Myringotomy and Tympanostomy Tube Placement: Update.
Charles D. Bluestone, MD. FACS, FAAP
Introduction
Since beveled grommet tympanostomy tubes were re-introduced in the 1950s by Beverly
Armstrong, 1 they have become extremely popular for treating and preventing middle-ear disease
(MED) in children and adults and were widely embraced very early by Otolaryngologists, 2
including me. They were recommended by several authors in the 19th century but didn’t come
into wide use until the invention of operating microscope in the mid-20th century.3 Because
bacterial otorrhea is a common complication following tube insertion and ototopical
antimicrobial drops were not available until relatively recently, acceptance when they were first
introduced was likely greatly impeded.
I used the Paparella ventilation (tympanostomy) tubes4 shortly after their introduction in the early
1970s, especially the smallest ones for infants and those older patients with very narrow external
ear canals. Prior to that in the 1960s, I first used tubes I made by using a short piece of No. 90
plastic tubing and creating the bi-flanged ends over a Bunsen burner.
Today, after circumcision, myringotomy with tympanostomy tube (M & T) insertion is the most
common surgical procedure performed in children that requires general anesthesia; in the United
States about 2 million tubes are inserted annually through the eardrums of more than 1 million
individuals in this age group. The number of adults is uncertain as most are inserted in
Otolaryngologist’s offices and clinics with the aid of local/topical anesthesia and with limited
reporting. Currently, we now have the results of randomized controlled trials (RCT) to arrive at
criteria for tube insertion and there are official Guidelines for indications. I stress a shared
decision-making (SDM) approach between the clinician and the patient/family to decide to
operate or not. Also, the Society for Middle-Ear Disease (SMED) and this website
(www.societyformiddleeardisease.org), has up-to-date information for the clinician and
caregivers related to M & T for this common malady.
Importance of Official Guidelines for Management of Middle-Ear Disease
Dissemination of official Guidelines on the diagnosis and management of otitis media (OM) is
an important mission of SMED. One of the leading aims of the Society is not only to disseminate
these Guidelines to health-care professionals around the world, but to help community (lay
individuals) understand the issues. Most of these Guidelines have been developed by experts in
the field who rely on outcomes of clinical trials that have complied with scientific rigor needed
to answer clinically important questions, so-called evidence-based medicine (EBM).
Unfortunately, some recent reports 5 have revealed that physician non-compliance with these
Guidelines remains a problem.
As opposed to the frequent bias of a single individual, who often is an investigator of his or her
own research, Guidelines’ committees are composed of many experts and even community
members who contribute to the recommendations. Below, I report both on studies I have been
part of and Guidelines that are unbiased in their conclusions.
Several countries have official Guidelines on diagnosis and management of OM and these are
listed on the SMED website. Most have been written for professionals in medical jargon and not
for the community, but some contain language directed at individuals in the community. Thus,
another important mission of SMED is to empower patients and their families when discussing
management with their primary care physician (PCP) and Otolaryngologist and to be proactive in
the decision-making process when faced with options to treat or not treat and which treatments
are safe and effective. Today, SDM is preferred over the paternalistic approach common among
many clinicians in the past. This discussion should be in terms that the non–health-care
professional will fully understand. Hopefully, dissemination of these Guidelines to health-care
professionals, as well as to patients and their caregivers, will create more informed and better
health care for middle-ear disease (MED) in the future.
Current Guidelines for OM from those Countries that have them are on this SMED website
under Guidelines.
Randomized Controlled Trials (RCTs)
Otitis media with effusion
In the past, several studies addressed the efficacy of M & T for treatment of chronic otitis media
with effusion (OME), currently the most common indication, but all had problems in design and
methodology. However, there were three well-designed and conducted RCTs:
1. Gates and colleagues6 evaluated 578 San Antonio, Texas, children in a trial that randomly
assigned children, aged 4 to 8 years, who had chronic OME that was unresponsive to
antimicrobial therapy, into one of four random arms: 1) myringotomy (M) without tube
placement, 2) M & T, 3) adenoidectomy and M, and 4) adenoidectomy and M & T. The study
did not include a control group of no surgery, but all three of the other treatments did statistically
better than M only and was associated with too many procedures. Thus, this operation was not
recommended. In fact, the M arm was dropped earlier than completion of the trial when we
learned of this poor outcome. (Full disclosure: I was the monitor on this trial and involved in this
decision.)
