CI Following VS Removal or Labyrinthectomy

The Ohio State University

Status: Enrolling

Conditions: Meniere Disease; Vestibular Schwannoma

Treatments: Device: Cochlear Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03795675

2017H0273

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Meniere's Disease/Vestibular Schwannoma

Experimental group

Description:

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.

Treatment:

Device: Cochlear Implant