Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
Completed · Not applicable
Conditions studied: Unilateral Acoustic Neuroma, Meniere's Disease
In brief
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 benefit from cochlear implantation on speech perception and localization tasks. If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.
Key facts
- Study ID
- NCT02309099
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 10
- Starts
- 2014-11-01
- Expected to finish
- 2017-11-08
- Last updated by the study team
- 2019-01-07
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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