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.
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.
| Device | ESTEEM |
| Classification Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Generic Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Applicant | ENVOY MEDICAL CORPORATION |
| Date Received | 2014-06-12 |
| Decision Date | 2014-09-10 |
| PMA | P090018 |
| Supplement | S027 |
| Product Code | OAF |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENVOY MEDICAL CORPORATION 4875 White Bear Parkway white Bear Lake, MN 55110 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090018 | Original Filing | |
| S041 | 2022-03-23 | Normal 180 Day Track No User Fee |
| S040 | ||
| S039 | 2019-09-05 | Normal 180 Day Track No User Fee |
| S038 | 2019-08-28 | 30-day Notice |
| S037 | 2018-05-02 | Real-time Process |
| S036 | 2017-05-10 | 30-day Notice |
| S035 | 2017-03-17 | 30-day Notice |
| S034 | 2017-03-13 | 135 Review Track For 30-day Notice |
| S033 | 2016-10-28 | Real-time Process |
| S032 | 2016-04-21 | Normal 180 Day Track No User Fee |
| S031 | 2016-02-04 | Normal 180 Day Track No User Fee |
| S030 | 2015-09-23 | Normal 180 Day Track No User Fee |
| S029 | 2015-03-23 | Real-time Process |
| S028 | 2014-12-31 | 30-day Notice |
| S027 | 2014-06-12 | Real-time Process |
| S026 | 2014-05-23 | Real-time Process |
| S025 | 2014-03-12 | 30-day Notice |
| S024 | 2013-08-08 | Real-time Process |
| S023 | 2013-08-01 | 30-day Notice |
| S022 | ||
| S021 | 2013-05-29 | 30-day Notice |
| S020 | 2013-05-01 | Special (immediate Track) |
| S019 | 2013-04-19 | Special (immediate Track) |
| S018 | 2012-08-29 | 30-day Notice |
| S017 | 2011-11-14 | 30-day Notice |
| S016 | 2011-11-02 | Normal 180 Day Track |
| S015 | ||
| S014 | 2011-10-24 | Real-time Process |
| S013 | 2011-08-26 | Real-time Process |
| S012 | 2011-08-16 | 30-day Notice |
| S011 | 2011-06-14 | 135 Review Track For 30-day Notice |
| S010 | 2011-05-20 | Normal 180 Day Track No User Fee |
| S009 | 2011-05-10 | Real-time Process |
| S008 | 2010-10-27 | 30-day Notice |
| S007 | 2010-08-18 | 30-day Notice |
| S006 | ||
| S005 | 2010-08-09 | 30-day Notice |
| S004 | 2010-07-27 | 135 Review Track For 30-day Notice |
| S003 | 2010-06-17 | Normal 180 Day Track No User Fee |
| S002 | 2010-06-17 | Normal 180 Day Track No User Fee |
| S001 | 2010-04-07 | Normal 180 Day Track |