15 Participants Needed

Vestibular Implant for Age-Related Hearing Loss

CL
CC
KL
Overseen ByKelly Lane (Study Coordinator)
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research shows that vestibular implants can help people with balance issues, even after many years of problems, by creating a sense of head movement. This suggests that similar technology might help with age-related hearing loss by improving balance and possibly enhancing hearing.12345

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

JP

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

The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant
Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen
I am between 65-90 years old with a balance disorder not improved by therapy for over a year.
See 5 more

Exclusion Criteria

You cannot handle the initial testing procedures.
You have a history of fainting or feeling dizzy before eye tests that measure 3D eye movements.
My liver disease is severe (Child-Pugh class C).
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo unilateral surgical placement of a vestibular implant

Single procedure
1 visit (in-person)

Activation and Initial Treatment

Activation of the vestibular implant and initial treatment phase with continuous motion-modulated electrical stimulation

3 weeks
1 visit (in-person)

Long-term Treatment

Participants continue daily use of the vestibular implant system

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Trial Overview The Labyrinth Devices MVI™ Multichannel Vestibular Implant System is being tested in this single-arm open-label study. It aims to restore vestibular reflexes which help maintain steady posture and vision in those suffering from chronic imbalance due to inner ear function loss.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: vestibular implantExperimental Treatment1 Intervention
Up to 15 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System

Labyrinth Devices MVI™ Multichannel Vestibular Implant System is already approved in United States for the following indications:

🇺🇸
Approved in United States as Labyrinth Devices MVI Multichannel Vestibular Implant System for:
  • Bilateral vestibular hypofunction (BVH)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Labyrinth Devices, LLC

Collaborator

Trials
4
Recruited
90+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Recent advancements in vestibular implants show promise for patients with bilateral vestibulopathy, as surgical interventions to stimulate ampullary neurons have been demonstrated to be viable.
Studies indicate that while vestibular implants won't restore normal function, they can lead to significant improvements in physical and social functioning, supported by both animal and limited human research.
Replacing semicircular canal function with a vestibular implant.Merfeld, DM., Lewis, RF.[2014]
In a study involving three subjects with unilateral Meniere's disease, simultaneous labyrinthectomy and cochlear implantation led to significant improvements in sound localization and speech perception over a 6-month period, with sound localization error decreasing from 63 degrees to 22 degrees with the cochlear implant activated.
Participants also experienced a remarkable reduction in tinnitus severity, with the Tinnitus Handicap Inventory score improving from an average of 42 preoperatively to 0 at 6 months, alongside overall enhancements in quality of life measures.
Simultaneous labyrinthectomy and cochlear implantation in unilateral meniere's disease.Perkins, E., Rooth, M., Dillon, M., et al.[2022]
In a study of 22 patients with end-stage Menière's Disease, labyrinthectomy combined with cochlear implantation significantly improved hearing, as indicated by a statistically significant increase in pure tone averages post-surgery.
While 67% of patients experienced complete resolution of vertigo symptoms, elderly patients (over 70 years) showed a higher risk of persistent instability, highlighting the need for caution in this age group.
Surgical Labyrinthectomy and Cochlear Implantation in Menière's Disease.Sykopetrites, V., Giannuzzi, AL., Lauda, L., et al.[2021]

References

Replacing semicircular canal function with a vestibular implant. [2014]
Simultaneous labyrinthectomy and cochlear implantation in unilateral meniere's disease. [2022]
Surgical Labyrinthectomy and Cochlear Implantation in Menière's Disease. [2021]
Vestibular Implantation Can Work Even After More Than 20 Years of Bilateral Vestibular Hypofunction. [2023]
Cochlear implantation in patients with bilateral Ménière's syndrome. [2019]
[Development of a vestibular implant for the rehabilitation of bilateral deafness]. [2009]
Results From a Second-Generation Vestibular Implant in Human Subjects: Diagnosis May Impact Electrical Sensitivity of Vestibular Afferents. [2021]
Electrical Vestibular Stimulation in Humans: A Narrative Review. [2020]
Control of Disabling Vertigo in Ménière's Disease Following Cochlear Implantation without Labyrinthectomy. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. [2021]
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