Vestibular Implant for Age-Related Hearing Loss
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using medications, drugs, or alcohol that interfere with vestibular compensation, you may not be eligible to participate.
What data supports the effectiveness of the Vestibular Implant for Age-Related Hearing Loss treatment?
How is the Vestibular Implant treatment different from other treatments for age-related hearing loss?
The Vestibular Implant treatment is unique because it uses electrical stimulation to restore vestibular function, similar to how a cochlear implant restores hearing. Unlike traditional treatments like medication or surgery, this implant directly targets the vestibular system to improve balance and stability.678910
What is the purpose of this trial?
This trial tests a surgically implanted device that sends electrical signals to the balance nerve in older adults with severe balance issues. The device aims to restore natural balance reflexes by mimicking the functions of the damaged inner ear. The vestibular implant is a hybrid system based on a modified cochlear implant designed to restore balance by delivering motion information to the central nervous system using electrical stimulation.
Research Team
John Carey, MD
Principal Investigator
Johns Hopkins School of Medicine
Eligibility Criteria
This trial is for older adults aged 65-90 with severe balance and vision issues due to bilateral vestibular hypofunction, who haven't improved after a year of rehab. They must be vaccinated per certain protocols, have specific hearing levels, agree not to swim or use heavy machinery during the study, and be able to travel for tests and exercises.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Participants undergo unilateral surgical placement of a vestibular implant
Activation and Initial Treatment
Activation of the vestibular implant and initial treatment phase with continuous motion-modulated electrical stimulation
Long-term Treatment
Participants continue daily use of the vestibular implant system
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Labyrinth Devices MVI™ Multichannel Vestibular Implant System is already approved in United States for the following indications:
- Bilateral vestibular hypofunction (BVH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Labyrinth Devices, LLC
Collaborator
National Institute on Aging (NIA)
Collaborator