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Vestibular SchwannomaNCT03795675

CI Following VS Removal or Labyrinthectomy

A study testing Cochlear Implant in people with Vestibular Schwannoma and Meniere Disease, run by Ohio State University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Vestibular Schwannoma, Meniere Disease
What is being tested?
Cochlear Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
14 Jan 2019to 31 Dec 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
  • Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
  • Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences
  • For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve

Who cannot join

  • Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas
  • Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma
  • Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation
  • Active middle ear disease
  • Greater than 70 years of age
  • Vestibular schwannoma greater than 2 cm
  • Patient refusal of receiving pneumococcal vaccine
  • Any contra-indication(s) for undergoing surgery.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Cochlear Implantation During Vestibular Schwannoma Removal or During Labyrinthectomy Surgery for Treatment of Meniere's Disease

This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.

Being tested
Cochlear Implant
Keywords
Cochlear implants
Medical subject headings
Neuroma, Acoustic, Meniere Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cochlear ImplantDevice

    Cochlear implant device to be implanted at time of surgical intervention.

Study groups in NCT03795675
Study groupRoleWhat they receive
Meniere's Disease/Vestibular SchwannomaExperimentalIndividuals diagnosed with Meniere's disease and undergoing labyrinthectomy or diagnosed with vestibular schwannoma and undergoing surgical excision via translabyrinthine approach for treatment will receive cochlear implant at the time of surgery.
Receives: Device: Cochlear Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Sound Detection Testing

    Sounds that vary in pitch (frequency) will be presented in a sound field to identify hearing thresholds in decibels (dB). Participant indicates when a sound is detected/perceived when listening with the cochlear implant. The softest sound at each specific frequency (125, 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hertz (Hz)) will be recorded in dB hearing level.

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

  2. Change in Speech Perception Testing

    Arizona (AZ) Bio sentences (speech perception test comprised of 660 unique sentences, presented in 33 independent lists of 20 sentences each) and the Maryland consonant-vowel nucleus-consonant (CNC) (10 phonetically balanced 50-word lists) word lists will be presented through a sound field speaker, and participant will be asked to repeat back the sentences and/or word that was heard. Background noise will be presented in conjunction with the sentences/words at various signals to noise levels (quiet [no noise], +0 dB and +5 dB signal to noise ratio). The percentage of sentences/words correctly repeated will be calculated for each test (AZ Bio, CNC) at each signal to noise level. Higher percentages indicate better word and sentence recognition ability.

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

  3. Change in Sound Localization Testing

    Participant listens to bursts of sounds (100 trials of pink noise [random noise having equal energy per octave and having more low-frequency components than white noise; the power per hertz decreases as the frequency increases] presented randomly from seven speakers in a half-moon orientation and identifies which speaker presented the sounds. Two testing conditions will be evaluated (implant on, implant off). Total percentage of sounds correctly identified for each condition (0-100%) will be calculated, with a larger percentage indicating higher accuracy. Additionally, root mean square error (average of total degree of error when localizing) will be calculated for each trial.

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

Secondary outcomes (3)

  1. Change in Speech, Spatial and Qualities of Hearing Scale (SSQ) Scores

    Subjective questionnaire designed to study the relationship of disability and handicap across many listening domains using 49 questions in a clinician/patient interview format. The scale is sub-divided into three domains: 14 items on speech hearing, 17 items on spatial hearing (direction and distance judgments), and 18 items on "other" functions and qualities of hearing. The "other" qualities section contains items related to recognition and segregation of sounds, clarity, naturalness, and listening effort. Items are scored with ratings of 0 to 10, with 0 representing complete inability with regard to the item in question and 10 representing perfect ability. The average score (0-10) for each subscale/domain is reported individually.

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

  2. Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores

    Questionnaire encompassing hearing and speech, psychological, and social domains and is used to evaluate quality of life. This questionnaire contains six subdomains of hearing that are rated categorically (1-5 (never-always) and "not applicable"). The subdomains are 1. Basic sound perception, 2. Advanced sound perception (in difficult daily listening situations or background noise), 3. Speech production, 4. Self-esteem, 5. Activity limitations, 6. Social interaction. The answer categories must first be transformed (1=0, 2=25, 3=50, 4=75 and 5=100). Afterwards, the final subdomain score is computed by adding together all the item scores and dividing by the number of completed items, resulting in a range of scores from 0 to 100. A higher score reflects a greater ability.

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

  3. Change in Tinnitus Handicap Inventory (THI) Scores

    Subjective questionnaire that identifies, qualifies, and evaluates the difficulties that may be experienced due to tinnitus. It is a 25-item questionnaire grouped into three subscales: functional, emotional and catastrophic responses. The functional subscale items reflect the effect of tinnitus on mental, social, occupational and physical functioning. The emotional subscale items probe the individual's emotional reactions to tinnitus, and the catastrophic response items address whether tinnitus makes the respondent feel desperate, trapped, hopeless or out of control. A "yes" response is given 4 points, a "sometimes" response 2 points and a "no" response 0 points. The questionnaire yields scores for each subscale and a total score that ranges from 0 and 100, with high scores indicating a greater handicap. The total score of this questionnaire represents the overall severity of tinnitus: slight (0-16), mild (18-36), moderate (38-56), severe (58-76) or catastrophic (78-100).

    Measured: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start14 Jan 2019
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795675
Sponsor's protocol ID
2017H0273
Status last verified
May 2026
First submitted
7 Dec 2018
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cochlear Implant in people with Vestibular Schwannoma and Meniere Disease, run by Ohio State University at 1 site in United States.

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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sound Detection Testing (time frame: Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03795675.

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 16 Oct 2026.

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