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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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Pediatric Study


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General
Application Number P970051 S028/ PAS001
Current Plan Approved 03/01/2005
Study Name Pediatric Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs
Detailed Study Protocol Parameters
Study Design Description This is a multi-center, prospective, single-arm study. It is a was a within-subject self-control experiment design.
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.
Sample Size At least 50 patients; up to 5 centers
Data Collection 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.
Follow-up Visits and Length of Follow-up 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
Interim Safety Information Study completed. See Final Study Results
Number of Patients 69 enrolled and implanted patients above 12 months of age
Number of Sites 7 centers
Follow-up Rate 72.50%
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
Strengths & Weaknesses Low follow up rate. No controls.
Label Changes None


Pediatric Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Semi-annual report (Pediatric Study) 09/01/2007 08/31/2007 On Time
Final Report 04/01/2009 07/01/2009 Overdue/Received
FINAL Report 04/01/2009 04/01/2009 On Time
Request to withdraw report 05/04/2009 05/04/2009 On Time


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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