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 bone and has an electrode that stimulates the vestibular nerve. A sound processor is worn behind the ear and powers the implant via the coil. The study will be conducted in adults with bilateral vestibulopathy (BVP) who have normal to severe hearing loss in the inner ear. The study participants will undergo a series of tests that include evaluations of their balance and hearing and self-reported questionnaires on their balance and general health.
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.
Early feasibility stage (first 6 subjects enrolled): moderate to severe hearing loss with PTA of 41-70 dB HL on the ear to be implanted.
Late feasibility stage (12 subjects): normal hearing to severe hearing loss with PTA ≤ 70 dB HL on the ear to be implanted.
Ability to use the device and follow a personalized rehabilitation program.
Dynamic Gait Index > 18 and Functional Gait Assessment > 22
Ossification or other inner ear anomalies that prevent full insertion of electrodes.
Middle ear disorders including conductive hearing loss.
Retro cochlear or central origins of hearing impairment.
Single group
vestibular implant
Devicevestibular implant
Change in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant
Change in Dynamic Gait Index (DGI) score. Score range (0-24). Higher score means better outcome.
Change in Functional Gait Assessment (FGA) score from baseline to six months post-activation of the vestibular implant
Change in Functional Gait Assessment (FGA) score. Score range (0-30). Higher score means better outcome.
Change in Posturography - Sensory Test score from baseline to six months post-activation of the vestibular implant
Change in Posturography - Sensory Organization Test score. Score range (0-100%). Higher score means better outcome.
Change in Posturography - Limits of Stability test score from baseline to six months post-activation of the vestibular implant
Change in Posturography - Limits of Stability test score. Scale range (0-100). Higher score means better outcome.
Change in Dizziness Handicap Inventory (DHI) score from baseline to six months post-activation of the vestibular implant
Change in Dizziness Handicap Inventory (DHI) score. Score range (0-100). Higher score means worse outcome.
Change in Fall Efficacy Scales International (FES-I) score from baseline to six months post-activation of the vestibular implant
Change in Fall Efficacy Scales International (FES-I) score. Score range (16-64). Higher score means worse outcome.
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Cochlear
Lead sponsor
European Innovation Council
Collaborator
