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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 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.
 
DeviceSONATA TI 100 COCHLEAR IMPLANT
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS033
Date Received04/28/2008
Decision Date06/20/2008
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE USE OF AN ALTERNATIVE HYBRID COMPONENT IN THE MANUFACTURE OF THE SONATATI100 COCHLEAR IMPLANT CALLED THE ¿SONATA HYBRID 2¿. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SONATATI100 COCHLEAR IMPLANT AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE BILATERAL SEVERE TO PROFOUND SENSORINEURAL HEARING LOSS DETERMINED BY A PURE TONE AVERAGE OF 70 DB OR GREATER AT 500 HZ, 1000 HZ, AND 2000 HZ. LIMITED BENEFIT FROM AMPLIFICATION IS DEFINED BY TEST SCORES OF 40% CORRECT OR LESS IN BEST-AIDED LISTENING CONDITION ON CD RECORDED TESTS OF OPEN-SET SENTENCE RECOGNITION (HEARING IN NOISE TEST [HINT] SENTENCES). CHILDREN AGED TWELVE (12) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000 HZ. IN YOUNGER CHILDREN, LITTLE OR NO BENEFIT IS DEFINED BY LACK OF PROGRESS IN THE DEVELOPMENT OF SIMPLE AUDITORY SKILLS IN CONJUNCTION WITH APPROPRIATE AMPLIFICATION AND PARTICIPATION IN INTENSIVE AURAL HABILITATION OVER A THREE (3) TO SIX (6) MONTH PERIOD. IN OLDER CHILDREN, LACK OF AID BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBOURHOOD TEST (MLNT) OR LEXICAL NEIGHBOURHOOD TEST (LNT), DEPENDING UPON THE CHILD'S COGNITIVE ABILITY AND LINGUISTIC SKILLS. A THREE (3) TO SIX (6) MONTH HEARING AID TRIAL IS REQUIRED FOR CHILDREN WITHOUT PREVIOUS EXPERIENCE WITH HEARING AIDS. RADIOLOGICAL EVIDENCE OF COCHLEAR OSSIFICATION MAY JUSTIFY A SHORTER TRIAL WITH AMPLIFICATION.
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