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

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OSB Lead-Extended Follow-up of PMA study


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General
Application Number P090018 / PAS001
Current Plan Approved 08/16/2010
Study Name OSB Lead-Extended Follow-up of PMA study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Final Study Results
Number of Patients 51
Number of Sites 3
Follow-up Rate 98% at 4 months, 98% at 10 months, 65% at 2 years, 73% at 3 years, 86% at 4 years, 100% at 5 years
Safety Findings A total of three (3) SADEs in three (3) subjects have been reported during the PAS, in the second through fifth year of post-implant follow-up. These included a sore behind the implant ear caused by glasses requiring surgical intervention; once incision breakdown after battery replacement procedure; and one involved progression of external auditory canal abscess to transcanal infection, requiring explantation of the device.
Effect Findings Overall mean Speech Reception Threshold (SRT) scores show significant improvement with Esteem compared with pre-implant baseline aided condition through the 4-year follow-up. Through 4-year

follow-up, the 95% LCB for the mean difference relative to baseline aided condition ranges from +6.3 dB to +10.9 dB, greater than the +5 dB criteria for superiority. At the 5-year follow-up, the 95% LCB for the mean difference relative to baseline aided condition is +0.8 dB, greater than the -5 dB criteria for non- inferiority.

Through the 4-year follow-up, the Esteem improves Word Recognition Scores (WRS) in a majority of subjects (ranging from 64% to 79%) compared to the pre-implant aided condition. At the 5-year follow- up, the Esteem improves word recognition scores in 49% of subjects, and scores the same in 41% of subjects compared to the pre-implant aided condition.

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 high follow-up rate.
Label Changes Yes. A labeling update is recommended regarding the lifetime of the battery, long term device

effectiveness and a newly identified device failure ┬┐fluid ingress due to header abrasion┬┐ is of consideration.



OSB Lead-Extended Follow-up of PMA study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/15/2010 09/16/2010 Overdue/Received
one year report 03/17/2011 03/16/2011 On Time
18 month report 09/15/2011 09/15/2011 On Time
2 year report 03/16/2012 03/14/2012 On Time
3 year report 03/16/2013 03/29/2013 Overdue/Received
4 year report 03/16/2014 03/14/2014 On Time
Final Report 03/16/2015 03/17/2015 Overdue/Received
resp to R19 RDEF-final report 08/01/2015 07/31/2015 On Time


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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