Medical Policy Medical Policy
Policy Num: 07.001.128
Policy Name: Balloon Dilation of the Eustachian Tube
Policy ID: [07.001.128] [Ac / B / M+ / P+] [7.01.158]
Last Review: October 16, 2025
Next Review: October 20, 2026
Related Policies:
07.001.151 - Balloon Ostial Dilation for Treatment of Chronic and Recurrent Acute Rhinosinusitis
| Population Reference No. | Populations | Interventions | Comparators | Outcomes |
| 1 | Individuals: · With chronic obstructive eustachian tube dysfunction despite medical management | Interventions of interest are: · Balloon dilation of the eustachian tube | Comparators of interest are: · Continued medical management · Mechanical pressure equalization device · Tympanostomy · Eustachian tuboplasty other than balloon dilation | Relevant outcomes include: · Symptoms · Change in disease status · Quality of life · Treatment-related morbidity |
Eustachian tube dysfunction (ETD) 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 ETD can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas. Balloon dilation of the eustachian tube (BDET) is a procedure intended to improve patency by inflating a balloon in the cartilaginous part of the eustachian tube to cause local dilation.
For individuals who have chronic obstructive ETD despite medical management who receive BDET, the evidence includes randomized controlled trials (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 RCTs 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 followup. 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 that the technology results in an improvement in the net health outcome.
Clinical input was sought to help determine whether the use of BDET for individuals with chronic obstructive ETD despite medical management would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 4 respondents, including 1 specialty society-level response including physicians with academic medical center affiliation and 3 physician-level responses affiliated with an academic medical center.
For individuals who have chronic obstructive ETD who receive BDET, 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 ETD for 3 months or longer in 1 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
Further details from clinical input are included in the Appendix.
The objective of this evidence review is to determine whether balloon dilation of the eustachian tube improves the net health outcome in patients with chronic eustachian tube dilatory dysfunction.
Balloon dilation of the eustachian tube (BDET) for treatment of chronic obstructive eustachian tube dysfunction (ETD) may be considered medically necessary under the following conditions:
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
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)
Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam)
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
AND
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.
AND
If the individual had a history of tympanostomy tube placement, symptoms of obstructive ETD should have improved while tubes were patent.
AND
The individual does not have patulous ETD or another contraindication to the procedure (see Policy Guidelines).
AND
The individual's ETD has been shown to be reversible (see Policy Guidelines).
AND
Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to barochallenge such as pressure changes while flying).
AND
The individual has not had a previous BDET procedure.
Balloon dilation of the eustachian tube is considered investigational if the above criteria are not met.
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).
The following individuals should not be considered for balloon dilation of the eustachian tube:
Individuals with patulous eustachian tube dysfunction (ETD).
A diagnosis of patulous ETD is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
Individuals with extrinsic reversible or irreversible causes of ETD 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).
Individuals with aural fullness but normal exam and tympanogram.
Individuals 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
Individuals with a middle ear effusion at the time of BDET may benefit from concurrent myringotomy with or without tympanostomy tube placement.
Please see the Codes table for details.
BlueCard/National Account Issues
State or federal mandates (eg, 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.
Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.
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,
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 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 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.
| Device | Manufacturer | Date Cleared | 510(k) No. | Indication |
| Acclarent Aera Eustachian Tube Balloon Dilation System | Acclarent, Inc. | 01/16/2018 | K171761; K230742 | Eustachian tube dilation |
| Xpress ENT Dilation System | Entellus Medical, Inc. | 04/05/2017 | K163509 | Eustachian tube dilation |
| Nuvent Eustachian Tube Dilation Balloon | Medtronic Xomed, Inc. | 08/16/2021 | K210841 | Eustachian tube dilation |
| Audion Et Dilation System | Entellus Medical, Inc. | 04/12/2022 | K220027 | Eustachian tube dilation |
| Vensure Balloon Dilation System | Fiagon GmbH | 05/26/2023 | K230065 | Eustachian tube dilation |
Multiple devices have been given a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II, FDA product code: PNZ) (Table 1).
This evidence review was created in February 2018 and has been updated regularly with searches of the PubMed database. The most recent literature search was conducted through August 1 , 2024.
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 1 or more intended clinical use 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. Randomized controlled trials 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.
The purpose of balloon dilation of the eustachian tube (BDET) 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 (ETD) despite medical management.
The following PICO was used to select literature to inform this review.
The relevant population of interest is individuals with chronic obstructive ETD despite medical management.
Eustachian tube dysfunction occurs when the functional valve of the eustachian tube 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.
The therapy being considered is BDET.
Balloon dilation of the eustachian tube is a procedure intended to improve the patency by inflating a balloon in the cartilaginous part of the 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.
Medical management of ETD 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.
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 1 year to appropriately establish a clinically meaningful improvement.
| 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 ETD. Pressure, pain, feeling clogged, cold/sinusitis problems, crackling/popping, ringing, and muffled hearing. Patients rate the severity of 7 symptoms on a scale ranging from 1 (no problem) to 7 (severe problem). Dividing the total score by 7 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 to 2 indicate no to mild symptoms, 3 to 5 moderate symptoms, and 6 to 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 eustachian tube 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 eustachian tube 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 |
ETD: eustachian tube dysfunction; MCID: minimal clinically important difference.
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.
Froehlich et al (2020) conducted a systematic review and meta-analysis of balloon dilation for ETD (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 to 12 months).
Aboueisha and colleagues (2022) published a meta-analysis of balloon dilation for eustachian tube dysfunction (BDET) in children.7, The authors searched PubMed, Embase, Web of Science, Cochrane, Clinicaltrials.gov, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) databases and identified 7 studies that examined the safety and efficacy of BDET in pediatric patients from database inception to March 2021. The evidence base encompassed 6 retrospective cohort studies and 1 prospective cohort study with a matched retrospective control group. Among these studies, 4 were designed as single-arm investigations, while 3 studies compared the outcomes of BDET with ventilation tube insertion (VT). Utilizing the methodological index for non-randomized studies (MINORS) criteria, two reviewers evaluated the potential bias in the included studies. The overall quality assessment revealed a moderate quality level, with the comparative studies achieving an average score of 17.3 and the non-comparative studies achieving 10.6.
