XprESS Eustachian Tube Dilation Study

XprESS Eustachian Tube Dilation Study

Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Inclusion Criteria:

• ≥18 years old
• Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
• Have an overall ETDQ-7 score ≥3.0
• Have record of failed medical management for Eustachian tube dysfunction

Exclusion Criteria:

• Require concomitant procedures at the time of the study enrollment or procedure
• Have patulous Eustachian tube
• Have ear tubes in place or perforation of the tympanic membrane
• Have evidence of internal carotid artery dehiscence
• Be pregnant at the time of enrollment
• Be currently participating in other drug or device studies