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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameimplant, cochlear
Generic Namecochlear implant
PMA NumberP960058
Date Received12/30/1996
Decision Date06/26/1997
Product Code
MCM[ Registered Establishments with MCM ]
Docket Number 97M-0396
Notice Date 09/23/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. Clarion is indicated for the following: 1)children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted; 2)profound, bilateral sensorineural deafness; 3)undergone or be willing to undergo a hearing aid trail with appropriately fitted hearing aids; 4)lack of benefit from appropriately fitting hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word 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.
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