Clinical Trial: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Brief Summary: The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who meet conventional indications for implantation in one ear, but do not meet the conventional indications for implantation in the other ear (asymmetric hearing loss) using the HiResolution Bionic Ear System.
Detailed Summary:
Sponsor: Advanced Bionics
Current Primary Outcome:
- Change in Speech Perception (Implanted Ear only) [ Time Frame: Baseline and Twelve months ]CNC word scores compared to preimplant word scores
- Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, only) [ Time Frame: Baseline and Twelve months ]Unaided audiometric thresholds compared to preimplant
- Change in Speech Perception (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]AzBio sentence scores in noise twelve months post implantation compared to preimplant bilateral sentence scores
- Change in Lateralization Ability Testing (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]Lateralization ability compared to preimplantation
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Advanced Bionics
Dates:
Date Received: June 7, 2016
Date Started: October 2016
Date Completion: March 2018
Last Updated: October 26, 2016
Last Verified: October 2016
