The n e w e ng l a n d j o u r na l of m e dic i n e

Cl inic a l Decisions
Interactive at nejm.org

Tympanostomy Tubes for Recurrent Otitis Media

This interactive feature addresses the approach to a clinical issue. A case vignette is followed by specific options, neither of which
can be considered either correct or incorrect. In short essays, experts in the field then argue for each of the options as assigned.
Readers can participate in forming community opinion by choosing one of the options and, if they like, providing their reasons.

C a s e V igne t t e of his tympanic membrane abnormalities with-

out residual effusion. He has been developing
A 2-Year-Old Boy with Recurrent normally and says approximately 100 words,
Acute Otitis Media often as two-word phrases. The child’s mother
inquires about placement of tympanostomy
Clement Lee, M.D. tubes to prevent future episodes of otitis media.
A 2-year-old boy is brought to an urgent care You must decide whether to refer the child for
clinic with otalgia and fever. A day earlier, he placement of tympanostomy tubes or to recom-
had started pulling at his ears, was fussier than mend conservative medical management.
usual, and ate less than usual. This morning he
had seemed well enough to go to day care, but T r e atment O p t i ons
the day-care provider called the family to take Which one of the following approaches would
him home because fever had developed (tem- you take for this patient? Base your choice on the
perature of 39.1°C). In the urgent care clinic, he literature, your own experience, published guide-
is afebrile and his vital signs are normal. How- lines, and other relevant information.
ever, he looks uncomfortable, and physical ex-
amination is notable for a bulging right tympanic 1. Refer the child for placement of tympanostomy
membrane with an absent light reflex. Acute tubes.
otitis media is diagnosed, and amoxicillin is 2. Recommend conservative medical management.
prescribed.
This is the fourth time that acute otitis media To aid in your decision making, we asked two
has been diagnosed in this child within the past experts in the field to summarize the evidence
year. Because of these episodes, he has missed in favor of approaches assigned by the editors.
multiple days of day care, and his mother has Given your knowledge of the issue and the evi-
missed multiple days of work. All interval exami- dence described by the experts, which approach
nations between episodes have shown resolution would you choose?

O p t i on 1
Refer the Child for Placement
of Tympanostomy Tubes
Diego Preciado, M.D., Ph.D.
Although the decision to place a tympanostomy
tube in a child with appropriately diagnosed re-
current acute otitis media depends on shared
decision making between the health care pro-
vider and the child’s parent or caregiver, the
clinical vignette would lead me to strongly favor
referral of the child to an otolaryngologist for
consideration (and likely recommendation) of
tube placement. In cases of unambiguous recur-
rent acute otitis media such as that described,
defined by three or more episodes in a 6-month
period or four or more episodes in 1 year, evi-
dence suggests that myringotomy and tube place-
ment should be considered. On the basis of
several randomized, controlled trials that showed
a reduction of 0.55 to 2.5 subsequent episodes of
acute otitis media per year, the American Acad-

