Clinical trial · Interventional
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
NCT02309099CI-TRIAL-00036375completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Meniere's Disease | — | UNRESOLVED | — |
| Unilateral Acoustic Neuroma | Vestibular Schwannoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cochlear Implant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cochlear Implant
- description
- Cochlear implantation of the affected ear
- interventionNames
- Device: Cochlear Implant
Primary outcomes (13)
- measure
- Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time
- timeFrame
- Intervals within the first 12 months of device use
- description
- Testing open-set word understanding. Recorded CNC Words lists were presented to the participant while listening to the cochlear implant alone and contralateral ear plugged/masked. Resultant score is a percentage of words correct. A higher score is better.
- measure
- Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time
- timeFrame
- Intervals within the first 12 months of device use
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Scheduled to undergo a surgical procedure that will result in profound hearing loss in the surgical ear \[unilateral vestibular schwannoma wtih planned translabyrinthine surgery or unilateral Meniere's disease with planned labyrinthectomy\] \[diagnosed by UNC investigators\] 2. Pure-tone average (PTA) less than or equal to 35 decibels Hearing Level (dB HL) in the contralateral ear \[no evidence of retrocochlear dysfunction\] 3. Unaided consonant-nucleus-consonant (CNC) words score greater than or equal to 80% in the contralateral ear 4. Greater than 18 years of age at implantation 5. Realistic expectations 6. Willing to obtain appropriate meningitis vaccinations 7. No reported cognitive issues \[pass the Mini Mental State Examination screener\] 8. Able and willing to comply with study requirements, including travel to investigational site 9. Obtain Centers for Disease Control and Prevention (CDC) recommended meningitis vaccinations prior to surgery Exclusion Criteria: 1. History of implantable technology in either ear, such as a bone-conduction implant 2. Non-native English speaker \[speech perception materials presented in English\] 3. Inability to participate in follow-up procedures (unwillingness, geographic location)
References
Publications (5)
- BACKGROUNDLustig LR, Yeagle J, Niparko JK, Minor LB. Cochlear implantation in patients with bilateral Meniere's syndrome. Otol Neurotol. 2003 May;24(3):397-403. doi: 10.1097/00129492-200305000-00009. PMID 12806291
- BACKGROUNDOsborn HA, Yeung R, Lin VY. Delayed cochlear implantation after surgical labyrinthectomy. J Laryngol Otol. 2012 Jan;126(1):63-5. doi: 10.1017/S0022215111002374. Epub 2011 Sep 14. PMID 21914249
- BACKGROUNDPai I, Dhar V, Kelleher C, Nunn T, Connor S, Jiang D, O'Connor AF. Cochlear implantation in patients with vestibular schwannoma: a single United Kingdom center experience. Laryngoscope. 2013 Aug;123(8):2019-23. doi: 10.1002/lary.24056. Epub 2013 Apr 24. PMID 23616085
- BACKGROUNDWareing MJ, O'Connor AF. The role of labyrinthectomy and cochlear implantation in Meniere's disease. Ear Nose Throat J. 1997 Sep;76(9):664-6, 668, 671-2. No abstract available. PMID 9309909
- BACKGROUNDZanetti D, Campovecchi CB, Pasini S, Nassif N. Simultaneous translabyrinthine removal of acoustic neuroma and cochlear implantation. Auris Nasus Larynx. 2008 Dec;35(4):562-8. doi: 10.1016/j.anl.2007.11.011. Epub 2008 Feb 19. PMID 18243617