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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.
 
DeviceESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
4875 WHITE BEAR PARKWAY
WHITE BEAR LAKE, MN 55110
PMA NumberP090018
Date Received08/04/2009
Decision Date03/17/2010
Product Code OAF 
Docket Number 10M-0244
Notice Date 05/20/2010
Advisory Committee Ear Nose & Throat
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ESTEEM. THE ESTEEM IS INTENDED TO ALLEVIATE HEARING LOSS IN PATIENTS BY REPLICATING THE OSSICULAR CHAIN AND PROVIDING ADDITIONAL GAIN. THE ESTEEM IS INDICATED FOR PATIENTS WITH HEARING LOSS THAT MEET THE FOLLOWING CRITERIA: 1) 18 YEARS OF AGE OR OLDER;2) STABLE BILATERAL SENSORINEURAL HEARING LOSS;3) MODERATE TO SEVERE SENSORINEURAL HEARING LOSS DEFINED BY PURE TONE AVERAGE (PTA);4) UNAIDED SPEECH DISCRIMINATION TEST SCORE GREATER THAN OR EQUAL TO 40%;5) NORMALLY FUNCTIONING EUSTACHIAN TUBE;6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT 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 S007 S008 S009 S010 S011 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S023 S024 S025 S026 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S041 
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