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Prior Authorization Review PanelMCO Policy Submission

A separate copy of this form must accompany each policy submitted for review. Policies submitted without this form will not be considered for review.

Plan: Aetna Better Health Submission Date: 09/04/2018

Policy Number: 0418 Effective Date: Revision Date: 08/16/2018

Policy Name: Myringotomy and Tympanostomy Tube

Type of Submission – Check all that apply: New Policy Revised Policy* Annual Review – No Revisions

*All revisions to the policy must be highlighted using track changes throughout the document. Please provide any clarifying information for the policy below:

CPB 0418 Myringotomy and Tympanostomy Tube

This CPB has been revised to state that soft-tissue fillers (e.g., hyaluronic acid and Prolaryn gel) are considered experimental and investigational for the treatment of patulous Eustachian tube.

Name of Authorized Individual (Please type or print):

Dr. Bernard Lewin, M.D.

Signature of Authorized Individual:

of 31 Myringotomy and Tympanostomy Tube - Medical Clinical Policy Bulletins | Aetna

(https://www.aetna.com/)

Myringotomy and TympanostomyTube

Policy History

Last

Review

08/16/2018

Effective: 05/04/2000

Next Review:

04/25/2019

Review

History

Definitions

Additional Information

Number: 0418

Policy *Please see amendment forPennsylvaniaMedicaid at theend of this CPB.

Aetna considers myringotomy and tympanostomy tube (also known as ventilation

tube and gr ommet) insertion medically necessary for any of the following

indications:

1. Autophony due to patulous eustachian tube; or

2. Barotitis media control; or

3. Children with cleft palate and history of otitis media with effusion and persistent hearing loss; or

4. Cholesteatoma; or

5. Chronic retraction of tympanic membrane or pars flaccida; or

6. Complications of otitis media such as meningitis, facial nerve paralysis, coalescent mastoiditis, or brain abscess; or

7. Otitis media with effusion after 3 months or longer and bilateral hearing

impairment (defined as 20 dB hearing threshold level or worse in both ears)

(tympanostomy tube); or

8. Recurrent episodes of acute otitis media (more than 3 episodes in 6 months or more than 4 episodes in 12 months) (tympanostomy tube); or

9. Severe otalgia in acute otitis media (myringotomy); or

10. To obtain a culture (diagnostic tympanocentesis/myringotomy) of the middle ear fluid prior to beginning or changing antimicrobial therapy (this may be necessary

http://qawww.aetna.com/cpb/medical/data/400_499/0418_draft.html 08/30/2018

http://www.aetna.com/cpb/medical/data/400_499/0418.html

https://www.aetna.com/

http://qawww.aetna.com/cpb/medical/data/400_499/0418_draft.html

Myringotomy and Tympanostomy Tube - Medical Clinical Policy Bulletins | Aetna Page 2 of 31

Clinical

Policy

Bulletin

Notes

in situations such as otitis media that has failed to respond to appropriate

antimicrobial therapy, or for otitis media in individuals or neonates who are

immunocompromised).

Notes:

OtoScan laser-assisted myringotomy (also called tympano-laserostomy, laser-

assisted tympanostomy [LAT] or OtoLAM) is considered to be as effective as

traditional myringotomy and is safe. The same selection criteria apply to bot h laser

myringotomy and the traditional myringotomy.

Tympanostomy tube insertion is considered not medically necessary for children

with a single episode of otitis media with effusion (OME) of l ess than 3 months’

duration

Tympanostomy tube insertion is considered not medically necessary for children

with recurrent acute otitis media (AOM) who do not have middle ear effusion in

either ear at the time of assessment for tube candidacy.

Aetna considers myringotomy and t ympanostomy tube insertion experimental and

investigational for all other indications (e.g., the prevention of hearing impairment in

children w ith Cornelia de Lange syndrome without above-listed indications for tube

placement) because its effectiveness for indications other than the ones listed above

has not been established.

Aetna considers the use of soft-tissue fillers (e.g., hyaluronic acid and Prolaryn gel)

experimental and investigational for the treatment of patulous Eustachian tube

because their effectiveness has not been established.

Aetna considers the use of (i) phosphorylcholine-coated tympanostomy tube; and

(ii) vancomycin-coated tympanostomy tube experimental and investigational

because their effectiveness has not been established.

Aetna considers the EarPopper device for the treatment of otitis media with effusion

and all other conditions (e.g., eustachian tube dy sfunction and negative pressure as

a consequence of elevation changes from airline travel, diving, and sinusitis surgery,

etc.) experimental and investigational because of insufficient evidence of its

effectiveness.

08/30/2018



Aetna considers endoscopic balloon dilation of the Eustachian tube for the treatment

of Eustachian tube dysfunction experimental and investigational because of

insufficient evidence of its effectiveness.

Background

Myringotomy and Tympanostomy Tube:

A myringotomy is an incision of the tympanic membrane to allow ventilation of the

middle ear, drainage of middle ear fluid, or to obtain cultures from an infected middle

ear. In children with middle-ear effusions, initial treatment often consists of

observation or antibiotic therapy even though recent evidence indicated that the

benefit of antibiotics for otitis media with effusion (Lous et al, 2005) and acute otitis

media (Schilder et al, 2004) is limited. Most cases of otitis media with effusion

resolve spontaneously within 3 months of onset.

An alternative t o myringotomy with tube p lacement is a new tympanostomy

procedure by CO2 laser without ventilation tubes, (also called tympanolaserostomy

or laser-assisted tympanostomy [LAT]). OtoLAM™ (ESC Medical Systems,

Needham, MA) is performed with a computer-driven laser and a video monitor to

pinpoint the exact location for the hole. It programs the precise size of the hole into

the computer. The laser then takes just 1/10 of a second to create the opening,

without damaging surrounding skin or structures in the ear. The hole stays open for

several weeks and this provides ventilation of the middle ear without the need for

tube placement. Studies showed that the CO2 laser was especially effective in

vaporizing the tympanic membrane, especially when there was fluid behind t he

tympanic membrane t o protect the promontory. Laser myringotomies maintain

patency slightly longer than t hat produced by cold-knife myringotomy (3 to 6 weeks

versus 48 to 72 hours) but have not been pr oven to be more efficacious in the

management of effusion than simple myringotomy. A randomized controlled study (n

= 208) found that laser myringotomy is safe but less effective than ventilation tube in

the treatment of chronic otitis media with effusion (Koopman et al, 2004).

