Clinical UM Guideline

This document addresses the use of balloon dilation of the Eustachian tubes (BDET), also known as balloon dilatation Eustachian tuboplasty. Balloon dilation of the Eustachian tubes is an endoscopic procedure that usually approaches the Eustachian tubes trans-nasally to expand and stretch the Eustachian tube using a balloon catheter. It is proposed to relieve chronic ear congestion and middle ear and mastoid infections.

Note: Please see the following related document(s):

• CG-SURG-46 Myringotomy and Tympanostomy Tube Insertion
• CG-SURG-73 Balloon Sinus Ostial Dilation

Medically Necessary:

A single treatment of unilateral or bilateral balloon dilation of the Eustachian tubes via nasal endoscopy is considered medically necessary when all the following criteria are met for the ear(s) to be treated (A, B, C, D, and E):

1. The individual is 18 years of age or older; and
2. The individual’s history and physical exam include all the following (1, 2, 3, and 4):
   1. Eustachian tube dysfunction:
      1. Has been present for 3 months or more; and
      2. Persists despite medical therapy of any associated conditions (if present) such as allergic rhinitis, rhinosinusitis, or laryngopharyngeal reflux; and
   2. Otoscopic examination shows either of the following (i or ii):
      1. Persistent otitis media with effusion; or
      2. Tympanic membrane retraction; and
   3. Nasal endoscopic examination does not show physical obstruction of the Eustachian tube; and
   4. Either of the following (i or ii):
      1. Abnormal tympanogram tracings (Type B or C); or
      2. Symptoms consistent with baro-challenge induced Eustachian tube dysfunction (that is: recurrent aural fullness, popping, or pain that reproducibly occurs with changes in pressure); and
3. If history includes placement of tympanostomy tube(s), demonstrated improvement of obstructive Eustachian tube symptoms while the tube(s) were in place; and
4. No history of previous balloon dilation of the Eustachian tubes; and
5. No contraindication for balloon dilation, for example:
   1. Carotid abnormalities in the skull base; or
   2. Nasopharyngeal or skull base neoplasm; or
   3. Patulous Eustachian tube.

Not Medically Necessary:

Balloon dilation of the Eustachian tubes is considered not medically necessary when the criteria above are not met, and for all other indications.

Repeat balloon dilation of the Eustachian tube is not medically necessary for all indications.

Trans-tympanic balloon dilatation of the Eustachian tube is not medically necessary for all indications.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed, or when the code describes a procedure or situation designated in the Clinical Indications section as not medically necessary.

The diagnosis of Eustachian tube dysfunction (ETD) is considered for individuals with symptoms due to difficulty in equalizing pressure between the middle ear and the environment. Typical symptoms include aural fullness, aural pressure, hearing loss, and ear pain. ETD occurs in 2 main forms: obstructive dysfunction and patulous dysfunction. Obstructive dysfunction can result from inflammation of nasopharyngeal mucosae due to infection, allergy, or laryngopharyngeal or gastroesophageal reflux. Less common causes of obstructive dysfunction include mechanical obstruction due to hypertrophy of the adenoids, nasopharyngeal tumors, or scarring or deformity due to trauma. Patulous dysfunction is less common than obstructive dysfunction. The term patulous describes a condition in which the Eustachian tube is chronically patent. Symptoms suggesting patulous dysfunction include loudly hearing one’s own voice or an echo of one’s own voice (autophony), audible respirations, pulsatile tinnitus, and/or aural fullness (Tucci, 2019). BDET is contraindicated for patulous ETD (Tucci, 2019).

Based on estimates from surveys administered between 2001-2012 (Oehlandt, 2022; Shan, 2019), ETD affects 4-5% of adults. Medical management is frequently used for treatment of associated conditions, but success rates are limited. Established surgical approaches include myringotomy (creating a hole in the eardrum) and tympanostomy (small tubes implanted through a hole in the ear drum). (Tucci, 2019).