The pooled studies included a total of 408 children, averaging 9.9 years of age, with an average follow-up period of 19.2 months. In almost all cases (except for one study where data was not available on pre-treatment), patients had a history of prior surgeries, including VT plus adenoidectomy or VT alone. Aggregating data from all 7 studies, the pooled complications exhibited an incidence rate of 5.1% (95% confidence interval [CI], 3.1 to 8.4), with self-limited epistaxis being the most frequently reported complication. Following BDET, the proportion of patients with Type A tympanogram increased from 15.1% to 73.6% (95% CI, 58% to 84.9%) and the number of patients with Type B tympanogram decreased from 64.2% in the pre-operative period to 16.1% (95% CI, 8.5 to 28.4) post-operatively pooling data from 5 studies. All pooled post-operative outcomes had high heterogeneity with the exception of complication rate, which had a low level of heterogeneity. In the 3 studies that compared BDET to VT, a significant difference in the rate of failure (need for reoperation, persistent type B tympanogram, or persistence of symptoms) was observed, favoring the BDET group (OR, 0.24; 95% CI, 0.1 to 0.4; I2, 80.9%) however high heterogeneity was observed across the 3 studies pooled for this estimate.
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 ETD before and after balloon dilation.
| 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 ETD | 448 patients (2 to 202) 445 ears (2 to 234) | 3 RCTs, 5 prospective observational, 4 case series | 6 weeks to 12 months |
ETD: eustachian tube dysfunction; RCTs: randomized controlled trials.
| 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 | 3/2261 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 to 37.5) | 13.9% (1.5 to 35.6) | NA | 22.1% (2.0 to 55.0) |
| 6 weeks % (95% CI) | 53.5% (47.0, 59.8) | NR | 71.2% (58.8 to 82.1) | 58.9% (40.4 to 76.2) | 53.0% (29.1 to 76.2) | 53.8% (31.1 to 75.7) |
| Pooled Difference Pre-Post (95% CI): | NA | -2.13 (-3.02 to -1.24); p.0004 | 58.0% (52.0 to 63.3); p<.001 | 45.0% (39.9 to 49.8); p<.0001 | NA | 31.7% (22.5 to 40.4), p<.0001 |
| I2 (p value) | NR | 87% (.0004) | NR | NR | NR | NR |
1Type 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.Two randomized controlled trials have evaluated BDET for obstructive ETD (Tables 5 to 7).8,9, Both compared BDET plus medical management to medical management alone for 6 weeks. Following the 6-week followup 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 ETD (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.8, 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 a ETBC, including those randomized to the intervention and those who crossed over following the 6-week randomized phase.10, 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) conducted a RCT evaluating BDET versus continued medical therapy for treating 60 participants with persistent ETD. The primary efficacy outcomes were symptoms as measured by the ETDQ-7 score and the primary safety outcome was rate of complications. 9, 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<.006) and tympanic membrane position (p<.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.11, 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 to 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 eustachian tube 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.
| Study name (NCT Number)Publications | Countries | Dates | Key Eligibility Criteria | Outcome Measures and Duration of Followup | Intervention | Comparator |
| The Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (NCT02087150)Poe et al (2017)8,;NCT0208715010, | U.S., 21 sites | 2014-2016 | Inclusion: 22 years or older, persistent ETD, failure of medical management, positive diagnosis of ETD Exclusion:
| 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 StudyNCT02391584Meyer et al (2018)9,11, | U.S., 5 sites | 2015-2017 | Inclusion:18 years or older, diagnosed with symptoms of chronic ETD for at least 12 months, ETDQ-7 score ≥3.0, record of failed medical management Exclusion:
| 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
| Continued medical management
|
BDET: balloon dilation of the eustachian tube; ETDQ-7: Eustachian Tube Dysfunction Questionnaire; ETD: eustachian tube dysfunction; NCT: National Clinical Trial.
| 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) 8,;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)9, | ||||||
| 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.
| 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)10, | ||||||
| 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 eustachian tube, both described as mild. | |
| XprESS Eustachian Tube Dilation StudyNCT02391584Meyer et al (2018)9,11, | ||||||
| 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.
| Study | Population | Intervention | Comparator | Outcomes | Follow-Up |
| Poe et al (2017)8, |
|
| |||
| Meyer et al (2018) 9, |
|
|
BDET: balloon dilation of the eustachian tube; FDA: Food and Drug Administration. The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.
| Study | Allocation | Blinding | Selective Reporting | Follow-Up | Power | Statistical |
| Poe et al (2017)8, |
|
| ||||
| Meyer et al (2018)9, |
|
CI: confidence interval. The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Data Completeness key: 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). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.
| Population Reference No. 1 Policy Statement | [X] Medically Necessary | [ ] Investigational |
The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.
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.
Clinical input was sought to help determine whether the use of balloon dilation of the eustachian tube (BDET) for individuals with chronic obstructive eustachian tube dysfunction (ETD) despite medical management would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice. In response to requests, clinical input was received from 4 respondents, including 1 specialty society-level response including physicians with academic medical center affiliation and 3 physician-level responses affiliated with an academic medical center.
For individuals who have obstructive ETD who receive BDET, 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 ETD for 3 months or longer in 1 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 to 6 weeks of a nasal steroid spray, if indicated.
Further details from clinical input are included in the Appendix.
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.
In 2019, the American Academy of Otolaryngology published a clinical consensus statement on BDET.2, The target population was defined as adults ≥18 years who are candidates for BDET because of obstructive 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.
In 2019, the National Institute for Health and Care Excellence (NICE) published updated guidance on BDET.12, The guidance was based on a rapid review of the evidence,13, 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 ETD refractory to medical treatment.
Not applicable.
There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.