In an update of the 1994 clinical practice guideline Otitis Media With Effusion in

Young Children, developed by the AHCPR, the American Academy of Family

Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and the

American Academy of Pediatrics Subcommittee on otitis media with effusion (2004)

recommended that clinicians should manage children with otitis media with effusion

(OME, aged 2 months through 12 years) who are not at risk with watchful waiting for




3 months from the date of effusion onset (if known), or from the date of diagnosis (if

onset is unknown). Children with persistent OME who are not at risk should be re-

examined at 3- to 6-month intervals until the effusion is no longer present, significant

hearing loss is identified, or structural abnormalities of the eardrum or middle ear are

suspected. When a child becomes a surgical candidate, tympanostomy tube

insertion is the preferred initial procedure. Candidates for surgery include children

with OME lasting 4 months or longer with persistent hearing loss or other signs and

symptoms, recurrent or persistent OME in children at risk regardless of hearing

status, and OME and structural damage to the tympanic membrane or middle ear.

The tube usually remains in place for several months, although it may be rejected

sooner or remain in place for years. Adenoidectomy should not be performed

unless a distinct indication exists (nasal obstruction, chronic adenoiditis); repeat

surgery should consist of adenoidectomy plus myringotomy, with or without tube

insertion. Furthermore, tonsillectomy alone or myringotomy alone should not be

used to treat OME (Rosenfeld et al, 2004).

A Cochrane review (Lous et al, 2005) stated that the most common medical

treatment options for OME include the use of decongestants, mucolytics, steroids,

anti-histamines and antibiotics. The effectiveness of these therapies, however, has

not been established. Surgical treatment options include grommet (ventilation or

tympanostomy tube) insertion, adenoidectomy or both. Moreover, the benefits of

grommets in children appear small. The effect of grommets on hearing diminished

during the first year. Potentially adverse effects on the tympanic membrane are

common after grommet insertion. Thus, an initial period of watchful waiting seems

to be an appropriate management strategy for most children with OME.

Randomised controlled studies are needed before more detailed conclusions about

the effectiveness of grommets can be drawn.

In a multi-center, randomized controlled study (n = 395), Paradise et al (2005)

concluded that in otherwise healthy children younger than 3 years of age who have

persistent middle-ear effusion within the duration of effusion (9 months) that these

patients were studied, prompt insertion of tympanostomy tubes does not improve

developmental outcomes at 6 years of age.

In a "follow-up" study, Paradise et al (2007) examined tympanostomy tubes and

developmental outcomes at 9 to 11 years of age. These researchers enrolled 6,350

infants soon after birth and evaluated them regularly for middle-ear effusion. Before

3 years of age, 429 children with persistent effusion were randomly assigned to




undergo the insertion of tympanostomy tubes either promptly or up to 9 months later

if effusion persisted. They assessed literacy, attention, social skills, and academic

achievement in 391 of these children at 9 to 11 years of age. Mean (+/- SD) scores

on 48 developmental measures in the group of children who were assigned to

undergo early insertion of tympanostomy tubes did not differ significantly from the

scores in the group that was assigned to undergo delayed insertion. These

measures included the Passage Comprehension subtest of the Woodcock Reading

Mastery Tests (mean score, 98 +/- 12 in the early-treatment group and 99 +/- 12 in

the delayed-treatment group); the Spelling, Writing Samples, and Calculation

subtests of the Woodcock-Johnson III Tests of Achievement (96 +/- 13 and 97 +/-

16; 104 +/- 14 and 105 +/- 15; and 99 +/- 13 and 99 +/- 13, respectively); and

inattention ratings on visual and auditory continuous performance tests. The authors

concluded that in otherwise healthy young children who have persistent middle-

ear effusion, as defined in this study, prompt insertion of tympanostomy tubes does

not improve developmental outcomes up to 9 to 11 years of age.

In an editorial that accompanied the study by Paradise and associates, Berman

(2007) stated that the consistency of the findings of Paradise et al during prolonged

follow-up periods provided convincing evidence that persistent middle-ear effusion in

otherwise normal children does not cause developmental impairments.

Allen (2007) conducted a retrospective chart review to determine if intravenous

access is necessary during the performance of myringotomy with tube insertion. The

study included 50 pediatric patients divided equally into 2 groups: group 1, who did

not have intravenous access established before the procedure, and group 2, who

did have intravenous access established. To be enrolled, patients in both groups

had to be less 12 years of age or younger, have an American Society of

Anesthesiologists physical status classification of P1 or P2, and had to have

undergone no adjunctive procedure with the myringotomy. Induction time was

significantly shorter in group 1 (average: 6.96 +/- 2.72 mins) than in group 2

(average: 9.80 +/- 3.82 mins; p = 0.004). Operating time and total operating room

time were not significantly different between the 2 groups. Additionally, 24 of 25

patients in group 1 had their pain managed with acetaminophen or no medication at

all, while 9 of 25 group 2 patients received acetaminophen and 13 received

intravenous pain medication. Interestingly, no patients in group 1 required anti-

emetics, whereas 4 patients in group 2, who were given intravenous or

intramuscular narcotics, received anti-emetic medications. These findings indicate

that myringotomy with tube insertion can be safely accomplished without




establishing intravenous access. Induction times and time under general anesthesia

were significantly increased when intravenous access was obtained. The findings

also suggest that acetaminophen provides adequate post-operative pain control in

this patient population and that the use of intravenous or intramuscular narcotics

increases the risk of post-operative nausea.

Spielmann et al (2008) stated that there is a paucity of evidence to guide the post-

operative follow-up of patients undergoing middle-ear ventilation tube insertion for the

first time. This study was undertaken to identify current practice at the authors'

institution and to inform subsequent change in their follow-up procedure. Two cycles

of data collection and analysis were performed. All pediatric patients undergoing

ventilation tube insertion for the first time were identified. Patients who had

previously undergone ventilation tube insertion or additional procedures such as

adenoidectomy or tonsillectomy were excluded. The first data collection period

comprised all of the year 2000, and the second 18 months over 2003 to 2004. A

minimum of 20 months' follow-up was allowed for. Data regarding clinical findings

and audiometry were recorded at each follow-up appointment. A total of 50 patients

meeting the criteria for inclusion in the first cohort were identified. There were a total

of 156 appointments between surgery and data collection (a mean of 3.12 per

child). A total of 113 (72 %) appointments lead to no medical intervention. The only

statistically significant difference between patients requiring further ventilation tube

insertion (n = 10) and those not requiring further treatment during the study period (n

