PMA P000025S017

Device

COMBI 40+COCHLEAR IMPLANT SYSTEM

Applicant

Med-El Corp.

PMA number

P000025

Supplement

S017

Product code

MCM

Decision date

2008-07-10

Classification

Implant, Cochlear

Generic name

Implant, cochlear

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].

Summary

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