FDA.reportPublic FDA data

PMA P960058S131

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
Product code
MCM
Decision date
2019-08-30
Generic name
Implant, cochlear
Approval order statement
Approval of the HiRes Fidelity 120 and HiRes Optima sound processing strategies for adults and pediatric patients 12 months and older.Approval of the ClearVoice and Front-End Processing features of StereoZoom, UltraZoom, SoundRelax, WindBlock, and EchoBlock for pediatric population 6 years and older.

Current openFDA PMA Record#

Device
HiResolution Bionic Ear System
Applicant
Advanced Bionics
PMA number
P960058
Supplement
S131
Product code
MCM
Generic name
Implant, cochlear
Decision date
2019-08-30
Decision code
APPR
Date received
2018-09-07
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval of the HiRes Fidelity 120 and HiRes Optima sound processing strategies for adults and pediatric patients 12 months and older.Approval of the ClearVoice and Front-End Processing features of StereoZoom, UltraZoom, SoundRelax, WindBlock, and EchoBlock for pediatric population 6 years and older.