CI Following VS Removal or Labyrinthectomy

  • End date
    Dec 10, 2025
  • participants needed
  • sponsor
    Ohio State University
Updated on 10 April 2021
ct scan
cochlear implant


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.

Condition Meniere's Disease, Acoustic Neuroma, vestibular schwannoma
Treatment Cochlear Implant
Clinical Study IdentifierNCT03795675
SponsorOhio State University
Last Modified on10 April 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note