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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Cochlear New Enrollment SSD/UHL Study


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P970051 S205/ PAS001
Date Original Protocol Accepted 03/11/2022
Date Current Protocol Accepted  
Study Name Cochlear New Enrollment SSD/UHL Study
Device Name Nucleus 24 Cochlear Implant System
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 Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This clinical study will be conducted as a prospective, nonrandomized, single-arm multicenter investigation in which each participant serves as his/her own control.
Study Population Individuals 18 years or older (Group A) and children 5 years to 17 years 11 months (Group B)
Sample Size 60 subjects at 15 sites
30 subjects aged 18 and above
20 subjects aged 5-11 years; 11 months
10 subjects aged 12-17 years; 11 months
Key Study Endpoints Primary Effectiveness Endpoints:
1. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SONNH).
2. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SONCI).
3. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SON0).

Primary Safety Endpoint
1. Incidence of procedural and device related adverse events reported through the duration of the study
Secondary Effectiveness Endpoints
1. Mean improvement in word recognition at 12 months in the CI alone condition compared to preoperative aided performance in the poorer hearing ear alone.
2. Improvement in patient reported spatial hearing at 12 months post-activation compared to the reported outcome preoperatively.

Additionally, longitudinal hearing performance, 12-months to 36 months will be analyzed.
Follow-up Visits and Length of Follow-up 36 months
Interim or Final Data Summary
Interim Results N/A
Actual Number of Patients Enrolled 4 subjects, 0 subjects implanted
Actual Number of Sites Enrolled 8
Patient Follow-up Rate N/A


Cochlear New Enrollment SSD/UHL Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/11/2022 09/08/2022 On Time
1 year report 03/11/2023    
18 month report 09/11/2023    
2 year report 03/10/2024    
3 year report 03/10/2025    
4 year report 03/09/2026    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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