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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
Classification Nameimplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
PMA NumberP090018
Date Received08/04/2009
Decision Date03/17/2010
Product Code
OAF[ Registered Establishments with OAF ]
Docket Number 10M-0244
Notice Date 05/20/2010
Advisory Committee Ear Nose & Throat
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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; and 9) minimum 30 days of experience with appropriately fit hearing aids.
Approval Order Approval Order
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 
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