- Device
- Nucleus® Hybrid™ Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S046
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2022-04-29
- Decision code
- APPR
- Date received
- 2022-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification to Cochlear Research Platform Software resulting in version 2.0 of the software. This software update makes minor performance changes to existing electrocochleography functionality and implements a new software design to allow for introduction of future functionality.