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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.
 
DeviceESTEEM
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantEnvoy Medical Corporation
4875 White Bear Pkwy.
White Bear Lake, MN 55110
PMA NumberP090018
Supplement NumberS027
Date Received06/12/2014
Decision Date09/10/2014
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO CAPACITANCE SPECIFICATIONS FOR THE ESTEEM SENSOR AND DRIVER COMPONENTS, AND THE ESTEEM SYSTEM IS INTENDED TO ALLEVIATE HEARING LOSS INPATIENTS 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 TUBE6) NORMAL MIDDLE EAR ANATOMY;7) NORMAL TYMPANIC MEMBRANE;8) ADEQUATE SPACE FOR ESTEEM IMPLANT DETERMINED VIA A HIGH RESOLUTION CT SCAN; AND 9) MINIMUM 30 DAYS OF EXPERIENCE WITH APPROPRIATELY FIT HEARING AIDS.
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