Other Disorders of Vestibular Function, BilateralNCT05674786
Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction
A study testing Labyrinth Devices MVI™ Multichannel Vestibular Implant System in people with Other Disorders of Vestibular Function, Bilateral and Bilateral Vestibular Deficiency (BVD), run by Johns Hopkins University at 1 site in United States.
Trial summary
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Read more about this study
- Who is it for?
- Ages 22 to 90 years
- Conditions the study is for
- Other Disorders of Vestibular Function, Bilateral, Bilateral Vestibular Deficiency (BVD), Gentamicin Ototoxicity
- What is being tested?
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 31 Mar 2027
- Phase
- Interventional
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 22 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 22-90 years diagnosed with ototoxic, idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction inadequately responsive to vestibular rehabilitation for greater than 1 year as determined by pre-inclusion history, vestibular testing and clinical examination conducted by a board-certified neurotologist, neurologist or other physician skilled in diagnosis of vestibular disorders
- Hearing status: (1) Hearing in the candidate ear for implantation is equivalent to or worse than that in the contralateral ear; and (2) hearing in the contralateral ear is good enough to allow functional communication in case hearing in the implanted ear is lost after implantation. Specifically, the contralateral ear must satisfy all of the following criteria:
- 0.5/1/2/4 kHz pure-tone-average threshold (PTA) hearing better than (i.e., less than) 70 dB HL; and
- ear-specific sentence recognition score using the recorded AzBio Sentence Test presented at 60 dB SPL-A in quiet must be >60% when tested under either the unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition; and
- ear-specific word recognition score using the recorded Consonant-Nucleus-Consonant (CNC) Word Recognition Test presented at 60 dBHL in quiet must be >60% when tested under either the unaided condition or, if 0.5/1/2/4 kHz PTA>50 dB, the best-aided condition
- Caloric responses consistent with severe or profound bilateral loss of labyrinthine function, as indicated by one or more of the following: (a) summed speed of caloric responses to warm and cool supine caloric stimuli totaling <10°/sec per ear for each of both ears; (b) summed speed of ice water caloric responses during supine and prone head orientation tests totaling <10°/sec per ear for each of both ears; or (c) speed of ice water caloric responses during supine head orientation tests <5°/sec per ear for each of both ears, with a lack of nystagmus reversal on quickly flipping from supine to prone
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- Prior MRI imaging of the brain, internal auditory canals and cerebellopontine (CP) angle showing a patent labyrinth, present vestibular nerve, patent cochlea, present cochlear nerve, and absence of internal auditory canal/cerebellopontine angle tumors or other central causes of vestibulo-ocular reflex dysfunction or sensorineural hearing loss
- Prior CT imaging of the temporal bones showing a facial nerve canal with normal caliber and course, middle ear without evidence of chronic otitis media or tympani membrane perforation or cholesteatoma, a mastoid cavity with adequate aeration for surgical access to each semicircular canal, skull thickness ≥3 mm at the planned well site, and scalp soft tissue thickness ≤7 mm. This criterion may be satisfied without additional imaging if an existing head CT or MRI already demonstrates those findings
- Vaccinations as recommended per Johns Hopkins Cochlear Implant Center and United States Centers for Disease Control and Prevention protocols to reduce the risk of meningitis in subjects undergoing cochlear implantation, as described at this site: https://www.cdc.gov/vaccines/vpd/mening/public/dis-cochlear-faq-gen.html
- Motivated to travel to the study center, to undergo testing and examinations required for the investigational study, and to participate actively in a vestibular rehabilitation exercise regimen
- The participant must agree not to swim or to use or operate vehicles, heavy machinery, powered tools or other devices that could pose a threat to the participant, to others, or to property throughout the duration of participation in the study and until at least 1 month after final deactivation of the MVI Implant
Who cannot join
- Inability to understand the procedures and the potential risks involved as determined by study staff
- Inability to participate in study procedures due to blindness, ≤ ±10° neck range of motion, cervical spine instability, ear canal stenosis or malformation sufficient to prevent caloric testing
- Diagnosis of acoustic neuroma/vestibular schwannoma, chronic middle ear disease, cholesteatoma, or central nervous system causes of vestibulo-ocular reflex dysfunction, including chronic and continuing use of medications, drugs or alcohol at doses sufficiently great to interfere with vestibular compensation
- Vestibular dysfunction known to be caused by reasons other than labyrinthine injury due to ototoxicity, ischemia, trauma, infection, Meniere's disease, or genetic defects known to act on hair cells
- Lack of labyrinth patency or vestibular nerve as determined by MRI of the brain with attention to the internal acoustic meatus
- Any contraindication to the planned surgery, anesthesia, device activation and deactivation, or participation in study assessments, as determined by the surgeon, anesthesiologist, or designee, including known intolerance of any materials used in any component of the investigational devices that will come in contact with the subject
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- History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to screening
- Orthopedic, neurologic or other nonvestibular pathologic conditions of sufficient severity to confound posture and gait testing or other tests used in the study to assay vestibular function.
