Vestibular Implant for Age-Related Hearing Loss

Overseen By Kelly Lane (Study Coordinator)

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Alcohol, others

Disqualifiers: Blindness, Pregnancy, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device designed to assist individuals with balance and vision problems due to bilateral vestibular hypofunction. Researchers aim to determine if the vestibular implant (Labyrinth Devices MVI™ Multichannel Vestibular Implant System) can enhance balance and reduce dizziness by stimulating the nerve responsible for balance. The trial seeks participants aged 65 to 90 who have experienced balance issues for over a year without relief from other treatments. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for balance issues.

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 prior data suggests that this vestibular implant is safe for age-related hearing loss?

Research has shown that the Labyrinth Devices MVI™ Multichannel Vestibular Implant System holds promise for human safety. In one study, four patients with balance issues due to ear damage found that this implant could safely improve their balance. Another study, involving up to eight participants, examined long-term effects and also supported the implant's safety for individuals with serious balance problems.

Although research remains in the early stages, these studies suggest that the vestibular implant is generally well-tolerated. No major safety concerns emerged. However, since the device is still under study, potential participants should discuss any risks with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for age-related hearing loss, which often include hearing aids or cochlear implants, the Labyrinth Devices MVI™ Multichannel Vestibular Implant System offers a novel approach by focusing on the vestibular system. This system is unique because it targets both hearing and balance, addressing issues that traditional devices do not. Researchers are excited about this treatment because it has the potential to improve not just hearing, but also balance and spatial orientation, which can greatly enhance quality of life for older adults.

What evidence suggests that the Labyrinth Devices MVI Multichannel Vestibular Implant System is effective for age-related hearing loss?

Research has shown that a vestibular implant, like the one studied in this trial, can assist people with balance and vision issues due to vestibular hypofunction. Studies have found that this implant sends electrical signals to the balance nerve, improving balance reflexes. As a result, it helps people stand steady and walk better. Patients report feeling less disabled and experiencing an improved quality of life after receiving the implant. Early findings suggest the implant partially restores the natural reflexes needed for stable posture and clear vision. ^{1 2 3 4 6}

Who Is on the Research Team?

John Carey, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

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).

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: vestibular implant Experimental Treatment 1 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)

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing semicircular canal function with a vestibular implant. Merfeld, DM., Lewis, RF.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Labyrinthectomy and Cochlear Implantation in Menière's Disease. Sykopetrites, V., Giannuzzi, AL., Lauda, L., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous labyrinthectomy and cochlear implantation in unilateral meniere's disease. Perkins, E., Rooth, M., Dillon, M., et al.[2022]

A vestibular implant successfully elicited artificial sensations of head movement in a 55-year-old man who had experienced 23 years of bilateral vestibular hypofunction, demonstrating the potential for long-term recovery of vestibular function.

The electrically evoked vestibulo-ocular reflexes (eeVOR) showed alignment and magnitude similar to those seen in patients implanted less than 10 years after onset, indicating that prosthetic stimulation can effectively restore vestibular responses even after a prolonged period of dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular Implantation Can Work Even After More Than 20 Years of Bilateral Vestibular Hypofunction. Schoo, DP., Ayiotis, AI., Fernandez Brillet, C., et al.[2023]

Cochlear implantation in patients with Ménière's syndrome and severe to profound hearing loss resulted in significant improvements in speech recognition and overall auditory function, with average postoperative scores showing substantial gains compared to preoperative levels.

The study suggests that previous vestibular surgeries do not prevent successful cochlear implantation, indicating that patients with fluctuating symptoms from Ménière's syndrome can still benefit from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cochlear implantation in patients with bilateral Ménière's syndrome. Lustig, LR., Yeagle, J., Niparko, JK., et al.[2019]

A vestibular implant is being developed to help people with bilateral vestibular loss, similar to how cochlear implants assist those with bilateral deafness.

Initial experiments with human subjects in Geneva have begun, marking an important step in the rehabilitation of balance disorders caused by vestibular loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a vestibular implant for the rehabilitation of bilateral deafness]. Guyot, JP., Sigrist, A., Kos, I.[2009]

The study involved three patients with severe-profound deafness and bilateral vestibular loss who received vestibular-cochlear implants, revealing that the cause of vestibular loss significantly affects the outcomes of the implant.

Two of the subjects demonstrated robust vestibular responses with high eye movement velocities from electrical stimulation, suggesting that the sensitivity of vestibular afferents varies based on the underlying condition, which may influence the effectiveness of vestibular implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results From a Second-Generation Vestibular Implant in Human Subjects: Diagnosis May Impact Electrical Sensitivity of Vestibular Afferents. Rubinstein, JT., Ling, L., Nowack, A., et al.[2021]

Electrical vestibular stimulation (EVS) is being explored as a treatment for bilateral vestibulopathy, with three promising approaches: vestibular co-stimulation with cochlear implants, vestibular implants, and galvanic vestibular stimulation.

While all three methods have shown effectiveness in stimulating vestibular function, there is currently no consensus on which approach is best suited for specific patient types, indicating a need for further research to determine their applicability and efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Vestibular Stimulation in Humans: A Narrative Review. Sluydts, M., Curthoys, I., Vanspauwen, R., et al.[2020]

In a case series of five patients with Ménière's disease and profound hearing loss, cochlear implants effectively controlled disabling vestibular symptoms, with no reported vestibular crises post-surgery.

All patients experienced improvements in hearing and a reduction in tinnitus, indicating that cochlear implants can be a safe and effective treatment for both hearing loss and associated vestibular issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of Disabling Vertigo in Ménière's Disease Following Cochlear Implantation without Labyrinthectomy. Canale, A., Dalmasso, G., Albera, R., et al.[2022]

The new multichannel vestibular prosthesis (MVP) is designed to restore vestibular function in individuals with bilateral loss of vestibular sensation, potentially alleviating symptoms like chronic disequilibrium and postural instability.

Improvements in the MVP include a smaller size, lower power consumption, and enhanced electrode design for better nerve coupling, which were validated through both bench-top tests and in vivo experiments with a rhesus macaque monkey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and performance of a multichannel vestibular prosthesis that restores semicircular canal sensation in rhesus monkey. Chiang, B., Fridman, GY., Dai, C., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02725463

Multichannel Vestibular Implant Early Feasibility Study This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6948863/

Continuous vestibular implant stimulation partially restores ... We report binocular 3D VOR responses of 4 human subjects with ototoxic bilateral vestibular loss unilaterally implanted with a Labyrinth Devices Multichannel ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2814663

Patient-Reported Outcomes After Vestibular Implantation ... The study results suggest that patient-reported benefit supports the use of vestibular implantation for treating bilateral vestibular hypofunction.

4. withpower.com withpower.com/trial/phase-ototoxicity-2023-53052

Vestibular Implant for Age-Related Hearing Loss This trial tests a surgically implanted device that sends electrical signals to the balance nerve in older adults with severe balance issues.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06500975

Long Term Outcomes After Vestibular Implantation This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, ...

6. link.springer.com link.springer.com/article/10.1007/s40136-024-00502-8

Vestibular Implantation | Current Otorhinolaryngology ... Vestibular implants are an investigational technology with the potential to provide treatment options for patients with chronic bilateral vestibulopathy.