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

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

Medically Necessary:

A single treatment of unilateral or bilateral balloon dilation of the Eustachian tubes considered medically necessary when all the following criteria are met for the ear(s) to be treated (A through F):

1. The individual is 18 years of age or older; and
2. The procedure is conducted via nasal endoscopy; and
3. The individual’s history and physical exam include all the following (1, 2, 3, and 4):
   1. Eustachian tube dysfunction (i and ii):
      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
4. If history includes placement of tympanostomy tube(s), demonstrated improvement of obstructive Eustachian tube symptoms while the tube(s) were in place; and
5. No history of previous balloon dilation of the Eustachian tubes; and
6. 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.

This document describes clinical studies and expert recommendations, and explains when balloon dilation of the Eustachian tubes (BDET) is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

The Eustachian tubes connect the middle ear to the back of the nose and help equalize pressure in the ears. Eustachian tube dysfunction happens when the tube does not open and close as it should. This can make it difficult to balance pressure between the middle ear and the outside environment. Symptoms may include the feeling of fullness in the ear, ear pressure, hearing loss, ear pain, or discomfort during changes in air pressure. BDET, also called balloon dilatation Eustachian tuboplasty, is a procedure used to treat obstructive Eustachian tube dysfunction. During BDET, a doctor places a small balloon through the nose into the Eustachian tube and briefly inflates it to widen the tube. The goal is to reduce symptoms such as ear fullness, pressure, pain, hearing problems, repeated middle ear fluid buildup, or repeated infections. The procedure also has risks, including bleeding, pain, infection, injury to nearby structures, and other complications. Some people may not improve after treatment.

Before considering BDET, experts recommend a complete evaluation. This includes a medical history, physical examination, hearing tests, pressure testing of the ear, and examination of the nose with a small camera. Other causes of symptoms, such as allergies, sinus disease, reflux, growths, or a permanently open Eustachian tube, should also be evaluated and treated when possible.

What the Studies Show

Studies suggest that some adults have symptom improvement after BDET. Studies in adults suggest that BDET may improve symptoms, ear pressure test results, and Eustachian tube function for some people, especially during the first few months after treatment. Serious complications were uncommon in the studies, although minor problems such as nosebleeds, temporary pain, or discomfort occurred in some people. However, many studies had important limitations, including small numbers of participants, lack of blinding, people switching from the comparison group to the treatment group, and limited long-term follow-up. A recent independent review of all available clinical trials found that BDET may improve symptoms for up to 3 months. However, the available studies were not strong enough to determine whether these improvements continue over the longer term. In one study, people who underwent BDET did not have better outcomes than those who underwent a simulated procedure designed to mimic the treatment without actually dilating the Eustachian tube.

For children and adolescents, most studies have serious weaknesses that limit their ability to accurately reflect the real impact of the procedure. Most studies looked back at procedures that have already been done instead of following people over time. Many participants also had other procedures at the same time as BDET, making it difficult to know how much improvement was due to BDET, the other procedure, or both. Most also have short follow-up times limiting understanding of how long the results of procedures last. Better studies are needed to know if BDET improves health and to better understand its long-term safety and effectiveness in children and adolescents and which children are most likely to benefit.

When is Balloon Dilation of the Eustachian Tubes Clinically Appropriate?

BDET may be appropriate when all of the following apply:

• The person is 18 years of age or older; and
• The procedure is performed through the nose using a small camera called a nasal endoscope; and
• The person has had obstructive Eustachian tube dysfunction for at least 3 months that did not improve after treatment of related conditions, such as allergic rhinitis, rhinosinusitis, or laryngopharyngeal reflux, when those conditions are present; and
• An ear examination shows either persistent fluid behind the eardrum or a pulled-in eardrum; and
• A nasal endoscopy shows there is no physical blockage of the Eustachian tube; and
• Testing shows abnormal pressure in the middle ear or the person has symptoms that happen repeatedly during changes in air pressure, such as ear fullness, popping, or pain during flying or diving; and
• If the person previously had ear tubes (tympanostomy tubes), their symptoms improved while the tubes were in place; and
• The person has not had BDET before; and
• The person does not have a condition that makes the procedure unsafe, such as certain blood vessel abnormalities near the skull base, a growth near the Eustachian tube or skull base, or a patulous Eustachian tube, which is a tube that stays abnormally open.

