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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
PMA NumberP840024
Supplement NumberS077
Date Received09/21/1998
Decision Date09/25/1998
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of four minor design changes to the audallion beamformer noise reduction system: 1)switch on/off circuit improvements 2) replacement of the lc filter with an rc filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the audiallion regarding item 2), the rc filter will improve the rejction of the overall rf interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the audallion, enabling the device to be more user friendly.