|
|
| 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
|
