The DILATE study: a prospective cohort study of balloon dilatation for Eustachian tube dysfunction in patients with...

This study evaluates the safety and utility of Eustachian tube balloon dilatation in treating Eustachian tube dysfunction symptoms in adults without middle-ear disease.

A prospective cohort study was performed. Adults with dilatory Eustachian tube dysfunction symptoms and no middle-ear disease underwent Eustachian tube balloon dilatation. A clinical assessment including tympanometry, pure tone audiometry, otoscopy, ability to Valsalva, and Eustachian Tube Dysfunction Questionnaire-7 was performed pre-operatively and repeated during a 12-month follow-up period.

Fifteen participants were enrolled. The mean pre-operative Eustachian Tube Dysfunction Questionnaire-7 score of 4.6 reduced to 2.5 at six weeks (P < 0.01), 3.0 at six months (P = 0.02) and 2.6 at 12 months (P < 0.01) post-operatively. All patients without evidence of negative middle-ear pressure had Eustachian Tube Dysfunction Questionnaire-7 score improvements. There were no post-operative complications.

Eustachian tube balloon dilatation is safe and effective at treating Eustachian tube dysfunction in patients with no middle-ear disease or evidence of negative middle-ear pressure.