|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P970051 S028/ PAS001 |
Date Original Protocol Accepted |
03/01/2005
|
Date Current Protocol Accepted |
03/01/2005
|
Study Name |
Pediatric Study
|
Device Name |
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Infant: 29 days-2 yrs,
Child: 2-12 yrs,
Adolescent: 13-18 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
This is a multi-center, prospective, single-arm study. It is a was a within-subject self-control experiment design.
|
Study Population |
The study includes patients as per device indication. The device is Intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
|
Sample Size |
At least 50 patients; up to 5 centers
|
Key Study Endpoints |
Children under 3 years of age: * Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) Children 3 to 5 years of age: * Meaningful Auditory Integration Scale (MAIS) * Multisyllabic Lexical Neighborhood Test (MLNT), if child is developmentally capable. Children 5 years and up * Lexical Neighborhood Test (LNT) * Hearing In Noise Test for Children (HINT-C) 3 Sentences in Quiet. Complication questionnaires.
|
Follow-up Visits and Length of Follow-up |
A follow-up evaluation was to take place 1 month post-activation and threshold and comfort levels were to be assessed. The auditory performance was to be assessed at 3, 6 and 12 months post-activation, using the same tests given at pre-operative evaluation. In addition, to monitor safety, complication questionnaires were to be completed by investigators at initial activation and at 1-month, 3-months, 6-months, and 12-months post-activation. All complications and adverse events were to be obtained from the investigational sites and entered into a computer database by complaint type.
|
Interim or Final Data Summary |
Interim Results |
Study completed. See Final Study Results
|
Actual Number of Patients Enrolled |
69 enrolled and implanted patients above 12 months of age
|
Actual Number of Sites Enrolled |
7 centers
|
Patient Follow-up Rate |
72.50%
|
Final Safety Findings |
No unanticipated AEs and 9 complications overall. Type of Complication - Number of occurrences - Rate of occurrence per 100 implant years Dizziness - 2 - 2.60 Dermatological Issues - 2 - 2.60 Facial Nerve Stimulation - 1 - 1.3 Revision Surgery following accident - 1 - 1.3 Short/Open Electrodes - 3 - 3.91
|
Study Strengths & Weaknesses |
Low follow up rate. No controls.
|
Recommendations for Labeling Changes |
None
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