In 2019, the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) published a set of consensus statements regarding the use of BDET (Tucci, 2019). The published consensus statements were reached using the Delphi method. This involved the iterative consideration of statements by a panel representing a variety of medical specialty societies until consensus was reached. The target population for the statements was adults 18 years of age or older who had symptoms for 3 months or longer that significantly affected their quality of life or functional health status. The panel reached consensus on the following 18 statements regarding selection of candidates for BDET:

1. A comprehensive history and physical exam, including otoscopy, are essential parts of the diagnostic evaluation of a candidate for BDET.
2. Nasal endoscopy is an essential part of the diagnostic evaluation prior to BDET.
3. BDET is contraindicated for patients diagnosed as having a patulous ETD.
4. Nasal endoscopy in patients who are candidates for BDET is necessary for assessing the ET lumen and assessing the feasibility of transnasal access to the nasopharynx.
5. A diagnosis of patulous ETD is suggested by symptoms of autophony of voice, audible respirations, pulsatile tinnitus, and/or aural fullness.
6. The benefit of repeat BDET after a prior ineffective BDET has not been determined.
7. Symptoms of obstructive ETD can include aural fullness, aural pressure, hearing loss, and otalgia.
8. Tympanometry is an essential part of the diagnostic evaluation prior to BDET. 8.50 0
9. Establishing a diagnosis of obstructive ETD requires ruling out other causes of aural fullness such as patulous ETD, temporomandibular joint disorders, extrinsic obstruction of the ET, superior semicircular canal dehiscence, and endolymphatic hydrops.
10. Patient-reported symptom scores alone are insufficient to establish a diagnosis of obstructive ETD.
11. Nasal endoscopy is necessary to rule out extrinsic causes of ETD.
12. Comprehensive audiometry is an essential part of the diagnostic evaluation prior to BDET.
13. BDET is appropriate in patients with obstructive ETD who have failed medical therapy for identified treatable causes.
14. Common causes of obstructive ETD that benefit from identification and management are allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux.
15. Medical management of known pathology that could affect nasal or ET function is appropriate to perform prior to BDET.
16. Patients with a history of recurrent baro-challenge, defined as uncomfortable pressure in the ear upon exposure to ambient pressure changes that cannot be easily relieved, may improve following BDET.
17. There is no scientifically proven or standard medical therapy for ETD.
18. Pneumatic otoscopy can identify negative pressure in the middle ear space and can differentiate between adhesive and non-adhesive retractions of the tympanic membrane.

BDET is an endoscopic procedure proposed to relieve chronic ear congestion and middle ear and mastoid infections. In 2016, the US Food and Drug Administration (FDA) granted marketing authorization via the De Novo classification process for AERA^® Eustachian Tube Balloon Dilation System for adults 22 years and older. The FDA granted 510(k) marketing authorization in 2023 to include individuals 18 years of age and older and children and adolescents 8-17 years of age (see section on Balloon Dilatation of the Eustachian Tubes for Children and Adolescents below). The FDA granted 510k clearance for the XprESS^® ENT Dilation System in 2017 for adults 18 years and older. The Next Generation Balloon Dilation System was cleared by the FDA in 2020 for use with adults 18 years and older. Each device uses an endoscopically directed balloon to dilate the Eustachian tube. During the procedure, an endoscopic balloon catheter is inserted trans-nasally to expand the Eustachian tube.

