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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.
 
DeviceCOMBI 40+COCHLEAR IMPLANT SYSTEM
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
MED-EL CORP.
furstenweg 77a
innsbruck A-602-6020
PMA NumberP000025
Supplement NumberS017
Date Received12/17/2004
Decision Date07/10/2008
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH PULSARCI100 IMPLANTS AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: 1) ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE A SEVERE TO PROFOUND, BILATERAL SENSONNEURAL HEARING LOSS AND OBTAIN LIMITED BENEFIT FORM APPROPRIATELY FITTED BINAURAL HEARING AIDS [NOTE: THIS HEARING LOSS MAY BE EVIDENCED BY A BILATERAL PURE TONE AVERAGE OF 70 DB OR GREATER AT 500, 1000 AND 2000 HZ AND BY BEST-AIDED SCORE OF <=40% CORRECT ON OPEN-SET HEARING IN NOISE TEST SENTENCES (HINT)]; 2) CHILDREN TWELVE (12) MONTHS OF AGE AND OLDER WHO DEMONSTRATE A PROFOUND, BILATERAL SENSONNEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000 HZ AND OBTAIN LITTLE TO NO BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS [NOTE: THIS HEARING LOSS IN YOUNGER CHILDREN MAY BE EVIDENCED BY A LACK OF PROGRESS IN SIMPLE AUDITORY SKILL DEVELOPMENT, DESPITE APPROPRIATE AMPLIFICATION AND AURAL HABITATION, OVER A THREE TO SIX-MONTH PERIOD. THIS HEARING LOSS IN OLDER CHILDREN MAY BE EVIDENCED BY A SCORE OF <20% CORRECT ON THE MLNT OR LNT].
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