- Device
- Nucleus® 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S236
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2025-10-16
- Decision code
- APPR
- Date received
- 2025-07-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Cochlear™ ECochG Measures v3.0 software module within the Cochlear™ Clinical Extension Platform, to provide compatibility with devices approved under P970051/S225 (CI1000 Series implants, CP1110 Sound Processor, and CP1110S Surgical Processor) and existing acoustic components used with these new devices, in addition to devices already compatible with v2.0. The name of the software module is also changed from v2.0 Cochlear Research Platform ECochG Software module (within Cochlear Research Platform) to v3.0 Cochlear ECochG Measures module (within Cochlear Clinical Extension Platform).