- Subjects with estimated glomerular filtration rate (GFR) < 30 ml/min (MDRD formula) at screening
- Subjects with heart failure NYHA class III or IV
- Subjects with Child-Pugh class C cirrhosis
- Inadequately treated or unstable depression, suicidality as indicated by any affirmative answer to the 6-question screener version of the Columbia Suicide Severity Rating Scale (C-SSRS), or any other psychiatric disease or substance abuse history likely to interfere with protocol compliance
- Contraindications to scleral coil eye movement testing, including monocular blindness and a history of fainting vagal reactions to prior eye manipulations would exclude subjects from eye coil testing
- Inability to tolerate baseline testing protocols
- Recent corneal injury
- A history of cervical spine disease preventing head rotation
- A history of fainting or vagal reactions prior to eye manipulations that would preclude 3D eye movement coil testing
- Pregnancy, positive urine or serum pregnancy test at any time during study participation,
- Ability to become pregnant combined with failure or refusal to consistently use a highly effective method of contraception from at least 1 month prior to implantation to not before 1 month after both device deactivation and conclusion of study participation. Highly effective contraception methods include:
- Total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception for purposes of defining exclusion criteria for this study Female sterilization (surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before entering the study. A woman who has undergone oophorectomy without hysterectomy may participate in the study only after her reproductive status has been confirmed by subsequent hormone level assessment For female subjects of child-bearing potential, study participation is not excluded if the study candidate's male partner is the sole partner of the study candidate and has been vasectomized.
- Combination of any two of the following:
- Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example, hormone vaginal ring or transdermal hormone contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository In case of use of oral contraception, women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.
- Women who are nursing/lactating
- Any medical condition, judged by the investigator team, that is likely to interfere with a study candidate's participation in the study or likely to cause serious adverse events during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
Claudia Lee, 410-502-8209, vestibularimplant@jhmi.edu
Charles C Della Santina MDPhD (Lead Surgeon; CEO Labyrinth Devices LLC), 410-502-8047, vestibularimplant@jhmi.edu
About this study
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research focused on ototoxic cases has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to 8 individuals with non-ototoxic bilateral vestibular hypofunction, yielding a total of fifteen adults (age 22-90 years at time of enrollment) divided as equally as possible between ototoxic and non-ototoxic cases.
Read the detailed description
There is no adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to loss of semicircular canal function despite vestibular rehabilitation exercises. The experience of seven adults with bilateral vestibular hypofunction due to ototoxicity who underwent unilateral surgical placement of a vestibular implant and have received continuously motion-modulated electrical stimulation of the vestibular nerve for >6 months revealed that this approach can partially restore vestibular sensation and reflexes that normally maintain steady posture and vision. This study will examine long-term outcomes in that cohort and extend vestibular implant treatment to adults with idiopathic or non-ototoxic/non-central bilateral vestibular hypofunction. Within constraints on power and/or minimum detectable effect size due to limits on the number of study participants permitted under IDE G150198 and U01DC019364, the study will test the following hypotheses regarding unilateral vestibular implantation, activation and long-term (≥8 week) continuous/daily use:
- It is feasible, as quantified by implantation being achieved in all subjects undergoing attempted implantation surgery.
- It is safe, as determined by incidence of serious unanticipated adverse device-related events and as further quantified by proportions of:
- implanted ears with preservation of 4-frequency pure tone average for 0.5,1,2,4 kHz air-conducted audiometric detection thresholds ≤ 50 dB HL and ear-specific speech discrimination ≥50% (consistent with Class A or B per American Academy of Otolaryngology-Head and Neck Surgery 1995 guidelines13 ) or ≤ 30 dB change from preoperative baseline (if preoperative baseline is ≥20 dBHL) and ear-specific speech discrimination ≤30% worse than preoperative baseline (if preoperative baseline is ≤80%)
- participants with preservation of useful sound-field hearing by the above criteria, and
- implanted ears with preservation of otolith endorgan function, if present pre-operatively
- It is tolerable, as quantified by ≥6 mo duration of compliance with use.
- It is efficacious, as defined by nonzero improvement with respect to preoperative baseline in Vestibular Implant Composite Outcome score (VICO), which incorporates vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF-6D health utility (SF6DU).
- Conditions
- Other Disorders of Vestibular Function, Bilateral, Bilateral Vestibular Deficiency (BVD), Gentamicin Ototoxicity, Labyrinth Diseases, Vestibular Diseases, Sensation Disorders
- Being tested
- Labyrinth Devices MVI™ Multichannel Vestibular Implant System
- Keywords
- Vestibular, implant, prosthesis, labyrinth, ototoxicity, gentamicin, oscillopsia, disequilibrium, dizziness, vestibulopathy, inner ear
- Medical subject headings
- Bilateral Vestibulopathy, Labyrinth Diseases, Vestibular Diseases, Sensation Disorders, Ototoxicity, Dysequilibrium syndrome, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Labyrinth Devices MVI™ Multichannel Vestibular Implant SystemDevice
Also called Vestibular implantation and continuously motion-modulated stimulation
Unilateral implantation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System receiver/stimulator including insertion of electrode arrays in the semicircular canal ampullae of the inner ear, followed by motion-modulated prosthetic electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| vestibular implant | Experimental | Up to 8 participants will undergo implantation, activation and deactivation of a Labyrinth Devices MVI™ Multichannel Vestibular Implant System Receives: Device: Labyrinth Devices MVI™ Multichannel Vestibular Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
PM1.1: Dynamic Gait Index (DGI) during motion-modulated implant stimulation at 6 months post-implantation, relative to pre-operative baseline, aggregated across all implant users.
DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.
Measured: Pre-intervention to 6 months post-implantation
PM1.2: Gain (VHITG) of the vestibulo-ocular reflex, as measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, aggregated across all implant users.
During video head impulse testing (vHIT), rotational eye and head movement are measured by a goggle-mounted camera and motion sensor during brief, fast ~10 degree head rotations about the axis of a semicircular canal being tested. Performance is quantified by vestibulo-ocular reflex (VOR) gain, which a ratio of eye movement to head movement (in this case the integral of eye velocity relative to the head and the additive inverse of the integral of head velocity, respectively). VHITG, the average vHIT VOR gain for each of the three semicircular canals of the implanted ear, typically ranges from 0 to 1, with higher numbers indicating better performance.
Measured: Pre-intervention to 6 months post-implantation
Secondary outcomes (67)
EM1.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 6 months post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 6 months post-implantation, in vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: Pre-intervention to 6 months post-implantation
EM1.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
BOT comprises 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points, 4 is best). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: Pre-intervention to 6 months post-implantation
EM1.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: Pre-intervention to 6 months post-implantation
EM1.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, aggregated for all implanted participants.
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: Pre-intervention to 6 months post-implantation
EM2.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 6 months post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 6 months post-implantation, in vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: Pre-intervention to 6 months post-implantation
EM2.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
BOT includes 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: Pre-intervention to 6 months post-implantation
EM2.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: Pre-intervention to 6 months post-implantation
EM2.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: Pre-intervention to 6 months post-implantation
EM2.5: Dynamic Gait Index (DGI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.
Measured: Pre-intervention to 6 months post-implantation
EM2.6: Gain (VHITG) of the vestibulo-ocular reflex, measured using the vHIT averaged for the three implanted semicircular canals, relative to pre-operative baseline, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
During video head impulse testing (vHIT), rotational eye and head movement are measured by a goggle-mounted camera and motion sensor during brief, fast ~10 degree head rotations about the axis of a semicircular canal being tested. Performance is quantified by vestibulo-ocular reflex (VOR) gain, which a ratio of eye movement to head movement (in this case the integral of eye velocity relative to the head and the additive inverse of the integral of head velocity, respectively). VHITG, the average vHIT VOR gain for each of the three semicircular canals of the implanted ear, typically ranges from 0 to 1, with higher numbers indicating better performance.
Measured: Pre-intervention to 6 months post-implantation
EM3.1: Vestibular Implant Composite Outcome (VICO) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
Vestibular Implant Composite Outcome (VICO) score incorporates changes in vestibulo-ocular reflex gain during video head impulse testing, postural stability, gait, dizziness handicap, and health-related quality of life at 6 months post-implantation, relative to pre-operative baseline. VICO (t=6months post-op) score is the sum of changes, from preoperative baseline to 6 months post-implantation, in vestibulo-ocular reflex gain during passive head impulse rotation (VHITG); postural stability as quantified by the Bruininks-Oseretsky Test of Motor Proficiency, 2nd Edition Balance Subtest 5 (BOT); gait stability as quantified by Dynamic Gait Index (DGI); Dizziness Handicap Inventory (DHI); and SF6D health utility (SF6DU); with each component's contribution scaled to the corresponding test's minimally important difference (MID). Score 0-100, higher scores indicate better outcomes.
Measured: Pre-intervention to 6 months post-implantation
EM3.2: Bruininks-Oseretsky Test of Motor Proficiency 2nd Edition Balance Subtest 5 (BOT) score 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
BOT includes 9 postural tasks scored by an examiner: standing with both feet on a line, standing on one leg, tandem walking, walking on a line with eyes open and eyes closed, and standing on a balance beam. Each task is performed twice and scored (0-4 points). The BOT score is the sum of the best scores for each task. It ranges from 0 to 36 points, with higher scores meaning better outcome and minimally important difference 4.5 points.
Measured: Pre-intervention to 6 months post-implantation
EM3.3: Dizziness Handicap Inventory (DHI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
Dizziness Handicap Inventory (DHI) is a 25-question survey designed to quantify self-rated disability due to dizziness and unsteadiness, with scores ranging from 0 (least disabled, best outcome) to 100 (worst outcome). The minimally important difference is 18 points.
Measured: Pre-intervention to 6 months post-implantation
EM3.4: SF6D utility (SF6DU) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
SF6DU is a unitless health utility score computed from patient-reported replies to the SF6 health-related quality of life survey and ranging from 0 to 1, with higher scores meaning better outcome and minimally important difference 0.03 points.
Measured: Pre-intervention to 6 months post-implantation
EM3.5: Dynamic Gait Index (DGI) score at 6 months post-implantation, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.
