A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration

Recruiting N/A Interventional Study
Vestibulopathy Moderate to Severe Hearing Loss Normal Hearing Balance Deficits Vestibular Abnormality
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
Cochlear · Industry
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About This Trial
The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and programming software. The implant is designed to preserve hearing in the implanted ear. The vestibular implant is surgically placed under the skin just behind the ear in the mastoid…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Adults of 18 years or older with bilateral vestibulopathy \>1 year of evolution without benefit from conventional rehabilitation treatment. Symptoms unlikely to improve according to clinicians´ estimation. * Hearing impairment ranging from: 1. Early feasibility stage (first…
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