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RECRUITING
NCT06805175
NA

A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration

Sponsor: Cochlear

View on ClinicalTrials.gov

Summary

The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software. The implant is designed to preserve hearing in the implanted ear. The vestibular implant is surgically placed under the skin just behind the ear in the mastoid bone and has an electrode that stimulates the vestibular nerve. A sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with bilateral vestibulopathy (BVP) who have normal to severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of their balance and hearing and self-reported questionnaires on their balance and general health.

Official title: A Prospective, Multicentric, Staged Feasibility Study to Evaluate the Safety and Performance of the Second-generation Otolith Vestibular Implant in Adults With Vestibular Dysfunction to Mitigate Imbalance. BionicVEST2

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-09-18

Completion Date

2026-10

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DEVICE

vestibular implant

vestibular implant

Locations (3)

ZAS Augustinus

Antwerp, Wilrijk, Belgium

C.H.U. Insular & Materno-Infantil Hospital.(SCS) Las Palmas University. (ULPGC)

Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

Clinica Universitad de Navarra (CUN)

Pamplona, Navarre, Spain