Approval Order Statement
APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (COMBI 40+). THE DEVICE IS INTENDED TO PROVIDE THE OPPORTUNITY TO DETECT AND RECOGNIZE AUDITORY INFORMATION THROUGH ELECTRICAL STIMULATION OF THE AUDITORY NERVE FOR SERVER TO PROFOUNDLY HEARING-IMPAIRED INDIVIDUALS WHO OBTAIN LITTLE OR NO BENEFIT FROM CONVENTIONAL ACOUSTIC AMPLIFICATION IN THE BEST-AIDED CONDITION. THE COMBI 40+ IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS OF 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 EIGHTEEN (18) MONTHS TO SEVENTEEN (17) YEARS ELEVEN (11) MONTHS MUST DEMONSTRATE A PROFOUND, BILATERAL SENSORINEURAL HEARING LOSS WITH THRESHOLDS OF 90 DB OR GREATER AT 1000HZ. 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 AIDED BENEFIT IS DEFINED AS < 20% CORRECT ON THE MULTI-SYLLABIC LEXICAL NEIGHBORHOOD TEST (MLNT) OR LEXICAL NEIGHBORHOOD 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. |
