Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy|
- Six months CNC word scores in the CI alone condition [ Time Frame: six months ] [ Designated as safety issue: No ]Efficacy of the revised current cochlear implant indications will be determined using a comparison between preoperative (ear to be implanted) and postoperative (cochlear implant alone) outcome measures. The primary study endpoint, 6 months postimplant activation, will be a statistically significant difference between the mean, preoperative CNC word score (ear to be implanted) and the postoperative (cochlear implant alone) score for candidates who currently perform outside the approved cochlear implant indications.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Device: cochlear implant
Cochlear implant surgery
Other Name: implantable hearing device
Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on monosyllabic words (CNC) who do not meet current approved speech perception criteria with the widely used sentence measure HINT in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.