When is this not Clinically Appropriate?

BDET is not clinically appropriate when the criteria above are not met.

Repeat BDET is not clinically appropriate because studies have not shown whether repeating the procedure improves health. Better studies are needed to know if repeat BDET improves health.

Trans-tympanic BDET, which is performed through the eardrum instead of through the nose, is not clinically appropriate because studies have not shown that it improves health. Better studies are needed to know if this approach improves health.

Unnecessary or unproven procedures can lead to needless worry, or to treatment that does not help.

(Return to Description)

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.

Summary

Eustachian tube dysfunction (ETD) is characterized by symptoms such as ear fullness, pressure, hearing loss, and ear pain resulting from impaired pressure equalization between the middle ear and the environment. ETD may be obstructive or patulous. Balloon dilation of the Eustachian tube (BDET) is indicated only for obstructive ETD and is contraindicated in patulous ETD because dilation can worsen symptoms in that condition. Since symptoms of ETD overlap with those of allergic rhinosinusitis, laryngopharyngeal reflux, temporomandibular disorders, and other conditions, those potentially treatable causes should be evaluated and managed before BDET is considered. The 2019 American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) clinical consensus statement recommends a comprehensive diagnostic evaluation, including history, physical examination, audiometry, tympanometry, and nasal endoscopy to confirm obstructive ETD, exclude alternative diagnoses and anatomic obstruction, and identify appropriate candidates for treatment before considering BDET.

Randomized controlled trials and systematic reviews suggests that BDET can improve patient symptoms, tympanometry findings, and Eustachian tube function in carefully selected adults with chronic obstructive ETD persists despite appropriate medical management. Benefits appear greatest during the first several months after treatment, and serious complications are uncommon. The available evidence also supports limiting treatment to individuals with objective evidence of obstructive ETD, such as persistent middle ear effusion, tympanic membrane retraction, or abnormal tympanometry, because these characteristics were consistently used to select participants in clinical trials. Likewise, improvement while tympanostomy tubes were in place supports that symptoms are attributable to impaired Eustachian tube function rather than another disorder. However, many studies have important methodological limitations, including lack of blinding, high crossover and attrition rates, and limited long-term comparative follow-up. Recent systematic reviews, including a 2025 Cochrane review, conclude that the certainty of evidence remains low, benefits beyond three months remaining uncertain, and the only sham-controlled did not demonstrate a statistically significant benefit over sham treatment.

Evidence is insufficient to support repeat BDET because no controlled studies have established that repeating the procedure improves clinical outcomes after an unsuccessful initial treatment. Similarly, trans-tympanic approaches have not been adequately evaluated and therefore cannot be considered established alternatives to the standard transnasal technique studied in the clinical literature.

For children and adolescents, the available evidence remains limited and consists primarily on retrospective studies and observational cohorts, and pooled analyses derived from overlapping investigator groups. Frequent concurrent surgical procedures, incomplete objective outcome data, relatively short follow-up, and the absence of randomized controlled pediatric trials make it difficult to isolate the independent effect of BDET or determine its long-term clinical effectiveness. Although the AAO-HNS has published a position statement supporting BDET in carefully selected pediatric patients with refractory obstructive ETD, it also acknowledges the need for higher-quality randomized controlled trials. Consequently, current evidence is insufficient to establish the long-term clinical utility, safety, and effectiveness of BDET in individuals younger than 18 years.

Discussion

The diagnosis of ETD is considered for individuals with symptoms resulting from difficulty 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.

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 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 2015, 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 to17 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 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-week follow-up. For this cohort of treated individuals, the study shows that the observed 6-week 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 retrospective 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. This study’s retrospective design limited control over data quality, confounding variables, and missing data. The absence of a control group limits the ability to compare the incidence of complications observed with BET to those associated with alternative treatments for Eustachian tube dysfunction.

