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Multichannel Vestibular Implant Early Feasibility Study

NCT02725463 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-09

No results posted yet for this study

Summary

Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of vestibular hair cell function. Preclinical studies have demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular prosthesis can partially restore vestibular reflexes that maintain steady posture and vision. This pilot clinical feasibility study of a multichannel vestibular implant system will evaluate this approach in up to ten human subjects with bilateral vestibular deficiency due to gentamicin ototoxicity or other causes of inner ear dysfunction.

Conditions

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

Interventions

DEVICE

Labyrinth Devices MVI™ Multichannel Vestibular Implant

Sponsors & Collaborators

  • 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 (Independent/Nonconflicted IRB Protocol PI) · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02725463 on ClinicalTrials.gov