Balloon Dilation of the Eustachian Tube - CAM 701158

Description
Eustachian tube dysfunction occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure is frequently due to inflammation and can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo. Chronic obstructive eustachian tube dysfunction can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas. Balloon dilation of the eustachian tube is a procedure intended to improve patency by inflating a balloon in the cartilaginous part of the eustachian tube to cause local dilation.

Additional Information
2020 Input

For individuals who have chronic obstructive eustachian tube dysfunction who receive balloon dilation of the eustachian tube, clinical input supports that this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients using the following criteria:

  • Obstructive eustachian tube dysfunction for 3 months or longer in one or both ears that significantly affects quality of life or functional health status;
  • The patient has undergone a comprehensive diagnostic assessment; including history and physical exam, tympanometry if the tympanic membrane is intact, nasopharyngoscopy, and comprehensive audiometry; and
  • Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4-6 weeks of a nasal steroid spray, if indicated.

 

Background
Eustachian Tube Function and Dysfunction
The eustachian tube connects the middle ear space to the nasopharynx. It ventilates the middle ear space to equalize pressure across the tympanic membrane, clears mucociliary secretions, and protects the middle ear from infection and reflux of nasopharyngeal contents.1 Normally, the tube is closed or collapsed and opens during swallowing, sneezing or yawning. Eustachian tube dysfunction occurs when the functional valve of the eustachian tube fails to open and/or close properly. This failure may be due to inflammation or anatomic abnormalities. Symptoms of chronic obstructive ETD can include aural fullness, aural pressure, hearing loss, and otalgia. In milder cases, eustachian tube dysfunction may only be apparent in situations of barochallenge (inability to equalize with rapid barometric pressure changes), with otherwise normal function in stable ambient conditions.2

Diagnosis
Because the symptoms of ETD are nonspecific, clinical practice guidelines emphasize the importance of ruling out other causes of ETD with a comprehensive diagnostic assessment that includes patient-report questionnaires, history and physical exam, tympanometry, nasal endoscopy, and audiometry to establish a diagnosis.2

Medical and Surgical Management of Eustachian Tube Dysfunction
Medical management of eustachian tube dysfunction (ETD) is directed by the underlying etiology. Treatment of identified underlying conditions, such as systemic decongestants, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; or treatment of mass lesions, may be useful in resolving ETD.

Patients who continue to have symptoms following medical management may be treated with surgery such as myringotomy with the placement of tympanostomy tubes or eustachian tuboplasty. These procedures create an alternative route for ventilation of the middle ear space but do not address the functional problem at the eustachian tube. There is limited evidence and no randomized controlled trials (RCTs) supporting use of these surgical techniques for this indication.3 Additionally, surgery may be associated with adverse events such as infection, perforation, and otorrhea. Tympanostomy tube placement may be a repeat procedure for the life of the patient, and the risk of complications from tympanostomy tubes increases with increasing numbers of tube placements and duration of tube placement.

Balloon Dilation of the Eustachian Tube
Balloon dilation is a tuboplasty procedure intended to improve the patency of the cartilaginous eustachian tube to cause local dilation. During the procedure, a saline-filled balloon catheter is introduced into the eustachian tube through the nose using a minimally invasive transnasal endoscopic method. Pressure is maintained for 2 minutes or less, after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.4,5

Balloon dilation of the eustachian tube can be done as a standalone procedure or in conjunction with other procedures such as adenoidectomy, intranasal surgery (e.g., septoplasty, turbinate procedures or sinus surgery), surgery for obstructive sleep apnea or sleep disturbed breathing, and myringotomy with our without tympanostomy tube placement. This evidence review addresses BDET as a standalone procedure.

Regulatory Status

Table 1. Devices Cleared by the U.S. Food and Drug Administration

Device Manufacturer Date Cleared 510(k) No. Indication
Acclarent Aera Eustachian Tube Balloon Dilation System Acclarent Inc. 01/16/2018 K171761 Eustachian tube dilation
Xpress ENT Dilation System Entellus Medical Inc. 04/05/2017 K163509 Eustachian tube dilation

In September 2016, the AERA® (Acclarent) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II, FDA product code: PNZ). The new classification applies to this device and substantially equivalent devices of this generic type. The AERA® is cleared for dilating the ET in patients ages 22 and older with persistent eustachian tube dysfunction (ETD).

