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.
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup 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
Final 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.
Final Effectiveness 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.
Study Strengths and 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.
Recommendations for Labeling Changes
Yes. A labeling update is recommended regarding the lifetime of the battery, long term device
and a newly identified device failure ¿fluid ingress due to header abrasion¿ is of consideration.