Actively Recruiting
A Prospective, Multicentric, Staged Feasibility Study to Evaluate the Safety and Performance of the Second-generation Otolith Vestibular Implant in Adults With Vestibular Dysfunction to Mitigate Imbalance
Led by Cochlear · Updated on 2025-11-25
18
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cochlear
Lead Sponsor
E
European Innovation Council
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an experimental vestibular implant system can improve balance in adults with bilateral vestibulopathy who have normal to severe hearing loss. The implant system includes a vestibular implant surgically placed behind the ear in the mastoid bone, combined with a cochlear implant sound processor and programming software, designed to preserve hearing in the implanted ear. The study aims to assess safety and performance in restoring balance in this population. Participants will receive the vestibular implant device, which stimulates the vestibular nerve via an electrode. The sound processor worn behind the ear powers the implant. The study includes a baseline pre-surgery phase and a six-month post-implantation follow-up period to evaluate changes in balance and hearing function. The intervention is implanted surgically and assessed over time. During the study, participants will undergo various tests to evaluate balance and hearing, including the Dynamic Gait Index, Functional Gait Assessment, posturography sensory tests, and questionnaires on dizziness, fall risk, and quality of life. Hearing thresholds will also be monitored. Assessments occur from baseline up to six months after activation of the implant. Safety and device-related adverse events will be closely monitored throughout the study.
CONDITIONS
Brief 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 without benefit from conventional rehabilitation
- Hearing loss ranging from moderate to severe or normal hearing in the ear to be implanted
- Diagnosis of bilateral or probable bilateral vestibulopathy based on Barany Society criteria
- Anatomical conditions suitable for implantation as evaluated 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
- Retro cochlear or central hearing impairment
- Medical contraindications for surgery
- Cognitive disorders, depression, or dementia interfering with device use or evaluation
- Cerebellar ataxias without bilateral vestibulopathy and CANVAS
- Known genetic ataxias and diagnoses such as DFNA9
- Downbeat nystagmus syndrome
- Persistent Postural-Perceptual Dizziness
- Use of vestibular suppressant medications
- Prominent oculomotor disorders
- Peripheral neuropathies
- Central gait disorders from specific neurological conditions
- Excessive alcohol or drug intoxications
- Psychological or psychiatric disorders interfering with participation
- Inability or unwillingness to comply with study requirements
- Unrealistic expectations about the procedure and device
- Study personnel or immediate family members
- Employees of Cochlear or contracted organizations
- Pregnant or breastfeeding women
- Participation in another interventional study within 30 days prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to a few days
Participants receive the vestibular implant surgery and immediate post-operative care to ensure initial recovery.
1 surgical visit and immediate post-operative visits
Duration - 6 months
Participants use the vestibular implant and follow a personalized rehabilitation program to restore balance.
Regular follow-up visits during the 6 months post implantation
Duration - Up to 6 months post-activation
Participants are monitored for device safety, performance, and functional improvements after active treatment.
Periodic follow-up visits up to 6 months post activation
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
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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