In December 2016, the XprESS ENT Dilation System (Entellus Medical, Plymouth, MN) was cleared for marketing by the FDA through the 510(k) process (K163509). The FDA determined this device was substantially equivalent to existing devices for use in eustachian tube dysfunction (ETD). The predicate devices are XprESS Multi-Sinus Dilation System (K152434) and AERA® Eustachian Tube Balloon Dilation System.

Policy 
Balloon dilation of the eustachian tube for treatment of chronic obstructive eustachian tube dysfunction may be considered MEDICALLY NECESSARY under the following conditions:

  1. Adults (age 22 years and older) with symptoms of obstructive eustachian tube dysfunction (aural fullness, aural pressure, otalgia, and/or hearing loss) for 12 months or longer in one or both ears that significantly affects quality of life or functional health status  (Aural fullness and pressure must be present ((see Policy Guidelines)), AND 
  2. The patient has undergone a comprehensive diagnostic assessment; including patient-reported questionnaires, history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy, and comprehensive audiometry, with the following findings:
    • Abnormal tympanogram (Type B or C), OR
    • Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam), AND 
  1. Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4-6 weeks of a nasal steroid spray, and if indicated, including but not limited to:
    • Other causes of aural fullness such as temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence, and endolymphatic hydrops have been ruled out, OR
    • If the patient had a history of tympanostomy tube placement, symptoms of obstructive eustachian tube dysfunction should have improved while tubes were patent, OR
    • The patient does not have patulous eustachian tube dysfunction or another contraindication to the procedure (see Policy Guidelines), OR
    • The patient’s eustachian tube dysfunction has been shown to be reversible (see Policy Guidelines), OR
    • Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to baro-challenge such as pressure changes while flying), OR
    • The patient has not had a previous BDET procedure 

Balloon dilation of the eustachian tube is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY if the above criteria are not met.

Policy Guidelines
Symptoms of obstructive eustachian tube dysfunction may include aural fullness, aural pressure, otalgia, and hearing loss. Nearly all patients will have aural fullness and aural pressure. Many patients will have otalgia, but hearing loss may not be present in all patients (e.g., patients with Type C tympanograms).

Contraindications to Balloon Dilation of the Eustachian Tube

  • The following patients should not be considered for balloon dilation of the eustachian tube:
    • Patients with patulous eustachian tube dysfunction
      • A diagnosis of patulous ETD is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
    • Patients with extrinsic reversible or irreversible causes of eustachian tube dysfunction including, but not limited to:
      • craniofacial syndromes, including cleft palate spectrum
      • neoplasms causing extrinsic obstruction of the eustachian tube
      • history of radiation therapy to the nasopharynx
      • enlarged adenoid pads
      • nasopharyngeal mass
      • neuromuscular disorders that lead to hypotonia/ineffective eustachian tube dynamic opening
      • systemic mucosal or autoimmune inflammatory disease affecting the mucosa of the nasopharynx and eustachian tube (e.g., Samter’s triad, Wegener’s disease, mucosal pemphigus) that is ongoing/active (i.e., not in remission)
    • Patients with aural fullness but normal exam and tympanogram
    • Patients with chronic and severe atelectatic ears

Reversibility of Eustachian Tube Dysfunction

Reversibility of eustachian tube dysfunction can be demonstrated by several means, including any of the following:

  • The patient states that they are able to relieve the pressure by performing a Valsalva maneuver to “pop” their ears
  • Performing a Valsalva maneuver produces temporary improvement of the patient’s tympanogram to Type A tympanogram
  • Performing a Valsalva maneuver causes the member’s middle ear to aerate, which is indicated by the provider visualizing lateral movement of the tympanic membrane on otoscopy

Balloon Dilation of the Eustachian Tube Used in Combination with Other Procedures

  • Patients undergoing BDET concurrent with sinus ostial dilation should meet the same diagnostic criteria for BDET as those undergoing BDET alone.
  • Patients with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement

Coding
Please see the Codes table for details.

Benefit Application 
BlueCard/National Account Issues
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Rationale 
Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function — including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical uses of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Balloon Dilation for Chronic Obstructive Eustachian Tube Dysfunction
Clinical Context and Therapy Purpose
The purpose of balloon dilation of the eustachian tube is to provide a treatment option that is an alternative to or an improvement on existing therapies in patients with chronic obstructive eustachian tube dysfunction despite medical management.

The question addressed in this evidence review is: Does balloon dilation of the eustachian tube improve the net health outcome in patients with chronic obstructive eustachian tube dysfunction?