2. We conducted two trials that addressed M & T for this disease. The first was reported in 1989
by Mandel and coworkers,7 which was an RCT involving 109 Pittsburgh children who had
chronic OME that had been unresponsive to antimicrobial therapy and randomly assigned
subjects to receive: 1) M, 2) M & T, or 3) no surgery (control). During this 3-year trial, subjects
were evaluated monthly and whenever an ear, nose, and throat illness supervened. Patients who
had M&T had less MED and better hearing than either children who had only M or those
subjects in the control group. In addition, one-half of the subjects in the M group had to have an
M&T during the first year of the trial because of an excessive number of M’s and development
of “significant” hearing loss; none of these subjects had this degree of hearing loss when they
entered the trial. M provided no major advantage over no surgery (i.e., control) regarding
percentage of time with OME, number of bouts of acute otitis media (AOM), and number of
subsequent surgical procedures. We concluded that M&T provided more effusion-free time and
better hearing than either M or no surgery, but some patients who received tubes did develop
otorrhea, and perforation was a problem in one of the children. Because we considered the
interpretation of this trial to be difficult because of the complexities of the design, the protocol
was revised and a second clinical trial was conducted.
3. In our second trial reported in 1992, Mandel and colleagues8 randomized 111 children into the
same three groups as in the first study: 1) M, 2) M&T, and 3) no surgery (control). As in the first
trial, subjects were reexamined at least every month for 3 years. Outcomes observed in this trial
were similar to those reported in the first study. Again, subjects in the M&T group had less time
with OME and better hearing than either those children who had only M performed or the group
that had no surgery.
On the basis of our two randomized clinical trials that evaluated a total of 220 subjects, we
recommended M & T as the first surgical procedure to perform, as opposed to M alone, for
children who have chronic OME 3 months or longer. Even though Gates and colleagues
recommended an adenoidectomy and M as “the initial surgical procedure,” we recommended
reserving adenoidectomy for those children who required another surgical procedure if OM
recurred after extrusion of the initial tube. This recommendation was made because the study by
Gates and colleagues showed that adenoidectomy in their population was only a little better than
M&T and since in our two trials approximately 50% of the subjects required only one M&T
during the trial. If the child has significant nasal obstruction caused by obstructive adenoids,
however, adenoidectomy and M or M&T as an initial procedure is a reasonable option; this
decision should be shared between the clinician and family (i.e., SDM).
Guidelines: Myringotomy and tympanostomy tube placement for chronic otitis media with
effusion
The first attempt at a Guideline for OME in the United States was in 1994, and was led by my
late partner Sylvan E. Stool, who convened a committee to prepare a Clinical Practice Guideline
for OME in young children.9 That Guideline is now outdated. This was then followed by a
Guideline that was published in 2004 by the American Academies of Otolaryngology-Head Neck
Surgery, Pediatrics, and Family Physicians.10 That committee recommended M&T as the
preferred initial procedure when a child becomes a surgical candidate, and adenoidectomy not be
performed unless another indication is present, such as nasal obstruction or chronic/recurrent
acute adenoiditis. Repeat surgery should consist of adenoidectomy plus M or M&T. I am in
agreement with this indication, but with the option of adenoidectomy for repeat surgery.
More recently, in 2013, the American Academy of Otolaryngology-Head and Neck Surgery
(AAOHNS) published a Clinical Practice Guideline for M&T in children. 11 This committee
recommended M&T in at-risk children (e.g., speech, language, or learning problems) with
unilateral or bilateral OME hat is unlikely to resolve quickly and persists for 3 months or longer.
