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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 NumberS058
Date Received05/07/2007
Decision Date07/02/2007
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 three ?vacuum bake air flow enhancements? to the hires90k cochlear implant, as follows: 1) the bottom cover shield inside the hires90k case was modified from having a ?v?-shaped channel to having a larger ?u?-shaped channel. 2) holes were added to the insulating kapton disc. 3) slots were implemented inside the feedthrough case. The device, as modified, will be marketed under the trade name hiresolution bionic ear system and is indicated for individuals aged 12-months and older with severe-to-profound sensorineural hearing loss to restore a level of auditory sensation via electrical stimulation of the auditory nerve.