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 after 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 experienced improvement in their 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.

In a 2025 single-blind RCT, Gey and colleagues assessed BDET as an adjunct to tympanoplasty for chronic inflammatory middle ear disease in 68 adults (34 per group). The study found that the addition of BDET did not significantly improve hearing outcomes compared to tympanoplasty alone, with the difference in air-bone gap reduction not reaching statistical significance (95% CI, -9.1 to 3.5 dB; p=0.08). ETS and ETDQ-7 scores also failed to demonstrate any meaningful additional benefit. Based on these findings, the authors concluded that BDET offers a “limited additive benefit” in this context, and the researchers ultimately noted that ETBD "should not be routinely performed as an add-on" to tympanoplasty for chronic inflammatory middle ear disease.

A 2025 Cochrane systematic review by Swords and colleagues provides a comprehensive analysis of the evidence for BDET in adults. After reviewing nine RCTs, the authors concluded that there is low-certainty evidence that BDET may result in a clinically meaningful improvement in ETD symptoms, as measured by the ETDQ-7, for up to 3 months when compared to non-surgical medical management. However, the review found that the evidence for any benefit beyond 3 months is very uncertain. Critically, in the one sham-controlled trial that was analyzed, BDET did not show a statistically significant improvement in symptoms over the sham procedure, raising questions about the degree to which a placebo effect contributes to reported outcomes in unblinded studies. The authors rated the overall certainty of evidence as low to very low, citing risks of bias, imprecision due to low enrollment, and the indirectness of comparisons. Furthermore, only short-term data (up to 3 months) were sufficient to support meta-analysis with any confidence. While no serious adverse events were reported in the trials, the review cautioned that the studies were underpowered to detect rare complications.

In 2025, Joo reported the results of a prospective, multicenter, RCT involving 116 adult participants with chronic suppurative otitis media and a minimum 6-month history of Eustachian tube dysfunction treated with BDET with medical management (n=60, 62 ears) compared to medical management alone (n=56, 59 ears). Participants were excluded if they had any of the following: patulous ET dysfunction, fluctuating sensorineural hearing loss, acute otitis media, cleft palate or history of cleft palate repair, or craniofacial abnormalities. Participants were followed for an 8 week evaluation period. At baseline, no participants were able to perform a successful Valsalva maneuver. In the BDET group, 38.7% of ears (24/62) and 46.8% (29/62) of ears were reported to have successful Valsalva maneuvers at 2 and 8 weeks post-procedure, respectively. In the control group, 15.3% of ears (9/59) demonstrated a successful Valsalva maneuver at 8 weeks, demonstrating a significant improvement in the BDET group compared to controls at 8 weeks (p<0.001). The BDET group demonstrated significantly more improvement in ETDQ-7 scores at 8 weeks compared to controls, with an average reduction of -6.2±9.4 compared to -2.6±8.6 in the control group (p=0.028). The BDET group demonstrated a significantly improved air conduction threshold, decreasing from 45.6±22.3 dB HL to 39.6±24.1 dB HL (p<0.001). The authors did not report the between group differences for this measure. They did report on between group differences in air-bone gap, stating that it decreased more significantly in the BDET group (-5.8±11.4 dB HL) compared to the control group (-0.2±10.5 dB HL) at the 8-week follow-up (p=0.023). No serious procedure- or device-related adverse events were reported, including no reported occurrence of postoperative patulous ET dysfunction, massive bleeding, or false passage formation in the BET group. The authors conclude that their results demonstrate the safety and efficacy of BDET with medical management for the treatment of chronic suppurative otitis media. However, they note several limitations limiting the value of this study, including lack of blinding, inclusion of only a few bilaterally treated cases, complicating ETDQ result analysis, and a relatively short follow-up period.

