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

Study acronym: BionicVEST2
StatusRecruiting
PhaseNot applicable
SponsorCochlear
Started
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Record History

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  1. Primary and study completion dates: Oct 2026 to Jun 2027v7
  2. Site details revised at 2 of 3 sitesv6
  3. Start date changed from estimate of Sep 2025 to Sep 18, 2025v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2025 to Sep 2025
    • Site details revised at 3 of 3 sites
    v4
  5. Site contacts updated at 3 of 3 sites
    • Collaborators expanded, about 3 words
    v3
  6. Secondary endpoints: details revised at 5 of 7 entriesv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cochlear
28 trials monitored
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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.
Trial Details
NCT Number NCT06805175
Lead Sponsor Cochlear
Collaborators: European Innovation Council
Conditions
(from sponsor)		 Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits, Vestibular Abnormality
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov