CI Following VS Removal or Labyrinthectomy

Launched by OHIO STATE UNIVERSITY · Jan 3, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the safety and effectiveness of using cochlear implants in patients who are having surgery to remove a vestibular schwannoma (a benign tumor on the hearing and balance nerve) or a labyrinthectomy (a procedure for Meniere's disease). After these surgeries, patients typically lose hearing on the side that was treated. The trial aims to see if a cochlear implant can help restore hearing in these individuals, allowing them to better detect sounds and understand speech.

To be eligible for the trial, participants need to be between 18 and 70 years old, have a confirmed diagnosis of vestibular schwannoma or Meniere's disease, and be set to undergo the specific surgeries mentioned. They should also be able to speak English, as the study involves understanding speech tasks. During the trial, participants will receive the cochlear implant after surgery and will be monitored over the next year, answering questions about their hearing and quality of life at various follow-up visits. While there are potential risks associated with cochlear implant surgery, such as device failure or irritation at the surgical site, many participants may experience significant benefits, like improved sound detection and speech understanding.

Gender

ALL

Eligibility criteria

• 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.