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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 Namecochlear implant (adult)
PMA NumberP940022
Supplement NumberS016
Date Received11/16/2000
Decision Date01/12/2001
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for incorporation of the size-reduced speech processor to be worn behind the ear, known as the platinum bte(tm) sound processor. The device, as modified, will be marketed under the trade name clarion(r) multi-strategy cochlear implant platinum bte sound processor. The device is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve. Adults: 1) 18 years of age or older 2) profound, bilateral sensorineural deafness (>=90db) 3) postlingually deafened 4) lack of benefit from appropriately fitted hearing aids.