The following PICO was used to select literature to inform this review.

Patients
The relevant population of interest is individuals with chronic obstructive eustachian tube dysfunction despite medical management.

Eustachian tube (ET) dysfunction occurs when the functional valve of the ET fails to open and/or close properly, frequently due to inflammation. Symptoms may include ear fullness, recurrent barochallenge (difficulty clearing the ears with changes in ambient pressure), hearing loss, otalgia, and tinnitus.

Patients with chronic obstructive eustachian tube dysfunction are managed by otolaryngologists and primary care providers in an outpatient clinical setting.

Interventions
The therapy being considered is balloon dilation of the eustachian tube.

Balloon dilation of the ET is a procedure intended to improve the patency by inflating a balloon in the cartilaginous part of the ET to cause local dilation. During the procedure, a saline-filled balloon catheter is introduced into the eustachian tube through the nose using a minimally invasive transnasal endoscopic method. Pressure is maintained for 2 minutes or less, after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia.

Comparators
Medical management of eustachian tube dysfunction is directed by the underlying etiology: treatment of viral or bacterial rhinosinusitis; systemic decongestants, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; and treatment of mass lesions. Treating underlying conditions, if identified, may be useful in resolving ETD. Patients who continue to have symptoms following medical management may be treated with surgery such as myringotomy with the placement of tympanostomy tubes, methods of eustachian tube dilation other than balloon dilation, or mechanical pressure equalization devices.

Outcomes
The general outcomes of interest are symptoms, change in disease status, quality of life, and treatment-related morbidity. Specific outcome measures are described in Table 2. Initial follow-up examinations are typically done at 4 to 6 weeks to judge early efficacy. Follow up should be at least one year to appropriately establish a clinically meaningful improvement.

Table 2. Outcome Assessment of Chronic Obstructive Eustachian Tube Dysfunction

Outcome Measure Description MCID, if known
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) Validated, standardized, 7-item patient-reported questionnaire to assess symptom severity associated with eustachian tube dysfunction.
Pressure, pain, feeling clogged, cold/sinusitis problems, crackling/popping, ringing, and muffled hearing.
Patients rate the severity of seven symptoms on a scale ranging from 1 (no problem) to 7 (severe problem). Dividing the total score by seven yields the mean item score.
A total score of ≥14.5 and mean item score of ≥2.1 indicate ETD. Scores in the range of 1-2 indicate no to mild symptoms, 3-5 moderate symptoms, and 6-7 severe symptoms.
0.5 point improvement
Normalization is defined as a mean item score <2.1 or a total score <14.5
Valsava maneuver Patient breathes out while closing the nose and mouth to direct air to the ET and help them open.
Modified: gentle nose blow with simultaneous swallow
Positive (ability to perform the maneuver when needed)
Negative (unable to perform the maneuver)
Tympanometry Measures the mobility of the tympanic membrane and graphically displays results in tympanograms. Tympanograms are classified by the height and location of the tympanometric peak.
Type A indicates normal middle ear and ET function; type B indicates poor tympanic membrane mobility (“flat” tympanogram); and type C indicates the presence of negative middle ear pressure.
Type A (normal)
Otoscopy findings Visual examination of the tympanic membrane using an otoscope.
Classifies tympanic membrane as abnormal (retracted membrane, effusion, perforation, or any other abnormality identified on exam) or normal
Normal tympanic membrane

ET: eustachian tube; ETD: eustachian tube dysfunction; MCID: minimal clinically important difference.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

  • To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  • In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  • To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
  • Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Froehlich et al. (2020) conducted a systematic review and meta-analysis of balloon dilation for eustachian tube dysfunction (Tables 3 and 4).6 Twelve studies were included in the meta-analysis, including 3 RCTs, 5 prospective observational studies, and 4 case series. One RCT (Liang et al., 2016) that compared balloon dilation to tympanic paracentesis reported tympanometry and otoscopy scores but not symptoms. The other 2 RCTs compared balloon dilation plus medical management to medical management alone and used the ETDQ-7 to measure symptoms. Table 3 summarizes results at 6 weeks. Pooled analyses showed improvements in subjective and objective measures including ETDQ-7 scores, tympanograms, otoscopy exams, and ability to perform a Valsalva maneuver. Improvements appeared to be maintained in studies with longer-term follow-up (3-12 months).