There have been several case studies and a handful of randomized controlled trials (RCTs) addressing BDET. In 2018, Poe and colleagues reported the results of a pivotal trial for the AERA^® Eustachian Tube Balloon Dilation System. This trial included 323 participants (462 ears) 22 years and older with persistent (12 weeks or more) Eustachian tube dilatory dysfunction that was refractory to medical management. All participants had either a 4-week course of nasal steroids or a course of oral steroid therapy in the previous 12 months. A pool of 81 participants were treated as a lead-in population to acclimate the investigators to the study procedure. The remaining participants were randomized in a 2:1 manner to undergo treatment with BDET with concurrent medical management (n=162, with 100 [61.7%] completing study) or continued medical management (n=80, with 71 [88.8%] completing the study). The condition was confirmed by tympanometry, the Eustachian Tube Dysfunction Questionnaire-7 symptom scoring tool (ETDQ-7), and nasal endoscopy. Participants were allowed to continue concomitant use of other medications to treat sinus or nasal conditions when deemed to be medically necessary at the discretion of the investigator. Follow-up continued to 24 weeks. After 6 weeks, control participants were permitted to cross over to the BDET group and followed through 12 weeks. A majority of participants in the control arm completed the 6-week follow-up and then crossed over to the BDET group before the 12-week follow-up (82%, 59/71). At the 6-week follow-up, significantly more BDET group participants had normal tympanograms (51.8% vs. 13.9%, p<0.0001). ETDQ-7 improvement was significantly greater in the BDET group compared to controls at 6 weeks (56.2% vs. 8.5%, p<0.001). Worsening of tympanograms was noted in 4% of BDET participants and 5.7% of controls (no p-value provided). The number of participants with a positive modified Valsalva maneuver was better in the BDET group vs. controls at 6 weeks (32.8% vs. 3.1%). No device- or procedure-related serious adverse events were reported. At 24 weeks, tympanogram normalization was 62.2% in the BDET group. Only 9 of the original 81 control group members remained in the study at the 24 weeks follow-up and no comparison to the controls was possible after that time point. Only 100 of the 149 participants (67.1%) in the original BDET arm remained in the study at the 12-weeks follow-up. The high rate of attrition makes it possible that the outcomes for these missing group members, if known, could have affected the results of the study. Neither the participants nor their treating providers were blinded to the study’s intervention. Medication use was permitted at the discretion of the treating provider. The study did not report or analyze the medication use of study participants. Potential between-group differences in medication use introduces the possibility that performance bias confounded the results. Due to significant attrition in the control arm, this study was essentially uncontrolled after the 6-weeks follow-up. The 6-weeks outcomes did show significantly more tympanogram normalization in the BDET group. This improvement appeared to persist for those treated with BDET through the 24-weeks follow-up.

In 2019, Anand and colleagues published the results of a 52-week continuation of the Poe study detailed above. This trial included outcomes for 136 participants in the BDET group, 73 control participants, and 74 of the lead-in period participants. Out of the 73 control original participants, 70 (95.9%) received BDET after their 6-week follow-up. At 52 weeks, the authors reported that the number of BDET-group participants maintaining normalized tympanograms and normalized ETDQ-7 scores remained unchanged from the 6-week time point (tympanograms: 51.0% vs. 55.5%, ETDQ-7 scores: 57% vs. 63.6%). No device-related adverse events were reported. The authors acknowledge that, due to high attrition in the control group, no meaningful comparison between the BDET and control groups could be made after the 6-weeks follow-up. For this cohort of treated individuals, the study shows that the observed 6-weeks improvement in tympanograms and ETDQ-7 scores were sustained at the 52-week follow-up.

In 2016, Dalchow and colleagues reported the results of a prospective case series involving 202 participants (342 dilations) from a single treatment center in Germany. Prior to BDET, all participants received a complete ENT evaluation including tympanometry, audiometry, nasopharyngotoscopy, otomicroscopy, and digital volume tomography of the temporal bone. Tympanoplasty was performed for 124 of the 342 participants (36%) at the time of BDET. The authors computed a “tube score” consisting of the tympanogram type (A, B, or C) and the R value, which represents the latency time for Eustachian tube opening during tubomanometry . The R value indicates whether Eustachian tube opening is normal (R < 1), delayed (R > 1), or absent (R near 0). The tube score was used to evaluate pre- and postoperative tube function. Participants underwent follow-up with postoperative assessments at 1 month (n=175, 86.6%), 3 months (n=92, 45.5%), 9 months (n=29, 14.4%) and 12 months (n=19, 9.4%). The mean pre-treatment tube score was 2.23 ± 1.147 and was reported to have significantly improved to 2.68 ± 1.011 at 1 year (no p-value provided). There is significant overlap for the confidence intervals of the pre- and post-treatment tube scores in this study. The authors of this paper noted that tube scoring systems “are mostly non-validated tests and do not give clear evidence of tubal dysfunction.” They also note that “a validated, standardized instrument is needed to select indication criteria and a questionnaire to assess quality of life before and after EET has to be established.”