= 40) was the average hearing threshold (p < 0.01). These findings prompted a

change in the post-operative regime; all patients undergoing ventilation tube insertion

were subsequently seen at 3 months for a pure tone audiogram, and further

review depended on clinical and audiometric findings. Records for 84 children

were identified and collected for the second cohort, there were a total of 154

appointments (a mean of 1.83 per child). In only 18 appointments (12 %) were

normal findings and hearing recorded and children given a further review

appointment. Sixteen of 29 (55 %) children with abnormal clinical findings (otorrhea,

tube blockage or extrusion) required some form of intervention (p < 0.05). Twenty-

six had a mean hearing threshold worse than 20 dB at first review. Nineteen (73 %)

required further intervention of some sort (p < 0.01). The authors concluded that

these findings demonstrated that the vast majority of review appointments resulted in

no clinical intervention. Thus, these investigators question the need for regular

follow-up in this patient group. Twenty per cent (10 of 50 and 18 of 84) of the

patients required further ventilation tube insertion within the study periods. This is

consistent with rates reported in the literature. Children with abnormal clinical




findings or a mean hearing threshold greater than 20 dB were significantly more

likely to require further intervention. The authors recommended one post-operative

review with audiometry, 3 months after surgery. At this initial appointment, further

review should be offered to those children with poor hearing, early extrusion,

blockage or infection, as they are more likely to require further ventilation tube

insertion.

In a Cochrane review on grommets (ventilation tubes) for recurrent acute otitis

media in children, McDonald et al (2008) concluded that ventilation tubes have a

significant role in maintaining a "disease-free" state in the first 6 months after

insertion. They stated that more research is needed to investigate the effect

beyond 6 months. Furthermore, clinicians should consider the possible adverse

effects of grommet insertion before surgery is undertaken.

Campbell and colleagues (2009) stated that primary ciliary dyskinesia is an

autosomal recessively inherited group of disorders of ciliary ultra-structure.

Otolaryngologists are frequently involved in the management of some of the most

common symptoms of primary ciliary dyskinesia including chronic rhinitis, sinusitis,

and OME. A dilemma for otorhinolaryngologists is whether ventilation tubes are of

benefit in children with primary ciliary dyskinesia and OME and what effective

alternatives exist. The authors addressed this issue via a literature review and case

presentation. An extensive review of the literature was undertaken and a discussion

of the advantages and disadvantages of ventilation tubes in the management of OME

in these children was presented and compared with that of the general population.

These investigators presented a case of a 9-month old boy with

Kartagener's syndrome and chronic bilateral OME to illustrate their findings. A total

of 8 papers were identified, all with small study numbers. The main outcome

measures were hearing, otorrhea and tympanic membrane structural changes. The

natural history of OME and hearing loss in primary ciliary dyskinesia appears to be

fluctuant into adulthood. Thus, OME in primary ciliary dyskinesia does not resolve by

the age of 9 years, regardless of treatment, as previously assumed. Ventilation

tube insertion (VTI) improves hearing in primary ciliary dyskinesia, but may lead to a

higher rate of otorrhea when compared to the general population. Tympanic

membrane changes were clinically insignificant. The patient eventually underwent

successful insertion of bilateral ventilation tubes with a marked improvement in

hearing and language with minimal otorrhea. The authors concluded that the highest

level of evidence found for the management of OME in children with primary ciliary

dyskinesia was level IV. Currently, the evidence is inconclusive and




conflicting. While these findings are promising, clearly higher quality research on a

larger number of patients is required to definitively evaluate the management

options for OME in these children.

Coated Tympanostomy Tubes:

Methicillin-resistant staphylococcus aureus (MRSA) infections and colonization in

children have increased in recent years. Moreover, bacterial biofilm formation has

been implicated in the high incidence of persistent otorrhea following tympanostomy

tube insertion. It has been suggested that the tube material may be an important

factor in the persistence of such otorrhea. Development of MRSA otorrhea after

tympanostomy tube placement is a growing concern. Jang and associates (2010)

evaluated the effect of using vancomycin and chitosan coated tympanostomy tubes

on the incidence of MRSA biofilm formation in-vitro. Three sets each of

vancomycin-coated silicone tubes (n = 5), commercial silver oxide-coated silicone

tubes (n = 5) and uncoated tympanostomy tubes (as controls; n = 5) were compared

as regards resistance to MRSA biofilm formation after in vitro incubation. Scanning

electron microscopy showed that the surfaces of the silver oxide-coated tubes

supported the formation of thick biofilms with crusts, comparable to the appearance

of the uncoated tubes. In contrast, the surface of the vancomycin-coated

tympanostomy tubes was virtually devoid of MRSA biofilm. The authors concluded

that vancomycin-coated tympanostomy tubes resist MRSA biofilm formation. They

noted that pending further study, such tubes show promise in assisting the control of

MRSA biofilm formation.

In a prospective, randomized, double-blind controlled trial, Hong et al (2011)

compared the post-operative complication rates of phosphorylcholine-coated

fluoroplastic tympanostomy tubes versus uncoated fluoroplastic tympanostomy

tubes. A total of 240 children with recurrent acute otitis media and chronic otitis

media with effusion were randomized to receive a phosphorylcholine-coated tube in

one ear and an uncoated tube in the other. Post-operatively, patients were assessed

at 2 weeks and 4, 8, 12, 18, and 24 months to ascertain the incidence of otorrhea,

tube lumen blockage, and early extrusion. Out of 240 children, 5 withdrew an

d 16 were lost to early follow-up. The mean age was 43.8 months. There were no

statistically significant differences in the incidence of post-operative otorrhea, tube

blockage, and extrusion. The authors concluded that phosphorylcholine-coated

fluoroplastic ventilation tubes do not offer any advantages over uncoated standard

fluoroplastic tympanostomy tubes.




The EarPopper Device:

The EarPopper is a non-invasive device for treating conditions such as otitis media

with effusion, middle ear effusion, aerotitis/barotitis and eustachian tube dy sfunction,

without the need for surgery or antibiotics. It delivers a constant, regulated stream of

air into the nasal cavity through the nostril with a 1-oz infant nasal syringe equipped

with a plastic tip. During the moment of swallowing, the air is diverted up the

eustachian t ube clearing and ventilating t he middle ear. The EarPopper relieves the

negative ear pressure allowing any accumulated fluids to drain. The Australia and

New Zealand Horizon Scanning Network's assessment on "EarPopper™ for the

treatment of otitis media in children" (2007) deemed this technology as "yet to

emerge"; and it does not receive approval from the Australian Therapeutic Goods

Administration. The assessment noted that the evidence suggested that the

EarPopper™ may provide a safe and effective treatment option in the short-term with

minimal clinical impact on health pr actitioners as it can be used at home; and

recommended that this technology be monitored.

