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.