In 2017, Skevas and colleagues published the results of a multi-center analysis describing the rates of cervicofacial and mediastinal emphysema following 3670 BDET procedures in 2272 participants treated at four centers across Europe. The ages ranged from 2 to 83 years. Postoperative emphysema limited to parotid region cheek and soft and hard palate developed in 7 participants. Another 3 developed emphysema of the soft tissues associated with pneumomediastinum. The overall complication rate involving pneumomediastinum was reported as 0.27%. None of the participants experienced serious clinical signs or symptoms beyond cutaneous crepitations. After prophylaxis with an antibiotic and abstinence from Valsalva maneuver all 10 participants achieved complete resolution and recovery of the emphysema within 2-6 postoperative days.

In 2018, Meyer and colleagues reported the results of a pivotal RCT for the XprESS^® ENT Dilation System. This study involved 60 participants who were 18 or older and had persistent (> 12 months) ETD. Participants were randomized to receive treatment with either balloon dilation (n=31) or medical therapy (n=29). Eligible participants had all received treatment with either a 4-week course of nasal steroids or a course of oral steroid therapy in the previous 12 months. Participants were followed for 1 year, but control participants had the option to undergo balloon dilation after their 6-week follow-up if their symptoms persisted. This crossover occurred in 23 of the 29 control group participants (79.3 %). The 6 control group participants who continued medical management were no longer included in the study. The crossover cohort underwent balloon dilation treatment and continued through the remainder of the trial. This resulted in 49 total participants whose outcomes were reported at 12 months. No adverse events were reported in either group. At the 6-week follow-up, participants with abnormal baseline assessments who were treated with BDET experienced significantly more improvement in the tympanogram type (p < 0.006) and in tympanic membrane position (p < 0.001) compared to the control group participants. The mean overall EDTQ-7 score improvement at 6 weeks was -2.9 ± 1.4 for the balloon dilation group and -0.6 ± 1.0 for the control group. The authors reported that technical success was 100%. Most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation. Although these 12-month results are encouraging, the elimination of the control group after the 6-week follow-up prevents comparison of long-term outcomes for BDET and medical treatment.

In 2019, Cutler and colleagues published the results of a follow-up study of the experimental arm of the trial reported by Meyer et al. in 2019. Out of the 49 participants completing the initial 12-month study, 47 were included in this follow-up study. The mean follow-up for all participants was 29.4 months (range 18-42 months). Overall, ETDQ-7 scores were significantly reduced from a mean of 4.5 at baseline to 2.0 at last measured timepoint (p<0.0001). Additionally, each individual component of the ETDQ-7 tool was likewise significantly improved (p<0.0001 for all). Only 1 participant underwent repeat dilation procedure concurrently with FESS for rhinosinusitis. The ability to clear the ears with the Valsalva maneuver increased from 28.3% to 73.9% (p<0.0001). Type A tympanograms also increased from 70% to 86.3% (p=0.005). In participants with abnormal middle ear assessments at baseline, tympanic membrane position was normalized in 76% (p<0.0001), Valsalva maneuver response was positive (p<0.0001), and normalization of tympanograms occurred in 62.5% (p<0.001). These results show that, for the individuals who completed the study, BDET was associated with significant long-term improvements in several patient-centered outcomes. As with the underlying Meyer study, the early elimination of the control group prevents comparison of these results with the outcomes for medical treatment.