Some currently ongoing and unpublished trials that might influence this review are listed in Table 10.
| NCT No. | Trial Name | Planned Enrollment | Completion Date |
| Ongoing | |||
| NCT05719207 | Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction | 76 | Dec 2024 |
| NCT05998356 | Long-term Assessment of Balloon Eustachian Tuboplasty for Obstructive Eustachian Tube Disease: A Multicenter Single-blinded Randomized Controlled Study | 96 | Jan 2027 |
| Unpublished | |||
| NCT03499015 | Balloon Dilation of the Eustachian Tube in Children: a Randomized Side-controlled Clinical Trial | 50 | Oct 2020 (recruitment status unknown; last update Nov 2018) |
| NCT04136977a | XprESS Eustachian Tube Balloon Dilation Registry | 169 | Aug 2020 (completed; results submitted July 21, 2021, but quality control review process not yet concluded) |
| NCT03886740 | Tympanostomy Tubes Versus Eustachian Tube Dilation | 32 | Aug 2021 ( withdrawn, difficulty enrolling) |
| NCT05270031 | Balloon Dilation of the Eustachian Tube | 58 | Feb 2026 (terminated, lack of funding) |
NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial.
| Codes | Number | Description |
| CPT | 69705 | Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral |
| 69706 | Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); Bilateral | |
| HCPCS | N/A | |
| ICD-10-CM | 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 | |
| | H68.001-H68.029 | Eustachian salpingitis code range |
| H69.80-H69.93 | Other specified and unspecified disorders of Eustachian tube code range | |
| | H71.00-H71.93 | Cholesteatoma of middle ear code range |
| | H72.00-H72.93 | Perforation of tympanic membrane code range |
| H81.01-H81.09 | Meniere's disease, code range | |
| H81.311-H81.49 | Peripheral and Central vertigo code range | |
| | H90.0-H90.A32 | Conductive and sensorineural hearing loss 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 |
| Date | Action | Description |
|---|---|---|
| 10/16/2025 | Annual Review | No change |
| 10/07/2024 | Annual Review | Policy updated with literature review through August 1, 2024; no references added. Policy statements unchanged. |
| 10/11/2023 | Annual Review | Policy updated with literature review through August 3, 2023; reference added. Policy statements unchanged. A paragraph for promotion of greater diversity and inclusion in clinical research of historically marginalized groups was added to Rationale section. |
| 10/06/2022 | Annual Review | Policy updated with literature review through June 20, 2022; no references added. Minor refinements to policy statements; intent unchanged |
| 10/18/2021 | Annual Review | Policy updated with literature review through August 3, 2021; no references added. Policy statement unchanged. CPT 69705 and 69706 added. |
| 10/20/2020 | Policy Reviewed | The ICD 10 CM :H81.01-H81.09 Meniere's disease code range were deleted from this version. Policy updated with literature review through July 12, 2020. references added. Clinical input was added. Policy statement changed: Balloon dilation of the eustachian tube for treatment of patients with chronic obstructive eustachian tube dysfunction may be considered medically necessary |
| 08/27/2020 | Policy Reviewed | No change |
| 03/18/2020 | Policy Reviewed | Policy Stament Unchanged |
| 03/26/2019 | Policy Created | New Policy |
In 2020, clinical input was sought to help determine whether the use of balloon dilation of the eustachian tube for individuals with chronic eustachian tube dilatory dysfunction despite medical management would provide a clinically meaningful improvement in net health outcome and whether the use is consistent with generally accepted medical practice.
Clinical input was provided by the following specialty societies and physician members identified by a specialty society or clinical health system:
American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS)
Dennis S. Poe, MD, PhD, Otolaryngology, Professor of Otolaryngology, Harvard Medical School and Boston Children’s Hospital **
Anonymous, Otolaryngology/Neurotology, Associate Professor at an academic medical center
Anonymous, Neurotology, Associate Professor at an academic medical center
* Indicates that no response was provided regarding conflicts of interest related to the topic where clinical input is being sought. ** Indicates that conflicts of interest related to the topic where clinical input is being sought were identified by this respondent (see Appendix).
Clinical input provided by the specialty society at an aggregate level is attributed to the specialty society. Clinical input provided by a physician member designated by a specialty society or health system is attributed to the individual physician and is not a statement from the specialty society or health system. Specialty society and physician respondents participating in the Evidence Street® clinical input process provide review, input, and feedback on topics being evaluated by Evidence Street. However, participation in the clinical input process by a specialty society and/or physician member designated by a specialty society or health system does not imply an endorsement or explicit agreement with the Evidence Opinion published by BCBSA or any Blue Plan.
| Specialty Society | ||||||
| # | Name of Organization | Clinical Specialty | ||||
| 1 | American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) | Otolaryngology | ||||
| Physician | ||||||
| # | Name | Degree | Institutional Affiliation | Clinical Specialty | Board Certification and Fellowship Training | |
| 2 | Dennis S. Poe | MD, PhD, | Professor of Otolaryngology, Harvard Medical School and Boston Children’s Hospital | Otolaryngology | Board: Otolaryngology, Subspecialty Board: Neurotology, Fellowship: Neurotology | |
| 3 | Anonymous | MD | Associate Professor at an academic medical center | Otolaryngology/Neurotology | Otolaryngology and Neurotology | |
| 4 | Anonymous | MD. MBA. MPH | Associate Professor at an academic medical center | Neurotology | AbOto-HNS | |
| # | 1) Research support related to the topic where clinical input is being sought | 2) Positions, paid or unpaid, related to the topic where clinical input is being sought | 3) Reportable, more than $1,000, health care‒related assets or sources of income for myself, my spouse, or my dependent children related to the topic where clinical input is being sought | 4) Reportable, more than $350, gifts or travel reimbursements for myself, my spouse, or my dependent children related to the topic where clinical input is being sought | ||||
| YES/NO | Explanation | YES/NO | Explanation | YES/NO | Explanation | YES/NO | Explanation | |
| 1 | No | No | No | No | ||||
| 2 | Yes | I was the PI for the FDA-mandated clinical trial of the balloon dilation technology in support of the application for FDA clearance. We received support for research administration and clinical care of the subjects. I did not receive any support for my time nor payment for clinic visits or surgery. | Yes | I am a consultant for Acclarent corp., one of the manufacturers of the balloon device. They reimburse me for my time and expenses, but I have no royalties from their products and no equity interest in the company. | Yes | I continue to serve as a consultant to Acclarent to further advance the technology for the treatment of Eustachian tube disorders | Yes | In my consultant role, my travel is reimbursed for me to participate in R&D and to teach programs to educate surgeons on Eustachian tube disorders and use of the balloon technology. |
| 3 | No | No | No | No | ||||
| 4 | No | No | No | No | ||||
Individual physician respondents answered at individual level. Specialty Society respondents provided aggregate information that may be relevant to the group of clinicians who provided input to the Society-level response. NR = not reported
Question 1. We are seeking your opinion on whether using balloon dilation of the eustachian tube for individuals with chronic eustachian tube dilatory dysfunction despite medical management (see criteria below) provides a clinically meaningful improvement in net health outcome.
