Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial

Objectives/Hypothesis To assess balloon dilation of the Eustachian tube with Eustachian tube balloon catheter in conjunction with medical management as treatment for Eustachian tube dilatory dysfunction. Study Design In this prospective, multicenter, randomized, controlled trial, we assigned, in a 2:1 ratio, patients age 22 years and older with Eustachian tube dilatory dysfunction refractory to medical therapy to undergo balloon dilation of the Eustachian tube with balloon catheter in conjunction with medical management or medical management alone. Methods The primary endpoint was normalization of tympanogram at 6 weeks. Additional endpoints were normalization of Eustachian Tube Dysfunction Questionaire‐7 symptom scores, positive Valsalva maneuver, mucosal inflammation, and safety. Results Primary efficacy results demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter + medical management compared to medical management alone. Tympanogram normalization at 6‐week follow‐up was observed in 51.8% (72/139) of investigational patients versus 13.9% (10/72) of controls (P