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A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06805175•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults of 18 years or older with bilateral vestibulopathy \>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms unlikely to improve according to clinicians´ estimation.
•Hearing impairment ranging from:
•1. 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.
•2. Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.
•Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research \[van de Berg et al., 2020\]:
•a. Unsteadiness when walking or standing plus at least one of the following: i. Movement-induced blurred vision or ii. Oscillopsia during walking or quick head/body movements, and/or iii. Worsening of unsteadiness in darkness and/or on uneven ground b. Symptoms greatest during head movement and not compensated after rehabilitation program. c. Bilaterally reduced or absent angular VOR function documented by at least one of the following major criteria: i. Pathological horizontal angular VOR gain ≤ 0.6 and at least one vertical angular VOR gain \< 0.7, measured by the video-HIT technique. ii. Reduced caloric response (sum of bithermal max. peak SPV on each side ≤6◦/sec for 30 sec water stimuli or \<10◦/sec for 60 sec of air stimuli). In case only one of two criteria from c. are matched, the remaining test(s) should comply with the following minor criteria: 1) Bilaterally pathological VOR gains of at least two semicircular canals \< 0.7, measured by the video- HIT or scleral-coil technique 2) Reduced caloric response (sum of bithermal max. peak SPV on each side \<10°/sec for water and air stimuli of ≥30 sec). d. Absent cVEMP and oVEMP responses in the ear to be implanted.
•Anatomical optimal conditions for implantation evaluated by CT and MRI:
•vestibule permeability ascertained and present intact vestibular nerve.
•Ability to use the device and follow a personalized rehabilitation program.
•Ability to undergo the surgery.

Exclusion Criteria

•Dynamic Gait Index \> 18 and Functional Gait Assessment \> 22
•Ossification or other inner ear anomalies that prevent full insertion of electrodes.
•Middle ear disorders including conductive hearing loss.
•Retro cochlear or central origins of hearing impairment.
•Medical contraindications for surgery.
•Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation of the VI.
•Cerebellar ataxias without bilateral vestibulopathy and CANVAS.
•Known genetical indication for ataxia.
•Known diagnosis of DFNA9.
•Downbeat nystagmus syndrome.
+13 more criteria

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

Key Dates

Start Date

September 18, 2025

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

November 25, 2025

Enrollment

ESTIMATED participants

Conditions

VestibulopathyModerate to Severe Hearing LossNormal HearingBalance DeficitsVestibular Abnormality

Interventions

vestibular implant

DEVICE

Contacts

PRS Specialist

CONTACT

+612294286555 cltd-prs-admin@cochlear.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss

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