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.
This is a multi-center, prospective, single-arm study. It is a was a within-subject self-control experiment
Study Population Description
The study includes patients as per device indication. The device is Intended to restore a
level of auditory sensation via the electrical stimulation of the auditory nerve.
At least 50 patients; up to 5 centers
Children under 3 years of age: * Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) Children 3 to
5 years of age: * Meaningful Auditory Integration Scale (MAIS) * Multisyllabic Lexical Neighborhood Test (MLNT), if child is developmentally capable. Children 5 years and up * Lexical Neighborhood Test (LNT) * Hearing In Noise Test for Children (HINT-C) 3 Sentences in Quiet. Complication questionnaires.
Followup Visits and Length of Followup
A follow-up evaluation was to take place 1 month post-activation and threshold and comfort levels
were to be assessed. The auditory performance was to be assessed at 3, 6 and 12 months post-activation, using the same tests given at pre-operative evaluation. In addition, to monitor safety, complication questionnaires were to be completed by investigators at initial activation and at 1-month, 3-months, 6-months, and 12-months post-activation. All complications and adverse events were to be obtained from the investigational sites and entered into a computer database by complaint type.
Final Study Results
Actual Number of Patients Enrolled
69 enrolled and implanted patients above 12 months of age
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
No unanticipated AEs and 9 complications overall. Type of Complication - Number of occurrences - Rate
of occurrence per 100 implant years Dizziness - 2 - 2.60 Dermatological Issues - 2 - 2.60 Facial Nerve Stimulation - 1 - 1.3 Revision Surgery following accident - 1 - 1.3 Short/Open Electrodes - 3 - 3.91