PMA P960058S093
- Device
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S093
- Product code
- MCM
- Decision date
- 2012-03-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL OF AN OPTIONAL NOISE REDUCTION ALGORITHM CALLED CLEARVOICE. CLEARVOICE IS A MODIFIED VERSION OF THE APPROVED FIDELITY 120 SOUND PROCESSING STRATEGY.
Current openFDA PMA Record#
- Device
- AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Applicant
- Advanced Bionics
- PMA number
- P960058
- Supplement
- S093
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2012-03-12
- Decision code
- APPR
- Date received
- 2011-10-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF AN OPTIONAL NOISE REDUCTION ALGORITHM CALLED CLEARVOICE. CLEARVOICE IS A MODIFIED VERSION OF THE APPROVED FIDELITY 120 SOUND PROCESSING STRATEGY.