Møller (2025) reported the results of a Danish retrospective case series study involving 511 adult participants (1001 ears) who received in-office BDET for Eustachian tube dysfunction-related conditions and followed for 3 and 12 months. Participants all had tympanogram Type B or C2 (200-400 daPa), an ETDQ-7 score higher than 14.5, and clinical examination including otomicroscopy and endoscopy of the ET and nasopharynx indicating Eustachian tube dysfunction. All participants completed the 3 month follow-up and 446 (91%) completed the 12 month follow-up.  The authors reported that a total of 774 ears (77%, p<0.001) improved from type B or C2 tympanogram to type C1 or A tympanogram 3 months follow-up. 12 month data was not provided. At 3 months, 116 participants were considered failed cases, and 73 (63%) were treated with tympanostomy tubes. A total of 931 ears (93%) completed 12 months follow-up, with 730 (78%, p<0.01) improving from B or C2 to A or C1. A successful Valsalva maneuver was achieved by 76% of participants at 3 months and 84% at 12 months. Normalization of EDTQ-7 measures were reported in 82% and 80% at the 3- and 12-month endpoints. No cases of patulous Eustachian tubes were reported. Minor adverse effects, including temporary epistaxis were less than 2%. The authors concluded that BDET was safe and efficacious in the treatment of Eustachian tube dysfunction. As noted with the earlier described case series studies, lack of prospective data collection, control groups, blinding, etc., limit the utility of such results.

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 a 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 to 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 2023, 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 that enrolled participants who underwent BDET to treat recurrent symptoms after having undergone tympanostomy tube placement and adenoidectomy. Outcomes for these children were compared to those of a matched cohort of 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 and 8 in the tympanostomy tube insertion group experienced failure. Dilated Eustachian tubes had a significantly lower risk of failure than those who underwent tympanostomy tube insertion (adjusted Hazard Ratio [HR], 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 study group 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 a 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.”

Ahluwalia and colleagues (2024) retrospectively reviewed 36 ears in 19 children (mean age 11.4 ± 3.1 years) who underwent concurrent BDET and tympanostomy tube (TT) placement for chronic ETD. Over a mean follow-up of 32-months, 94.4% of ears (34/36) remained failure-free, with a Kaplan-Meier 2-year failure-free probability of 97% (95% CI, 92-100). All participants had normal tympanograms and audiograms within the first 12 months; only 2 ears (5.6%) needed repeat TT (at 16 and 38 months), and 1 ear (2.8%) developed acute otitis media. Notably, audiometry beyond 12 months was only performed in symptomatic children. All participants had adjunctive procedures, including turbinate reduction and adenoidectomy in many cases, which precludes attribution of the outcomes to BDET alone. While these outcomes compare favorably with historical TT failure rates of 30% to 50%, the lack of a control group and potential confounding by the use of concurrent adjunctive procedures limit conclusions about the specific contribution of BDET.

