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

Area of Science:

• Otolaryngology
• Medical Devices
• Clinical Trials

Background:

• Eustachian tube dilatory dysfunction (ETDD) affects numerous adults, often refractory to conservative medical therapies.
• Current treatments for ETDD may not fully restore Eustachian tube function, necessitating novel approaches.

Purpose of the Study:

• To evaluate the efficacy and safety of Eustachian tube balloon dilation combined with medical management for ETDD.
• To compare this combined approach against medical management alone in a randomized controlled trial.

Main Methods:

• A prospective, multicenter, randomized controlled trial was conducted with adult patients (age ≥ 22) diagnosed with ETDD.
• Patients were assigned 2:1 to receive either balloon dilation plus medical management or medical management alone.
• Primary endpoint was tympanogram normalization at 6 weeks; secondary endpoints included symptom scores, Valsalva maneuver, mucosal inflammation, and safety.

Main Results:

• Balloon dilation with medical management showed significantly higher tympanogram normalization rates (51.8% vs. 13.9% at 6 weeks, P < .0001).
• The investigational group experienced superior improvement in Eustachian Tube Dysfunction Questionnaire-7 scores (56.2% vs. 8.5%, P < .001) and other functional measures.
• No serious adverse events related to the device or procedure were reported.

Conclusions:

• Eustachian tube balloon dilation in conjunction with medical management is a superior treatment for adult ETDD.
• The procedure demonstrates significant efficacy in restoring Eustachian tube function and alleviating symptoms with a favorable safety profile.