f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Adult Study


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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.
Study Strengths & Weaknesses Prospective Randomized Controlled Study
Recommendations for Labeling Changes Label needs to be updated to refelct the findings of the Adult PAS study


Adult Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year Report 03/01/2006 03/08/2006 Overdue/Received
18 month report 09/01/2006 10/02/2006 Overdue/Received
2 year report 03/01/2007 03/14/2007 Overdue/Received
Final Report (Adult Study) 09/01/2007 08/31/2007 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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