Patient selection criteria are further defined as:
Eustachian tube dilatory dysfunction for 3 months or longer in one or both ears that significantly affects quality of life or functional health status; and
Failure to respond to appropriate medical management of potential co-occurring conditions such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 12 weeks of a nasal steroid spray, unless contraindicated; and
The patient has undergone a comprehensive diagnostic assessment; including tympanometry, nasopharyngoscopy, audiometry, and nasal endoscopy; and
The patient has not been diagnosed as having patulous eustachian tube dysfunction.
Please respond based on the evidence and your clinical experience. Please address these points in your response:
Relevant clinical scenarios (e.g., a chain of evidence) where the technology is expected to provide a clinically meaningful improvement in net health outcome;
Specific outcomes that are clinically meaningful;
Are there any additional patient inclusion/exclusion criteria or clinical context important to consider in identifying individuals for this indication (eg, atelectatic ears? osseous erosion? failure after ear tube insertion? documented conductive hearing loss? type B or C tympanogram in ear to be dilated? use in children and if so what age cut-off?);
Supporting evidence from the authoritative scientific literature (please include PMID).
| # | Rationale |
| 1 | The AAO-HNS believes nasal steroid sprays are indicated for the treatment of nasal congestion due to allergic rhinitis. Effects should occur within first 36 hours. It is not indicated, nor is it FDA approved, for the treatment of Obstructive Eustachian Tube dysfunction (OETD). Therefore, from AAO-HNS Clinical Practice Guideline (2015), “based on the above data, it is reasonable to assume that efficacy would be reached after 1 week of therapy at the most and, if none is observed, the treatment might be considered ineffective.” (1) If OETD may be due at least in part from allergic rhinitis, 4 weeks duration should be sufficient to determine if the medication will be effective. Nasal steroid sprays have been shown to be ineffective in an RCT when used to treat OETD. (2) If rhinosinusitis is present, appropriate treatment may have included the use of prior antibiotics and sometimes surgery. If laryngopharyngeal reflux is present, antacids or proton pump inhibitors should demonstrate efficacy within a 4-week treatment course. (3) Indications for Balloon Dilation of the Eustachian tube (BDET) The AAO-HNS believes that the following would be appropriate: Balloon dilation of the eustachian tube (BDET) for treatment of adults (18 years of age and older) with chronic obstructive eustachian tube dysfunction may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:
In patients that meet the above criteria, BDET is not necessarily contra-indicated for the following conditions:
The two most common clinical scenarios are described below: 1) An adult has developed persistent (3 or months) symptoms in one or both ears of aural fullness (blocked or pressure sensation), hearing loss, and difficulty clearing the ear(s), especially on flights or submerging in a pool. There may have been one or more episodes of ear infection (acute otitis media) or middle ear fluid (otitis media with effusion). During the course of the ear complaint, the patient has been evaluated for possible underlying causes such as allergic rhinitis, rhinosinusitis or laryngopharyngeal reflux, which are the most common co-morbidities. If a co-morbidity has been identified, it has been treated appropriately for at least 4 weeks and has failed to show improvement in symptoms. The patient may have been treated with a tympanostomy tube, one or more times. If a tube was placed, the patient’s symptoms should have improved while it was patent, although complete resolution may not have occurred. In the event of tube extrusion, the patient’s symptoms have recurred, and additional treatment is being considered. The patient has not had complaints of persistent, chronic autophony of voice and breathing to suggest possible patulous Eustachian tube. There is difficulty or inability to clear their ear fullness sensation (“pop their ear”) with autoinsufflation. One example of autoinsufflation is a modified Valsalva maneuver (nose and mouth closed, gently blowing nose to raise intranasal pressure and simultaneous swallow). Examination: Otoscopy shows retraction of the tympanic membrane with evidence of negative pressure within the middle ear. There may be a middle ear effusion, a retraction pocket that is fixed, atelectasis of a portion of the tympanic membrane, or even cholesteatoma. The presence of negative pressure may be confirmed by pneumatic insufflation. Testing: Audiogram shows a conductive hearing loss. Tympanogram shows evidence of negative pressure (type B or C curves). Nasal/nasopharyngeal endoscopy: Endoscopy is done while the patient is at rest and when performing swallows and yawns (dynamic exam). In most cases, some pathology will be observed, usually inflammation. Examples of inflammatory changes can be edema, erythema, cobblestoning (lymphoid hyperplasia), hypertrophied tubal tonsil tissue, reduced opening of the lumen. This patient meets the indications for either a tympanostomy tube (primary, repeat, or long-term tube depending on whether tubes have been used previously) or a balloon dilation of the Eustachian tube. As a tube does not treat the source of the Eustachian tube dysfunction, there may be a preference for BDET if symptoms have returned after previous tube placement. The risk of complications from tympanostomy tubes increases with increasing numbers of tube placements and duration of tubes. (4) 2) An adult has developed persistent (3 or months) symptoms in one or both ears of aural fullness (blocked or pressure sensation), hearing loss and difficulty clearing the ear(s) that occurs consistently on flights, diving into a pool, high elevators or with other significant changes in ambient pressure (termed baro-challenge). There have not been any other ear problems, but the pain is significant when baro-challenged. Measures such as oral or nasal decongestants, nasal steroid sprays (only for allergic rhinitis patients) have not been helpful. (33-36)Examination:
