Status:
COMPLETED
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Med-El Corporation
Conditions:
Unilateral Acoustic Neuroma
Meniere's Disease
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease be...
Detailed Description
The treatment for cases of vestibular schwannoma or Meniere's disease may require a translabyrinthine surgical approach. This surgical approach results in a complete loss of hearing in the surgical ea...
Eligibility Criteria
Inclusion
- Scheduled to undergo a surgical procedure that will result in profound hearing loss in the surgical ear \[unilateral vestibular schwannoma wtih planned translabyrinthine surgery or unilateral Meniere's disease with planned labyrinthectomy\] \[diagnosed by UNC investigators\]
- Pure-tone average (PTA) less than or equal to 35 decibels Hearing Level (dB HL) in the contralateral ear \[no evidence of retrocochlear dysfunction\]
- Unaided consonant-nucleus-consonant (CNC) words score greater than or equal to 80% in the contralateral ear
- Greater than 18 years of age at implantation
- Realistic expectations
- Willing to obtain appropriate meningitis vaccinations
- No reported cognitive issues \[pass the Mini Mental State Examination screener\]
- Able and willing to comply with study requirements, including travel to investigational site
- Obtain Centers for Disease Control and Prevention (CDC) recommended meningitis vaccinations prior to surgery
Exclusion
- History of implantable technology in either ear, such as a bone-conduction implant
- Non-native English speaker \[speech perception materials presented in English\]
- Inability to participate in follow-up procedures (unwillingness, geographic location)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02309099
Start Date
November 1 2014
End Date
November 8 2017
Last Update
January 7 2019
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517