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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
Applicant
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS172
Date Received10/10/2017
Decision Date03/17/2020
Product Code MCM 
Docket Number 20M-1116
Notice Date 03/19/2020
Advisory Committee Ear Nose & Throat
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the IFU for Nucleus 24 Cochlear Implant System: 1) The Nucleus 24 Cochlear Implant System is intended for individuals 18 years of age or older who have bilateral, pre, peri or postlinguistic sensorineural hearing impairment and obtain limited benefit from appropriate binaural hearing aids.2) These individuals typically have moderate to profound hearing loss in the low frequencies and profound (>= 90 dB HL) hearing loss in the mid to high speech frequencies. Limited benefit from amplification is defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tape-recorded tests of open set sentence recognition.3) The Nucleus 24 cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids.4) Children two years of age or older may demonstrate severe to profound hearing loss bilaterally.5) In younger children, limited benefit is defined as lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six-month period. It is recommended that limited benefit be quantified on a measure such as the Meaningful Auditory Integration Scale or the Early Speech Perception test.6) In older children, limited benefit is defined as <= 30% correct on the open set Multisyllabic Lexical Neighborhood Test (MLNT) or Lexical Neighborhood Test (LNT), depending upon the childs cognitive and linguistic skills. A three to six-month hearing aid trial is recommended for children without previous aided experience.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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