Durability of results BDET has been shown to cause histological changes within the lumen of the Eustachian tube, including reduction in inflammation within the mucosa and elimination of the submucosal lymphoid hyperplasia. (10, 11) The pretreatment histopathology and post-operative changes are similar to findings with adenoidectomy. Therefore, permanent histological improvement would be expected, similar to adenoidectomy. However, if there is an on-going co-morbidity that may induce inflammation, adenoid tissue can regrow and the adenoid-like tissue within the lumen of the Eustachian tube could also regrow. Ongoing medical attention to possibly relevant co-morbidities may be important in durability of results, similar to adenoidectomy. (10) All of the studies to date with one year or longer duration of follow up have demonstrated that the results have been stable and durable. (8,9,12-15) |
| 2 | Suggested edits to the indication and patient selection criteria: Population for the indication: Preferred terminology by AAOHNS Clinical Consensus Statement is Obstructive Eustachian tube dysfunction as opposed to Patulous Eustachian tube dysfunction. Suggested edits to the patient selection criteria:
Rationale for above edits: Nasal steroid sprays are indicated for the treatment of nasal congestion due to allergic rhinitis. Effects should occur within first 36 hours. It is not indicated, nor is it FDA approved for the treatment of Obstructive Eustachian Tube dysfunction (OETD). Therefore, from AAOHNS CPG (2015), “based on the above data, it is reasonable to assume that efficacy would be reached after 1 week of therapy at the most and, if none is observed, the treatment might be considered ineffective.” (1) If OETD may be due at least in part from allergic rhinitis, 4 weeks duration should be sufficient to determine if the medication will be effective. Nasal steroid sprays have been shown to be ineffective in an RCT when used to treat OETD. (2) If rhinosinusitis is present, appropriate treatment may have included the use of prior antibiotics and sometimes surgery. If laryngopharyngeal reflux is present, antacids or proton pump inhibitors should demonstrate efficacy within a 4 week treatment course. (3) Indications for Balloon Dilation of the Eustachian tube (BDET) The Massachusetts Society of Otolaryngology and I worked with BCBS MA to draft the following indications in their policy # 018, It states: “Balloon dilation of the eustachian tube (BDET) for treatment of adults (18 years of age and older) with chronic obstructive eustachian tube dysfunction may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:
These criteria are all consistent with the AAOHNS Clinical Consensus Statement on Balloon Dilation of the Eustachian Tube. (4) BDET is considered investigational (excluded) in:
BDET may be indicated in selected patients for the following conditions:
Clinical Scenarios The two most common clinical scenarios are described below: Scenario 1 An adult has developed persistent (3 or more months) symptoms in one or both ears of aural fullness (blocked or pressure sensation), hearing loss and difficulty clearing the ear(s), especially on flights or submerging in a pool. There may have been one or more episodes of ear infection (acute otitis media) or middle ear fluid (otitis media with effusion). During the course of the ear complaint, the patient has been evaluated for possible underlying causes such as allergic rhinitis, rhinosinusitis or laryngopharyngeal reflux, which are the most common co-morbidities. If a co-morbidity has been identified, it has been treated appropriately for at least 4 weeks and has failed to show improvement in symptoms. The patient may have been treated with a tympanostomy tube, one or more times. If a tube was placed, the patient’s symptoms should have improved while it was patent, although complete resolution may not have occurred. In the event of tube extrusion, the patient’s symptoms have recurred and additional treatment is being considered. The patient has not had complaints of persistent, chronic autophony of voice and breathing to suggest possible patulous Eustachian tube. There is difficulty or inability to clear their ear fullness sensation (“pop their ear”) with autoinsufflation. One example of autoinsufflation is a modified Valsalva maneuver (nose and mouth closed, gently blowing nose to raise intranasal pressure and simultaneous swallow). Examination:
Testing:
Nasal/nasopharyngeal endoscopy
This patient meets the indications for either a tympanostomy tube (primary, repeat or long-term tube depending on whether tubes have been used previously) or a balloon dilation of the Eustachian tube. As a tube does not treat the source of the Eustachian tube dysfunction, there may be a preference for BDET if symptoms have returned after previous tube placement. The risk of complications from tympanostomy tubes increases with increasing numbers of tube placements and duration of tubes. (4) Scenario 2 An adult has developed persistent (3 or more months) symptoms in one or both ears of aural fullness (blocked or pressure sensation), hearing loss and difficulty clearing the ear(s) that occurs consistently on flights, diving into a pool, high elevators or with other significant changes in ambient pressure (termed barochallenge). There have not been any other ear problems, but the pain is significant when barochallenged. Measures such as oral or nasal decongestants, nasal steroid sprays (only for allergic rhinitis patients) have not been helpful. Examination:
Testing:
Nasal/nasopharyngeal endoscopy
This patient meets the indications for either a tympanostomy tube or a balloon dilation of the Eustachian tube. Most patients will not want to have tube placed for the indication of relieving barochallenge complaints for altitude changes or swimming and BDET may be the preferred option. (4) Specific outcomes that are clinically meaningful
Note that once a retraction pocket has become adherent (“fixed”), relief of negative pressure by BDET or a tube will not be expected to release the adhesions binding down the retraction. Progression of the pocket, erosion of ossicles or development of cholesteatoma may continue despite resolution of the Eustachian tube dysfunction that initiated the process, but correction of the dysfunction is important to limit progression and to prevent recurrence after surgical treatment of the retraction pocket or cholesteatoma. (5,6) Durability of results BDET has been shown to cause histological changes within the lumen of the Eustachian tube, including reduction in inflammation within the mucosa and elimination of the submucosal lymphoid hyperplasia. (10, 11) The pretreatment histopathology and post-operative changes are similar to findings with adenoidectomy. Therefore, permanent histological improvement would be expected, similar to adenoidectomy. However, if there is an on-going co-morbidity that may induce inflammation, adenoid tissue can regrow and the adenoid-like tissue within the lumen of the Eustachian tube could also regrow. Ongoing medical attention to possibly relevant co-morbidities may be important in durability of results, similar to adenoidectomy. (10) All of the studies to date with one year or longer duration of follow up have demonstrated that the results have been stable and durable. (8,9,12-15) |
