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|
- CNC Monosyllabic Word Score - Treated Ear [ Time Frame: Six months ] [ Designated as safety issue: No ]
The primary study endpoint will be a statistically significant difference between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
|Study Start Date:||May 2012|
|Study Completion Date:||January 2014|
|Primary Completion Date:||January 2014 (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 Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337076
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Colin Driscoll, MD||Mayo Clinic|