RecruitingNot Applicable

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

Belgium, Spain18 participantsStarted 2025-09-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
. Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant

Timeframe: Baseline (pre-surgery) to 6 months post implantation

Change in Functional Gait Assessment (FGA) score from baseline to six months post-activation of the vestibular implant

Timeframe: Baseline (pre-surgery) to 6 months post implantation

Trial details

NCT IDNCT06805175

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

Contact for this trial

PRS Specialist

+612294286555 cltd-prs-admin@cochlear.com

View on ClinicalTrials.gov More Vestibulopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
. Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.

What they're measuring

Change in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant

Timeframe: Baseline (pre-surgery) to 6 months post implantation

Change in Functional Gait Assessment (FGA) score from baseline to six months post-activation of the vestibular implant

Timeframe: Baseline (pre-surgery) to 6 months post implantation