In 2020, Froehlich and colleagues published a systematic review and meta-analysis on the safety and efficacy of BDET in adults. The review included RCTs as well as prospective and retrospective studies. Twelve studies comprised of 448 participants met inclusion criteria for meta-analysis. At 6 weeks, the mean ETDQ-7 scores decreased by 2.13 from (95% confidence interval [CI], -3.02 to -1.24; p<0.001) and 53.0% of study participants demonstrated improvement in tympanograms (p<0.001). At the longest follow-up (3-12 months), 50.5% of individuals had improved tympanograms from baseline (p<0.001). No significant difference was demonstrated between tympanogram results at 6 weeks compared to long term (p=0.535). The percent of normal otoscopy exams increased by 30.0% from baseline to 6 weeks (p<0.001) and further improved to 55.4% over the long-term (p<0.001). There was a 67.8% increase in the proportion of study participants able to perform a Valsalva maneuver in the long term compared to baseline (p<0.001). The authors concluded that BDET appears to be associated with improvement in subjective and objective outcomes and that this improvement appears stable at 3 to 12 months after dilation.

Balloon Dilatation of the Eustachian Tubes for Children and Adolescents

In 2019, Si and colleagues conducted a double-blind RCT involving 120 participants aged 15-75 with adhesive otitis media (adOM) who were assigned to one of four groups: 1) conservative therapy, 2) BDET, 3) cartilage tympanoplasty, or 4) combined BDET and cartilage tympanoplasty. The authors did not describe prior treatments given to study participants. There were 30 participants in each group and the follow-up period was 2 years. All participants had baseline hearing loss. No significant pretreatment differences were noted between the tympanoplasty alone and combined groups. Both the tympanoplasty alone and combined groups had significant improvements in air-bone gap compared to controls (p<0.1), but no differences were found between these two groups. The BDET-alone group did not have a significant reduction in their mean air-bone gap. All three surgical groups had significant improvements in the Tinnitus Handicap Inventory (THI) compared to the control group (p<0.05). Results from the Chronic Otitis Media Outcome Score-15 (COMOT-15) indicated significant improvements in all surgical groups (p<0.05). Eustachian tube scores (ETS) improved in both the BDET-only and combined groups compared to controls and compared to tympanoplasty alone (p<0.05 for both). Two participants in the BDET-alone group reported patulous Eustachian tube post-operatively which resolved spontaneously within 1 year. This study showed that, for this group of individuals with adOM as compared to controls, BDET did not significantly improve hearing loss but was associated with greater improvement in Eustachian tube score, THI, visual analog score of ear stuffiness, and COMOT-15. The average participant age was 43 and the authors did not report a subgroup analysis based on the participants’ ages.

In 2020, Chen and colleagues reported the results of a retrospective non-randomized controlled trial involving 50 participants aged 4-14 years with otitis media with effusion. Participants who received myringotomy and tympanostomy tube placement in conjunction with Eustachian tube dilation (n=25) were compared those who received myringotomy and tympanostomy tube placement only (n=25). The method of selecting participants for the study was not explained. The authors did not specify what, if any, prior treatments were given to participants. Adenoidectomy was conducted in participants found to have adenoid hypertrophy (n=16 in the balloon group and n=17 in the control group). The authors reported a statistically significant difference in air-bone gap between the two groups at 18 months. The mean differences of the balloon group were lower by about 4 dB HL) when compared to the control group (p=0.05). At 18 months the cure rate was 76.1 % for the balloon group vs. 60.9% in the controls (p=0.116), and total effective rates were 93.5% and 89.1%, respectively (p=0.71). No serious adverse events or complications were reported. While significant improvements in air-bone gap measurements at 18 months were reported, differences in cure rate and total effective rates were not significantly different.

