Balloon Dilation of the Eustachian Tube: 12-Month Follow-up of the Randomized Controlled Trial Treatment Group

Abstract

Objective Obstructive eustachian tube dysfunction (OETD) affects up to 5% of adults; however, available treatment strategies have limitations. It was previously reported that balloon dilation of the eustachian tube (BDET) with the eustachian tube balloon catheter + medical management (MM) results in a significantly higher proportion of subjects with normalized tympanograms versus MM alone at 6- and 24-week follow-up. The current analysis extends these initial findings by investigating the durability of BDET + MM treatment outcomes through 52 weeks. Study Design Prospective cohort follow-up study from the treatment group in a previously reported multicenter randomized controlled trial. Setting Twenty-one investigational sites across the United States. Subjects and Methods Here we report on secondary and exploratory endpoints for patients with OETD who previously failed MM and were randomized to the BDET + MM cohort. Analyses of tympanogram outcomes are reported by ear, unless specified otherwise, as a more accurate measure of durability of the procedure over time. Results Among subjects randomized to BDET + MM, the overall number with normalized tympanograms and ETDQ-7 scores (Eustachian Tube Dysfunction Questionnaire–7) remained comparable to those reported at 6- versus 52-week follow-up: tympanograms, 73 of 143 (51.0%) versus 71 of 128 (55.5%); ETDQ-7, 79 of 142 (55.6%) versus 71 of 124 (57.3%). The overall number of ears with normalized tympanograms also remained comparable, with 117 of 204 (57%) versus 119 of 187 (63.6%). Conclusions The present study suggests that the beneficial effects of BDET + MM on tympanogram normalization and symptoms of subjects with refractory OETD demonstrate significant durability that is clinically relevant through 52 weeks.