PMA P960058S177

Device: HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S177
Product code: MCM
Decision date: 2026-09-04
Classification: Ear, Nose, Throat
Generic name: Implant, cochlear
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval to remove the non-tamperproof battery door in the HiResolution Bionic Ear System external processor and replace it with a validated tamperproof door in the packaged configuration of the M Zn-Air Battery Pak (CI-5501).

Current openFDA PMA Record#

Device: HiResolution Bionic Ear System
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S177
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2026-09-04
Decision code: APPR
Date received: 2026-08-07
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement, which requested approval to remove the non-tamperproof battery door in the HiResolution Bionic Ear System external processor and replace it with a validated tamperproof door in the packaged configuration of the M Zn-Air Battery Pak (CI-5501).