• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail
-

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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


             

OSB Lead-Extended f/u study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Application Number P130016 / PAS001
Current Plan Approved 09/11/2014
Study Name OSB Lead-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 Design Description 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 Description 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.
Data Collection 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)


OSB Lead-Extended f/u 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 03/19/2015 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    
four year report 03/19/2018    
five year report 03/19/2019    


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

Related Links

-
-