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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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Extended f/u study

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Study Status Completed
Application Number /
Requirement Number
P130016 / PAS001
Date Original Protocol Accepted 03/20/2014
Date Current Protocol Accepted 09/11/2014
Study Name Extended f/u study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is an extended follow-up of the premarket cohort. The purpose of the study is to evaluate the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in implanted subjects out to 5 years post-activation. It is a prospective, multicenter, non-controlled, non-randomized study
Study Population Subjects from the original pivotal study and
associated Continued Access study who remain implanted with Hybrid L24 Implant, enrolled in the study, and have not met their 5 year post-activation interval.
Sample Size Up to 35 subjects.
Key Study Endpoints The primary safety endpoint will be the comparison of the type
and frequency of adverse events and serious adverse events occurring over the course of this study up to the 5 year post- activation interval as compared to the pivotal clinical study for the Hybrid L24 implant.
The co-primary efficacy endpoints for this study will be the
assessment of statistical significance of the within-subject differences for two speech recognition tests (CNC test and AzBio test), measured in two conditions: the implant ear and both ears
Follow-up Visits and Length of Follow-up 5 years post-activation for each subject
2 years post-activation (if not yet completed), 3 years post- activation (if not yet completed), 4 years post-activation (if not yet completed), 5 years post-activation (if not yet completed)
Interim or Final Data Summary
Actual Number of Patients Enrolled 35
Actual Number of Sites Enrolled 8
Patient Follow-up Rate 100% at 5 years*
The primary endpoint for this investigation is 5 years post-activation of the Hybrid L24 device.
As of March 18, 2019, all 35 enrolled subjects have reached this designated study phase.
Final Safety Findings A total of eight (8) Adverse Events (AEs) occurred during this PAS.
Serious AEs in three (3) subjects were reported during the PAS, but only one (1) was related to the study
device. This included a significant decline in residual low frequency hearing thresholds that was
accommodated by explantation of the study device and replacement with a traditional cochlear implant
was accomplished electrode array. There were no unanticipated adverse device effects reported. In
general, the type and frequency of adverse events and serious adverse events occurring over the course
of this study up to 5 year post-activation interval as compared to the pivotal clinical study for the Hybrid
L24 implant
Final Effect Findings Through the 5-year post-activation follow-up, the Hybrid
L24 improves overall mean CNC Word (words in quiet) and AzBio (sentences in noise at +5 dB SNR)
scores compared with pre-implant baseline unilateral and bilateral conditions. The device benefit is
sustainable over the five years of follow up.
Study Strengths & Weaknesses This is a single arm study with no comparator; however, the subjects
served as their own control. It is a long-term study (up to 5 years post-implantation) with a high followup
Recommendations for Labeling Changes Yes. A labeling update is recommended to reflect the findings of the study.

Extended f/u study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 09/18/2014 09/19/2014 Overdue/Received
one year report 03/20/2015 03/19/2015 On Time
18 month report 09/18/2015 09/17/2015 On Time
two year report 03/19/2016 03/17/2016 On Time
three year report 03/19/2017 03/17/2017 On Time
four year report 03/19/2018 03/14/2018 On Time
five year report 03/19/2019 03/18/2019 On Time
final report 08/01/2019 08/02/2019 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

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