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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study


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General
Application Number P130016 / PAS002
Current Plan Approved 04/08/2015
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.

Sample Size 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.

Data Collection 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.

Follow-up Visits and Length of Follow-up 5 years post-activation for each subject.

Preoperative candidacy assessment/ Baseline evaluation Surgery, Initial activation, 3 months post-activation, 6 months post-activation, 12 months post-activation, Annual evaluation thereafter to 5 years post-activation


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/18/2014 09/19/2014 Overdue/Received
one year report 03/20/2015 03/20/2015 On Time
18 month report 09/18/2015 09/17/2015 On Time
two year report 03/19/2016 03/17/2016 On Time
three year report 03/19/2017    
four year report 03/19/2018    
five year report 03/19/2019    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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