The latest committee developing Guidelines for OME has been convened (2015) by AAOHNS.
Following its deliberations and the published report, we hopefully will see more clarification for
indications for M&T for this disease entity. When available, it will be posted on the SMED
website.
Recurrent acute otitis media (AOM)
Three RCTs tested the efficacy of M&T for prevention of recurrent AOM.
1. Gebhart12 in Columbus, Ohio, evaluated OM-prone infants, of whom 50% had M&T and 50%
had no surgery. Efficacy was demonstrated, but infants with MEE were also enrolled, and
follow-up was limited to 6 months.
2. Gonzalez and coworkers, 13 conducted an RCT in the United States Army that enrolled 65
otitis-prone infants into a trial that randomly assigned subjects into three groups: 1) sulfisoxazole
prophylaxis, 2) M&T, and 3) placebo. Similar to the Gebhart trial, infants were entered with and
without middle-ear effusion (MEE), not stratified, and observed for only 6 months. Infants in the
tympanostomy group did significantly better if they had MEE at entry, but the attack rates of
AOM were not reduced significantly in those subjects who were effusion-free at the time of
random assignment.
3. Casselbrant and colleagues14 randomly assigned 264 Pittsburgh children aged 7 to 35 months
to one of three groups: 1) amoxicillin prophylaxis (20mg/kg/d in 1 dose at bedtime), 2) M&T,
and 3) placebo. Unlike the two previously reported trials, we entered only patients who had no
MEE and observed the children monthly and whenever an ear, nose, and throat illness
supervened for 2 years. The average rate of new bouts of AOM was significantly reduced in
those subjects who were in the amoxicillin prophylaxis group compared with the M&T or
placebo group. There was no significant difference between the M&T and placebo groups for
this outcome measure. Postoperative otorrhea through a tympanostomy tube was considered to
be an episode of AOM, which occurred at about the same rate as the number of episodes of
AOM in the placebo group. However, the bouts of otorrhea were usually asymptomatic
(diagnosed during routine follow-up visits) and less troublesome than when AOM developed in
the placebo and amoxicillin prophylaxis groups. When the average portion of time with OM of
any type (i.e., AOM, otorrhea, or OME) was evaluated, the M&T group had only 6.6%
compared with 10% for the amoxicillin group and 15% for subjects who received placebo;
tubes had significantly less OM of any type than the prophylaxis and placebo groups, P <.001.
The amoxicillin group had adverse side effects in 7%, primarily urticaria and vaginitis, and 3.9%
of the M&T group developed persistent perforation of the tympanic membrane; all of these
eventually healed spontaneously.
Since relatively long-term antimicrobial prophylaxis may be related to development of resistant
bacteria, this question was addressed in the trial, but there were no consistent differences in
percentages of b-lactamase–positive Haemophilus influenzae or Moraxella catarrhalis found in
serial nasopharyngeal cultures between those who received amoxicillin prophylaxis and those
who were in the placebo group. During the 2-year trial, 70% of the subjects who were randomly
assigned to the M&T group required only one procedure, whereas 26% needed a second M&T;
only one child (1%) had to have three sets of tubes. At that time, we recommended that
amoxicillin prophylaxis be the first method used to prevent recurrent AOM in infants and young
children, the age group included in the trial. If this failed, M&T was the next option. We also
recommended that children who are prescribed prophylaxis be reevaluated periodically, even if
they are symptom-free, since asymptomatic MEE may develop. But, that recommendation was
made before awareness that long-term, low-dosage of antibiotic, especially amoxicillin, is
associated with the emergence of antibiotic-resistant otic pathogens, e.g., pneumococcus. Thus,
antibiotic prophylaxis should be on an individual basis, such as children who are anesthetic risks,
or whose parents choose to withhold surgery, and then it should be considered an option, (i.e.,
SDM).
