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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-New Enrollment Study


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General
Study Status Progress Adequate
Application Number P130016 / PAS002
Date Current Protocol Accepted 09/22/2017
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a new enrollment study.

The Nucleus Hybrid L24 Implant System New Enrollment Study will be conducted as a repeated-measures single-subject experiment.

Additional data will come from subjects in the Hybrid Extended Duration Study as well as real world evidence (RWE) from a retrospective study of patients at the University of Iowa. Data from the Hybrid Extended Duration study will be pooled with the New Enrollment study for analysis of effectiveness. Data from both the Hybrid Extended Duration study and the RWE study at the University of Iowa will be pooled with the New Enrollment study for analysis of safety.

Study Population Description Subjects will include a minimum of 50 newly implanted individuals, 18 years of age and older, who will be implanted with the Hybrid L24 cochlear implant from up to 25 investigational centers.

Data collected from two additional sources, including the Nucleus Hybrid Extended Duration post approval study and/or a retrospective review of standard of care clinical records will be included for a total population of up to 85 subjects for effectiveness analysis and 150 individuals for safety analysis.



Sample Size A total of 150 subjects would provide a precision (defined as the halfwidth of a two-sided 95% confidence interval) of approximately 11.9% or smaller. The three sources of data include:

1) A minimum of 50 subjects from this New Enrollment post approval study

2) Up to 35 subjects in continued follow-up in the Hybrid Extended Duration post approval study

3) A minimum of 65 subjects who were implanted outside of this New Enrollment post approval study following device approval and commercial availability using standard of care techniques.



This calculation is based on an exact binomial confidence interval.



Additionally, speech performance will be characterized in a total of 85 target subjects (range: 50-100 subjects, precision 4.7% - 8.2%).



Data Collection The primary effectiveness endpoint for this study will include the within- subject differences for a monosyllabic word recognition test, measured in two conditions: the implant ear alone and when using both ears together through 5 years post-activation

• Word recognition in quiet as evaluated with the Consonant Nucleus- Consonant (CNC) test



The secondary effectiveness endpoint for this study will include the within- subject differences for

a sentence recognition test:

• Sentence recognition in noise) best unilateral condition as evaluated with the AzBio test



The primary and secondary safety endpoints are the same as previous protocol.



Follow-up Visits and Length of Follow-up 5 years post-activation for each subject.

Preoperative candidacy assessment/ Baseline evaluation Surgery, Initial activation, 3 months post-activation, 6 months post-activation, 12 months post-activation, Annual evaluation thereafter to 5 years post-activation


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/18/2014 09/19/2014 Overdue/Received
one year report 03/20/2015 03/20/2015 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    
five year report 03/19/2019    
six year report 03/18/2020    
seven year report 03/18/2021    
eight year report 03/18/2022    
nine year report 03/18/2023    
10 year report 03/17/2024    
11 year report 03/18/2025    
Final Report 02/01/2026    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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