An Agency for Healthcare Research and Quality’s report on “Otitis media with

effusion: Comparative effectiveness of treatments” (AHRQ, 2012) stated that

“Though not in widespread use, the technique of autoinflation [which is what

EarPopper tries to accomplish] has been used as a treatment for OME. The goal of

autoinflation is to use either a Valsalva maneuver or external device to equalize

middle ear and oropharyngeal pressure, essentially transiently opening the

Eustachian tube. A 2006 Cochrane Collaboration study included 6 RCTs examining

the use of autoinflation versus no treatment for hearing loss associated with OME.

Studies included children, adults, and special populations and concluded that the

evidence for the use of autoinflation in the short-term was favorable; however, given

the small number of studies and lack of long-term follow-up, the long-term effects

could not be determined”.

In a randomized, single-blinded, controlled trial, Banigo et al (2016) provided an

independent evaluation of the safety and effectiveness of the EarPopper in

improving hearing outcomes in children with OME and reducing the ventilation tube

insertion rate. A total of 29 children aged between 4 and 11 years diagnosed with

persistent OME lasting at least 3 months with an average hearing of 25 decibels

Hearing Leve (dBHL) or worse in the better ear were randomized to a treatment or

control group for 7 weeks using random computer-generated codes. Syndromic

children, children with developmental delay, previous grommets and cleft palate

were excluded. The audiologists were blinded at the final post-treatment




audiogram. After the 7-week period, the mean improvement in air conduction across

all frequencies was 10.9 dBHL in the treatment group (p < 0.001) and 3.6 dBHL

in the control group (p = 0.201). At every frequency, the treatment group had larger

improvements in air conduction, the largest being at 4 kHz where the mean air

conduction in both ears improved by 14.8 dBHL. Compliance with the EarPopper

was over 90 %, the only side-effect reported being discomfort in the ears immediately

after use, which resolved and did not affect compliance. The ventilation tube

insertion rate was 53.3 % in the treatment group and 78.6 % in the control group.

Median follow-up time for all patients is 47.7 months. The authors concluded

that the findings of this study showed that the EarPopper is a safe and effective

therapeutic option for children with hearing loss from persistent OME, and it reduces

the rate of ventilation tube insertion; they stated that more studies with larger sample

sizes are needed to support their findings.

Tympanostomy Tube Insertion in Children with Cleft Palate:

Hornigold et al (2008) noted that between July 1984 and March 1987, all children

that underwent repair for primary cleft palate at the Queen Victoria Hospital were

enrolled in a clinical trial. Those found to have OME at time of surgery had a t-tube

inserted into 1 randomized ear, while the other ear received no treatment. The

object of the study was to re-assess patients from the original trial to discover the

impact of the unilateral t-tube 20 years later. A total of 22 patients were identified as

potential study participants. Of this group, 14 were contactable and 7 agreed

to participate in the follow-up study. Main outcome measures were persistent

symptomatology, otoscopy, pure tone audiometry and tympanometry. Follow-up

results were compared within the original treatment groups from the primary study,

on an intention-to-treat basis. Otoscopically the ears were normal in 2 of the 7

treated ears compared with 4 of the 7 non-treated ears. All the other ear ears had

various types of chronic otitis media. Four of the 7 had hearing of greater than 10

dB in the treated ear compared with the non-treated ear. The authors concluded

that these findings would indicate need for caution in the use of t-tubes in the cleft

population and raises the question of long-term follow-up to assess for secondary

cholesteatoma.

In a systematic review, Ponduri et al (2009) examined if early routine grommet

insertion in children with cleft palate has a beneficial effect on hearing and speech

and language development compared with conservative management. The main

outcome measure was the effect of early routine grommet placement on the degree

of conductive hearing loss. Secondary outcome measures included differences in




hearing level, possible side effects, speech and language development, and quality

of life. These researchers identified 368 citations for review. From a review of the

titles, 34 potentially relevant papers were selected. Of these, 18 studies met the

inclusion criteria, including 8 case series, 6 historical cohort studies, 3 prospective

cohort studies, and 1 randomized trial. Most studies were either small or of poor

quality or both. The results of the studies were contradictory, with some studies

suggesting early placement of grommets was beneficial and others reporting there

was no benefit. The authors concluded that there is currently insufficient evidence

on which to base the clinical practice of early routine grommet placement in children

with cleft palate.

Boonacker et al (2014) stated that otitis media (OM) is a leading cause of medical

consultations, antibiotic prescription and surgery in children. The surgical

procedures offered to children with recurrent or persistent OM are insertion of

grommets, adenoidectomy or a combination of the two. There is clear National

Institute for Health and Care Excellence guidance for the use of grommets in

subgroups of children with persistent OME, but similar guidance is not available for

adenoidectomy, either in persistent OME or in recurrent AOM. These researchers

(I) developed a m odel to predict t he risk of children r eferred for adenoidectomy

having a prolonged duration of their OM; (IIa) evaluated the overall effect of

adenoidectomy, with or without grommets, on OM using individual patient data (IPD);

and ( IIb) identified those subgroups of children who are most likely to benefit from

adenoidectomy with or without gr ommets. A number of electronic databases were

searched from their inception including the Cochrane Ear, Nose and Throat

Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials

(CENTRAL), PubMed, EMBASE, the Cumulative Index to Nursing and Allied Health

Literature (CINAHL), metaRegister of Current Controlled Trials (mRCT),

ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP),

ClinicalStudyResults.org and Google. Studies eligible for inclusion in this IPD meta-

analysis were randomized controlled trials (RCTs) in children up to 12 years of age

diagnosed with recurrent AOM and/or persistent OME in which adenoidectomy (with

or without grommets) was compared with non-surgical treatment or grommets alone.

The final selection of eligible studies and the quality assessment were carried out

according t o standard m ethods and disagreement was resolved by discussion. A

total of 503 articles were identified of which 10 trials were included in the meta-

analysis; 8 of these were at a low risk of bias and 2 were at moderate risk. The

primary outcome was failure at 12 months, defined by a set of persisting symptoms

and signs. In the prognostic analysis 56 % of those children referred for



http://ClinicalStudyResults.org

http://ClinicalTrials.gov


adenoidectomy (but randomized to the non-surgical group) failed to improve (38 %

of the children with recurrent AOM and 89 % of the children with persistent OME).

Children who had adenoidectomy had a greater chance of clinical improvement.