Measured: Pre-intervention to 6 months post-implantation
EM3.6: Gain (VHITG) of the vestibulo-ocular reflex, measured using the video head impulse test averaged for the three implanted semicircular canals, relative to pre-operative baseline, for the subgroup of participants who have ototoxic adult-onset BVH
During video head impulse testing (vHIT), rotational eye and head movement are measured by a goggle-mounted camera and motion sensor during brief, fast ~10 degree head rotations about the axis of a semicircular canal being tested. Performance is quantified by vestibulo-ocular reflex (VOR) gain, which a ratio of eye movement to head movement (in this case the integral of eye velocity relative to the head and the additive inverse of the integral of head velocity, respectively). VHITG, the average vHIT VOR gain for each of the three semicircular canals of the implanted ear, typically ranges from 0 to 1, with higher numbers indicating better performance.
Measured: Pre-intervention to 6 months post-implantation
SM0.1: Type of unanticipated adverse device effects as of 6 months post-implantation
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by (type of) changes from pre-intervention to 6 months post-implantation
Measured: Pre-intervention to 6 months post-implantation
SM0.2: Incidence of unanticipated adverse device effects as of 6 months post-implantation
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by incidence of adverse device-related events from pre-intervention to 6 months post-implantation
Measured: Pre-intervention to 6 months post-implantation
SM0.3: Severity of unanticipated adverse device effects as of 6 months post-implantation
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by severity of adverse device-related events from pre-intervention to 6 months post-implantation
Measured: Pre-intervention to 6 months post-implantation
SM1.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), aggregated across all implant users
BonePTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side bone-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 80 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), aggregated across all implant users
AirPTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side air-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 120 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), aggregated across all implant users
CNCWi is the percentage of monosyllabic consonant-nucleus-consonant words correctly repeated when presented via an earphone speaker on the implanted side in a sound-isolation booth while a masking noise is played to the contralateral ear at 40 dB above its bone-conduction 4-frequency pure tone detection threshold if that threshold is at least 10 dB better than that of the ear being tested. CNCWi ranges from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, aggregated across all implant users
AzBios is the percentage of words correctly repeated when a set of 20 Arizona Biology sentences (randomly chosen without repeats from 15 sets) is presented at a moderate level (60 dB SPL) along with masking noise (simultaneous presentation of ten sentences from another set at aggregate sound level 55 dBSPL) to both ears via a sound field speaker in a sound-isolation booth. Scores range from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, aggregating data across all implanted participants (ClassABCNCWa)
For ClassABCNCW, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and CNCWi not worse than 50%. ClassABCNCW proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, aggregating across all implanted participants (ClassABAzBioa)
For ClassABAzBio, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and sound-field-presentation Arizona Biology sentences-in-noise discrimination score (AzBios) not worse than 50%. ClassABAzBio proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.7: Change in implant-side ear distortion-product otoacoustic emission (DPOAE) signal-to-noise ratio for responses to tones centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz (an 8-valued vector), aggregated across all implant users
Distortion-product otoacoustic emissions (DPOAE) are sounds generated by a normal cochlea and detectable using a microphone in the ear canal when pairs of pure tones (centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are presented to the ear. DPOAE signals (and 8-valued vector for responses to stimuli centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are quantified in dB relative to the frequency-specific noise floor recorded by the same microphone before onset of stimulation. Response range is 0-15 dB, with higher values meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.8: Changes in implant-side tympanometry responses (a 3-valued vector comprising peak compliance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), aggregated across all implant users
Tympanometry involves using an ear canal microphone to measure ear canal acoustic admittance (conventionally reported in units of mL) and volume (in mL) by sensing reflection of a 226 Hz tone presented via a speaker in the ear canal while ear canal pressure is slowly varied from -400 to 200 decaPascals. Negative bias pressures pull the ear drum outward, positive bias pressures push the ear drum inward, and acoustic admittance is greatest when the ear drum is in a neutral anatomic position, neither retracted inward nor ballooned outward. Results are conventionally represented graphically then summarized by a three-valued vector comprising peak compliance (range 0-2mL, values closer to normal range of 0.3-1.4 mL meaning more normal outcome), pressure at which compliance peaks (range -400 to 200 decaPascal, values closer to 0 meaning more normal outcome), and ear canal volume (range 0-3 mL, values closer to normal adult range of 0.6-1.4 meaning more normal outcome).