Several earlier systematic reviews of observational studies have been published. Case series included in these reviews consistently reported that patients experienced improvement when comparing symptoms before and after balloon dilation. The studies varied in the type of medical management used to treat eustachian tube dysfunction before and after balloon dilation.

Table 3. Systematic Review Characteristics

Study Search End Date Included Studies Participants N (range) Study Designs Duration
Froehlich et al. (2020)6 January 2019 35 total,12 included in quantitative meta-analysis Adults with eustachian tube dysfunction 448 patients (2-202)
445 ears (2-234)
3 RCTs, 5 prospective observational, 4 case series 6 weeks-12 months

RCTs: randomized controlled trials

Table 4. Systematic Review Results

Study ETDQ-7 Normalization
(Proportion with score <2.1)
ETDQ-7 Mean Score Valsalva Maneuver
(Proportion able to perform)
Tympanometry Normalization
(Proportion with Type A)1
Tympanometry Improvement
(Proportion with change from Type B to Type A or from Type C to Type B)1
Otoscopy Findings
(Proportion with a normal finding)
N studies/patients
Study designs
2/245
RCTs
3/2,261 RCT,
1 prospective observational, 1 case series
6/436 ears
RCTs
12/606 ears
RCTs, prospective observational, case series
4/287 ears 7/252 ears
Baseline%
(95% CI)
NA NR 13.2%
(0.7-37.5%)
13.9%
(1.5-35.6)
NA 22.1%
(2.0-55.0)
6 weeks
% (95% CI)
53.5%
(47.0, 59.8)
NR 71.2%
(58.8% -82.1%)
58.9
(40.4-76.2)
53.0%
(29.1-76.2)
53.8%
(31.1-75.7)
Pooled Difference Pre-Post (95% CI):

NA

-2.13
(-3.02, -1.24); P =.0004
58.0%
(52.0%-63.3%); P<.001
45.0% (39.9-49.8); P <.0001 NA 31.7% (22.5-40.4), P<0001
I2 (p-value) NR 87% (.0004) NR NR NR NR

1 Type A indicates normal middle ear and ET function; type B indicates poor tympanic membrane mobility (“flat” tympanogram), and type C indicates the presence of negative middle ear pressure.
CI: confidence interval; ETDQ-7: 7-item Eustachian Tube Dysfunction Questionnaire; N: sample size; NA: not applicable; NR: not reported; RCT: randomized controlled trial

Randomized Controlled Trials
Two randomized controlled trials have evaluated BDET for obstructive eustachian tube dysfunction (Tables 5-7).7,8 Both compared BDET plus medical management to medical management alone for 6 weeks. Following the 6-week follow-up period, patients who were randomized to medical management alone could elect to receive BDET and were followed up to 52 weeks in an extension phase.

The balloon catheter used in Poe et al. (2017) was a custom-designed eustachian tube balloon catheter (ETBC) (Acclarent). Eligible patients had persistent patient-reported symptoms of eustachian tube dysfunction ( ETDQ-7 mean item score ≥2.1) and abnormal tympanometry (type B or type C), and failed medical management including either a minimum of 4 weeks of daily use of an intranasal steroid spray or a minimum of 1 course of an oral steroid.7 Each investigator was required to perform 3 successful balloon dilation procedures in nonrandomized “lead-in” patients who were then followed for durability and safety outcomes. Randomization and analyses were performed at the person-level whether or not the patient had unilateral or bilateral ETD. The primary efficacy outcome (normalization of tympanometry) was assessed by both site investigators and a blinded, independent evaluator; discrepancies were resolved by a second independent evaluator. For bilaterally treated patients, both ears had to be rated as normalized for that patient to be considered normalized for the primary outcome.

Anand et al. (2019) reported 52-week data on 128 patients who received an ETBC, including those randomized to the intervention and those who crossed over following the 6-week randomized phase.9 Of 128 patients with normalized tympanogram at 6 weeks, 71 remained normalized at 52 weeks and 71 of 124 had normalized scores on the ETDQ. Some ears failed to normalize at earlier visits but converted at subsequent follow-up visits. Overall,119 of 187 (63.6%) ears had type A tympanograms at 52 weeks, either remaining normal throughout the study or converting to normal. There were no device- or procedure-related serious adverse events during the 52-week follow-up period.

