Clinical Trial: Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
Brief Summary: The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
Detailed Summary:
Sponsor: Advanced Bionics
Current Primary Outcome:
- Unaided pure-tone hearing threshold measurements [ Time Frame: Three months ]Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
- Speech perception testing [ Time Frame: Up to 19 months ]Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)
- Questionnaire data [ Time Frame: Up to 19 months ]Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition
Original Primary Outcome:
- Unaided pure-tone hearing threshold measurements (Phase I) [ Time Frame: One month ]Unaided pure tone hearing threshold measurement in the implanted ear 1 month after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)
- Unaided pure-tone hearing threshold measurements (Phase II) [ Time Frame: Up to 14 months ]Unaided pure tone hearing threshold measurements (using pure-tone average of 125 - 1000 Hz for comparison) in the treated ear compared to pre-implant audiometric thresholds
- Speech perception testing (Phase II) [ Time Frame: Up to 14 months ]Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)
- Questionnaire data (Phase II) [ Time Frame: Up to 14 months ]Speech, Spatial Qualities (SSQ) questionnaire post-implant compared to pre-implant condition
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Advanced Bionics
Dates:
Date Received: July 10, 2014
Date Started: April 2014
Date Completion: December 2018
Last Updated: October 31, 2016
Last Verified: October 2016