CI Following VS Removal or Labyrinthectomy

NCT03795675 | Recruiting FDA Device

• 1 other identifier: 2017H0273
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vestibular Schwannoma; Meniere Disease

Keywords

Cochlear implants

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (3)

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

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

• Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) Scores

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

• Change in Tinnitus Handicap Inventory (THI) Scores

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

Study Arms (1)

Meniere's Disease/Vestibular Schwannoma

EXPERIMENTAL

Individuals 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.

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

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

Meniere's Disease/Vestibular Schwannoma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• Advanced Bionics: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Neuroma, Acoustic; Meniere Disease

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Endolymphatic Hydrops; Labyrinth Diseases

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Oliver Adunka, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan Hiss, AuD

CONTACT

614-366-1549; Meghan.Hiss@osumc.edu

William Riggs, AuD

CONTACT

614-293-9750; William.Riggs@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Clinical Otolaryngology

Study Record Dates

• First Submitted: December 7, 2018
• First Posted: January 8, 2019
• Study Start: January 14, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

US (1)