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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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ODE Lead-MED-EL EAS Extended f/u Study


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General
Study Status Progress Adequate
Application Number P000025 S084/ PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-MED-EL EAS Extended f/u Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own 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 an extended follow-up of the premarket cohort. The purpose of the study is to evaluate the long term safety and effectiveness of the MED-EL EAS Implant in implanted subjects out to 5 years post-activation. It is a prospective, multicenter, non-controlled, non-randomized study.
Study Population Description Up to 68 subjects from the original pivotal study who remain enrolled in the study, implanted with a MED-EL EAS device and have not reached their 5 year post-activation interval will be invited to participate.



Sample Size The sample size requirements are based on the desire for adequate power for the primary effectiveness endpoint. The hypothesis test is a paired one-sample non-inferiority test of the mean CNC word score. The test will be performed at the one-sided 0.05 alpha level based on a 10% non-inferiority margin. The planned minimum sample size of 55 subjects would yield 90% power for this endpoint, based on an assumed difference of zero and a standard deviation of 25. A higher degree of power would be maintained for a smaller standard deviation.



Data Collection Effectiveness endpoints:

The primary effectiveness endpoint will be CUNY sentence test score in noise at five years (60 months) post-implantation compared to the 12-month follow-up interval, measured in two conditions: CI alone and EAS in the implanted ear.

The secondary effectiveness endpoints will be 1) CNC word score in quiet at five years (60 months) post-implantation compared to the 12-month follow-up interval, measured in two conditions: CI alone and EAS in the implanted ear; and 2) global score on the APHAB questionnaire, completed based responses in the everyday listening condition at five years (60 months) post-implantation compared to the 12-month follow-up interval.



Safety endpoints:

The primary safety endpoint will be the number and proportion of subjects experiencing device-related adverse events. Expected adverse events include those listed in the original clinical trial protocol, in particular:

Profound or total loss of residual hearing

Infection or inflammation

Vertigo, dizziness, or balance problems

Tinnitus

Implant migration/extrusion

Skin flap problems

Device-related or programming problems

Uncomfortable sounds during stimulation

Temporary pain or numbness

Device failure leading to explantation



The secondary safety endpoint is residual hearing at five years (60 months) post-implantation that will be summarized and presented as the amount of low-frequency pure-tone average (125, 250, 500, 750, and 1000Hz) shift, the degree of residual hearing, and as a function of the HEARING scale.



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





ODE Lead-MED-EL EAS Extended f/u Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/16/2017 03/16/2017 On Time
one year report 09/15/2017 09/22/2017 Overdue/Received
18 month report 03/16/2018    
two year report 09/15/2018    
three year report 09/16/2019    
four year report 09/14/2020    
five year report 09/14/2021    


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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