Meyer et al. (2018) was an RCT evaluating eustachian tube balloon dilation versus continued medical therapy in 60 participants with persistent eustachian tube dysfunction. The primary efficacy outcomes were symptoms as measured by the ETDQ-7 score and the primary safety outcome was rate of complications.8 Mean (standard deviation) change in overall ETDQ-7 score at 6 weeks was 2.9 (1.4) for balloon dilation compared with 0.6 (1.0) for medical management: balloon dilation was superior to medical management (p <.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p < 0.006) and tympanic membrane position (p < 0.001) were significantly better for balloon dilation than control. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation. Cutler et al. (2019) reported longer-term follow-up data from this trial.10 Of 58 patients from the original study who were eligible for the extension study, 47 were enrolled (81.0%) The mean follow-up time was 29.4 months post-procedure (range 18-42 months). Changes from baseline at the end of the longer-term follow-up period were similar to improvements observed at 1 year on outcome measures including the ETDQ-7, normalized tympanogram, ability to perform the Valsalva maneuver, and patients' satisfaction with the outcome of the procedure. One patient underwent a revision ET dilation after 362 days, performed concurrently with balloon dilation for recurrent sinus disease. No other surgeries or adverse events were reported.

Study limitations are summarized in Tables 8 and 9. Limitations included a lack of blinding, which could bias reports of patient-reported symptoms, and short (6-week) comparative follow-up period.

Table 5. Randomized Controlled Trials of Balloon Dilation of the Eustachian Tube: Study Characteristics

Study name (NCT Number)
Publications
Countries Dates Key Eligibility Criteria Outcome Measures and Follow-Up Duration Intervention Comparator
The Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (NCT02087150) Poe et al. (2017)7; NCT020871509, U.S., 21 sites 2014-2016

Inclusion: 22 years or older, persistent ETD, failure of medical management, positive diagnosis of ETD

Exclusion:

  • Anatomy that requires an adjunctive surgical procedure
  • Concomitant nasal or sinus procedures planned on the same day as surgical procedure
  • Concomitant ear procedures planned on the same day as surgical procedure
  • History of major surgery of the head or neck within four (4) months prior to surgery
  • History of patulous ET
  • History of fluctuating sensorineural hearing loss
  • Active acute otitis media
  • Tympanic membrane perforation
  • Tympanosclerosis
  • Acute upper respiratory infection
  • Temporomandibular joint disorder
  • Cleft palate
  • Craniofacial syndrome
  • Cystic fibrosis
  • Ciliary dysmotility syndrome
  • Systemic mucosal or immunodeficiency disease
  • Intolerance of medication for ETD
  • Prior intervention of Eustachian tube
Primary: Tympanogram normalization (Type A) in all indicated ears at 6 weeks.
Secondary: Improvement of 0.5 points on ETDQ-7 at 6 weeks. Exploratory: Tympanogram normalization (Type A) at 12, 24, and 52 weeks ETDQ-7 Improvement at 12, 24, 52 weeks
Work and activity impairment at 6, 12, 24,52 weeks
BDET plus medical management (daily nasal steroid spray for 6 weeks) 162 patients (234 ears) Medical management alone (daily nasal steroid spray for 6 weeks) 80 patients (117 ears)
XprESS Eustachian Tube Dilation Study NCT02391584 Meyer et al. (2018)8,10 U.S., 5 sites 2015-2017 Inclusion:18 years or older, diagnosed with symptoms of chronic eustachian tube dysfunction for at least 12 months, ETDQ-7 score ≥3.0, record of failed medical management

Exclusion:
  • Require concomitant procedures at the time of the study enrollment or procedure
  • Have patulous eustachian tube
  • Have ear tubes in place or perforation of the tympanic membrane
  • Have evidence of internal carotid artery dehiscence
  • Being pregnant at the time of enrollment
  • Being currently participating in other drug or device studies
Primary: Mean change in overall ETDQ-7 at 6 weeks, complication rate through 6 months post-procedure
Secondary: technical success rate, revision rate at 12 months, mean change in ETDQ-7 at 3 months, 6 months and 12 months
BDET
  • 31 patients
Continued medical management
  • 29 patients

BDET: balloon dilation of the eustachian tube; ETDQ-7: Eustachian Tube Dysfunction Questionnaire; ETD: eustachian tube dysfunction; NCT: National Clinical Trial.