Mukerji (2024) published the results of a retrospective single-center case series study Evaluating BDET in 43 individuals (85 ears) aged 3 to 18 years (mean age 13.3 years) with recurrent acute otitis media or chronic otitis media and history of at least 2 prior TT placement. The study population was reported by three groups, based on what post-treatment assessment they received. Group 1 consisted of participants who had an ETDQ‐7 survey score both pre‐ and post-dilation. Group 2 consisted of participants who completed both pre‐ and post-dilation tympanogram. Group 3 included participants who completed both the ETDQ‐7 survey and tympanogram. All procedures were conducted with the Acclarent AERA Eustachian Tube Balloon Dilation System. However, numerous concomitant procedures were allowed, including tympanostomy tubes (n=12), myringotomy (n=19), adenoidectomy (n=21), inferior turbinate out-fracture (n=43), and tympanoplasty or myringoplasty (n=1), limiting the ability to isolate the independent effect of BDET. All but one participant underwent bilateral procedures. Complete follow-up data was available for 37 (86%) participants. The first follow‐up occurred at an average of 3.8 months (range 1‐28 months). An additional follow-up was available for 22 participants (51%) had subsequent follow‐up at a mean of 12.9 months (range 4‐28 months). ETDQ-7 outcomes were available for only 15 Group 1 participants. Mean ETDQ-7 scores improved from 3.9 preoperatively to 2.5 postoperatively, and 8 of 15 participants (53.3%) achieved the authors' definition of symptom normalization (mean ETDQ-7 score < 2.1). Notably, 5 of these 8 participants also underwent concurrent adenoidectomy. Group 2 included 31 participants (61 ears). The authors reported that 37 ears (60.7%) had improvement in post-dilation tympanograms, defined as a change from type B to A, B to C, or C to A. However, 18 (29.5%) did not show any change in tympanometry post-dilation. In this group, 26 patients underwent a concurrent adenoidectomy (48.4%). Both the ETDQ‐7 and a tympanogram were completed in 15 participants (30 ears). An improvement in both ETDQ‐7 and tympanogram was reported in 18 out of 30 ears (60%). Concurrent adenoidectomy was conducted in 5 of these participants (33.3%), and 4 (80%) showed improvement. Concurrent turbinate out‐fracture was done for all participants (100.0%) and adenoidectomy done in about half (48.8%). No major complications were reported. However, some adverse events were reported, including one case of self‐resolving hemotympanum and 2 cases of self‐limiting (less than 6 weeks) autophony. Although the study reported improvements in symptom scores and tympanograms following BDET, the findings should be interpreted with caution. The retrospective, uncontrolled design, incomplete and selective outcome reporting (ETDQ-7 data available for only 15 participants), relatively short follow-up, and extensive use of concomitant procedures substantially limit the ability to attribute the observed improvements to BDET alone. Additional limitations include the use of the ETDQ-7, which has not been validated in children or proxy respondents, and the absence of consistent audiometric outcome data. These methodological concerns were also highlighted in a subsequent letter to the editor by Rosenfeld (2025), which additionally questioned the lack of a control group, potential selection bias in participant inclusion, and the overall study design.

Ahluwalia (2025) reported the safety outcomes of BDET in a retrospective single-center case series of 71 pediatric participants (139 ears) with conservative treatment-refractory chronic Eustachian tube dysfunction, chronic otitis media, or recurrent acute otitis media. The study evaluated postoperative complications and did not assess clinical effectiveness. All participants were aged 11 ± 7 years (range 4-17) who underwent BDET and had undergone tympanostomy tube placement at least once (mean=2.3 sets). All procedures were conducted with the Acclarent AERA Eustachian Tube Balloon Dilation System. Concurrent procedures performed included out-fracture of inferior turbinates (83.1%), tympanostomy tube placement (66.2%), myringoplasty/tympanoplasty (29.6%), adenoidectomy (15.5%), tonsillectomy (2.8%), mastoidectomy (1.4%), removal of cholesteatoma (1.4%), and nasal cautery (1.4%). The first postoperative visit between 4 to 6 weeks post-procedure was attended by 100% of participants. Additionally, 64 of 71 (90%) attended their second post-operative visit at least 6 months after the procedure (mean follow-up 1.7 ± 1 years). Five participants (7.0%) experienced complications, all classified as minor (Clavien-Dindo grade I). These complications included self-limited tinnitus, transient hyperacusis, nausea, otalgia and otorrhea, and epistaxis that were all conservatively managed and resolved by the last visit. The authors concluded, “BDET is shown to be a relatively safe procedure when performed in the pediatric population.” However, the findings should be interpreted cautiously because this retrospective uncontrolled case series was conducted at a single institution, frequently combined BDET with concurrent surgical procedures that may have contributed to postoperative events, and was designed only to assess short- and intermediate-term safety.

