Clinical Trial: Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant

Brief Summary: The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.

Detailed Summary:
Sponsor: Cochlear

Current Primary Outcome:

• Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) [ Time Frame: 6 Months Postactivation ]

  The co-primary study endpoints will be statistically significant differences between the mean, preoperative monosyllabic CNC word score (unilateral acoustic, ear to be implanted) and the postoperative monosyllabic CNC word scores (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.

  The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and scored as a total number of words correct, which will be expressed as a percentage correct for this study.

• AzBio Sentence Score in Noise - Treated Ear (Co-Primary) [ Time Frame: 6 Months Postactivation ]

  The co-primary study endpoints will be statistically significant differences between the mean, preoperative AzBio Sentences score in noise (unilateral acoustic, ear to be implanted) and postoperative AzBio Sentences score in noise (Hybrid mode) for the activated, Hybrid L24 cochlear implant subjects.

  The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts towards the overall score.

Original Primary Outcome:

Current Secondary Outcome:

• Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear [ Time Frame: 6 Months Postactivation ]

  Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:

  The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field. The percentage of subjects that scored equal to or better than they did in the pre-operative unilateral acoustic-only condition will be reported.

• AzBio Sentence Score-Treated Ear [ Time Frame: 6 Months Postactivation ]

  Secondary efficacy endpoints using binomial comparisons (based on the postoperative Hybrid condition) are as follows:

  The AzBio Sentence Test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in'unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score. The percentage of subjects that scored equal to or better than they did in the pre-operative acoustic only condition will be reported.

Original Secondary Outcome:

Information By: Cochlear

Dates:
Date Received: May 14, 2008
Date Started: April 2008
Date Completion:
Last Updated: June 19, 2015
Last Verified: June 2015