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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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OSB Lead-Esteem New Enrollment 2


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General
Study Status Progress Inadequate
Application Number P090018 / PAS003
Date Current Protocol Accepted 03/18/2016
Study Name OSB Lead-Esteem New Enrollment 2
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 a new enrollment study. It is a prospective, non-randomized, multicenter study, and it aims to evaluate the safety and efficacy of the device implanted by newly-trained surgeons in subjects suffering from moderate to severe hearing loss.

Study Population Description Subjects 18 years of age and older who have moderate to severe sensorineural hearing loss (HL) defined by Pure Tone Average (PTA), have a healthy middle ear, have an unaided speech discrimination score of equal to or better than 40%, and have previously worn a hearing aid for a minimum of 30 days are eligible for inclusion in the Post Approval Study.

Sample Size 120 subjects in 5 to 10 investigational sites. The sample size is based on testing the following hypothesis:

Facial Pareses/paralysis:

Based upon a null hypothesis of 7% and a hypothesized true rate of 2% of facial paresis/paralysis, 109 subjects at 1 month would provide at least 80% power for testing the hypothesis.

Data Collection To demonstrate that the Esteem® System is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the word recognition score at 50 dB.

Primary Endpoints:

1) Comparison of the speech reception threshold (SRT) using the Esteem® System as compared to the pre-implant aided condition.

2) Comparison of word recognition score using the Esteem® as compared to the pre-implant aided condition.

3) The analysis of the incidence of SADEs and device failures and replacements at each follow-up.

4) The analysis of the incidence of facial pareses/paralysis at 1 month follow-up.

5) Comparison of the bone conduction threshold with forehead placement compared to the pre-implant bone conduction threshold.

Secondary Endpoints:

1) To show that the Esteem® System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB scores.

2) To gather subject feedback and comments on the use of the Esteem® System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem® Questionnaire.

Follow-up Visits and Length of Follow-up The subjects will be followed for 1 year.



Device will be activated during activation visit (8weeks+/- 2week post implant. Subjects will be followed at 1, 4 and 10 months post-activation.



OSB Lead-Esteem New Enrollment 2 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/18/2016 04/08/2016 Overdue/Received
one year report 09/18/2016 09/19/2016 Overdue/Received
18 month report 03/18/2017 03/17/2017 On Time
unscheduled report 06/28/2017 06/28/2017 On Time
two year report 09/18/2017 09/18/2017 On Time
three year report 09/17/2018    
four year report 09/17/2019    
Final Report 01/17/2020    


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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