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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 NumberS068
Date Received12/09/1996
Decision Date04/04/1997
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 for marketing of the audallion beam forming pre-processor and for approval of device effectiveness claims for the audallin as used wit the nucleus 22 channel cochlear implant system (speak speech processor). The audallion is indicated for use by adults who are using the nucleus 22 channel cochlear implant system to aid them in improving speech understadning in noisy environments when the speech and the noise are not coming from the same direction.
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