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

NCT06805175 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-11-25

No results posted yet for this study

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.

Conditions

  • Vestibulopathy
  • Moderate to Severe Hearing Loss
  • Normal Hearing
  • Balance Deficits
  • Vestibular Abnormality

Interventions

DEVICE

vestibular implant

vestibular implant

Sponsors & Collaborators

  • European Innovation Council

    collaborator OTHER

  • Cochlear

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-18
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Belgium
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06805175 on ClinicalTrials.gov