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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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Nucleus 24 Pediatric Post-Approval Study


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P970051 S172/ PAS001
Date Original Protocol Accepted 05/15/2020
Date Current Protocol Accepted  
Study Name Nucleus 24 Pediatric Post-Approval Study
Device Name NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs
Detailed Study Protocol Parameters
Study Objectives The Nucleus 24 Cochlear Implant Pediatric Post Approval Study (PAS) combines an extended follow-up study (Cohort 1) and a new, prospectively-designed, retrospective study (Cohort 2) to assess long-term safety and effectiveness of cochlear implantation up to a minimum of 2 years post-implantation in children aged 9-12 months. It is a retrospective, non-controlled, non-randomized, multicenter study.
Study Population All available 84 subjects who were enrolled in the pre-market, prospectively-designed, retrospective study for the extended follow-up study (Cohort 1) and a minimum of 50 subjects implanted at age of 9-12 months for the new, prospectively-designed, retrospective study (Cohort 2).
Sample Size Cohort 1 will consist of 84 subjects from the original study. Cohort 2 will include at least 50 new subjects.
Key Study Endpoints Primary effectiveness endpoint:
To evaluate the performance of the cochlear implant on parental questionnaires. Formal hypothesis tests are planned to establish superiority of the 24-month post-operative condition over the pre-operative condition. A within-subject analysis will be conducted on a minimum of 80% of subjects who have the same pre- to post-operative parental questionnaire available for comparison. Additional statistical hypothesis tests will be based on t-tests with a one-sided 0.025 alpha level. The formal statistical analysis plan will include a non-parametric test to be used in the event the conditions of normality are not met.
Results will be compared to the existing body of literature regarding the administration of these metrics in both typical-hearing and hearing-impaired populations.

Secondary Effectiveness endpoint:
To evaluate the performance of the implant on audiometric thresholds. A descriptive analysis of change in audiometric thresholds pre- to post-operatively will be conducted to demonstrate the effectiveness of the device in providing access to sound.

Primary safety endpoint:
To demonstrate the rate of adverse events gathered in Cohort 2 and in the extension of Cohort 1 is qualitatively similar to the events reported in the original RWE dataset.
At a minimum, adverse events will be sorted into the following categories:
temperature regulation issues and/or instances of arrhythmia during surgery
post-operative complications
facial nerve injuries
swelling/irritation related to the device(s)
ear-related infections/conditions
CSF leak
device migration/extrusion due to skull growth (in young children)
readmissions to the hospital within 30 days of surgery
skin flap breakdown
extrusions

Rate of device-/procedure-/otologic-related events will be classified using the criteria outlined in Cohen and Hoffman (1991) and compared to the published literature.
Follow-up Visits and Length of Follow-up 2 years post-implantation for each subject.

Interim or Final Data Summary
Interim Results N/A
Actual Number of Patients Enrolled 84 (Cohort 1); 50 (Cohort 2)
Actual Number of Sites Enrolled 5
Patient Follow-up Rate Cohort 1 100% - Cohort 2 100%
Study Strengths & Weaknesses N/A


Nucleus 24 Pediatric Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/15/2020 09/21/2020 Overdue/Received
1 year report 03/17/2021 03/15/2021 On Time
18 month report 09/15/2021 09/14/2021 On Time
2 year report 03/17/2022 03/15/2022 On Time
final report 09/13/2022 09/15/2022 Overdue/Received


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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