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.9: Changes in Tinnitus Handicap Inventory (THI), aggregated across all implant users
The Tinnitus Handicap Inventory (THI) survey is set of questions designed to quantify self-perceived handicap due to tinnitus. THI score ranges from 0-100. Higher scores mean worse outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.10: Changes in Autophony Index (AI), aggregated across all implant users
The Autophony Index (AI) survey is set of questions designed to quantify self-perceived autophony (hearing one's voice or other internally-generated body sounds). AI score ranges from 0-104. Higher scores mean worse outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, aggregated across all implant users
Cervical vestibular-evoked myogenic potentials (cVEMPs) are a measure of saccule-mediated inhibition of sternocleidomastoid muscle electromyographic (EMG) activity during presentation of loud tones to the ipsilateral ear. After normalizing to average rectified EMG activity (in microvolts) prior to sound stimulation, cVEMP amplitudes (in microvolts) are unitless. Values range from 0 to ~10, with larger values suggesting increased saccule activity and generally indicating better outcomes, except that values above 3.0 suggest abnormally high saccule sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, aggregated across all implant users
Ocular vestibular-evoked myogenic potentials (oVEMPs) are a measure of utricle-mediated electromyographic (EMG) activity of inferior oblique and inferior rectus extraocular muscles during presentation of loud tones to the contralateral ear. Amplitude ranges from 0 to ~50 microvolts, with larger values generally suggesting increased utricle activity and better outcomes but values above 17 microvolts suggesting abnormally high utricle sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, aggregated across all implant users
A participant's vision is occluded by a bucket oriented so that its axis aligns with the participant's nasooccipital axis. The examiner rotates the bucket about the axis to a new orientation, the participant reorients it until a line drawn on the floor of the bucket is judges by the participant to be Earth-vertical and deviation of that line from true vertical is recorded. Values range over -15 to 15 degrees, with smaller absolute values meaning more normal outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), aggregated across all implant users
Scalp thickness at the location of implanted magnets (Tscalp) is measured in mm using a magnetic sensor. Range is 0 to 10 mm, with values closer to the range 3-7mm indicating better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM1.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, aggregated across all implant users
Assess safety of the intervention, aggregating data across all implanted participants (diversified across ototoxic and non-ototoxic/non-central adult-onset BVH), as determined by changes in hearing and otolith endorgan function indicated by changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
BonePTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side bone-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 80 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
AirPTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side air-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 120 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
CNCWi is the percentage of monosyllabic consonant-nucleus-consonant words correctly repeated when presented via an earphone speaker on the implanted side in a sound-isolation booth while a masking noise is played to the contralateral ear at 40 dB above its bone-conduction 4-frequency pure tone detection threshold if that threshold is at least 10 dB better than that of the ear being tested. CNCWi ranges from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
AzBios is the percentage of words correctly repeated when a set of 20 Arizona Biology sentences (randomly chosen without repeats from 15 sets) is presented at a moderate level (60 dB SPL) along with masking noise (simultaneous presentation of ten sentences from another set at aggregate sound level 55 dBSPL) to both ears via a sound field speaker in a sound-isolation booth. Scores range from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preop baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, for non-ototoxic/non-central adult-onset BVH participants (ClassABCNCWn)
For ClassABCNCW, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and CNCWi not worse than 50%. ClassABCNCW proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preop baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, for non-ototoxic/non-central BVH participants (ClassABAzBion)
For ClassABAzBio, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and sound-field-presentation Arizona Biology sentences-in-noise discrimination score (AzBios) not worse than 50%. ClassABAzBio proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.7: Change in implant-side distortion-product otoacoustic emission (DPOAE) signal/noise ratio for response to tones centered on 0.75/1/1.5/2/3/4/6/8 kHz, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Distortion-product otoacoustic emissions (DPOAE) are sounds generated by a normal cochlea and detectable using a microphone in the ear canal when pairs of pure tones (centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are presented to the ear. DPOAE signals (and 8-valued vector for responses to stimuli centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are quantified in dB relative to the frequency-specific noise floor recorded by the same microphone before onset of stimulation. Response range is 0-15 dB, with higher values meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.8: Changes in implant-side tympanometry response (3-valued vector comprising peak admittance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), for the participants who have non-ototoxic/non-central adult-onset BVH
Tympanometry involves using an ear canal microphone to measure ear canal acoustic admittance (conventionally reported in units of mL) and volume (in mL) by sensing reflection of a 226 Hz tone presented via a speaker in the ear canal while ear canal pressure is slowly varied from -400 to 200 decaPascals. Negative bias pressures pull the ear drum outward, positive bias pressures push the ear drum inward, and acoustic admittance is greatest when the ear drum is in a neutral anatomic position, neither retracted inward nor ballooned outward. Results are conventionally represented graphically then summarized by a three-valued vector comprising peak compliance (range 0-2mL, values closer to normal range of 0.3-1.4 mL meaning more normal outcome), pressure at which compliance peaks (range -400 to 200 decaPascal, values closer to 0 meaning more normal outcome), and ear canal volume (range 0-3 mL, values closer to normal adult range of 0.6-1.4 meaning more normal outcome).