The size of that effect is, in general, small but persists for at least 2 years. Two

subgroups of children are most likely to benefit from adenoidectomy: (i) children

aged less than 2 years with recurrent AOM -- 16 % of those who had

adenoidectomy failed at 12 months whereas 27 % of those who did not have

adenoidectomy failed [rate difference (RD) 12 %, 95 % Cl: 6 % to 18 %; number

needed to treat (NNT) = 9]; (ii) children aged greater than or equal to 4 years

with persistent OME -- 51 % of those who had adenoidectomy failed at 12

months whereas 70 % of those who did not have adenoidectomy failed (RD 19

%, 95 % Cl: 12 % to 26 %; NNT = 6). No significant benefit of adenoidectomy was

found in children aged greater than or equal to 2 years with recurrent AOM and

children aged less than 4 years with persistent OME. The authors concluded that

adenoidectomy is most beneficial in children with persistent OME aged greater than

or equal to 4 years. A smaller beneficial effect was found in children with recurrent

AOM aged less than 2 years. Consideration must be given to the balance between

benefits and harms. Future research is required in a number of key areas, including

defining the best methods of selecting, developing and administering patient-

reported outcome measures to assess the value of treatments for children with

persistent OME and recurrent AOM and upper respiratory infections; investigating

the clinical effectiveness and cost-effectiveness of hearing aids (air or bone

conduction) and the use of interventions to improve classroom acoustics for children

with different degrees of persistence and severity of hearing loss associated with

OME; and investigating why professionals' and parents'/carers' treatment

preferences vary so much both nationally and internationally. The authors did not

understand why adenoidectomy works in different subgroups at different ages, nor

its effects in special populations, such as children with Down syndrome. They stated

that there is also a need for further research on the impact and optimal management

of otitis media in these special situations and others, such as in childre

n with a cleft palate or developmental problems.

Kuo and colleagues (2014) stated that no consensus has yet been reached with

regard to the link between OME, hearing loss, and language development in children

with cleft palate. These researchers examined the effectiveness of VTI for

OME in children with cleft palate. A dual review process was used to assess eligible

studies drawn from PubMed, Medline via Ovid, Cumulative Index to Nursing and

Allied Health Literature, Cochrane Library, and reference lists between 1948 and




November 2013. Potentially relevant papers were selected according to the full text

of the articles. Relevant data were extracted onto a data extraction sheet. A total of

9 high- or moderate-quality cohort studies were included in this study. Ventilation

tube insertion was administered in 38 % to 53 % of the OME cases, and more

severe cases appeared more likely to undergo VTI. Compared with conservative

forms of management (e.g., watchful waiting), VTI has been shown to be beneficial

to the recovery of hearing in children with cleft palate and OME. A growing body of

evidence demonstrated the benefits of VTI in the development of speech and

language in children with cleft palate and OME. These children face a higher risk of

complications than those undergoing conservative treatments, the most common of

which are eardrum retraction and tympano-sclerosis, with an incidence of

approximately 11 % to 37 %. The authors concluded that this review provided

evidence-based information related to the selection of treatment for OME in children

with cleft palate. They stated that additional RCTs are needed to obtain bias-

resistant evidence capable of reliably guiding treatment decisions.

Guidance from the National Institute for Health and Clinical Excellence (NICE, 2008)

states that the care of children with cleft palate who are suspected of having OME

should be undertaken by the local otological and audiological services with expertise

in assessing and treating these children in liaison with the regional multidisciplinary

cleft lip and palate team. Insertion of ventilation tubes at primary closure of the cleft

palate should be performed only after careful otological and audiological

assessment. Insertion of ventilation tubes should be offered as an alternative to

hearing aids in children with cleft palate who have OME and persistent hearing loss.

In a case-series with chart-review study, Kim and colleagues (2017) examined the

effect of VTI on long-term hearing outcomes in children with cleft palate. Children

with cleft palate diagnosis who underwent surgery at Rady Children's Hospital-San

Diego between 1995 and 2002 were included in this analysis. The primary outcome

studied was hearing acuity at 10 years of age. Independent variables studied

included gender, age at palate repair and first VTI, total number of VTs, number of

complications, and presence of tympanic membrane perforation. An increased

number of tubes was associated with a greater incidence of hearing loss at age 10,

even after adjusting for total number of otologic complications. The timing of initial

VTI did not have a significant effect on long-term hearing outcome in this study. The

authors concluded that while children with worse middle ear disease were more likely

to receive more tubes and have long-term conductive hearing loss as a result of

ear disease, the results of this study suggested that multiple VTI may not




contribute to improved long-term hearing outcomes. They stated that further

research focusing on long-term outcomes is needed to establish patient-centered

criteria guiding decision making for VTI in children with cleft palate.

Miscellaneous Information:

The American Academy of Otolaryngology-Head & Neck Surgery's clinical practice

guideline on "Tympanostomy tubes in children" (Rosenfeld et al, 2013) provided the

following recommendations:

▪ Clinicians should not perform tympanostomy tube insertion in children with

a single episode of OME of less than 3 months’ duration

▪ Clinicians should obtain an age-appropriate hearing test if OME persists for 3

months or longer (chronic OME) or prior to surgery when a child becomes a

candidate for tympanostomy tube insertion

▪ Clinicians should offer bilateral tympanostomy tube insertion to children

with bilateral OME for 3 months or longer (chronic OME) and documented

hearing difficulties

▪ Clinicians should re-evaluate, at 3- to 6-month intervals, children with chronic

OME who did not receive tympanostomy tubes until the effusion is no longer

present, significant hearing loss is detected, or structural abnormalities of the

tympanic membrane or middle ear are suspected

▪ Clinicians should not perform tympanostomy tube insertion in children with

recurrent acute otitis media (AOM) who do not have middle ear effusion in

either ear at the time of assessment for tube candidacy

▪ Clinicians should offer bilateral tympanostomy tube insertion to children

with recurrent AOM who have unilateral or bilateral middle ear effusion at

the time of assessment for tube candidacy

▪ Clinicians should determine if a child with recurrent AOM or with OME of any

duration is at increased risk for speech, language, or learning problems from

otitis media because of baseline sensory, physical, cognitive, or behavioral

factors

▪ In the perioperative period, clinicians should educate care-givers of children

with tympanostomy tubes regarding the expected duration of tube function,

recommended follow-up schedule, and detection of complications

▪ Clinicians should not encourage routine, prophylactic water precautions (use

of earplugs, headbands; avoidance of swimming or water sports) for children

with tympanostomy tubes.




Youssef and Ahmed (2013) compared long-term follow-up results of laser versus

classical myringotomy with ventilation tube insertion over 5 years. A total of 86

patients with bilateral OME were divided into 2 groups: (i) laser myringotomy group

and (ii) myringotomy with ventilation tube insertion group, with follow-up in

hearing results and recurrence rates over 5 years. The mean pa tency time of

myringotomy in laser group was 23 days, while the mean patency time of the

ventilation tubes ears was 4.0 months in myringotomy group. Twelve patients in

laser group ( 13.9 %) showed a recurrent OME compared to 9 patients in

myringotomy group (10.4 %). The authors concluded that laser fenestration is a less

effective alternative to m yringotomy and tube placement. The recurrence rates after

both procedures did not show statistical significance over long follow-up. It might be

considered as an effective alternative to classical surgery and i deal for short-term

ventilation.

