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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCLARION MULTI-STRATEGY COCHLEAR IMPLANT
Generic NameImplant, cochlear
ApplicantADVANCED BIONICS
28515 WESTINGHOUSE PLACE
VALENCIA, CA 91355
PMA NumberP960058
Date Received12/30/1996
Decision Date06/26/1997
Product Code MCM 
Docket Number 97M-0396
Notice Date 09/23/1997
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT. THE DEVICE IS INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATION TO CHILDREN WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CLARION IS INDICATED FOR THE FOLLOWING: 1)CHILDREN, 2 THROUGH 17 YEARS OF AGE. IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUNG AS 18 MONTHS MAY BE IMPLANTED; 2)PROFOUND, BILATERAL SENSORINEURAL DEAFNESS; 3)UNDERGONE OR BE WILLING TO UNDERGO A HEARING AID TRAIL WITH APPROPRIATELY FITTED HEARING AIDS; 4)LACK OF BENEFIT FROM APPROPRIATELY FITTING HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES SUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME IN QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORD RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST - WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL). BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT.
Supplements: S091 S092  S106 S037 S038 S040 S096 S100 S101 S114 S105 
S109 S097 S078 S079 S011 S021 S022 S023 S024 S025 S005 S006 
S007 S012 S033 S034 S035 S036 S001 S002 S003 S004 S032 S053 
S042 S043 S045 S046 S057 S058 S030 S031 S020 S049 S050 S015 
S119 S120 S013 S014 S008 S009 S010 S089 S090 S093 S094 S107 
S108 S111 S116 S102 S115 S098 S095 S112 S113 S117 S118 S099 
S103 S104 S026 S027 S028 S029 S055 S080 S081 S082 S070 S073 
S074 S075 S076 S061 S084 S047 S048 S085 S087 S054 S066 S121 
S122 S130 S126 S129 S139 S140 S141 S142 S148 S149 S152 S153 
S158 S159 S160 S161 S151 S128 S123 S124 S125 S131 S132 S134 
S135 S150 S136 S137 S138 S143 S144 S145 S146 S147 S133 S157 
S155 S156 S162 S154 S163 S164 
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