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.9: Changes in Tinnitus Handicap Inventory (THI), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
The Tinnitus Handicap Inventory (THI) survey is set of questions designed to quantify self-perceived handicap due to tinnitus. THI score ranges from 0-100. Higher scores mean worse outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.10: Changes in Autophony Index (AI), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
The Autophony Index (AI) survey is set of questions designed to quantify self-perceived autophony (hearing one's voice or other internally-generated body sounds). AI score ranges from 0-104. Higher scores mean worse outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Cervical vestibular-evoked myogenic potentials (cVEMPs) are a measure of saccule-mediated inhibition of sternocleidomastoid muscle electromyographic (EMG) activity during presentation of loud tones to the ipsilateral ear. After normalizing to average rectified EMG activity (in microvolts) prior to sound stimulation, cVEMP amplitudes (in microvolts) are unitless. Values range from 0 to ~10, with larger values suggesting increased saccule activity and generally indicating better outcomes, except that values above 3.0 suggest abnormally high saccule sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Ocular vestibular-evoked myogenic potentials (oVEMPs) are a measure of utricle-mediated electromyographic (EMG) activity of inferior oblique and inferior rectus extraocular muscles during presentation of loud tones to the contralateral ear. Amplitude ranges from 0 to ~50 microvolts, with larger values generally suggesting increased utricle activity and better outcomes but values above 17 microvolts suggesting abnormally high utricle sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
A participant's vision is occluded by a bucket oriented so that its axis aligns with the participant's nasooccipital axis. The examiner rotates the bucket about the axis to a new orientation, the participant reorients it until a line drawn on the floor of the bucket is judges by the participant to be Earth-vertical and deviation of that line from true vertical is recorded. Values range over -15 to 15 degrees, with smaller absolute values meaning more normal outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Scalp thickness at the location of implanted magnets (Tscalp) is measured in mm using a magnetic sensor. Range is 0 to 10 mm, with values closer to the range 3-7mm indicating better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM2.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH
Assess safety of the intervention, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH, as determined by changes in hearing and otolith endorgan function indicated by changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.1: Changes in implant-side bone-conduction 4-frequency (0.5, 1, 2, 4 kHz) pure tone average detection threshold (BonePTAi), for the subgroup of participants who have ototoxic adult-onset BVH
BonePTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side bone-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 80 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.2: Changes in implant-side air-conduction 4-frequency pure tone average detection threshold (AirPTAi), for the subgroup of participants who have ototoxic adult-onset BVH
AirPTAi is the 4-frequency average of pure tone detection thresholds, in dBHL, for implant-side air-conduction presentation of pure tones at 0.5, 1, 2 and 4 kHz. Range is -10 to 120 dBHL, with change toward smaller absolute values representing better (closer to normal) outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.3: Changes in implant-side consonant-nucleus-consonant word discrimination score (CNCWi), for the subgroup of participants who have ototoxic adult-onset BVH
CNCWi is the percentage of monosyllabic consonant-nucleus-consonant words correctly repeated when presented via an earphone speaker on the implanted side in a sound-isolation booth while a masking noise is played to the contralateral ear at 40 dB above its bone-conduction 4-frequency pure tone detection threshold if that threshold is at least 10 dB better than that of the ear being tested. CNCWi ranges from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.4: Changes in sound-field Arizona Biology (AzBios) sentences-in-noise discrimination score, for the subgroup of participants who have ototoxic adult-onset BVH
AzBios is the percentage of words correctly repeated when a set of 20 Arizona Biology sentences (randomly chosen without repeats from 15 sets) is presented at a moderate level (60 dB SPL) along with masking noise (simultaneous presentation of ten sentences from another set at aggregate sound level 55 dBSPL) to both ears via a sound field speaker in a sound-isolation booth. Scores range from 0-100% correct, with higher score meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.5: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and CNCWi ≤ 80%, respectively, aggregating across participants with ototoxic BVH (ClassABCNCWo)
For ClassABCNCW, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and CNCWi not worse than 50%. ClassABCNCW proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.6: Change in proportion of implanted ears with AAO-HNS 1995 Class A/B hearing or changes of ≤30dB and ≤30% from preoperative baseline AirPTAi ≥ 20dBHL and AzBios ≤ 80%, respectively, aggregating across participants with ototoxic BVH (ClassABAzBioo)
For ClassABAzBio, AAO-HNS (American Academy of Otolaryngology - Head \& Neck Surgery) 1995 Class A or B hearing is defined as AirPTAi not worse than 50 dBHL and sound-field-presentation Arizona Biology sentences-in-noise discrimination score (AzBios) not worse than 50%. ClassABAzBio proportion ranges from 0-100%, with higher values meaning better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.7: Change in implant-side distortion-product otoacoustic emission (DPOAE) signal/noise ratio for response to tones centered on 0.75/1/1.5/2/3/4/6/8 kHz, for participants who have ototoxic adult-onset BVH
Distortion-product otoacoustic emissions (DPOAE) are sounds generated by a normal cochlea and detectable using a microphone in the ear canal when pairs of pure tones (centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are presented to the ear. DPOAE signals (and 8-valued vector for responses to stimuli centered on 0.75, 1, 1.5, 2, 3, 4, 6 and 8 kHz) are quantified in dB relative to the frequency-specific noise floor recorded by the same microphone before onset of stimulation. Response range is 0-15 dB, with higher values meaning better outcome.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.8: Changes in implant-side tympanometry responses (a 3-valued vector comprising peak compliance in mL, pressure in decaPascals at peak admittance, and ear canal volume in mL), for the subgroup of participants who have ototoxic adult-onset BVH
Tympanometry involves using an ear canal microphone to measure ear canal acoustic admittance (conventionally reported in units of mL) and volume (in mL) by sensing reflection of a 226 Hz tone presented via a speaker in the ear canal while ear canal pressure is slowly varied from -400 to 200 decaPascals. Negative bias pressures pull the ear drum outward, positive bias pressures push the ear drum inward, and acoustic admittance is greatest when the ear drum is in a neutral anatomic position, neither retracted inward nor ballooned outward. Results are conventionally represented graphically then summarized by a three-valued vector comprising peak compliance (range 0-2mL, values closer to normal range of 0.3-1.4 mL meaning more normal outcome), pressure at which compliance peaks (range -400 to 200 decaPascal, values closer to 0 meaning more normal outcome), and ear canal volume (range 0-3 mL, values closer to normal adult range of 0.6-1.4 meaning more normal outcome).