Follow-Up Care After Grommet Insertion:

Mughal and colleagues (2016) stated that grommet insertion is a common procedure

in children. A lengthy otolaryngology follow-up can have an adverse impact on clinic

waiting times, new patient appointment availability, and pecuniary disadvantage for

the hospital. These investigators consolidated research and opinion concerning

follow-up care following grommet insertion in a pediatric population. The literature

between January 1990 and September 2015 was searched on Medline (Ovid),

Google Scholar, PubMed and Web of Science databases. Guidelines and

consensus of opinion from the United States advocate that an initial post-operative

review should take place within 4 weeks, and subsequent appointments every 6

months until grommet extrusion. Recent audit reports from the United Kingdom have

shown that some groups arrange their first post-operative review at 3 months, and

subsequent appointments vary considerably from no further follow-up to up to 24

months. Up to 75 % of follow-up appointments were scheduled despite normal

audiometry and clinical findings after grommet insertion, suggesting a large cohort of

patients may undergo unnecessary specialist clinic reviews. General practitioners

(GPs), audiologists or specialist nurses are potential alternative providers of regular

reviews to ensure normal hearing thresholds and an adequate tympanic membrane

healing course. The authors concluded that follow-up schedules are largely driven

by consensus of opinion. They noted that a significant number of follow-up

appointments in otolaryngology clinic appear to be redundant. Recently attention has

been drawn to earlier discharge from otolaryngology clinic with subsequent




follow-up in less resource- and cost-intensive clinics coordinated by GPs, audiologist

or nurses, which may help alleviate some out-patient workload on acute hospital

trusts.

Treatment of Hearing Impairment in Children with Cornelia de Lange Syndrome:

Jung and colleagues (2016) noted that Cornelia de Lange syndrome (CdLS) is a

multiple developmental disorder including hearing loss. The hearing impairment in

CdLS patients is not only sensori-neural hearing loss (SNHL), but also conductive

hearing loss (CHL). The authors examined hearing loss causes in CdLS patients

and evaluated the effect of VTI in the cases of CHL. A total of 32 patients clinically

diagnosed with CdLS were included in this retrospective case review. Audiological

evaluations and imaging studies such as a temporal bone computed tomogram or

brain magnetic resonance imaging (MRI) were performed for all patients. Hearing

rehabilitation (e.g., VTI, hearing aid fitting, or cochlear implantation) was chosen

depending on the audiological condition. Among the 32 CdLS patients who

underwent auditory brainstem response test, 81.2 % presented hearing loss.

Imaging studies showed that only middle ear lesions without inner ear anomalies

were identified in 56.3 %. Notably, the soft tissue lesion in middle ear was identified

even in the neonatal MRI. When 7 patients were thought to have CHL due to OME,

VTI was applied first. However, VTI rarely improved CHL post-operatively.

Moreover, middle ear lesion was not fluid effusion but soft tissue lesion according to

the intra-operative finding. These lesions were not eradicated even after revision

surgery of VTI. The authors concluded that VTI was ineffective to improve hearing

or eradicate OME in CdLS patients.

Janek and associates (2016) stated t hat patients with CdLS are reported t o have

CHL and SNHL, but there is little information per taining to the progression of hearing

loss over time. These investigators examined the pr evalence of CHL and SNHL in

adults and children w ith CdLS and looked for changes in SNHL over time. They

carried out a retrospective chart review of patients with CdLS presenting to a CdLS

clinic. Also, a written survey of clinical concerns was collected from additional

patients/families seen in the clinic and through t he Cornelia de Lange F oundation. A

total of 78 patients (50 % female) were included in the chart-review. Mean age was

16.8 ± 11.4 years (range of 0.6 to 50 y ears) and mean age at diagnosis of hearing

loss was 4.6 ± 10.6 years (n = 26); 5 patients (6.4 %) had severe t o profound SNHL

that improved w ith time, including 2 who had complete normalization of audiogram

results; 35 families/patients completed the clinical survey, and 45.5 % of the families




reported a noticeable improvement of hearing over time. The authors concluded that

CHL and SNHL are common in CdLS; and more than 50 % of the patients seen in

an adult CdLS clinic reported improvement in hearing loss over time, and a subset of

patients had an improvement in SNHL. In light of these findings, the authors

recommended longitudinal evaluations of hearing loss in these patients with both

auditory brainstem response and oto-acoustic emissions testing if SNHL is identified.

Endoscopic Balloon Dilation of the Eustachian Tube:

Catalano and colleagues (2012) stated that Eustachian tube dysfunction is a

common problem and trans-nasal endoscopic balloon dilation of the Eustachian tube

(ET) is a new surgical technique. These researchers reviewed the evolution of this

novel technique and studied the preliminary outcomes. Balloon catheter dilation of

the 100 Eustachian tubes in 70 adults was performed at a tertiary medical center

from January 2009 to January 2011. A 5-mm sinus balloon catheter was

endoscopically placed trans-nasally into the proximal ET to dilate the cartilaginous

ET. Cases were reviewed with respect to indications, outcomes, and complications.

Of the 100 ETs, ear fullness and pressure were improved in 71 % of patients studied

for 26.3 weeks (± 3.6). Of 8 patients followed for a minimum of 34 months, 87 %

reported persistent improvement; 1 complication was reported. The authors

concluded that endoscopic trans-nasal ET balloon dilation is a novel approach to

treating ET dysfunction. Benefits can be durable up to 3 years. Moreover, they

stated that this technique holds much promise and merits further investigation.

Jurkiewicz et al (2013) noted that the development of minimally invasive procedures

such as the balloon dilation Eustachian tuboplasty (BET) is an alternative to the

grommet tympanum membrane. BET is applied in the cases where, after elimination

of all factors influencing the ET and middle ear functioning, no sufficient improvement

is observed. These investigators presented the therapeutic benefits of the BET

method in the treatment of ETD caused by disorders in the middle ear ventilation.

The BET procedure was offered to 4 patients (3 men and 1 woman) after subjective,

physical, otorhino-laryngological and audiometric examinations includin

g pure tone audiometry, tympanometry and pressure-swallow test. As the method

was novel, pre-interventional CT angiography of the carotid arteries was performe

d in all patients. Any complications were noticed during and after the procedure

(bleeding or damage of regional mucosa) in any patients. These clinical studies

assessed the feasibility and safety of the BET during a short-term period -- on

ly a 6-week observation. The authors concluded that although patients revealed a




significant improvement of ET score, longer long-term studies are needed to

determine whether this method will demonstrate lasting benefits and safety in the

treatment of chronic Eustachian tube dysfunction.

