Balloon Dilation of the Eustachian Tube: Usability Analysis of a Four-Handed Insertion Technique.

Abstract

Balloon dilation of the Eustachian tube (BDET) is the preferred escalation for dilatory dysfunction unresponsive to conservative therapy. The TubaInsert introducer and TubaVent Short balloon catheter form a slim single-use BDET system requiring a four-handed technique with intraoperative endoscope handover. This enables two-handed catheter insertion. This study evaluated usability.Sixteen ENT physicians (aged 26-65) without prior four-handed BDET experience performed bilateral procedures on cadaveric heads. A surgical assistant guided the endoscope. The procedure was divided into 22 steps assessed by observation and user surveys.All 16 participants completed bilateral BDET successfully. In 32 test runs, full balloon application was achieved. All procedural steps, including four-handed insertion, were performed correctly (100% success). Endoscope handover did not impair technical safety or feasibility.This study shows high usability of the TubaInsert BDET system across users with varying experience. The four-handed technique appears reliable, technically safe, and potentially tissue-sparing.