| 3 | I view Eustachian tube balloon dilation as a moderately promising treatment for chronic hypoventilatory Eustachian tube dysfunction, although it remains to be determined which patients are most likely to benefit. As demonstrated by the two partially randomized prospective trials by Poe et al (PMID 30620688) and Meyer et al (PMID 29912819), 50-70% of treated patients appeared to achieve relatively durable improvements in tympanonometry (type B to C, type C to A , or type B to A), Eustachian tube dysfunction questionnaire results (ETDQ-7), and/or ability to valsalva the eadrum out. Although the results demonstrate a significant trend to improving Eustachian tube function, they hold the possibility that, when the procedure improves Eustachian tube function, it may help prevent otologic procedures that occur at the level of the tympanic membrane and mastoid which in turn may improve patient quality of life and decrease overall lifetime financial burden from medically necessary further otologic procedures. Meaningful outcomes of eustachian tube balloon dilation:
I believe that Eustachian tube balloon dilation to be at least or more efficacious than “medical therapy” for Eustachian tube hypoventilatory dysfunction as there is no proven medical therapy for this disorder. Tympanostomy tube placement is the gold standard for true eustachian tube hypoventilatory dysfunction, but carries a not-insignificant risk of perforation and otorrhea. Additionally, tympanostomy tube placement does not address the underlying cause of middle ear hypoventilation and may be a repeat procedure for the life of the patient. Mechanical pressure equalization devices as well as other methods of eustachian tube dilation other than balloon treatment have much less supportive evidence regarding their utility and efficacy. |
| 4 | Based on current literature and FDA approval, relevant scenarios are adult patients (>17 yoa) who have chronic obstructive ETD that has not responded to medical management. Documentation of ETD complaints, history of barotrauma, serous otitis media, adhesive otitis, atelectatic middle ear and failure after tympanoplasty, past abnormal tympanograms (B or C), efforts at medical management, allergy management and GERD/LPR management as clinically appropriate should support the diagnosis of ETD and appropriateness of BDET (1, 2, clinical experience). As chronic obstructive ETD may fluctuate, isolated normal tympanogram(s) in an individual with document abnormal tympanograms and recurrent chronic symptoms should not be an exclusion. It should be noted that there is level I evidence that intranasal steroids are no more effective than placebo in the treatment of ETD (3,4), and that there is no FDA approved medication for chronic obstructive ETD (5). Past PE tube placement, atelectatic tympanic membranes, previous middle ear or mastoid surgery and/or incus erosion should not be considered and inclusion or exclusion requirement, but history of past PE tube placement, atelectatic tympanic membranes, previous middle ear or mastoid surgery and/or incus erosion does go towards establishing the chronic nature of the ETD. (Clinical experience) Patients who have a history of cleft palate, have undergone surgery for cleft palate, have a history of radiation therapy to the nasopharynx, or surgery to the nasopharynx (other than adenoidectomy, previous BDET) should not be considered for BDET (6-9). Specific meaningful outcomes are resolution of ETD as suggested by history and normalization tympanogram (primary) and improvement in hearing (secondary) (6-9). The available literature on pediatric BDET is very limited, and primarily from Europe (10,11), with reports of success in children as young as 18 months. BDET certainly has the potential to be an effective treatment for pediatric ETD, though this reviewer based on what is currently known this reviewer is unable to provide a minimal age based on the literature. In my conversations with other colleagues, most children are sufficient grown by 8 yoa to be considered anatomically appropriate for the current technology, but that is expert opinion/clinical experience at this time.
|
NR = not reported
Question 2. Based on the evidence and your clinical experience for each of the clinical indications described in Question 1:
| # | YES / NO | Low Confidence | Intermediate Confidence | High Confidence | ||
| 1 | 2 | 3 | 4 | 5 | ||
| 1 | Yes | X | ||||
| 2 | Yes | X | ||||
| 3 | Yes | X | ||||
| 4 | Yes | X |
NR = not reported
Question 3. Based on the evidence and your clinical experience for each of the clinical indications described in Question 1:
| # | YES / NO | Low Confidence | Intermediate Confidence | High Confidence | ||
| 1 | 2 | 3 | 4 | 5 | ||
| 1 | Yes | X | ||||
| 2 | Yes | X | ||||
| 3 | Yes | X | ||||
| 4 | Yes | X |
NR = not reported
Question 4. Should balloon dilation of the eustachian tube only be done as a standalone procedure, or is it also appropriate to perform at the same time as a tympanoplasty or other middle ear surgery? Please describe such uses and supporting scientific citations (including the PMID).
| # | Response |
| 1 | Balloon Dilation of the Eustachian tube can be done in conjunction with other procedures. Examples of adjunctive procedures that might commonly be performed would be:
For tympanoplasty, mastoidectomy, or other ear surgery, this combination looks promising and, while there is a trend toward value in coupling these procedures reported in studies being conducted now, the evidence is not robust enough to confirm at this point. |
| 2 | Balloon Dilation of the Eustachian tube can be done in conjunction with other procedures. Examples of adjunctive procedures that might commonly be performed would be: Adenoidectomy Intranasal surgery (eg. Septoplasty, turbinate procedures or sinus surgery) Surgery for Obstructive Sleep Apnea or Sleep Disturbed Breathing Tympanostomy tubes Tympanoplasty, mastoidectomy or other ear surgery Evidence suggests that some adjunctive procedures might reduce the inflammatory burden within the upper aero-digestive tract and might aid in outcomes and durability of BDET. References
|
| 3 | Eustachian tube balloon dilation may be performed as a standalone procedure or as an addition to otologic surgery:
|
| 4 | BDET may be performed concomitantly with myringotomy with or without tube placement, turbinectomy, adenoidectomy, and/or tympanoplasty with or without mastoidectomy when these other procedures are clinically indicated (1-5).
