Post-Approval Studies (PAS) Database

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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AHL/SSD New Enrollment PAS

General
Study Status	Study Pending
Application Number / Requirement Number	P960058 S167/ PAS001
Date Original Protocol Accepted	09/18/2026
Date Current Protocol Accepted
Study Name	AHL/SSD New Enrollment PAS
Device Name	HiResolution™ Bionic Ear 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 yrs < 12 yrs, Adolescent: 13-18 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs

AHL/SSD New Enrollment PAS Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	01/20/2027
1 year report	07/22/2027
18 month report	01/20/2028
2 year report	07/21/2028
30 month report	01/19/2029
3 year report	07/21/2029

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background