In 2021, Cheng and colleagues published results from a retrospective cohort of Australians who underwent BDET. Outcomes for 96 Eustachian tube dilation operations performed on 62 study participants were reported. After a mean follow-up of 10 months, the cohort demonstrated a mean EDTQ-7 score improvement from 4.7 to 2.9 (p<0.01); improvement was achieved in 83.9% of individuals. All participants in the baro-challenge-induced subgroup achieved improvement in ETDQ-7 score. Complete resolution of symptoms (ETDQ <2.1) was experienced by 37.1% of the study cohort. No adverse safety events were reported. Although the cohort included individuals ranging in age between 16 and 78, the mean and median participant ages were 47.3 and 50 and there was no subgroup analysis based on age. The study did not control for or analyze the use of concurrent surgical procedures. Lack of randomization and blinding and the use of subjective outcomes make this trial’s results susceptible to placebo effects. The lack of a control group prevents comparison of this study’s results to the results of medical treatment.

In 2021, Toivonen and colleagues published results of a retrospective, matched cohort, single-center, single surgeon study to determine the safety and efficacy of BDET in children. The study involved 26 participants (46 Eustachian tubes) who had had persistent (> 18 months) symptoms of ETD and had failed medical treatment for allergy or gastroesophageal reflux. The procedure description in this paper describes treatment of individuals with patulous ETD but there is no separate discussion of results for such individuals. Participants ranged in age from 7 to 17 years. All participants in the active treatment cohort underwent BDET between 2013 and 2017 and all these participants also had adjunctive procedures at the time of BDET. The matching cohort was derived from individuals aged 7 to 17 years treated with tympanostomy tube placement at the same institution between 2010 and 2017. Cases and controls were matched as closely as possible for the number of previous tympanostomy tubes, age, sex, and history of adenoidectomy. The study defined treatment failure as recurrence of otitis media with effusion (OME), persistence of a type B or C tympanogram with decreased hearing, or the need for tympanostomy tube placement. For the 46 ears treated with BDET, tympanograms improved to type A in 50% at 6 months (N=39), 59% at 12 months (N=29), 53% at 24 months (N=17), and 85% at 36 months (N=14). The authors reported that 5 of the 46 ears treated with BDET met the study’s definition of treatment failure at 2 years, but they do not discuss the fact that only 17 of the treated 46 ears were available for evaluation 2 years after the procedure. They reported that 19 of the 46 ears treated with tympanostomy tubes met the definition of failure at 2 years, but they do not report whether this was among the full control cohort of 46 years or only among the controls matched to the remaining 17 BDET-treated ears. The paper does not give details of why these treatments were considered to have failed (for example, due to OME, abnormal tympanogram, or tympanostomy tube placement). This small, single center, single surgeon study’s results might not be generalizable to widespread use. Significant attrition raises the possibility that results for the individuals lost to follow up, if known, may have led to different study conclusions. The use of an asynchronous cohort raises the possibility that uncontrolled factors may have confounded the results. All BDET-treated individuals had adjunctive ear procedures at the time of BDET and it is possible that the observed results could be due to these other procedures. The published paper does not include a statement of the funding source. It is possible that the unblinded nature of the active treatment cohort may have influenced decisions to perform follow up procedures. This study’s results need to be confirmed with a prospective randomized trial.

In 2022, Aboueisha and colleagues published a systematic review and meta-analysis on the safety and efficacy of BDET in children and adolescents 18 and under. Seven articles reporting results for 408 children met inclusion criteria. The mean age of study participants was 10 years old, and the mean follow-up was 19.2 months. Following BDET, the percentage of abnormal tympanograms (Type B) decreased from 64.2% (95% CI, 53.3-73.8) to 16.1% (95% CI, 8.5-28.4) and air-bone gap decreased from a mean of 25.3 dB (95% CI, 18.9-31.6) to 10.2 dB (95% CI, 8.9-11.5). The pooled estimate of adverse events following BDET was 5.1% (95% CI, 3.2-8.1), the majority of which were epistaxis; no major adverse events reported. Three of the studies included in the analysis compared BDET to Eustachian tube insertion; post-operative air-bone gap decreased significantly more in the BDET group (mean difference -6.4 dB; 95% CI, -9.8, -3.1; p=0.002). Most of the included studies were retrospective cohort studies. The authors did not identify any RCTs studying the effects of BDET for children and adolescents. Several studies included individuals who had concurrent procedures such as tympanostomy tube insertion or adenoidectomy that may have confounded analysis of BDET’s effects.

