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U.S. Department of Health and Human Services

Post-Approval Studies

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Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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Application Number P130016
Current Protocol Accepted 04/08/2015
Study Name OSB Lead-New Enrollment Study
Study Status Progress Inadequate
Study Progress Reason Site enrollment milestones not met, Subject enrollment milestones not met
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group Historical 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 purpose of the study is the

longitudinal monitoring of   show the rest ...
Study Population Description 18 years of age and older, who will be implanted with the

Hybrid L24 cochlear implant   show the rest ...
Sample Size 100 subjects. In addition to this study of 100 newly- implanted

Hybrid subjects there are at   show the rest ...
Data Collection The co-primary efficacy endpoints for this study will be the

assessment of statistical significance of the   show the rest ...
Followup Visits and Length of Followup 5 years post-activation for each subject.

Preoperative candidacy assessment/ Baseline evaluation Surgery, Initial activation, 3 months   show the rest ...

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
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    
four year report 03/19/2018    
five year report 03/19/2019    

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