Long Term Outcomes After Vestibular Implantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-90
SponsorJohns Hopkins University

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

32 Participants
are divided into 1 treatment group

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