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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Namecochlear implant
ApplicantCOCHLEAR CORP.
PMA NumberP840024
Supplement NumberS070
Date Received04/24/1997
Decision Date06/11/1997
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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