|
Question 5. What is the appropriate duration of follow-up to assess outcomes after balloon dilation of the eustachian tube to establish a clinically meaningful improvement in net health outcome?
| # | Response |
| 1 | For general clinical practice, initial follow up examinations are typically done at 4 – 6 weeks to judge early efficacy (see Specific outcomes paragraph in responses to Q1). Nasal endoscopy to determine degree of inflammation and opening of the lumen of the Eustachian tube (“functional valve”) with swallows and yawns may be done as an option. (4) If a patient is doing well, a subsequent visit would be scheduled for one year post-operatively. Subsequent visits are done on an as-needed basis. Clinical trials may be planned to have additional follow-up visits and testing as per specific protocols (e.g. 6 weeks, 24 weeks, 52 weeks, annual visits for long-term results). |
| 2 | For general clinical practice, initial follow up examinations are typically done at 4 – 6 weeks to judge early efficacy (see Specific outcomes paragraph in responses to Q1). Nasal endoscopy to determine degree of inflammation and opening of the lumen of the Eustachian tube (“functional valve”) with swallows and yawns may be done as an option. (4) If a patient is doing well, a subsequent visit would be scheduled for one year post-operatively. Subsequent visits are done on an as-needed basis. Clinical trials may be planned to have additional follow-up visits and testing as per specific protocols (eg. 6 weeks, 24 weeks, 52 weeks, annual visits for long-term results). |
| 3 | For lack of better evidence, following the timelines of the partially randomized controlled studies by Poe et al and Meyer et al, I would suggest monitoring for health outcomes from Eustachian tube balloon dilation for 2 years. |
| 4 | Based on our current understanding, follow up should be up to one year to appropriately establish a clinically meaningful improvement from after balloon dilation of the Eustachian tube (1-4)
|
Question 6. Additional comments about the clinical context or specific clinical pathways for this topic and/or any relevant scientific citations (including the PMID) with evidence that demonstrates health outcomes you would like to highlight.
| # | Additional Comments |
| 1 | Epidemiology of Eustachian Tube dysfunction on health outcomes. Epidemiology and impact on health have become better characterized. A review of NHaNES data for adults from USA revealed a prevalence of obstructive Eustachian tube dysfunction (ETD) in 4.6%, which was considerably higher than previous estimates with smaller datasets. The economic, social and medical burdens of the disease in adults have been studied. The natural history of persistent obstructive ETD may include the development of acute otitis media, chronic otitis media with effusion, conductive or sensorineural hearing loss, vertigo, baro-challenge pain, tympanic membrane perforation, progressive tympanic membrane retraction with development of pockets or cholesteatoma and repeated interventions such as myringotomy or placement of tympanostomy tubes. (18,19, 20) Comparators Mechanical pressure equalization devices are cited several times in the document, but there is no evidence for long-term success. They include a balloon that is inflated by blowing it up from the nose or an electric pump to insufflate the nasal cavity. These devices have been shown to have some short-term benefit (< 90 days), but compliance is challenging. (21) Comparison to placement of tympanostomy tubes A tympanostomy tube will provide ventilation to the middle ear and is expected to relieve negative pressure, including middle ear effusions if previously present. Although this has been the standard procedure for relief of obstructive ETD, it is only beneficial for the duration that the tube remains patent. Consequently, repeated placement of tubes is common in adults with chronic obstructive ETD. Complications from tympanostomy tubes are well known and include infection, otorrhea, tympanosclerosis, persistent perforation requiring tympanoplasty repair, surgical removal of tubes, ingrowth of skin to produce cholesteatoma and a need to observe water precautions among others. Longer duration of tubes or repeated tubes may be associated with a higher rate of complications. (25) In contrast, BDET is a less invasive intervention as it involves no cutting of tissues and no need for implants. Additionally, BDET is targeted to the pathology causing obstructive ETD, rather than providing a temporary bypassing of the problem as is done with a tympanostomy tube. BDET has similarities to adenoidectomy It is well known that adenoid hypertrophy may contribute to obstructive ETD if it interferes with the opening process of the Eustachian tube during swallows and yawns. (26) Histology has shown the presence of adenoid-like lymphocytic infiltrates and hyperplasia of lymphoid follicles within the lumen of the ET. (10) Obstructive ETD is commonly seen in association with adenoid hypertrophy (i.e. lymphoid hyperplasia) when the bulk of the adenoid compromises the opening process of the ET during swallows and yawns. Hypertrophied adenoid-like tissue around the opening of the ET (tubal tonsil tissue) may further contribute to compromise of the opening of the ET. Therefore, treatment of obstructive ETD should be directed to the causes identified and may involve adenoidectomy, reduction of tubal tonsil tissue, or BDET for adenoid-like disease/inflammation within the lumen of the ET. Any of these procedures may be done in isolation or in combination as indicated. (5) Histological study has shown that the tissues within the ET before and after balloon dilation resemble those seen with the adenoid, pre- and post-adenoidectomy. Durability of BDET would be expected to mirror the results of adenoidectomy in controlling hypertrophy. (5,10) Observational Study There are a number of studies with longer term follow up that show durability of benefits ranging from 12 – 60 months. (5,9,12-15,22) The 2nd paragraph discusses the revision cases done in three case series. Selecting 3 studies to add up a cumulative prevalence of revision surgery is not statistically appropriate as it skews the data. The revisions should be examined against the total denominator analyzed by the systematic review from which those cases were taken. Alternatively, a proper meta-analysis should be done if the goal is to accrue data from multiple studies. It is possible that these 3 hand-picked studies involved inexperienced surgeons, poor patient selection, or failure to maintain medical control of possible relevant co-morbidities. The systematic reviews have not shown a high incidence of revision surgery. (8,23,24) |