Moller et al (2014) stated that balloon dilation of Eustachian tube is a novel method

for managing chronic ventilatory dysfunction in patients with chronic otitis media, as

an alternative to classic grommet insertion. Although few retrospective studies have

been conducted the method seems to be rapid, simple and safe with promising

short-term results. These researchers presented the method and summarized the

results of available studies. Optimization of patient selection is needed and the

authors discussed the development of better objective measurement methods as

well as the need for randomized prospective studies, which are currently being

conducted.

In a retrospective, cohort study, Gurtler et al (2015) assessed Eustachian tube

balloon dilation in the treatment of Eustachian tube dysfunction by objective

analysis, especially tubomanometry. Patients undergoing Eustachian tube balloon

dilation for treatment of Eustachian tube dysfunction were enrolled in this study.

Main outcome measures included subjective improvement, otomicroscopic findings,

tympanogram, air-bone gap in pure-tone audiogram, R-value in tubomanometry at 3

pressure measurements (30, 40, and 50 mbar) and the Eustachian Tube Score

(ETS). Eustachian tube balloon dilation was performed in 21 patients. The ETS

including the R-values, tympanogram, and air-bone gap all showed a statistically

positive outcome (p < 0.005) after Eustachian tube balloon dilation. Subjective

improvement was seen in 76 %. Normal R-values were achieved in 57 %.

Retraction processes of the tympanic membrane improved in 18 % of patients. Only

1 minor bleeding complication occurred. The authors concluded that Eustachian

tube balloon dilation constitutes a safe and very promising treatment option for

patients with Eustachian tube dysfunction based on early-outcome analysis; ETS

and specifically tubomanometry appeared promising as assessment tools but await

validation for use in the diagnostic workup and outcome analysis after ETBD. The

pathophysiologic mechanism of Eustachian tube balloon dilation remains unclear.

They stated that long-term analysis and stratification of patients are needed to better

evaluate the definite value of Eustachian tube balloon dilation.

In a retrospective analysis, Maier et al (2015) evaluated the role of balloon dilation of

the Eustachian tube in a large cohort of children with Eustachian tube dysfunction

who did not respond to other treatments and in whom a tumor could be ruled out as




the cause. These researchers retrospectively analyzed the medical records of 66

children (mean age of 8.12 years, range of 4 to 14 years) who underwent balloon

dilation of the Eustachian tube using the Bielefeld balloon catheter. There were no

complications during surgery. Clinical symptoms improved in more than 80 % of the

patients. No patient reported a deterioration of symptoms. Of the participating

parents, over 80 % were very satisfied or satisfied with the treatment outcome. The

authors concluded that balloon dilation is a rapid, simple, and safe method for

treatment of both adults and children with Eustachian tube dysfunction who did not

respond to other treatments. Moreover, they stated that further studies, ideally

multi-center studies, are needed to optimize the definition of existing and potential

new indications for this treatment approach, as well as to establish this treatment in

the management of children with refractory chronic Eustachian tube dysfunction.

Randrup and Ovesen (2015) performed a systematic review and meta-analysis of

the evidence on balloon Eustachian tuboplasty (BET) as a treatment modality for

Eustachian tube dysfunction (ETD). These investigators followed the PRISMA

guideline and registered with PROSPERO No. CRD42014009461. They searched

12 databases including PubMed and Embase from January 1, 2010 to April 7, 2014

for studies of BET. Main outcome measures included change in symptoms, middle

ear pathology, eardrum status, Eustachian tube function tests, hearing, adverse

events, complications, and health-related quality of life. Study quality was assessed

using the modified Delphi technique quality appraisal tool for case series studies.

Risk of bias was assessed using the Cochrane Collaboration's tool for assessing

risk of bias. A total of 9 case-series studies with 443 patients (642 tubes) were

included; population size ranged from n = 4 (7 tubes) to n = 210 (320 tubes). All

studies were of poor quality and featured a high risk of bias. These researchers

found reduction of patient symptoms in ETD questionnaire (p < 0.001), post-

operative normalization of the tympanic membrane, conversion of type B or type C

into type A tympanograms, reduced mucosal inflammation, increased number of

positive Valsalva test and Swallowing tests, improvement in Eustachian tube score,

reduction in Sino-Nasal Outcome Test (SNOT)-22 score (p = 0.001), and increased

quality of life (p = 0.001). No serious adverse events were found. The authors

concluded that the evidence of BET is poor and biased. No firm conclusions can be

made to identify patients who will benefit from the procedure or to accurately predict

surgical results. They stated that randomized controlled trials or case-control trials

are needed.




Hwang et al (2016) stated that Eustachian tube dysfunction is a disorder for which

there are limited medical and surgical treatments. Recently, Eustachian tube balloon

dilation has been proposed as a potential solution. These investigators performe

d a systematic literature review. Abstracts were selected for relevance, an

d pooled data analysis and qualitative analysis was conducted. A total of 9

prospective studies, describing 713 Eustachian tube balloon dilations in 474 patients

(aged 18 to 86 years), were identified. Follow-up duration ranged from 1.5 to 18

months. Ability to perform a Valsalva maneuver improved from 20 to 177 out of 245

ears following Eustachian tube balloon dilation and, where data were reported in

terms of patient numbers, from 15 to 189 out of 210 patients. Tympanograms were

classified as type A in 7 out of 141 ears pre-operatively and in 86 out of 141 ears

post-operatively. The authors concluded that prospective case series can confirm

the safety of Eustachian tube balloon dilation. As a potential solution for chronic

Eustachian tube dysfunction, further investigations are needed to establish a higher

level of evidence of efficacy.

Williams et al (2016) measured the success of Eustachian tube balloon dilation by

comparing pre- and post-operative middle ear pressures using tympanometric

testing. A retrospective chart review was performed on all patients who underwent

balloon dilation of the Eustachian tube by authors from 2010 to 2014. Pre and post-

operative tympanograms were analyzed and categorized based on type (Type A,

Type B, Type C). Success was defined by an improvement in tympanogram type:

Type B or C to Type A, or Type B to type C. Pre- and post-operative tympanograms

were further analyzed using middle ear pressure values. Follow-up ranged from 3 to

15 months. A total of 25 ears (18 patients) were included in the study. Overall 36 %

of ears had improvement in tympanogram type, and 32 % had normalization of

tympanogram post-operatively. The Jerger tympanogram type improved significantly

following the procedure (p = 0.04). Patients also had statistically significant

improvement in measured middle ear pressure post-operatively (p = 0.00

3). The authors concluded that the natural history of Eustachian tube dysfunction

is poorly understood, and evidence for current treatments are limited.

