The DILATE study: a prospective cohort study of balloon dilatation for Eustachian tube dysfunction in patients with no middle-ear disease.

OBJECTIVE

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

METHODS

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.

RESULTS

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.

CONCLUSION

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.