In 2022, Yang and colleagues sought to retrospectively identify clinical predictors of treatment response to BDET based on ETDQ-7 scores in 113 individuals who underwent the procedure. The study’s participants were between 13 and 77 with an average age of 49 years (SD 16 years). The study did not separately analyze results by age group. All participants had received at least 4 weeks of nasal or systemic steroid treatment before study entry. After a mean follow-up period of 13 months, 77% experienced > 0.5 point improvement in the ETDQ-7; 37% of the participants’ score normalized (ETDQ < 2.1). A higher pre-operative ETDQ-7 and a history of chronic rhinosinusitis or chronic otitis media were significantly associated with increased odds of ETDQ-7 score improvement. This retrospective chart review was limited to information included in the participant’s procedural record and may not have captured relevant prior treatments. Lack of blinding or controls, and the use of the subjective ETDQ measure as the outcome, increases the possibility that the observed improvements were due to a placebo effect. The duration of follow up ranged between 3 and 13 months, so this study does not permit conclusions about the long-term effects of BDET in children.

In 2024, Gurberg and colleagues published a retrospective matched cohort study which enrolled participants who underwent BDET after having undergone tympanostomy tube placement and adenoidectomy who had a recurrence of symptoms. Comparison was made with children receiving tympanostomy tube placement. Outcome measures were risk of failure (no change or worsening in tympanogram or recurrence of persistent middle ear effusion or retraction on otoscopy) and the need for additional surgery. A total of 33 Eustachian tubes were dilated in 20 participants, (ages 14 months-14 years); all had previously undergone tympanostomy tube placement and adenoidectomy. A normal post-operative tympanogram was observed in 80 % of cases who had undergone BDET. Mean follow up was 6.7 years; during that time, 2 cases in the BDET group experienced failure and 8 in the tympanostomy tube insertion group. Dilated Eustachian tubes had a significantly lower risk of failure than those who underwent tympanostomy tube insertion (adjusted Hazard Ratio=0.18; 95 % CI, 0.04 to 0.81; p=0.03). The probability of being failure free at 6 years was 88 % (95 % CI, 71 to 95 %) in the BDET cohort and 53 % (95 % CI, 33 to 70 %) in the tympanostomy tube insertion cohort. No complications were reported. All procedures were performed at 1 of 2 centers in Fort Worth, Texas, whereas the control cohort was derived from individuals treated in Boston, Massachusetts. The matching process accounted for the number of previous tympanostomy tubes, prior adenoidectomy, and gender; but did not account for possible differences in previous medical treatment or duration of ETD. Several children in the BDET group were noted to have had transient episodes of ETD after BDET but were not considered to have failed the treatment. The authors did not report a between-group difference in the need for additional tympanostomy tube insertion or adenoidectomy. Although this study reported improved tympanograms and reduced findings of middle ear effusion, it did not record differences in patient-centered outcomes such as symptoms or rates of otitis media. Prospective randomized trials are needed to confirm the results of this relatively small study.

In 2024, Ramagiri published the results of systematic review and meta-analysis to better characterize objective and subjective outcomes for BDET in children. A total of 11 articles (8 retrospective case series and 3 historic cohort studies) comprised of 589 participants (18 and younger) were included in the review (945 BDET procedures). No serious complications were reported and the pooled estimate of the rate of minor complications was 3.6% (95% CI, 2.0% to 6.2%; p<0.001 [self-limiting hemotympanum and epistaxis were most frequently reported]). The estimated average odds ratio of otitis media and retraction before and after BDET were 0.0033 (95% CI, 0.0010 to 0.0115; p<0.001). The authors conclude, “As the current body of evidence is based on retrospective case series and historic cohort studies, further research in the form of prospective cohort studies and RCTs would be needed before BDET can be recommended as evidence-based management.”