Eustachian tube balloon dilation is a safe procedure, and produces significant

improvement in tympanogram values up to 15 months post-operatively. They stated

that further refinement of patient selection and standardization of technique is

needed to optimize the effect of this therapy; long-term follow-up data will clarify the

persistence of the effect.




Furthermore, an UpToDate review on “Eustachian tube dysfunction” (Poe and

Hanna, 2017) states that “The choice of management strategies for isolated

Eustachian tube dysfunction remains controversial as randomized trial data are

limited, study outcomes vary widely between studies, and much of what is known

about the treatment of Eustachian tube dysfunction comes from animal rather than

human studies … Balloon dilation is a novel tuboplasty method to increase the

patency of the cartilaginous Eustachian tube. Similar to the concept of balloon

sinuplasty for the treatment of chronic sinusitis, a balloon catheter is used to dilate

the cartilaginous portion through a minimally invasive transnasal endoscopic

approach. Initial cadaveric studies and clinical trials are promising. A 2015

systematic review including 9 case series (443 patients) concluded that balloon

tuboplasty is a safe procedure but is still lacking good evidence of benefit”

Soft-Tissue Fillers for patulous Eustachian tubes

Schröder et al (2018) stated the Eustachian tube protects against secretion, germs

and sound pressure from the nasopharynx, it acts as a drain, and serves pressure

equalization in both directions so that the ear drum and sound-conducting apparatus

can vibrate optimally. The incidence of Eustachian tube dysfunction in adults is

about 1%, in children almost 40%. Symptoms are often unspecific. For diagnosis,

the Eustachian tube score (ETS-5) can be used in patients with a perforated ear

drum, and the ETS-7 score in patients with intact ear drum. Adenoid hypertrophy is

a frequent cause of obstructive tube dysfunction in children. Treatment of obstructive

dysfunction includes steroid nasal sprays and regular performance of the Valsalva

maneuver, as well as tube dilation with the Bielefelder balloon catheter. The

patulous Eustachian tube is treated with saline nasal irrigation, estrogen-nasal

ointment, and craniocervical manual therapy; causal treatments are evaluated.

Schröder et al (2015) stated a patulous Eustachian tube ([ET] tuba aperta) may

cause symptoms as autophony, breath synchronous tinnitus, pressure sensation,

and conductive hearing loss and thus lead to an enormous cutback in quality of life.

In combination with "sniffing," it can trigger the development of cholesteatoma.

Because of the ambiguous symptoms, the diagnosis can be challenging. A patulous

ET can only be diagnosed through a well-structured examination, including patient

history, physical examination with thorough observation of the movements of the

tympanic membrane, and tympanometry with reflex-decay. Transnasal endoscopic

injection of injectable soft-tissue bulking agent into the torus tubarius was performed

in 20 patients as a new treatment option for patulous ET. All patients were followed

up 6 weeks and 6 and 12 months after treatment. For each intervention, 0.8 to 2 mL




of injectable soft-tissue bulking agent was used. In nine patients, more than one

procedure was necessary. On follow-up, 10 out of 15 patients were satisfied with the

result. Only three out of 15 patients reported no improvement of their symptoms.

The procedure was minimally invasive, fast, and easy to perform. The authors

concluded there is no gold standard for the therapy of patulous ET. The injection of

soft-tissue bulking agent in the torus tubarius is a new minimally invasive therapeutic

approach, but much more clinical experience is needed.

Luu et al (2015) determined the effectiveness of currently available medical and

surgical interventions for treating symptoms of Patulous Eustachian Tube (PET)

through a comprehensive search of MEDLINE (January 1948 to July 8, 2015),

EMBASE (January 1974 to July 8, 2015), gray literature, hand searches, and cross-

reference checking. The review included original published reports evaluating an

intervention to treat the symptoms of patulous eustachian tube in patients 18 years

and older. Quality-of-case reviews were assessed with the National Institute of

Health (NIH) Quality Assessment Tool for Case Series Studies. The search strategy

identified 1,104 unique titles; 39 articles with 533 patients are included. The

available evidence consists of small case series and case reports. The most

common medical treatment was nasal instillation of normal saline. Surgical

treatments were categorized as mass loading of the tympanic membrane,

eustachian tube plugging, and manipulation of eustachian tube musculature. The

authors concluded that the available evidence for management of patients with PET

is poor in quality and consists predominantly of small case series. Further research

is needed to determine the comparative efficacy of the current treatments.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes covered if selection criteria are met:

69420 Myringotomy including aspiration and/or eustachian tube inflation

69421 Myringotomy including aspiration and/or eustachian tube inflation

requiring general anesthesia

69424 Ventilating tube removal requiring general anesthesia




Code Code Description

69433 Tympanostomy (requiring insertion of ventilating tube), local or topical anesthesia

69436 Tympanostomy (requiring insertion of ventilating tube), general anesthesia

HCPCS codes not covered for indications listed in the CPB:

C9745 Nasal endoscopy, surgical; balloon dilation of eustachian tube

CPT codes not covered for indications listed in the CPB:

EarPopper:

No specific code

Other CPT codes related to the CPB:

31000 - 31230 Incision and excision of accessory sinuses

31231 - 31297 Sinus endoscopy

42820 - 42821 Tonsillectomy and adenoidectomy

42830 - 42836 Adenoidectomy

ICD-10 codes covered if selection criteria are met:

H65.00 - H65.93 Nonsuppurative otitis media

H66.001 -

H66.93

Suppurative and unspecified otitis media

H69.00 - H69.03 Patulous Eustachian tube

H71.20 - H71.23

H71.90 - H71.93

Cholesteatoma of mastoid and unspecified part [middle ear]

H72.10 - H72.13 Attic perforation of tympanic membrane [Pars flaccida]

H90.0 - H91.93 Hearing loss

Q35.1 - Q37.9 Cleft lip and cleft palate

T70.0xx+ Otitic barotrauma

ICD-10 codes not covered for indications listed in the CPB (not all-inclusive):

H69.80 - H69.83 Other specified disorders of eustachian tube

H69.90 - H69.93 Unspecified eustachian tube disorder

Q87.1 Congenital malformation syndromes predominantly associated with short

stature [Cornelia de Lange syndrome]




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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

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general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

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for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2018 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0418 Myringotomy and

Tympanostomy Tube

There are no amendments for Medicaid.

www.aetnabetterhealth.com/pennsylvania revised 08/16/2018

http://www.aetnabetterhealth.com/pennsylvania

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