|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P970051 S028/ PAS002 |
Date Original Protocol Accepted |
03/01/2005
|
Date Current Protocol Accepted |
03/01/2005
|
Study Name |
Adult Study
|
Device Name |
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
|
General Study Protocol Parameters |
Study Design |
Randomized Clinical Trial
|
Data Source |
New Data Collection
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The study was conducted as a within-subject repeated-measures experiment (each subject served as his or her own control) to accommodate the heterogeneity of hearing-impaired populations. The study was an ABAB design in which subjects were randomly divided into Group A and Group B. Group A subjects were fit with ACE rates (a coding strategy using stimulation rates of 500 Hz, 900 Hz and 1200 Hz) at initial stimulation and Group B with the ACE RE rates (a coding strategy using stimulation rates of 1800 Hz, 2400 Hz and 3500 Hz).
|
Study Population |
Study subjects were to be 18 years of age and older, with post-lingual onset of bilateral severe to profound sensor-neural hearing loss. Subjects' preoperative CNC word recognition scores were to be <= 30% in the best-aided condition at 60 dB SPL
|
Sample Size |
50 patients
|
Key Study Endpoints |
Tests of auditory speech perception were the primary outcome: Hearing in Noise Test (HINT) sentences, City University of New York (CUNY) sentences and Consonant Nucleus Consonant (CNC) monosyllabic words/phonemes. Additional measures include routine psychophysical measurements, measurements of electrical impedance and a patient questionnaire.
|
Follow-up Visits and Length of Follow-up |
at week 0, 3, 5, 8, 10, 12, 14, 16, 24, 12-month
|
Interim or Final Data Summary |
Interim Results |
Study is completed. See Final Results
|
Actual Number of Patients Enrolled |
76 patients
|
Actual Number of Sites Enrolled |
14
|
Patient Follow-up Rate |
71%
|
Final Safety Findings |
There were progressive improvements in mean percent correct scores across the test intervals for CNC Words (60 dB SPL), HINT (in quiet) at 60 dB SPL, HINT (in noise) at 60 dB SPL and +10 dB signal-to-noise ratio (SNR), and CNC Words at 70 dB SPL.
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Study Strengths & Weaknesses |
Prospective Randomized Controlled Study
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Recommendations for Labeling Changes |
Label needs to be updated to refelct the findings of the Adult PAS study
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