84]Schoem SR, Willard A, Combs JT. A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion. Ear Nose Throat J. 2010 Sep;89(9):434-7.
http://www.ncbi.nlm.nih.gov/pubmed/20859868?tool=bestpractice.com
Oral antibiotics
Oral antibiotics are not recommended for OME treatment due to the risk of side-effects and inappropriate antibiotic prescribing outweighing the benefits.[1]Simon F, Haggard M, Rosenfeld RM, et al. International consensus (ICON) on management of otitis media with effusion in children. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1s):S33-9.
https://www.sciencedirect.com/science/article/pii/S187972961830005X
http://www.ncbi.nlm.nih.gov/pubmed/29398506?tool=bestpractice.com
[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
Oral antibiotics have been investigated in the treatment of OME, as bacteria have been detected in middle ear effusions.[85]Gok U, Bulut Y, Keles E, et al. Bacteriological and PCR analysis of clinical material aspirated from otitis media with effusions. Int J Pediatr Otorhinolaryngol. 2001 Jul 30;60(1):49-54.
http://www.ncbi.nlm.nih.gov/pubmed/11434953?tool=bestpractice.com
One Cochrane review of 23 trials investigated children (age 18 years and under) with a diagnosis of unilateral or bilateral OME at time of randomization, comparing oral antibiotics with a placebo group of no treatment or a therapy of unproven effectiveness (such as antihistamines, decongestants, mucolytics, and intranasal corticosteroids). It found:[86]Venekamp RP, Burton MJ, van Dongen TM, et al. Antibiotics for otitis media with effusion in children. Cochrane Database Syst Rev. 2016 Jun 12;2016(6):CD009163.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009163.pub3/full
http://www.ncbi.nlm.nih.gov/pubmed/27290722?tool=bestpractice.com
Oral antibiotics were associated with higher rates of OME resolution at 2-3 months
Use of oral antibiotics was associated with side-effects such as diarrhea, vomiting, and skin rash.
There is no consistent evidence that the higher rates of OME resolution is associated with improved hearing or speech outcomes or long-term benefits.[87]Mandel EM, Rockette HE, Bluestone CD, et al. Efficacy of amoxicillin with and without decongestant-antihistamine for otitis media with effusion in children. Results of a double-blind, randomized trial. N Engl J Med. 1987 Feb 19;316(8):432-7.
http://www.ncbi.nlm.nih.gov/pubmed/2880294?tool=bestpractice.com
[88]Mandel EM, Rockette HE, Paradise JL, et al. Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children. Pediatr Infect Dis J. 1991 Dec;10(12):899-906.
http://www.ncbi.nlm.nih.gov/pubmed/1766705?tool=bestpractice.com
Tympanostomy tube placement
Tympanostomy tube placement with or without adenoidectomy is the recommended treatment for chronic (≥3 months) OME in children who have hearing loss, speech delay, or are at risk for speech and other developmental sequelae.[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Tympanostomy tube placement in patients with persistent OME has been associated with improved hearing and quality of life.[92]Hellström S, Groth A, Jörgensen F, et al. Ventilation tube treatment: a systematic review of the literature. Otolaryngol Head Neck Surg. 2011 Sep;145(3):383-95.
http://www.ncbi.nlm.nih.gov/pubmed/21632976?tool=bestpractice.com
Tympanostomy tube placement is recommended in children with chronic (≥3 months) bilateral OME and either documented hearing loss or speech delay.[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
For children with chronic unilateral OME or bilateral OME without documented hearing loss, tympanostomy tubes may be placed if the child is at increased risk for developmental sequelae (i.e., where persistent OME is predicted or where serious outcomes are more likely).[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Tympanostomy tube placement is also recommended in children at risk of developmental sequelae if unilateral or bilateral OME is deemed as likely to persist for more than 3 months (based on a type B tympanogram).[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Obtain a hearing test prior to surgery.[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Tympanostomy tube placement is not recommended for children with a single episode of OME of less than 3 months' duration.[2]Rosenfeld RM, Shin JJ, Schwartz SR, et al. Clinical practice guideline: otitis media with effusion (update). Otolaryngol Head Neck Surg. 2016 Feb;154(1 suppl):S1-41.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599815623467
http://www.ncbi.nlm.nih.gov/pubmed/26832942?tool=bestpractice.com
[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
Adults
While there are no guidelines for tympanostomy tube placement in adults, in practice it can be considered for chronic OME with hearing loss and/or significant discomfort such as otalgia and aural fullness. In the authors' opinion, tympanostomy tube placement can also be a first-line treatment in adults when uncommon circumstances are compelling, on a case-by-case basis; for example, an adult patient who is a pilot or flight attendant may choose tympanostomy tube placement after the initial diagnosis in order to continue working.
Complications
Risks of tympanostomy tube placement include early tube extrusion, tube otorrhea, tube obstruction, tube retention, and tympanic membrane perforation.[93]Vlastarakos PV, Nikolopoulos TP, Korres S, et al. Grommets in otitis media with effusion: the most frequent operation in children. But is it associated with significant complications? Eur J Pediatr. 2007 May;166(5):385-91.
http://www.ncbi.nlm.nih.gov/pubmed/17225951?tool=bestpractice.com
[94]Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001 Apr;124(4):374-80.
http://www.ncbi.nlm.nih.gov/pubmed/11283489?tool=bestpractice.com
There may be a need to replace the tubes.
The most recent tympanostomy tube guidelines indicate that a routine postoperative course of antibiotic ear drops is not necessary (unless there is evidence of acute otitis media with a purulent effusion at the time of surgery).[53]Rosenfeld RM, Tunkel DE, Schwartz SR, et al. Clinical practice guideline: tympanostomy tubes in children (update). Otolaryngol Head Neck Surg. 2022 Feb;166(1_suppl):S1-55.
https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/01945998211065662
http://www.ncbi.nlm.nih.gov/pubmed/35138954?tool=bestpractice.com
See Acute otitis media.