Project Manuscript: HIFU Labyrinthectomy System Development and Comparative Clinical Validation Study

AbstractThis integrated project presents both the technical design specifications for a novel High-Intensity Focused Ultrasound (HIFU) labyrinthectomy system and a prospective randomized clinical trial protocol comparing this technology against standard chemical labyrinthectomy (gentamicin). The HIFU system represents a modular, image-guided robotic platform for millimeter-precise ablation of vestibular end organs in treatment-resistant Ménière's disease. Concurrently, the clinical study aims to: (1) establish non-inferiority of HIFU versus gentamicin for long-term vertigo control, and (2) definitively validate extended pure-tone audiometry (PTA) as the superior surrogate marker for ablation completeness compared to white noise detection threshold (WNDT). This dual manuscript bridges biomedical engineering innovation with rigorous clinical validation, addressing both technological implementation and diagnostic accuracy in ablative vestibular therapy.