Long Term Outcomes After Vestibular Implantation

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

• Bilateral Vestibular Hypofunction
• Bilateral Vestibular Deficiency
• Bilateral Vestibulopathy
• Gentamicin Ototoxicity
• Aminoglycoside Toxicity
• Vestibular Diseases
• Sensation Disorders
• Labyrinth Diseases
• Other Disorders of Vestibular Function

Interventions

DEVICE

Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Continuously motion-modulated stimulation delivered by a vestibular implant already implanted under a prior study protocol (Labyrinth Devices MVI™ Multichannel Vestibular Implant System)

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

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

  collaborator NIH

• Labyrinth Devices, LLC

  collaborator OTHER

• Johns Hopkins University

  lead 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

2024-12-01

Primary Completion

2029-12-31

Completion

2029-12-31

FDA Device

Yes

Countries

• United States

Study Locations