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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.
 
DeviceNUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
Generic Namecochlear implant with combined electrical stimulation and acoustic amplification
ApplicantCochlear Americas
13059 east peakview avenue
centennial, CO 80111
PMA NumberP130016
Date Received06/03/2013
Decision Date03/20/2014
Product Code PGQ 
Docket Number 14M-0327
Notice Date 04/10/2014
Advisory Committee Ear Nose & Throat
Clinical TrialsNCT00678899
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM. THE NUCLEUS® HYBRID L24 COCHLEAR IMPLANT SYSTEM IS INTENDED TO PROVIDE ELECTRIC STIMULATION TO THE MID-TO-HIGH FREQUENCY REGION OF THE COCHLEA AND ACOUSTIC AMPLIFICATION TO THE LOW FREQUENCY REGIONS, FOR PATIENTS WITH RESIDUAL LOW FREQUENCY HEARING SENSITIVITY. THE SYSTEM IS INDICATED FOR UNILATERAL USE IN PATIENTS AGED 18 YEARS AND OLDER WHO HAVE RESIDUALLOW-FREQUENCY HEARING SENSITIVITY AND SEVERE TO PROFOUND HIGH FREQUENCY SENSORINEURAL HEARING LOSS, AND WHO OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FIT BILATERAL HEARING AIDS. TYPICAL PREOPERATIVE HEARING OF CANDIDATES RANGES FROM NORMAL TO MODERATE HEARING LOSS IN THE LOW FREQUENCIES (THRESHOLDS NO POORER THAN 60 DB HL UP TO AND INCLUDING 500 HZ), WITH SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=75 DB HL) IN THE EAR TO BE IMPLANTED, AND MODERATELY SEVERE TO PROFOUND MID TO HIGH FREQUENCY HEARING LOSS (THRESHOLD AVERAGE OF 2000, 3000, AND 4000 HZ >=60 DB HL) IN THE CONTRALATERAL EAR. THE CNC WORD RECOGNITION SCORE WILL BE BETWEEN 10% AND 60%, INCLUSIVELY, IN THE EAR TO BE IMPLANTED IN THE PREOPERATIVE AIDED CONDITION AND IN THE CONTRALATERAL EAR WILL BE EQUAL TO OR BETTER THAN THAT OF THE EAR TO BE IMPLANTED BUT NOT MORE THAN 80% CORRECT. PROSPECTIVE CANDIDATES SHOULDGO THROUGH A SUITABLE HEARING AID TRIAL, UNLESS ALREADY APPROPRIATELY FIT WITH HEARING AIDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 
S049 S050 
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