Actively Recruiting
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
Led by Cochlear · Updated on 2025-11-25
18
Participants Needed
3
Research Sites
54 weeks
Total Duration
On this page
Sponsors
C
Cochlear
Lead Sponsor
E
European Innovation Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults of 18 years or older with bilateral vestibulopathy lasting more than 1 year and no benefit from rehabilitation treatment
- Hearing loss ranging from moderate to severe (PTA 41-70 dB HL) in early stage or normal to severe (PTA 70 dB HL) in late stage in the ear to be implanted
- Diagnosis of bilateral or probable bilateral vestibulopathy based on Barany Society criteria including symptoms and vestibular function tests
- Optimal anatomical conditions for implantation confirmed by CT and MRI
- Ability to use the device and follow a personalized rehabilitation program
- Ability to undergo surgery
You will not qualify if you...
- Dynamic Gait Index greater than 18 and Functional Gait Assessment greater than 22
- Inner ear anomalies preventing electrode insertion
- Middle ear disorders including conductive hearing loss
- Hearing impairment from retro cochlear or central origins
- Medical contraindications to surgery
- Chronic depression, dementia, or cognitive disorders interfering with device use or evaluation
- Cerebellar ataxias without bilateral vestibulopathy and CANVAS
- Known genetic ataxia or diagnosis of DFNA9
- Downbeat nystagmus syndrome
- Persistent Postural-Perceptual Dizziness
- Use of vestibular suppressant medications
- Oculomotor disorders with prominent oscillopsia
- Peripheral neuropathies
- Central gait disorders from certain neurological diseases
- Excessive alcohol or drug intoxication
- Psychological or psychiatric disorders interfering with device use or evaluation
- Inability or unwillingness to comply with study requirements
- Unrealistic expectations about benefits or risks
- Investigator site personnel or their immediate families
- Cochlear employees or affiliated contractors
- Pregnant or breastfeeding women
- Participation in another interventional clinical study within the past 30 days unless approved by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
ZAS Augustinus
Antwerp, Wilrijk, Belgium, 2610
Actively Recruiting
2
C.H.U. Insular & Materno-Infantil Hospital.(SCS) Las Palmas University. (ULPGC)
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain, 35016
Actively Recruiting
3
Clinica Universitad de Navarra (CUN)
Pamplona, Navarre, Spain, 31008
Actively Recruiting
Research Team
P
PRS Specialist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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