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 ]

Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid


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