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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNucleus® Hybrid™ L24 Cochlear Implant System
Generic NameCochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP130016
Supplement NumberS058
Date Received07/21/2025
Decision Date10/16/2025
Product Code PGQ 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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