Table 6. Randomized Controlled Trials of Balloon Dilation of the Eustachian Tube: Results at 6 Weeks

Study name (NCT Number)
Publications
ETDQ-7 Normalization (Score <2.1) ETDQ-7 Mean Change Valsalva Maneuver Positive Normalized Tympanogram (Type A) Otoscopy Results (Tympanic Membrane position normal) Adverse Events
The Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (NCT02087150) Poe et al. (2017)7; NCT02087150            
BDET plus medical management 77/137
(56.2%)
  32.8% increase in number of ears 72/139
(51.8%)
Not assessed 4 serious adverse events
No device- or procedure-related serious adverse events
Medical management alone 6/71
(8.5%)
  3.1% increase in number of ears 10/72
(13.9%)
  1 serious adverse event
No medication-related serious adverse events
P-value <.001   <.001 <.0001    
XprESS Eustachian Tube Dilation Study
NCT02391584
Meyer et al. (2018)8
           
BDET plus medical management   -2.9
(1.4)
8/17
(47.1%)
8/14
(57.1%)
10/15
(66.7%)
No complications
Medical management alone   -0.6
(1.0)
2/14
(1.3%)
1/10
(10.0%)
0/12
(0.0%)
No complications
P-value   <.0001 .068 .006 .001  

BDET: balloon dilation of the eustachian tube; ETDQ-7: Eustachian Tube Dysfunction Questionnaire; NCT: National Clinical Trial.

Table 7. Randomized Controlled Trials of Balloon Dilation of Eustachian Tube - Uncontrolled Extension Phase Results (52 weeks)

Study name (NCT Number) Publications ETDQ-7 Normalization (Score <2.1) at 52 Weeks ETDQ-7 Mean Change Valsalva Maneuver Positive at 52 Weeks Normalized Tympanogram (Type A) at 52 weeks Otoscopy Results (Tympanic Membrane position normal) Adverse Events
The Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (NCT02087150)9            
Number analyzed 124   230 (Ears) 128 (187 ears)   219
BDET plus medical management 71/124 (57.3%)   Ears: 185/230 (80,4%) Patients: 71/128 (55.5%) Ears: 119/187 (63.6%) Not assessed No device- or procedure-related serious adverse events
Two occurrences of patulous ET, both described as mild.
XprESS Eustachian Tube Dilation Study NCT02391584 Meyer et al. (2018)8,10            
N   49 47 80 49 49
BDET plus medical management   2.1 (SD reported in graph only) 31/47 (66.0%) 70/80 (87.5%) 42/49 (85.7%) No complications

BDET: balloon dilation of the eustachian tube; ETDQ-7: Eustachian Tube Dysfunction Questionnaire; NCT: National Clinical Trial.

Table 8. Randomized Controlled Trials: Study Relevance Limitations

Study Population Intervention Comparator Outcomes Follow-Up
Poe et al. (2017)7      
  1. Limited information on harms provided in the primary publication vs. FDA dossier
  1. Only 6 weeks of comparative data; longer follow-up of BDET to 52 weeks in subset of patients.
Meyer et al. (2018) 8
  1. Study enrollment criteria did not require abnormal middle ear functional assessments
     
  1. Comparative outcomes limited to 6 weeks; longer follow-up of BDET in subset of patients.
Key
  1. Intended use population unclear
  2. Clinical context for treatment is unclear
  3. Study population unclear
  4. Study population not representative of intended use
  5. Study population is subpopulation of intended use
  1. Not clearly defined
  2. Version used unclear
  3. Delivery not similar intensity as comparator
  1. Not clearly defined
  2. Not standard or optimal
  3. Delivery not similar intensity as intervention
  4. Not delivered effectively
  1. Key health outcomes not addressed
  2. Physiologic measures, not validated surrogates
  3. Not CONSORT reporting of harms
  4. Not established and validated measurements
  5. Clinically significant difference not prespecified
  6. Clinically significant difference not supported
  1. Not sufficient duration for benefits
  2. Not sufficient duration for harms

BDET: balloon dilation of the eustachian tube
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

Table 9. Randomized Controlled Trials: Study Design and Conduct Limitations

Study Allocation Blinding Selective Reporting Follow-Up Power Statistical
Poe et al. (2017)7  
  1. Blinding of patients not possible; may bias patient-reported measures
     
  1. Treatment effects and CIs not reported.
Meyer et al. (2018)8  
  1. Blinding of patients not possible; may bias patient-reported measures
       
