Nucleus® Hybrid L24 Cochlear Implant System
FDA premarket approval P130016/S058 · decided 2025-10-16
Approval details
- PMA number
- P130016
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Nucleus® Hybrid L24 Cochlear Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2025-07-21
- Decision date
- 2025-10-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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 Platfor
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