Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COMBI 40+COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | MED-EL CORP. FURSTENWEG 77a INNSBRUCK 6020 |
PMA Number | P000025 |
Supplement Number | S017 |
Date Received | 12/17/2004 |
Decision Date | 07/10/2008 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 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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