Balloon Dilation of the Eustachian Tube—A Pooled Analysis in Pediatric Patients

Clinical Question

Is balloon dilation of the Eustachian tube (BDET) safe and effective for children with chronic otitis media with effusion (COME) or recurrent acute otitis media (RAOM) refractory to prior tympanostomy tube placement?

Bottom Line

In this multi-institutional pooled analysis of 219 pediatric patients (425 ears), BDET demonstrated a favorable safety profile, significant improvement in tympanograms in over 80% of ears, and durable failure-free survival exceeding 87% at two years.

Background: Eustachian tube dysfunction (ETD) in children contributes to COME and RAOM, which are often managed with tympanostomy tubes (TTs). While TTs provide temporary ventilation, they do not address underlying Eustachian tube pathology, and recurrence after extrusion is common. Pediatric data on BDET remain limited, prompting pooled analysis to better define safety and durability.

Study Design: Retrospective pooled analysis of patient-level data from seven surgeons across six institutions. Children aged one to 17 years with COME or RAOM refractory to prior TT placement underwent BDET using 6×16 mm balloons. Outcomes included tympanogram changes, failure-free survival (absence of additional surgical intervention), and complications.

Setting: Seven surgeons across six surgical centers contributing retrospective real-world clinical data.

Synopsis: A total of 219 pediatric patients (425 ears) were included in the study, and the mean age was 11 years, while the mean follow-up was 3.4 years. Chronic otitis media with effusion accounted for 56% of cases, and RAOM for 44%. Pre- and post-tympanograms were available for 125 ears (29%). Overall, tympanograms improved in 83.7% of ears, with type B tracings markedly reduced post-operatively. Improvement rates were similar in the COME (84%) and RAOM (83%) groups.

Failure-free survival data were available for 124 patients (227 ears). At one year, failure-free probability was 93.8% (95% CI 89.7%–96.3%); at two years, 87.2% (95% CI 81.9%–91.0%); and at three years, 84.3%. Outcomes were comparable between COME and RAOM subgroups. All failures occurred within four years of surgery. Safety outcomes were favorable in the study, and no major complications (including internal carotid artery injury or pneumomediastinum) were reported. Mild complications occurred in 5.9% of patients and were transient.

Limitations include retrospective design, incomplete tympanogram follow-up, and inability to isolate the independent effect of adjunctive procedures. Nonetheless, this represents the largest pooled pediatric BDET cohort to date and supports its safety and durable efficacy in carefully selected patients.

Citation: Liu YC, et al. Balloon dilation of the Eustachian tube (BDET)-a pooled analysis in pediatric patients. Laryngoscope. 2025;135:4887-4893. doi:10.1002/lary.32356.

COMMENT: Balloon dilation of the Eustachian tube has been approved by the U.S. Food and Drug Administration (FDA) for pediatric patients since December 2023. This retrospective study presents the largest pooled analysis of BDET in pediatric patients with ETD. The results demonstrate that BDET has a favorable safety profile, as well as long-lasting durability, with over 93% of patients remaining failure-free at one year and over 87% at two years. The role of BDET in pediatric patients with ETD continues to evolve, but this study suggests that BDET may be a useful treatment for children with recurrent ETD.—Robert Hong, MD, PhD