| 2 | The EVIDENCE SUMMARY for Balloon dilation of the Eustachian tube was reviewed. Comments were annotated in the Summary. Additional comments are presented here. Epidemiology of Eustachian Tube dysfunction Epidemiology and impact on health have become better characterized. A review of NHaNES data for adults from USA revealed a prevalence of obstructive Eustachian tube dysfunction (ETD) in 4.6%, which was considerably higher than previous estimates with smaller datasets. The economic, social and medical burdens of the disease in adults have been studied. The natural history of persistent obstructive ETD may include the development of acute otitis media, chronic otitis media with effusion, conductive or sensorineural hearing loss, vertigo, barochallenge pain, tympanic membrane perforation, progressive tympanic membrane retraction with development of pockets or cholesteatoma and repeated interventions such as myringotomy or placement of tympanostomy tubes. (18,19, 20) Comparators Mechanical pressure equalization devices are cited several times in the document, but there is no evidence for long-term success. They include a balloon that is inflated by blowing it up from the nose or an electric pump to insufflate the nasal cavity. These devices have been shown to have some short-term benefit (< 90 days), but compliance is challenging. (21) Review of Evidence needs update – see comments in the EVIDENCE SUMMARY draft Observational Study There are a number of studies with longer term follow up that show durability of benefits ranging from 12 – 60 months. (5,9,12-15,22) The 2nd paragraph discusses the revision cases done in three case series. Selecting 3 studies to add up a cumulative prevalence of revision surgery is not statistically appropriate as it skews the data. The revisions should be examined against the total denominator analyzed by the systematic review from which those cases were taken. Alternatively, a proper meta-analysis should be done if the goal is to accrue data from multiple studies. It is possible that these 3 hand-picked studies involved inexperienced surgeons, poor patient selection, or failure to maintain medical control of possible relevant co-morbidities. The systematic reviews have not shown a high incidence of revision surgery. (8,23,24) Supplemental information Medicare National Coverage - Palmetto Region conducted a Local Coverage Determination (LCD) in 2019, performing a systematic review of the literature and a public commentary meeting was held on 10/07/2019. The proposal that would have denied coverage for BDET was retired on 02/13/2020 after the process was completed. American Medical Association (AMA) The AMA accepted the addition of two new Category 1 Current Procedural Terminology (CPT®) codes for BDET, effective January 1, 2021. (25) Additional responses to Q6 Overview of indications for BDET Chronic (≥ 3 months) obstructive Eustachian tube dysfunction as evidenced by at least one of the following:
A tympanostomy tube will provide ventilation to the middle ear and is expected to relieve negative pressure, including middle ear effusions if previously present. Although this has been the standard procedure for relief of obstructive ETD, it is only beneficial for the duration that the tube remains patent. Consequently, repeated placement of tubes is common in adults with chronic obstructive ETD. Complications from tympanostomy tubes are well known and include infection, otorrhea, tympanosclerosis, persistent perforation requiring tympanoplasty repair, surgical removal of tubes, ingrowth of skin to produce cholesteatoma and a need to observe water precautions among others. Longer duration of tubes or repeated tubes may be associated with a higher rate of complications. (26) In contrast, BDET is a less invasive intervention as it involves no cutting of tissues and no need for implants. Additionally, BDET is targeted to the pathology causing obstructive ETD, rather than providing a temporary bypassing of the problem as is done with a tympanostomy tube. BDET has similarities to adenoidectomy It is well known that adenoid hypertrophy may contribute to obstructive ETD if it interferes with the opening process of the Eustachian tube during swallows and yawns. (27) Histology has shown the presence of adenoid-like lymphocytic infiltrates and hyperplasia of lymphoid follicles within the lumen of the ET. (10) Obstructive ETD is commonly seen in association with adenoid hypertrophy (ie. lymphoid hyperplasia) when the bulk of the adenoid compromises the opening process of the ET during swallows and yawns. Hypertrophied adenoid-like tissue around the opening of the ET (tubal tonsil tissue) may further contribute to compromise of the opening of the ET. Therefore, treatment of obstructive ETD should be directed to the causes identified and may involve adenoidectomy, reduction of tubal tonsil tissue, or BDET for adenoid-like disease/inflammation within the lumen of the ET. Any of these procedures may be done in isolation or in combination as indicated. (5) Histological study has shown that the tissues within the ET before and after balloon dilation resemble those seen with the adenoid, pre- and post-adenoidectomy. Durability of BDET would be expected to mirror the results of adenoidectomy in controlling hypertrophy. (5,10) Office setting procedure BDET can be performed in either the operating room under general anesthesia or monitored sedation, or in an office setting with local anesthesia with proper patient selection. Although it is often compared to balloon sinuplasty, BDET has been found to be a technically more challenging procedure due in part to the location of the ET within the nasopharynx, posterior and lateral to the nasal cavity. Additionally, it has been shown to be more stimulating than sinuplasty, requiring careful and time-consuming protocols for administration of anesthetics and sedation for successful outcomes. (28-30) References see list in Question 7 |
| 3 | Eustachian tube hypoventilatory dysfunction is a frustrating cause for the majority of middle ear inflammatory disease. If successfully treatable in a moderate percentage of patients, even in what the randomized controlled studies suggest (50-70%), then a large number of patients may avoid repeat costly otologic surgery for recidivistic middle ear disease as well as improved quality of life. Ideally, I would like to see a randomized controlled study, long term, that would demonstrate these measurable endpoints. Such a study, however, would take at least 5-10 years to complete and the participation of multiple institutions. |
| 4 | I believe I have adequately covered the issues in the previous and following sections. |
NR = not reported
Question 7. Is there any evidence missing from the attached draft review of evidence that demonstrates clinically meaningful improvement in net health outcome?
| # | YES / NO | Citations of Missing Evidence |
| 1 | Yes | References :
|
| 2 | Yes | References:
|
| 3 | No | I do not believe the literature list provided is missing any major publications beyond what I have described in the above responses. |
| 4 | Yes | The following systematic review may help provide further evidence of clinically meaningful improvement from BDET. Plaza G, Navarro JJ, Alfaro J, Sandoval M, Marco J. Consensus on treatment of obstructive Eustachian tube dysfunction with balloon Eustachian tuboplasty. Acta Otorrinolaringol Esp. 2020 May-Jun;71(3):181-189. English, Spanish. doi: 10.1016/j.otorri.2019.01.005. Epub 2019 May 24. PMID: 31133274. |