More recently, Whittemore15 in reviewing the literature for tubes in preventing recurrent AOM,
cited our RCT as the only acceptable trial and concluded that the “level of evidence favoring
(tube) placement is 1b given there is an individual, randomized, controlled trial.” We then
published a “Letter to the Editor”16 to clarify certain aspects of our trial because there had been
some confusion related to its outcomes; we also wanted to provide our more current
recommendations as that report was more than 20 years old. I have addressed this clarification
and our recommendations above.
Guidelines: Myringotomy and tympanostomy tube placement for recurrent AOM
The American Academy of Pediatrics (AAP) in 2013 in its Clinical Practice Guideline on The
Diagnosis and Management of Acute Otitis Media17 includes the Key Action Statement:
Clinicians may offer tympanostomy tubes for recurrent AOM (three episodes in 6 months or 4
episodes in 12 months, with one episode in the preceding 6 months). (Evidence Quality: Grade
B, Rec. Strength: Option). It did note the same issue addressed above in our RCT14 in that it
stated there was no difference in number of episodes of AOM between the M&T group and the
placebo group over the 2 years. The criteria for the number of prior episodes for placement was
the same as our RCT.14
The AAOHNS (2013) in their Clinical Practice Guideline11 on Tympanostomy Tubes in Children
included an Action Statement Profile that clinicians should offer bilateral M&T in children with
recurrent AOM who have unilateral or bilateral MEE at the time of assessment for M&T
candidacy. The Committee cited the Gebhart and Gonzalez and colleagues studies12, 13 to support
this conclusion. Troubling is the Action Statement Profile that “Clinicians should not perform
tympanostomy tube insertion in children with recurrent acute otitis media who do not have MEE
(middle-ear effusion) in either ear at the time of assessment for tube candidacy.” In the
Casselbrant and colleagues14 trial discussed above, we specifically entered subjects without MEE
as we believed the trials by Gebhart and Gonzales and colleagues were confounded by the
inclusion of such children, and we wanted to determine the efficacy of M&T in children who
present with recurrent AOM who met our criteria, but had no MEE at the time of the initial
examination. We believe we showed efficacy in our trial given our election to include any acute
infection when the tympanic membrane was intact or not; we considered the post-tube otorrhea
to be not the same as acute disease when the eardrum was intact.
Physiologic Functions of the Eustachian Tube
As presented above, there are now results of RCTs showing that M&T can be beneficial in
selected infants and children because MED is reduced and hearing is restored, although there are
known complications and sequelae associated with the surgery. The rationale for the procedure
may be found in certain physiologic and pathophysiologic aspects of the nasopharynx,
Eustachian tube (ET), middle ear, and mastoid gas cell system that are related to the
pathogenesis of OM. The ET has three important physiologic functions in relation to the middle
ear (ME): 1) Pressure regulation of the ME, 2) clearance of secretions down the ET, and 3)
protection of the ME from the entry of unwanted nasopharyngeal secretions (Figures 1 and 2).
Figure 1. Pressure regulation function. During swallowing, the Eustachian tube opens by the
contraction of the tensor veli palatini muscle, which equilibrates pressure between the outside
atmosphere (nasopharynx) and the middle ear. (Permission granted from: Bluestone CD,
Casselbrant ML, Dohar, JE. Targeted Therapies Otitis Media and Otitis Externa. BC Decker.
2003: p. 34.)
Figure 2. Protective function of the Eustachian tube. (Permission granted from: Bluestone CD,
Casselbrant ML, Dohar, JE. Targeted Therapies Otitis Media and Otitis Externa. BC Decker.
2003: p. 35.)
A functioning tympanostomy tube maintains ambient pressure within the ME and mastoid and
provides adequate drainage both down the ET and through the tympanostomy tube. Thus, two
physiologic functions of the ET are fulfilled by the tympanostomy tube. But, the protective
function of the ET is impaired by M&T because a patent tympanostomy tube results in an
opening in the tympanic membrane, and the physiologic ME-ear gas cushion is not present if the
tympanic membrane is not intact (Figure 3).
