This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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; and9) minimum 30 days of experience with appropriately fit hearing aids.
| Device | ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM |
| Classification Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Generic Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Applicant | ENVOY MEDICAL CORPORATION |
| Date Received | 2009-08-04 |
| Decision Date | 2010-03-17 |
| Notice Date | 2010-05-20 |
| PMA | P090018 |
| Supplement | S |
| Product Code | OAF |
| Docket Number | 10M-0244 |
| Advisory Committee | Ear Nose & Throat |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ENVOY MEDICAL CORPORATION 4875 White Bear Parkway white Bear Lake, MN 55110 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |