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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.
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Cochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP970051
Supplement NumberS011
Date Received07/21/2000
Decision Date11/01/2000
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the electrode for the nucleus ci24 cochlear implant. The device, as modified, will be marketed under the trade name nucleus 24 contour cochlear implant system with the following changes to the indications for use: 1) approval to implant individuals, age 18 years and older, who obtain limited benefit from amplification as defined by test scores of <=50% correct in the ear to be implanted, (<=60% in the best aided listening condition) on tape recorded tests of open set sentence recognition. 2) approval to implant children 12 months of age and older who have bilateral profound sensorineural hearing loss and obtain limited benefit from appropriately fitted hearing aids.