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

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.

NCT Number	NCT06805175
Lead Sponsor	Cochlear Collaborators: European Innovation Council
Conditions	Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits, Vestibular Abnormality
Enrollment	18 participants
Start Date	2025-09-18
Primary Completion	2027-06 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-07