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.9: Changes in Tinnitus Handicap Inventory (THI), for the subgroup of participants who have ototoxic adult-onset BVH
The Tinnitus Handicap Inventory (THI) survey is set of questions designed to quantify self-perceived handicap due to tinnitus. THI score ranges from 0-100. Higher scores mean worse outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.10: Changes in Autophony Index (AI), for the subgroup of participants who have ototoxic adult-onset BVH
The Autophony Index (AI) survey is set of questions designed to quantify self-perceived autophony (hearing one's voice or other internally-generated body sounds). AI score ranges from 0-104. Higher scores mean worse outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.11: Changes in cervical vestibular-evoked myogenic potential (cVEMP) response amplitude, for the subgroup of participants who have ototoxic adult-onset BVH
Cervical vestibular-evoked myogenic potentials (cVEMPs) are a measure of saccule-mediated inhibition of sternocleidomastoid muscle electromyographic (EMG) activity during presentation of loud tones to the ipsilateral ear. After normalizing to average rectified EMG activity (in microvolts) prior to sound stimulation, cVEMP amplitudes (in microvolts) are unitless. Values range from 0 to ~10, with larger values suggesting increased saccule activity and generally indicating better outcomes, except that values above 3.0 suggest abnormally high saccule sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.12: Changes in ocular vestibular-evoked myogenic potential (oVEMP) response amplitude, for the subgroup of participants who have ototoxic adult-onset BVH
Ocular vestibular-evoked myogenic potentials (oVEMPs) are a measure of utricle-mediated electromyographic (EMG) activity of inferior oblique and inferior rectus extraocular muscles during presentation of loud tones to the contralateral ear. Amplitude ranges from 0 to ~50 microvolts, with larger values generally suggesting increased utricle activity and better outcomes but values above 17 microvolts suggesting abnormally high utricle sensitivity to sound.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.13: Changes in subjective visual vertical (SVV) as assessed using the Bucket Test, for the subgroup of participants who have ototoxic adult-onset BVH
A participant's vision is occluded by a bucket oriented so that its axis aligns with the participant's nasooccipital axis. The examiner rotates the bucket about the axis to a new orientation, the participant reorients it until a line drawn on the floor of the bucket is judges by the participant to be Earth-vertical and deviation of that line from true vertical is recorded. Values range over -15 to 15 degrees, with smaller absolute values meaning more normal outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.14: Changes in scalp thickness at the location of implanted magnets (Tscalp), for the subgroup of participants who have ototoxic adult-onset BVH
Scalp thickness at the location of implanted magnets (Tscalp) is measured in mm using a magnetic sensor. Range is 0 to 10 mm, with values closer to the range 3-7mm indicating better outcomes.
Measured: Preoperative baseline to 6 month post-operative assessment
SM3.15: Changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems, for the subgroup of participants who have ototoxic adult-onset BVH
Assess safety of the intervention, for the subgroup of participants who have ototoxic adult-onset BVH, as determined by changes in hearing and otolith endorgan function indicated by changes in all adverse events, including but not limited to events related to the surgical procedure, device and device systems
Measured: Preoperative baseline to 6 month post-operative assessment
TM1: Proportion of all implanted participants who continue to use the MVI system daily at 6 months post-implantation
Assess tolerance of the intervention, aggregating data across all implanted participants, as determined by the proportion of all implant recipients who continue to use the MVI system daily at 6 months post-implantation
Measured: 6 month post-operative assessment
TM2: Proportion of implanted participants with non-ototoxic/non-central adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
Assess tolerance of the intervention, for the subgroup of participants who have non-ototoxic/non-central adult-onset BVH, as determined by the proportion of implanted participants with non-ototoxic/non-central adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
Measured: 6 month post-operative assessment
TM3: Proportion of implanted participants with ototoxic adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
Assess tolerance of the intervention, for the subgroup of participants who have ototoxic adult-onset BVH, as determined by the proportion of implanted participants with ototoxic adult-onset BVH who continue to use the MVI system daily at 6 months post-implantation
Measured: 6 month post-operative assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start28 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Other Disorders of Vestibular Function, BilateralStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Labyrinth Devices, LLC
- Responsible party
- Sponsor
- Investigators
- John P Carey, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674786
- Sponsor's protocol ID
- IRB00335294
- Other IDs
- 1U01DC019364, JHU80640
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: publication of de-identified data via peer-reviewed journals
Publications
Sun DQ, Lehar M, Dai C, Swarthout L, Lauer AM, Carey JP, Mitchell DE, Cullen KE, Della Santina CC. Histopathologic Changes of the Inner ear in Rhesus Monkeys After Intratympanic Gentamicin Injection and Vestibular Prosthesis Electrode Array Implantation. J Assoc Res Otolaryngol. 2015 Jun;16(3):373-87. doi: 10.1007/s10162-015-0515-y. Epub 2015 Mar 20.
