Balloon dilation of the Eustachian tube with a seeker-based device: A registry of 169 patients

Abstract

Objective: To collect real-world data on the safety and effectiveness of balloon dilation of the Eustachian tube using a seeker-based device in patients with persistent/chronic symptoms of Eustachian tube dysfunction. Methods: A multicenter, prospective, single-arm registry was conducted from June 2018 through August 2020 at 10 US centers, including tertiary care and private practices. Primary endpoints included mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) and the serious related adverse event rate. Secondary endpoints include changes in middle ear assessments, surgical intervention rate, and changes in Sino-Nasal Outcome Test and Work and Activity Impairment (WPAI) questionnaires. Results: A total of 169 participants were treated with balloon dilation of the Eustachian tube, with 166 and 154 participants completing the 6-week and 6-month follow-ups, respectively. Repeated measures analysis of the change in ETDQ-7 scores indicated statistically significant improvement (−2.1; 95% CI −2.40, −1.84; P