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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameESTEEM
Classification Nameimplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
PMA NumberP090018
Supplement NumberS027
Date Received06/12/2014
Decision Date09/10/2014
Product Code
OAF[ Registered Establishments with OAF ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
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 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; and 9) minimum 30 days of experience with appropriately fit hearing aids.
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