Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction

Summary

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.

Conditions

• Other Disorders of Vestibular Function, Bilateral
• Bilateral Vestibular Deficiency (BVD)
• Gentamicin Ototoxicity
• Labyrinth Diseases
• Vestibular Diseases
• Sensation Disorders
• Bilateral Vestibular Hypofunction
• Bilateral Vestibulopathy
• Aminoglycoside Ototoxicity

Interventions

DEVICE

Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Unilateral implantation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System receiver/stimulator including insertion of electrode arrays in the semicircular canal ampullae of the inner ear, followed by motion-modulated prosthetic electrical stimulation.

Sponsors & Collaborators

• Johns Hopkins University

  lead OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Labyrinth Devices, LLC

  collaborator OTHER

Principal Investigators

• John P Carey, MD · Johns Hopkins School of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-28

Primary Completion

2026-12-31

Completion

2027-03-31

FDA Device

Yes

Countries

• United States

Study Locations