|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.|
|Classification Name||implant, hearing, active, middle ear, totally implanted|
|Applicant||ENVOY MEDICAL CORPORATION|
||Ear Nose & Throat
|Supplement Type||real-time process|
|Expedited Review Granted?|| 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.