FDA expansion of Acclarent’s AERA^® Eustachian Tube Balloon Dilation System was based on a systematic literature review comprised of both non-Acclarent and Acclarent devices and analyzed real-world evidence with data from published literature and unpublished data provided by physicians. No serious adverse events were reported in the expanded age group following BDET. The rate of minor adverse events was reported to be 8.2%. Efficacy data in 20 ears from individuals aged 8-17 years with chronic otitis media showed an improvement in tympanometry in 75% of procedures. A total of 84% of ears were failure-free after a mean of 2.7 years of follow-up (failure was defined as further surgery needed to treat BDET; for example, tympanostomy tube insertion or revision BDET).

Summary

The RCTs, cohort studies, meta-analysis and expert consensus described above show that a single BDET can be associated with significant improvement in objective and subjective outcomes in individuals 18 years of age and older.

There are currently no published prospective studies of BDET in children and adolescents. There is insufficient credible scientific evidence published in peer-reviewed medical literature to permit reasonable conclusions concerning the effect of BDET in children.

Peer Reviewed Publications:

1. Aboueisha MA, Attia AS, McCoul ED, Carter J. Efficacy and safety of balloon dilation of eustachian tube in children: Systematic review and meta-analysis. Int J Pediatr Otorhinolaryngol. 2022; 154:111048.
2. 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. 2019; 160(4):687-694.
3. Ashry Y, Kawai K, Poe D. Utility of adjunctive procedures with balloon dilation of the Eustachian tube. Laryngoscope Investig Otolaryngol. 2017; 2(6):337-343.
4. Bast F, Frank A, Schrom T. Balloon dilatation of the Eustachian tube: postoperative validation of patient satisfaction. ORL J Otorhinolaryngol Relat Spec. 2013; 75(6):361-365.
5. Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of Eustachian tube: a preliminary study. Otol Neurotol. 2012; 3(9):1549-1552.
6. Chen T, Shih MC, Edwards TS, et al. Eustachian tube dysfunction (ETD) in chronic rhinosinusitis with comparison to primary ETD: A systematic review and meta-analysis. Int Forum Allergy Rhinol. 2022; 12(7):942-951.
7. Chen S, Zhao M, Zheng W, et al. Myringotomy and tube insertion combined with balloon Eustachian tuboplasty for the treatment of otitis media with effusion in children. Eur Arch Otorhinolaryngol. 2020; 277(5):1281-1287.
8. Cheng H, Saxby A, Jufas N, et al. Balloon dilation eustachian tuboplasty for dilatory dysfunction: Safety and efficacy analysis in an Australian cohort. ANZ J Surg. 2021 Jul;91(7-8):1480-1484.
9. Choi SW, Oh SJ, Kim Y, et al. A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty. Sci Rep. 2021; 11(1):23296.
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Government Agency, Medical Society, and Other Authoritative Publications:

1. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical consensus statement: balloon dilation of the Eustachian tube. Otolaryngol Head Neck Surg. 2019; 161(1):6-17.
2. U.S. Food and Drug Administration (FDA). Acclarent Inc. De Novo Summary: AERA® Eustachian Tube Balloon Dilation System. December 04, 2015. Available at: https://www.accessdata.fda.gov/cdrh_docs/reviews/den150056.pdf. Accessed on June 27, 2024.
3. U.S. Food and Drug Administration (FDA). Acclarent Inc. 510(k) Summary: Next Generation Balloon Dilation System. December 13, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230742.pdf. Accessed on June 27, 2024.
4. U.S. Food and Drug Administration (FDA). Entellus Medical, Inc. 510(k)Summary: XprESS ENT Dilation System. https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163509.pdf. April 04, 2017. Available at: XprESS ENT Dilation System. Accessed on June 27, 2024.

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