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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
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS205
Date Received05/28/2021
Decision Date01/10/2022
Product Code MCM 
Docket Number 22M-0071
Notice Date 01/13/2022
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Cochlear Nucleus 24 cochlear implant system. The device is indicated for individuals with unilateral hearing loss who meet the following criteria:1) Individuals 5 years or older who have one ear with a severe to profound sensorineural hearing loss and obtain limited benefit from an appropriately fitted unilateral hearing device and one ear with normal or near normal hearing. a) In the ear to be implanted, a severe to profound sensorineural hearing loss defined as a PTA at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz of > 80 dB HL; andb) In the contralateral ear, normal or near normal hearing is defined as a PTA at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz <= 30 dB HL.2) Limited benefit from an appropriately fit unilateral hearing device is defined as a score of less than or equal to 5% on a Consonant Nucleus Consonant (CNC) word test. For individuals between 5 years and 18 years of age, insufficient functional access to sound in the ear to be implanted must be determined by aided speech perception test scores of 10% or less on developmentally appropriate word lists when tested in the ear to be implanted alone.3) It is recommended that prior to cochlear implantation, individuals with SSD have at least two (2) weeks to one (1) month experience wearing appropriately fit Contralateral Routing of Signal (CROS) hearing aid or another suitable hearing device.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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