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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
28515 westinghouse place
valencia, CA 91355
PMA NumberP960058
Supplement NumberS015
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/material
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(tm) 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. Children: 1) two years of age through 17 years, if x-rays demonstrate evidence of ossification, children as yound as 18 months may be implanted. 2) profound, bilateral sensorineural deafness (>=90db) 3) undergone or be willing to undergo a hearing adi trial with appropriately fitted hearing aids 4) lack of benefit from appropriately fitted hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones wuch as a child's inconsistent response to his/her name ion quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set work recognition (phonetically balanced kindergarten test-word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development.