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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® 24 Cochlear Implant System
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Dr.
Lone Tree, CO 80124
PMA NumberP970051
Supplement NumberS225
Date Received01/09/2024
Decision Date07/03/2025
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
1.A new series of Cochlear™ Nucleus® Implants: the CI1000 Series implants2.An updated sound processor with accessories: Nucleus® 8 Sound Processor 3.Two new sound processors with accessories: Kanso® 3 Sound Processor compatible with the CI1000 Series implants and Kanso® 3 Sound Processor compatible with commercial CI24RE, CI500 and CI600 Series implants4.A new Surgical Processor compatible with the CI1000 Series implants5.Three updated supporting software devices: Nucleus® SmartNav, Nucleus® Smart App, Custom Sound® Pro6.A new supporting software module: Cochlear™ Objective Measures
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