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.
Site enrollment milestones not met,
Subject enrollment milestones not met
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This is a new enrollment study. The purpose of the study is the
longitudinal monitoring of
newly implanted subjects with the Nucleus Hybrid L24 Cochlear Implant System to gather long term safety and effectiveness data on the device in a larger population than that reported in the pivotal study. This is a prospective, multicenter, repeat-measure, single arm, open label study.
Study Population Description
18 years of age and older, who will be implanted with the
Hybrid L24 cochlear implant
from up to 25 investigative centers.
100 subjects. In addition to this study of 100 newly- implanted
Hybrid subjects there are at
least an additional 35 eligible subjects remaining from the original cohort of 50 subjects in the Hybrid L24 pivotalstudy cohort. For characterizing the incidence of adverse events over time, such as the occurrence of low frequency hearing loss, a total of 150 subjects would provide a precision (defined as the halfwidth of a two-sided
95% confidence interval) of approximately 8.3% or smaller.
This calculation is based on an exact binomial confidence interval. Further, with this planned sample size for the combined cohorts, speech performance data on between 50 and 150 subjects will provide a precision of between 4.7% and 8.2% based on a standard deviation of approximately 29% as observed in the Hybrid L24 PMA data for the change in CNC and AzBio scores from preoperative to 6 months.
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.
The primary safety endpoint is the number and frequency of adverse events with corresponding 95% exact binomial confidence limits. These values will be qualitatively compared to the same rates observed in the pivotalstudy; no formal statistical comparisons will be conducted.
Secondary safety endpoints will include the following:
- Cumulative Safety Assessment: Adverse events with start dates prior to initial activation and each follow-up time interval will be tabulated.
- Procedure-Related Adverse Event Assessment:
Procedure-related events occurring during the follow- up period will be tabulated.
- Device-Related Adverse Event Assessment: Device- related events occurring during the follow-up period will be tabulated. The above two classes of events (procedure and device related) will be summarized as rates. The numerator for each rate will be the number of subjects with at least one procedure (or device) related adverse event. The denominator will be the total number of subjects.
- Rates (overall and procedure and device related) will also be summarized by type.
- Time to first adverse event (including total losses of residual hearing) will be summarized using Kaplan Meier plots. Exploratory proportional hazards regression models will be used to determine whether demographics and baseline characteristics are associated with risk for adverse events over follow-up. Hazard ratios and 95% confidence intervals for these analyses will be cited.