PMA P000025S010

Device

MED-EL COMBI 40+

Applicant

Med-El Corp.

PMA number

P000025

Supplement

S010

Product code

MCM

Decision date

2003-07-25

Classification

Implant, Cochlear

Generic name

Implant, cochlear

Approval order statement

APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE THE FOLLOWING ACCESSORIES FOR THE TEMPO+ SPEECH PROCESSOR: TELEMIC AND MICROPHONE TEST DEVICE (MTD). THE TELEMIC IS INDICATED FOR THE COMBI 40+ COCHLEAR IMPLANT USER WHO DESIRES EITHER A DIRECT CONNECTION TO A TELEPHONE OR AN INDUCTION LOOP OR ADDITIONAL AMPLIFICATION OF THE TEMPO+ SPEECH PROCESSOR INTERNAL MICROPHONE. THE MTD IS INDICATED FOR INDIVIDUALS WHO WISH TO QUALITATIVELY MONITOR THE MICROPHONE SIGNAL OF THE TEMPO+ SPEECH PROCESSOR.

Summary

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