- Device
- Nucleus Hybrid Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S048
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2022-10-31
- Decision code
- APPR
- Date received
- 2022-04-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- for a new sound processor (Nucleus 8 Sound Processor) and two supporting software devices (Custom Sound Pro and Nucleus Smart App