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.
Age range
22 Years – 90 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Identified adverse events to assess the safety and tolerability of the Labyrinth Devices Multichannel Vestibular Implant (MVI™)
Timeframe: Through study completion, an average of 1 year, that is: in visits 0 through 10
Assess the feasibility of the MVI, as determined by changes in 3-dimensional vestibulo-ocular reflex (3D VOR) gain and alignment compared to pre-intervention values and published data from subjects with normal vestibular function
Timeframe: Through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the preliminary efficacy of the MVI, as determined by changes in 3-dimensional vestibulo-ocular reflex (3D VOR) gain and alignment compared to pre-intervention values and published data from subjects with normal vestibular function
Timeframe: Through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI implantation on cochlear function, as indicated by changes in pure tone audiometry
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI use on cochlear function, as indicated by changes in pure tone audiometry
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI use on cochlear function, as indicated by changes in Consonant-vowel nucleus-consonant (CNC) speech recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI implantation on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10
Assess the effects of MVI use on cochlear function, as indicated by changes in Arizona Biomedical (AzBio) sentence recognition scores
Timeframe: through study completion, an average of 1 year, that is: in visits 0, and 3 through 10