CI Following VS Removal or Labyrinthectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/16/2019 |
| Start Date: | January 14, 2019 |
| End Date: | December 2025 |
| Contact: | Meghan Hiss, AuD |
| Email: | Meghan.Hiss@osumc.edu |
| Phone: | 614-366-1549 |
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.
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.
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.
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