About this trial
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.
Eligibility criteria
Qualifiers
Adults older than 22 years old who
have previously been enrolled in Johns Hopkins University Institutional Review Board protocol NA_00051349, IRB00335294 or IRB00346924 and
have previously been implanted with a vestibular implant under FDA IDE G150198
Disqualifiers
None
Trial design
Treatments tested in this trial
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Treatment groups
Sponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Labyrinth Devices, LLC
Collaborator