PubMed 25790951Sun DQ, Ward BK, Semenov YR, Carey JP, Della Santina CC. Bilateral Vestibular Deficiency: Quality of Life and Economic Implications. JAMA Otolaryngol Head Neck Surg. 2014 Jun;140(6):527-34. doi: 10.1001/jamaoto.2014.490.
PubMed 24763518Mitchell DE, Dai C, Rahman MA, Ahn JH, Della Santina CC, Cullen KE. Head movements evoked in alert rhesus monkey by vestibular prosthesis stimulation: implications for postural and gaze stabilization. PLoS One. 2013 Oct 17;8(10):e78767. doi: 10.1371/journal.pone.0078767. eCollection 2013.
PubMed 24147142Dai C, Fridman GY, Chiang B, Rahman MA, Ahn JH, Davidovics NS, Della Santina CC. Directional plasticity rapidly improves 3D vestibulo-ocular reflex alignment in monkeys using a multichannel vestibular prosthesis. J Assoc Res Otolaryngol. 2013 Dec;14(6):863-77. doi: 10.1007/s10162-013-0413-0. Epub 2013 Sep 8.
PubMed 24013822Ward BK, Agrawal Y, Hoffman HJ, Carey JP, Della Santina CC. Prevalence and impact of bilateral vestibular hypofunction: results from the 2008 US National Health Interview Survey. JAMA Otolaryngol Head Neck Surg. 2013 Aug 1;139(8):803-10. doi: 10.1001/jamaoto.2013.3913.
PubMed 23949355Valentin NS, Hageman KN, Dai C, Della Santina CC, Fridman GY. Development of a multichannel vestibular prosthesis prototype by modification of a commercially available cochlear implant. IEEE Trans Neural Syst Rehabil Eng. 2013 Sep;21(5):830-9. doi: 10.1109/TNSRE.2013.2259261. Epub 2013 May 1.
PubMed 23649285Davidovics NS, Rahman MA, Dai C, Ahn J, Fridman GY, Della Santina CC. Multichannel vestibular prosthesis employing modulation of pulse rate and current with alignment precompensation elicits improved VOR performance in monkeys. J Assoc Res Otolaryngol. 2013 Apr;14(2):233-48. doi: 10.1007/s10162-013-0370-7. Epub 2013 Jan 26.
PubMed 23355001Fridman GY, Della Santina CC. Progress toward development of a multichannel vestibular prosthesis for treatment of bilateral vestibular deficiency. Anat Rec (Hoboken). 2012 Nov;295(11):2010-29. doi: 10.1002/ar.22581. Epub 2012 Oct 8.
PubMed 23044664Rahman MA, Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn J, Hayden R, Melvin TA, Sun DQ, Hedjoudje A, Della Santina CC. Restoring the 3D vestibulo-ocular reflex via electrical stimulation: the Johns Hopkins multichannel vestibular prosthesis project. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3142-5. doi: 10.1109/IEMBS.2011.6090857.
PubMed 22255006Dai C, Fridman GY, Davidovics NS, Chiang B, Ahn JH, Della Santina CC. Restoration of 3D vestibular sensation in rhesus monkeys using a multichannel vestibular prosthesis. Hear Res. 2011 Nov;281(1-2):74-83. doi: 10.1016/j.heares.2011.08.008. Epub 2011 Aug 26.
PubMed 21888961Dai C, Fridman GY, Chiang B, Davidovics NS, Melvin TA, Cullen KE, Della Santina CC. Cross-axis adaptation improves 3D vestibulo-ocular reflex alignment during chronic stimulation via a head-mounted multichannel vestibular prosthesis. Exp Brain Res. 2011 May;210(3-4):595-606. doi: 10.1007/s00221-011-2591-5. Epub 2011 Mar 4.
PubMed 21374081Dai C, Fridman GY, Della Santina CC. Effects of vestibular prosthesis electrode implantation and stimulation on hearing in rhesus monkeys. Hear Res. 2011 Jul;277(1-2):204-10. doi: 10.1016/j.heares.2010.12.021. Epub 2010 Dec 31.
PubMed 21195755Della Santina CC. Regaining balance with bionic ears. Sci Am. 2010 Apr;302(4):68-71. doi: 10.1038/scientificamerican0410-68. No abstract available.
PubMed 20349578Fridman GY, Davidovics NS, Dai C, Migliaccio AA, Della Santina CC. Vestibulo-ocular reflex responses to a multichannel vestibular prosthesis incorporating a 3D coordinate transformation for correction of misalignment. J Assoc Res Otolaryngol. 2010 Sep;11(3):367-81. doi: 10.1007/s10162-010-0208-5. Epub 2010 Feb 23.
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