VestibulopathyBionicVEST2NCT06805175
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
A study testing vestibular implant in people with Vestibulopathy and Moderate to Severe Hearing Loss, run by Cochlear at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing
- What is being tested?
- vestibular implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Sep 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research [van de Berg et al., 2020]:
- Unsteadiness when walking or standing plus at least one of the following: i. Movement-induced blurred vision or ii. Oscillopsia during walking or quick head/body movements, and/or iii. Worsening of unsteadiness in darkness and/or on uneven ground b. Symptoms greatest during head movement and not compensated after rehabilitation program. c. Bilaterally reduced or absent angular VOR function documented by at least one of the following major criteria: i. Pathological horizontal angular VOR gain ≤ 0.6 and at least one vertical angular VOR gain < 0.7, measured by the video-HIT technique. ii. Reduced caloric response (sum of bithermal max. peak SPV on each side ≤6◦/sec for 30 sec water stimuli or <10◦/sec for 60 sec of air stimuli). In case only one of two criteria from c. are matched, the remaining test(s) should comply with the following minor criteria: 1) Bilaterally pathological VOR gains of at least two semicircular canals < 0.7, measured by the video- HIT or scleral-coil technique 2) Reduced caloric response (sum of bithermal max. peak SPV on each side <10°/sec for water and air stimuli of ≥30 sec). d. Absent cVEMP and oVEMP responses in the ear to be implanted.
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- Anatomical optimal conditions for implantation evaluated by CT and MRI:
- vestibule permeability ascertained and present intact vestibular nerve.
- Ability to use the device and follow a personalized rehabilitation program.
- Ability to undergo the surgery.
Who cannot join
- 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.
- Medical contraindications for surgery.
- Chronic depression, dementia and cognitive disorders that could, at the discretion of the clinician, significantly interfere with use or evaluation of the VI.
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- Cerebellar ataxias without bilateral vestibulopathy and CANVAS.
- Known genetical indication for ataxia.
- Known diagnosis of DFNA9.
- Downbeat nystagmus syndrome.
- Persistent Postural-Perceptual Dizziness.
- Vestibular suppressant medications.
- Oculomotor disorders (if oscillopsia is prominent).
- Peripheral neuropathies.
- Central gait disorders due to normal pressure hydrocephalus, frontal gait disorders, subcortical vascular encephalopathy or multiple sclerosis.
- Intoxications (i.e. excessive alcohol and/or drugs use).
- No current psychological or psychiatric disorder that could significantly interfere with use or evaluation of the VI.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent in the procedure and prosthetic device.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Pregnant or breastfeeding women.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless determined by the investigator or Sponsor to not impact this investigation).
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
C.H.U. Insular & Materno-Infantil Hospital.(SCS) Las Palmas University. (ULPGC)
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016
Remo Arts, +31615326086, rarts@cochlear.com
Erika Van Baelen, +32477311706, EVanBaelen@cochlear.com
- Recruiting
Clinica Universitad de Navarra (CUN)
Pamplona, Navarre, 31008
Remo Arts, +31615326086, rarts@cochlear.com
Erika Van Baelen, +32477311706, EVanBaelen@cochlear.com
Belgium1 site, 1 recruiting
- Recruiting
ZAS Augustinus
Antwerp, Wilrijk, 2610
Remo Arts, +31615326086, rarts@cochlear.com
Erika Van Baelen, +32477311706, EVanBaelen@cochlear.com
About this study
Official title: 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. BionicVEST2
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
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits, Vestibular Abnormality
- Being tested
- vestibular implant
- Keywords
- vestibular implant, vestibulopathy, cochlear implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular implantDevice
vestibular implant
| Study group | Role | What they receive |
|---|---|---|
| Implanted with a vestibular implant | Experimental | Not described Receives: Device: vestibular implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
Secondary outcomes (7)
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
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.
Measured: Baseline (pre-surgery) to 6 months post implantation
Device or procedure related adverse events in participants up to six months post-activation of the vestibular implant.
Listing of device or procedure related adverse events.
Measured: Baseline (pre-surgery) to 6 months post implantation
Change in hearing thresholds up to six months post-activation of the vestibular implant
Pre- vs post-surgery hearing thresholds difference (dB HL) measured at 250, 500, 1000, 2000, 4000, and 8000 Hz.
Measured: Baseline (pre-surgery) to 6 months post implant surgery
Change in EuroQol 5D (EQ5D-5L) quality of life score from baseline to six months post-activation of the vestibular implant
Change in EuroQol 5D (EQ5D-5L) quality of life score. Score range (-0.594-1). Higher score means better outcome.
Measured: Baseline (pre-surgery) to 6 months post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start18 Sep 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VestibulopathyStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Innovation Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805175
- Sponsor's protocol ID
- AI5851
- Acronym
- BionicVEST2
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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. BionicVEST2
- ClinicalTrials.gov ID
- NCT06805175
- Acronym / sponsor ID
- BionicVEST2 / AI5851
- Conditions
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits, Vestibular Abnormality
- Keywords
- vestibular implant, vestibulopathy, cochlear implant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- European Innovation Council
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted with a vestibular implant | Experimental | Device: vestibular implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Patients diagnosed with bilateral vestibulopathy or probable bilateral vestibulopathy based on the consensus document of the Barany Society on vestibular implant candidate criteria for research [van de Berg et al., 2020]:
- Anatomical optimal conditions for implantation evaluated by CT and MRI:
- vestibule permeability ascertained and present intact vestibular nerve.
Key exclusion criteria (23 listed)
- 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.
- Medical contraindications for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vestibular implantvestibular implant | Device | Implanted with a vestibular implant |
Primary outcome
Change in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
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
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Functional Gait Assessment (FGA) score. Score range (0-30). Higher score means better outcome.
7 secondary outcomes
Change in Posturography - Sensory Test score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Posturography - Limits of Stability test score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Dizziness Handicap Inventory (DHI) score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in Fall Efficacy Scales International (FES-I) score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
Device or procedure related adverse events in participants up to six months post-activation of the vestibular implant.
Time frame: Baseline (pre-surgery) to 6 months post implantation
Change in hearing thresholds up to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implant surgery
Change in EuroQol 5D (EQ5D-5L) quality of life score from baseline to six months post-activation of the vestibular implant
Time frame: Baseline (pre-surgery) to 6 months post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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MRI Performance and Risk Factors in Bilateral Vestibular Hypofunction
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Spatial Orientation, Navigation, and Neuropsychologic Function in Patients With Vestibular Implant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular implant in people with Vestibulopathy and Moderate to Severe Hearing Loss, run by Cochlear at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PRS Specialist (+612294286555, cltd-prs-admin@cochlear.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dynamic Gait Index (DGI) score from baseline to six months post-activation of the vestibular implant (time frame: Baseline (pre-surgery) to 6 months post implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.