Key
  1. Participants not randomly allocated
  2. Allocation not concealed
  3. Allocation concealment unclear
  4. Inadequate control for selection bias
  1. Not blinded to treatment assignment
  2. Not blinded outcome assessment
  3. Outcome assessed by treating physician
  1. Not registered
  2. Evidence of selective reporting
  3. Evidence of selective publication
  1. High loss to follow-up or missing data
  2. Inadequate handling of missing data
  3. High number of crossovers
  4. Inadequate handling of crossovers
  5. Inappropriate exclusions
  6. Not intent to treat analysis (per protocol for noninferiority trials)
  1. Power calculations not reported
  2. Power not calculated for primary outcome
  3. Power not based on clinically important difference
  1. Test is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event
  2. Test is not appropriate for multiple observations per patient
  3. Confidence intervals and/or p values not reported
  4. Comparative treatment effects not calculated

CI: confidence interval
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.

Summary of Evidence
For individuals who have chronic obstructive eustachian tube dysfunction despite medical management who receive balloon dilation of the eustachian tube, the evidence includes RCTs, prospective observational studies, case series, and systematic reviews of these studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Two 6-week randomized controlled trials found more improvement with balloon dilation plus medical management than medical management alone on patient-reported symptoms, ability to perform a Valsalva maneuver, proportion of patients with normalized tympanograms, and otoscopy findings. Durability of these effects was demonstrated at 52 weeks in the uncontrolled extension phase of both RCTs. No serious device- or procedure-related adverse events were reported through 52 weeks of follow-up. Multiple observational studies and case series have reported that patients experienced improvement when comparing symptoms before and after balloon dilation. The evidence is sufficient to determine the effects of the technology on the net health outcome.

Clinical Input From Physician Specialty Societies And Academic Medical Centers
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2020 Input

For individuals who have obstructive eustachian tube dysfunction who receive balloon dilation of the eustachian tube, clinical input supports this use provides a clinically meaningful improvement in net health outcome and indicates this use is consistent with generally accepted medical practice in a subgroup of appropriately selected patients using the following criteria:

  • Obstructive eustachian tube dysfunction for 3 months or longer in one or both ears that significantly affects quality of life or functional health status;
  • The patient has undergone a comprehensive diagnostic assessment; including history and physical exam, tympanometry if the tympanic membrane is intact, nasopharyngoscopy, and comprehensive audiometry; and
  • Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4-6 weeks of a nasal steroid spray, if indicated.

 

Practice Guidelines and Position Statements
American Academy of Otolaryngology- Head and Neck Surgery Foundation
In 2019, the American Academy of Otolaryngology published a clinical consensus statement on balloon dilation of the eustachian tube (BDET).2 The target population was defined as adults ages 18 years or older who are candidates for BDET because of obstructive eustachian tube dysfunction (ETD) in 1 or both ears for 3 months or longer that significantly affects quality of life or functional health status. The expert panel concluded:

  • BDET is an option for treatment of patients with obstructive ETD.
  • The diagnosis of obstructive ETD should not be made without a comprehensive and multifaceted assessment, including otoscopy, audiometry, and nasal endoscopy.
  • BDET is contraindicated for patients diagnosed as having a patulous ETD
  • Further study will be needed to refine patient selection and outcome assessment.

The authors emphasized the importance of identifying other potentially treatable causes of ETD, including allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, and noted that medical management of these disorders is indicated prior to offering BDET. They also noted that potential risks of BDET that are relevant to patient counseling include bleeding, scarring, infection, development of patulous ETD, and/or the need for additional procedures.

National Institute for Health and Care Excellence
In 2019, the National Institute for Health and Care Excellence (NICE) published updated guidance on BDET.11 The guidance was based on a rapid review of the evidence12 and stated, "Evidence on the safety and efficacy of balloon dilation for eustachian tube dysfunction is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit." NICE standard arrangements recommendations mean that there is enough evidence for doctors to consider the procedure as an option.

The guidance also noted:

  • The procedure was not effective in all patients, and there was little evidence on the benefit of repeat procedures.
  • The procedure is only indicated for chronic eustachian tube dysfunction refractory to medical treatment.

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 10.

Table 10. Unpublished Clinical Trials

NCT No. Trial Name Planned Enrollment Completion Date
Ongoing      
NCT04136977a XprESS Eustachian Tube Balloon Dilation Registry 300 Jul 2020
NCT03499015 Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial 50 Oct 2020
NCT04055714a Feasibility of Balloon Dilation of the Eustachian Tubes for Dilatory Dysfunction Under Local Anesthesia 25 Oct 2021
NCT03886740 Tympanostomy Tubes Versus Eustachian Tube Dilation 32 Aug 2021
NCT03556215 Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction 55 Nov 2020

NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial. 

