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 B (as adults) : 18-21 yrs,
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.
Up to 35 subjects.
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
Followup Visits and Length of Followup
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)