Liu (2025) reported the results of a retrospective pooled analysis of patient-level data from 219 children (425 ears) treated with BDET by seven surgeons at six institutions. The pooled dataset was derived from previously published studies originating from the participating investigators rather than an independent multicenter registry or prospectively designed pooled cohort and therefore represents an expanded analysis of previously reported experience rather than an independent validation of those findings. Among the 125 ears (29.4%) with paired pre- and post-procedure tympanograms, approximately 84% demonstrated improvement across diagnosis and age subgroups. No major complications were reported, but mild complications occurred in 5.9% of the study population, with none occurring in the 7 and younger group. Failure-free survival was defined as the absence of additional surgical intervention and therefore reflects avoidance of reoperation rather than direct evidence of sustained symptom resolution or normalization of Eustachian tube function. Concurrent procedures performed at the surgeon's discretion in 64.4% of participants, including myringotomy with or without tympanostomy tubes, revision adenoidectomy; inferior turbinate reduction, out-fracture, or lateralization; tonsillectomy; tympanoplasty or myringoplasty; tympanostomy tube removal; lysis of nasal synechia; mastoidectomy; or nasal mucosal biopsy. Interpretation of these findings is limited by several important methodological considerations. Relatively high failure-free survival rates were reported; however, objective tympanogram data were available for less than one-third of treated ears, and failure-free survival analyses included only 124 participants (227 ears; 56.6% of the study population). No statistical adjustment was performed for important sources of clinical heterogeneity, including differences among the six participating centers, seven surgeons, selection of concurrent procedures, BDET dilation times, or postoperative follow-up protocols. In addition, failure-free analyses treated each ear as an independent observation despite many participants contributing bilateral procedures, potentially violating the assumption of independent observations and affecting the precision of the reported estimates. Furthermore, the pooled analysis combined retrospective cohorts with differing study objectives, outcome collection methods, and follow-up durations, while the frequent use of concurrent procedures makes it difficult to attribute the reported outcomes to BDET alone. Although the pooled analysis reported favorable tympanogram improvement, low complication rates, and relatively high failure-free survival, the retrospective design, incomplete objective outcome data, absence of a control group, substantial clinical heterogeneity, and reliance on previously published cohorts contributed by overlapping investigators substantially limit confidence in the findings. Consequently, this study provides supportive but low-quality evidence regarding the safety and effectiveness of pediatric BDET.

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 to17 years old 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).

In 2025 the AAO-HNS published a position statement, rather than a formal evidence-based clinical practice guideline, titled, Eustachian Tube Balloon Dilation in the Pediatric Population. In that document, they state the following:

The American Academy of Otolaryngology-Head and Neck Surgery considers Eustachian Tube Balloon Dilatation (ETBD) as appropriate treatment for pediatric patients with Obstructive Eustachian Tube Dysfunction (OETD) resulting in chronic otitis media which is refractory to standard surgical interventions (eg - tympanostomy tube placement and adenoidectomy). Multiple studies have demonstrated the efficacy and safety of ETBD in the pediatric population, with evidence showing improvements in hearing, tympanogram, quality of life, and decreased likelihood for additional surgery. The procedure can be completed safely, as a stand-alone procedure or in combination with other procedures. The American Academy of Otolaryngology-Head and Neck Surgery thus considers ETBD as a proven and effective therapeutic option in a select group of pediatric patients. The recommendation for ETBD should be determined by a qualified Otolaryngology-Head and Neck surgeon.  A CT scan is not required preoperatively unless determined to be clinically indicated by the performing physicians. Otolaryngologists should use devices that are approved by the Food and Drug Administration (FDA) for these indications, and their use should adhere to the restrictions and guidelines specified by the appropriate governing agency, such as the FDA in the United States.

In support of this position, the AAO-HNS cites several retrospective case series, a matched cohort study, a pooled analysis of previously published retrospective cohorts, and a systematic review based largely on observational studies. Although these studies generally report favorable short- to intermediate-term outcomes and an acceptable safety profile, the overall body of evidence remains limited by the absence of randomized controlled pediatric trials, predominantly retrospective and uncontrolled study designs, frequent use of concurrent surgical procedures, incomplete objective outcome data, overlapping investigator cohorts, and reliance on surrogate outcomes such as tympanogram improvement and freedom from reoperation. Consequently, while the AAO-HNS position statement reflects the opinion of the specialty society, the currently available evidence remains insufficient to establish the clinical utility and long-term effectiveness of BDET in individuals younger than 18 years.