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 The n e w e ng l a n d j o u r na l
emy of Otolaryngology–Head and Neck Surgery
(AAO-HNS) recommended in 2013 that tubes be
offered for recurrent acute otitis media if a
middle-ear effusion is present on an otolaryn-
gologist’s examination.1 Given the well-docu-
mented difficulty in ascertaining the presence of
a middle-ear effusion,2 referral to an otolaryn-
gologist for a more comprehensive examination
such as tympanometry or pneumatic otoscopy is
warranted. In addition, evidence suggests that
even in patients with recurrent acute otitis media
without a middle-ear effusion, tympanostomy
tubes reduce the mean time with acute otitis
media in the ensuing 2 years.3
The question of whether tubes definitively
reduce subsequent episodes of acute otitis media
remains elusive. Although some trials have
shown a modest effect at reducing subsequent
episodes,4,5 a more recent trial did not show a
reduction in subsequent episodes over a 2-year
period.6 However, a substantial number of pa-
tients (54 of 121 patients; 44.6%) who were ini-
tially assigned to medical management crossed
over to the tympanostomy-tube group, prompting
a per-protocol analysis that slightly favored tym-
panostomy tubes, with rates (±SD) of 1.47±0.08
and 1.72±0.11 episodes of acute otitis media per
year over a 2-year period in the tympanostomy-
tube and medical-management groups, respective­
ly (a rate that was modestly lower, by 0.25 epi-
sodes per year, in the tympanostomy-tube group).6
Regardless of whether tympanostomy tubes
reduce subsequent episodes of acute otitis media,
several other potential benefits can be derived
from their placement. In the aforementioned
trial, several prespecified secondary outcome
measures favored tympanostomy tubes. Children
receiving tubes had a longer median time to the
first occurrence of acute otitis media than chil-
dren in the medical-management group (4.3 vs.
2.4 months; P = 0.01), and fewer children had
treatment failure (45% vs. 62%; P = 0.006). Chil-
dren in the tympanostomy-tube group also expe-
rienced fewer days of otitis-related symptoms
(2.0 vs. 8.3 days per year; P<0.001) and received
fewer days of systemic antimicrobial treatment
(8.8 vs. 12.9 days per year; P<0.001), and fewer
children in that group than in the medical-
management group had diarrhea over a 2-year
follow-up period (16% vs. 28% of children;
P = 0.02).6 These findings underscore additional
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of m e dic i n e
potential benefits of tympanostomy tubes, which
include decreased pain and the ability to manage
subsequent infections with topical antibiotics
alone. Tympanostomy tubes also can serve as a
highly effective drug-delivery mechanism, allowing
concentrated antibiotic eardrops to reach the
middle ear space directly through the tube lumen.7
Children with recurrent acute otitis media
seem to derive clear benefits from placement of
tympanostomy tubes. These benefits should be
counterbalanced with the risks of the procedure,
including risks associated with anesthesia, when
discussed in a shared-decision model with the
child’s caregivers and family.
Disclosure forms provided by the author are available with the
full text of this article at NEJM.org.
From the Division of Pediatric Otolaryngology, Children’s Na-
tional Hospital, George Washington University School of Medi-
cine, Washington, DC.
O p t i on 2
Recommend Conservative
Medical Management
Alejandro Hoberman, M.D.
This 2-year-old boy presents with severe acute
otitis media (defined by moderate or severe otal-
gia and a temperature of at least 39°C), meets
criteria for recurrent acute otitis media (≥3 epi-
sodes in 6 months or ≥4 in 12 months), has
normal speech and development, and has no
residual middle ear effusion between episodes.8
A discussion regarding tympanostomy tube place-
ment must consider several factors: the cost of
the procedure; the risks of anesthesia in young
children9; potential tube complications such as
tube otorrhea,10 blockage, extrusion or retraction
into the middle ear, and tympanosclerosis lead-
ing to mild conductive hearing loss; and the
progressive reduction in the incidence of acute
otitis media as children age.6,11 Trials supporting
the efficacy of tympanostomy tubes were con-
ducted before the widespread uptake of conju-
gate pneumococcal vaccines, showed mixed
results, and were limited by small numbers,
questionable diagnoses of acute otitis media,
short follow-up periods, and attrition bias. In a
recent trial,6 250 children between 6 and 35
months of age with recurrent acute otitis media
were randomly assigned to receive tympanosto-
 Clinical Decisions
my tubes or medical (antimicrobial) treatment,
with insertion of tympanostomy tubes in the
event of treatment failure, and were followed for
24 months. Episodes categorized as acute otitis
media were required to meet stringent diagnos-
tic criteria. Tympanostomy tubes did not result
in fewer episodes of acute otitis media than
medical management. Although children in the
medical-management group received more oral
antibiotics, there was no evidence of increased
bacterial resistance, more severe infections, or
a negative effect on the children’s or parents’
quality of life. In both groups, the incidence of
acute otitis media fell markedly with increasing
age, with an incidence that was approximately
50% lower during the second year than during
the first year of follow-up.6
Children are often labeled as having “recur-
rent” acute otitis media after episodes diagnosed
by multiple clinicians in primary care offices,
emergency departments, and urgent care facili-
ties, with variable levels of stringency of diagno-
sis. The problem is confounded by the fact that
children are generally not evaluated after treat-
ment; accordingly, residual otitis media with ef-
fusion noted on a subsequent visit for a new re-
spiratory illness may be misdiagnosed as acute
otitis media and counted as a recurrence. Although
the child in the vignette currently has acute oti-
tis media, we lack documentation of how the
previous episodes were diagnosed. Given the
child’s age (2 years), and given that the peak
incidence of acute otitis media occurs between
18 and 24 months, the expected rate of recur-
rence during the next year will most likely be
half that of the previous year.6 The season of the
year, which affects the likelihood of viral respi-
ratory infections, should also be considered;
conservative medical management is even more
reasonable if this child’s acute otitis media has
occurred toward the end of the respiratory virus
season. After treatment with effective antimicro-
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bial agents for 10 days, shared decision making
regarding tympanostomy tubes can be pursued;
however, in the study referenced above, episodic
antibiotic treatment worked just as well for the
majority of patients. Therefore, for most chil-
dren with recurrent acute otitis media, why
undergo the risks, cost, and inconvenience of
surgery?
Disclosure forms provided by the author are available with the
full text of this article at NEJM.org.
From the Department of Pediatrics, University of Pittsburgh
School of Medicine, Pittsburgh.
1. Rosenfeld RM, Schwartz SR, Pynnonen MA, et al. Clinical
practice guideline: tympanostomy tubes in children. Otolaryn-
gol Head Neck Surg 2013;​149:​Suppl 1:​S1-S35.
2. Rosenfeld RM. Diagnostic certainty for acute otitis media.
Int J Pediatr Otorhinolaryngol 2002;​64:​89-95.
3. Casselbrant ML, Kaleida PH, Rockette HE, et al. Efficacy of
antimicrobial prophylaxis and of tympanostomy tube insertion
for prevention of recurrent acute otitis media: results of a ran-
domized clinical trial. Pediatr Infect Dis J 1992;​11:​278-86.
4. Kujala T, Alho O-P, Luotonen J, et al. Tympanostomy with
and without adenoidectomy for the prevention of recurrences of
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Dis J 2012;​31:​565-9.
5. Gonzalez C, Arnold JE, Woody EA, et al. Prevention of recur-
rent acute otitis media: chemoprophylaxis versus tympanostomy
tubes. Laryngoscope 1986;​96:​1330-4.
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tubes or medical management for recurrent acute otitis media.
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8. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The diagno-
sis and management of acute otitis media. Pediatrics 2013;​
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9. McCann ME, Soriano SG. Does general anesthesia affect
neurodevelopment in infants and children? BMJ 2019;​367:​l6459.
10. Ah-Tye C, Paradise JL, Colborn DK. Otorrhea in young chil-
dren after tympanostomy-tube placement for persistent middle-
ear effusion: prevalence, incidence, and duration. Pediatrics 2001;​
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11. Johnston LC, Feldman HM, Paradise JL, et al. Tympanic
membrane abnormalities and hearing levels at the ages of 5 and
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tube insertion in the first 3 years of life: a prospective study in-
corporating a randomized clinical trial. Pediatrics 2004;​114(1):​
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DOI: 10.1056/NEJMclde2202050
Copyright © 2022 Massachusetts Medical Society.
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