References 

  1. Schilder AG, Bhutta MF, Butler CC, et al. Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. Oct 2015; 40(5): 407-11. PMID 26347263
  2. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical Consensus Statement: Balloon Dilation of the Eustachian Tube. Otolaryngol Head Neck Surg. Jul 2019; 161(1): 6-17. PMID 31161864
  3. Norman G, Llewellyn A, Harden M, et al. Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. Feb 2014; 39(1): 6-21. PMID 24438176
  4. Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol. Mar-Apr 2011; 32(2): 115-23. PMID 20392533
  5. Schroder S, Lehmann M, Ebmeyer J, et al. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. Dec 2015; 40(6): 629-38. PMID 25867023
  6. Froehlich MH, Le PT, Nguyen SA, et al. Eustachian Tube Balloon Dilation: A Systematic Review and Meta-analysis of Treatment Outcomes. Otolaryngol Head Neck Surg. Jun 02 2020: 194599820924322. PMID 32482125
  7. Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. May 2018; 128(5): 1200-1206. PMID 28940574
  8. Meyer TA, O'Malley EM, Schlosser RJ, et al. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. Aug 2018; 39(7): 894-902. PMID 29912819
  9. Anand V, Poe D, Dean M, et al. Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group. Otolaryngol Head Neck Surg. Apr 2019; 160(4): 687-694. PMID 30620688
  10. Cutler JL, Meyer TA, Nguyen SA, et al. Long-term Outcomes of Balloon Dilation for Persistent Eustachian Tube Dysfunction. Otol Neurotol. Dec 2019; 40(10): 1322-1325. PMID 31385858
  11. National Institute for Health and Care Excellence. Balloon dilation for chronic eustachian tube dysfunction. Interventional procedures guidance (IPG665). December 2019. https://www.nice.org.uk/guidance/ipg665. Accessed August 14, 2020.
  12. National Institute for Health and Care Excellence. Interventional procedure overview of balloon dilation for chronic eustachian tube dysfunction. https://www.nice.org.uk/guidance/ipg665/documents/overview-2 December 2019. Accessed August 14, 2020.

Coding Section

Codes Number Description
CPT 69705 (effective 01/01/2021) Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral
  69706 (effective 01/01/2021)  Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); bilateral 
HCPCS C9745 Nasal endoscopy, surgical; balloon dilation of eustachian tube
ICD-10-CM H68.001-H68.029 Eustachian salpingitis code range
  H69.80-H69.93 Other specified and unspecified disorders of Eustachian tube code range
  H65.00-H65.93 Nonsuppurative otitis media code range
  H66.001-H66.93 Suppurative and & unspecified otitis media code range
  H67.1-H67.9 Otitis media in diseases classified elsewhere code range
  H71.00-H71.93 Cholesteatoma of middle ear code range
  H72.00-H72.93 Perforation of tympanic membrane code range
  H90.0-H90.A32 Conductive and sensorineural hearing loss code range
  H81.311-H81.49 Peripheral and Central vertigo code range
  H91.01-H91.93 Other and unspecified hearing loss code range
  J30.0-J30.9 Vasomotor and Allergic rhinitis
  J31.0-J32.9 Chronic rhinitis and Sinusitis range
ICD-10-PCS 097F4ZZ Dilation of Right Eustachian Tube, Percutaneous Endoscopic Approach
  097F8DZ Dilation of Right Eustachian Tube with Intraluminal Device, Via Nat. or Artificial Opening Endoscopic
  097F8ZZ Dilation of Right Eustachian Tube, Via Nat. or Artif Opening Endoscopic
  097G4ZZ Dilation of Left Eustachian Tube, Percutaneous Endoscopic Approach
  097G8DZ Dilation of Left Eustachian Tube with Intraluminal Device, Via Natural or Artificial Opening Endoscopic
  097G8ZZ Dilation of Left Eustachian Tube, Via Natural or Artificial Opening Endoscopic
Type of Service Surgical  
Place of Service Office, Outpatient, Inpatient  

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2020 Forward     

02/11/2022

Interim review, updating rationale and removing appendix. 

10/01/2021 

Annual review, no change to policy intent. 

02/02/2021 

Interim update to reformat policy, no change to policy intent. 

12/10/2020 

Updating coding with 2021 coding. No other changes. 

10/20/2020

New Policy

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