Clinical Trial: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Brief Summary: The purpose of this study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.
Detailed Summary:
Sponsor: Advanced Bionics
Current Primary Outcome: Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array [ Time Frame: One month ]
Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as:
- Complete preservation of hearing: threshold shift ≤ 15 dB
- Partial preservation of hearing: threshold shift ≥ 16 dB with measurable thresholds
- No preservation of hearing: no measurable thresholds at ≤ 80 dB HL
Original Primary Outcome: Same as current
Current Secondary Outcome: Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array [ Time Frame: One month ]
Original Secondary Outcome: Same as current
Information By: Advanced Bionics
Dates:
Date Received: October 8, 2013
Date Started: October 2013
Date Completion:
Last Updated: May 20, 2015
Last Verified: April 2015