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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
The study was conducted as a within-subject repeated-measures experiment (each subject served as his or
her own control) to accommodate the heterogeneity of hearing-impaired populations. The study was an ABAB design in which subjects were randomly divided into Group A and Group B. Group A subjects were fit with ACE rates (a coding strategy using stimulation rates of 500 Hz, 900 Hz and 1200 Hz) at initial stimulation and Group B with the ACE RE rates (a coding strategy using stimulation rates of 1800 Hz, 2400 Hz and 3500 Hz).
Study Population Description
Study subjects were to be 18 years of age and older, with post-lingual onset of
bilateral severe to profound sensor-neural hearing loss. Subjects' preoperative CNC word recognition scores were to be <= 30% in the best-aided condition at 60 dB SPL
Sample Size
50 patients
Data Collection
Tests of auditory speech perception were the primary outcome: Hearing in Noise Test (HINT) sentences,
City University of New York (CUNY) sentences and Consonant Nucleus Consonant (CNC) monosyllabic words/phonemes. Additional measures include routine psychophysical measurements, measurements of electrical impedance and a patient questionnaire.
Followup Visits and Length of Followup
at week 0, 3, 5, 8, 10, 12, 14, 16, 24, 12-month
Final Study Results
Actual Number of Patients Enrolled
76 patients
Actual Number of Sites Enrolled
14
Patient Followup Rate
71%
Final Safety Findings
There were progressive improvements in mean percent correct scores across the test intervals for CNC
Words (60 dB SPL), HINT (in quiet) at 60 dB SPL, HINT (in noise) at 60 dB SPL and +10 dB signal-to-noise ratio (SNR), and CNC Words at 70 dB SPL.
Study Strengths and Weaknesses
Prospective Randomized Controlled Study
Recommendations for Labeling Changes
Label needs to be updated to refelct the findings of the Adult PAS study