Figure 3. A Nonintact tympanic membrane caused by a perforation or tympanostomy tube can
promote reflux of secretions from the nasopharynx into the middle ear because the middle ear air
cushion is impaired. (Permission granted from: Bluestone CD, Casselbrant ML, Dohar, JE.
Targeted Therapies Otitis Media and Otitis Externa. BC Decker. 2003: p. 42.)
Therefore, reflux of nasopharyngeal secretions into the ME can be enhanced when a
tympanostomy tube eliminates the ME gas cushion, a situation that can result in OM and
otorrhea. Also, the tube can result in organisms from the external canal entering the ME causing
tube otorrhea. The 2013 Guidelines from the AAOHNS 11 states that tube-associated otorrhea
should be treated with topical antibiotic drops and not oral antimicrobial agents for children who
have uncomplicated acute tube otorrhea. The ideal ET prosthesis would be a transtympanic tube
that fulfills all three of the important physiologic functions of the ET: pressure regulation,
drainage, and protection. (See also the SMED website (www.societyformiddleeardisease.org),
Resource Center/Professionals/Books, for the monograph Eustachian Tube Structure, Function
Role in Otitis Media, chapters on Physiology and Pathophysiology.)
Other Indications for Placement of Tympanostomy Tubes
My other indications, although not supported by clinical trials, for tympanostomy tube placement
are: Recurrent OME in which each episode does not become chronic but the cumulative
duration is considered excessive, such as 6 episodes in the previous 12 months; ET dysfunction
that is chronic or recurrent and unresponsive to medical management; atelectasis of the ME that
is chronic (with or without retraction pocket); suppurative complications (e.g., facial paralysis,
mastoiditis) at the time of tympanoplasty when ET dysfunction is chronic; and prevention of otic
barotrauma during hypobaric chamber treatment. Acceptable clinical trials for these relatively
uncommon indications are either not feasible due the limited number of patients or there are
ethical concerns, such as when suppurative complications occur. To me, the rationale for tubes
for ME infection that is persistent or when suppurative complications are present is similar to
incision and drainage of an abscess in other parts of the body. A tympanostomy tube is excellent
for desired drainage that is either short- or long-term.
Postoperative Follow-Up after Placement
When I first began to insert tympanostomy tubes in the 1960s, I routinely examined patients 2 to
4 weeks after the surgery to determine if the tubes were in place and patent, and to make sure
post-tympanostomy otorrhea was not present. I then examined patients every 3 months and
whenever otorrhea supervened until spontaneous extrusion occurred. After I found out the
routine 3- and 6-month visits were seldom necessary in most patients, I omitted these
examinations and routinely scheduled another examination 12 months postoperatively. About
that same time I realized most of the childrens’ primary care physicians were including an
examination of the ears when seeing them for well-child care and for sick visits. I also followed
those children and adults who I thought would not receive optimal postoperative follow-up care,
such as when they lived a long distance from their physician.
When Should Tympanostomy Tubes Be Removed?
In general, once tubes have been inserted, they should be permitted to extrude spontaneously into
the external auditory canal and not be removed too early. The rationale for such management is
based on experience rather than on any RCT. In children with tympanostomy tubes in place, ET
function has not been shown to change significantly, even after several months. Also, there are
differences in the life of tympanostomy tubes depending on the type; some have a short duration
while with others the tubes may remain in place for years, such as “permanent” long-term tubes.
But, there are indications to remove tubes in selected children. Tympanostomy tubes can be
removed as an office procedure without the aid of either local or general anesthesia, especially
when the tube is partially extruded or there is chronic infection involving the tympanic
membrane. In young children, however, tympanostomy tubes are frequently removed under
general anesthesia in the operating room since the procedure is frequently painful, and the rim of
the perforation can be denuded of epithelium and the defect closed (i.e., “paper patch”
myringoplasty). A recent report by Moon and coworkers18 on when retained Paparella type I
tubes should be removed in asymptomatic children recommends removal when tubes are retained
for more than 18 months as spontaneous extrusion seldom occurs after 18 months; removal prior
to 12 months resulted in an increased possibility of recurrence, and removal after 15 months
showed an increase in complications, such as perforation of the tympanic membrane.
