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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 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS070
Date Received04/24/1997
Decision Date06/11/1997
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
Approval Order Statement  
APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE. THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PINC SOCKET. THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION TO THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET. THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT IS INDICATED FOR USE IN ADULTS WITH BILATERAL, SENSORINEURAL, SEVERE-TO-PROFOUND DEAFNESS, AGES 18 YEARS AND OLDER, WHO OBTAIN UP TO 30% SPEECH RECOGNITION ON TESTS OF RECORDED SENTENCE MATERIALS IN THE BEST-AIDED CONDITION. IT IS INDICATED FOR USE IN CHILDREN WITH BILATERAL, SENSORINEURAL, PROFOUND DEAFNESS, AGES 2 YEARS TO 17 YEARS, WHO OBTAIN LITTLE OR NOT BENEFIT FROM CONVENTIONAL AMPLIFICATION IN THE BEST-AIDED TEST CONDITION.
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