HiResolution Bionic Ear System
FDA premarket approval P960058/S131 · decided 2019-08-30
Approval details
- PMA number
- P960058
- Supplement
- S131
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2018-09-07
- Decision date
- 2019-08-30
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- 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.
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