Peer Reviewed Publications:

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44. Schmitt D, Akkari M, Mura T, et al. Medium-term assessment of Eustachian tube function after balloon dilation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018; 135(2):105-110.
45. Schröder S, Lehmann M, Ebmeyer J, et al. Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015; 40(6):629-638.
46. Shan A, Ward BK, Goman AM, et al. Prevalence of Eustachian tube dysfunction in adults in the United States. JAMA Otolaryngol Head Neck Surg. 2019; 145(10):974-975.
47. Si Y, Chen Y, Xu G, et al. Cartilage tympanoplasty combined with Eustachian tube balloon dilatation in the treatment of adhesive otitis media. Laryngoscope. 2019; 129(6):1462-1467.
48. Silvola J, Kivekäs I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg. 2014; 151(1):125-130.
49. Singh T, Taneja V, Kulendra K, et al. Balloon Eustachian tuboplasty treatment of longstanding Eustachian tube dysfunction. J Laryngol Otol. 2017; 131(7):614-619.
50. Skevas T, Dalchow CV, Euteneuer S, et al. Cervicofacial and mediastinal emphysema after balloon Eustachian tuboplasty (BET): a retrospective multicenter analysis. Eur Arch Otorhinolaryngol. 2018; 275(1):81-87.
51. Toivonen J, Kawai K, Gurberg J, Poe D. Balloon dilation for obstructive Eustachian tube dysfunction in children. Otol Neurotol. 2021; 42(4):566-572.
52. Wang TC, Lin CD, Shih TC, et al. Comparison of balloon dilation and laser Eustachian tuboplasty in patients with Eustachian tube dysfunction: a meta-analysis. Otolaryngol Head Neck Surg. 2018; 158(4):617-626.
53. Williams B, Taylor BA, Clifton N, Bance M. Balloon dilation of the Eustachian tube: a tympanometric outcomes analysis. J Otolaryngol Head Neck Surg. 2016; 45:13.
54. Yang HH, Alonso J, Ishiyama A, et al. Clinical predictors of symptom improvement following Eustachian tube balloon dilation. Ann Otol Rhinol Laryngol. 2023; 132(9):1032-1039.
55. Yin G, Tan J, Li P. Balloon dilation of Eustachian tube combined with tympanostomy tube insertion and middle ear pressure equalization therapy for recurrent secretory otitis media. J Otol. 2019; 14(3):101-105.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology-Head and Neck Surgery. Eustachian tube balloon dilation in the pediatric population. July 8, 2025. Available at: https://www.entnet.org/resource/eustachian-tube-balloon-dilation-in-the-pediatric-population//. Accessed on August 4, 2026.
2. Llewellyn A, Norman G, Harden M, et al. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. 2014; 18(46):1-180, v-vi.
3. Swords C, Smith ME, Patel A, et al. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025;2(2): CD013429.
4. 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.
5. U.S. Food and Drug Administration (FDA). Acclarent Inc. 510(k) ACCLARENT AERA Eustachian Tube Dilation System. December 13, 2023. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230742.pdf. Accessed on August 4, 2026.
6. 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 August 4, 2026.
7. U.S. Food and Drug Administration (FDA). Entellus Medical, Inc. 510(k) Summary: XprESS ENT Dilation System. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163509.pdf. April 04, 2017. Available at: XprESS ENT Dilation System. Accessed on August 4, 2026.
8. U.S. Food and Drug Administration (FDA). Entellus Medical, Inc. 510(k)Summary: Audion ET Dilation System. April 04, 2017. Audion ET dilation system. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220027.pdf.  Accessed on August 4, 2026.
9. U.S. Food and Drug Administration (FDA). Medtronic Xomed, Inc. 510(k) Summary: NuVent Eustachian Tube Dilation Balloon. August 16, 2021. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163509.pdf. Accessed on August 4, 2026.
10. U.S. Food and Drug Administration (FDA). Spiggle & Theis Medizintechnik August, Inc. 510(k)Summary: XprESS ENT Dilation System. August 3, 2023. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K223542. Accessed on August 4, 2026.

AERA Eustachian Tube Balloon Dilation System
AUDION^® ET Dilation
Eustachian tube dilation
Eustachian tuboplasty
NuVent™ Eustachian Tube Dilation Balloon
Vensure^® Balloon Dilation Sys
XprESS ENT Dilation System

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