Removal of tympanostomy tubes depends on several factors, including the following:

Age of the child

Duration of time the tube has remained in place

Unilateral versus bilateral tubes

Status of the contralateral ear when that tympanic membrane is intact

Eustachian tube function

Presence or absence of recurrent or chronic otorrhea (and frequency, severity, and
duration of otorrhea)

Patency of the tube

Season of the year
Complications and Sequelae
As discussed above, post-tympanostomy tube otorrhea is a frequent complication but is usually
effectively treated with ototopical antibiotic drops; a recent study19 found that antibioticglucocorticoid ear drops were more superior and cost-effective than oral antibiotics. However,
there are other complications and also sequelae. Scarring of the tympanic membrane
(myringosclerosis) is present in up to one-half of patients after surgery that can be either
localized or even result in diffuse atrophy of the eardrum, with or without a retraction pocket;
tympanosclerosis is rarely present in the ME and ossicular chain. Atelectasis can occur in which
the tympanic membrane becomes flaccid and in the presence of ME-underpressures, and can
adhere to the medial wall of the ME and ossicles. Although many have questioned the presence
of long-term hearing loss following tube insertion, the 25-year follow-up study after tube
placement by Khodaverdi and colleagues20 concluded that M&T had no impact on long-term
hearing levels; also, that study found that hearing loss associated with pathology (e.g., atrophy
and myringosclerosis) was more common following M&T than in non-tubed ears, but the levels
were too small to have an impact.
Post-tympanostomy tube perforation of the eardrum can occur following spontaneous extrusion
or removal, the rate varying with the type of tube, number of insertions, and the life of the tube;
perforation occurs more frequently after “permanent” tubes are extruded or removed.
Postoperative tympanostomy tube obstruction is not uncommon, and a recent study21 reported a
rate of 10.6% and that serous MEE at the time of surgery and an increased time to the
postoperative visit were statistically significant indicators for occlusion. When a tube is
obstructed (usually with dried mucus) it may be able to be opened with thin viscosity ototopical
drops. If unsuccessful in older teenagers and adults, it can be opened with a thin wire with the
benefit of the operating microscope; in infants with the caregivers’ acceptance it can also be
opened with this procedure, but with the infant restrained. When all else fails, the tube can be
replaced. Very rarely an acquired cholesteatoma can be found at the site of placement, but when
identified early at postoperative follow-up visits, it can be removed with minor surgery.
In general, as concluded by Kay and colleagues22 from a meta-analysis, complications and
sequelae associated with M&T are either transient (e.g., otorrhea) or cosmetic, such as
myringosclerosis.
Summary and Conclusions
I have summarized the RCTs that have been conducted and current official Guidelines that have
provided the most frequent indications for M&T--OME and recurrent AOM. I also listed the
other more uncommon indications not supported by clinical trials, as their number of occurrences
are too few, or a clinical trial would be unethical, to be tested. Also, I have shown how
tympanostomy tubes provide two physiologic functions of the ET system—pressure regulation
and drainage (clearance). But, the third function--protection from unwanted nasopharyngeal
secretions and contamination of bacterial pathogens from the ear canal--is lacking and is
considered a complication associated with tube insertion. The current tubes are not a replacement
for all of the physiologic functions of the ET but provide a reasonable bypass for a dysfunctional
system until future research resolves the underlying causes of MED. As Otolaryngologists know,
a tracheotomy tube is life-saving in the face of a severely dysfunctional larynx, such as bilateral
vocal fold paralysis, but we don’t allow these patients to immerse their entire body in water.
Despite these potential drawbacks, as Mudry3 has concluded, the tympanostomy tube is indeed
“an ingenious invention of the mid-19th century.”
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June, 2015