PMA · Approved
ApprovedEsteem® Totally Implantable Hearing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envoy Medical Corporation · OAF Implant, Hearing, Active, Middle Ear, Totally Implanted
Approved on Aug 24, 2022 through premarket approval, which rests on the device’s own clinical evidence after a 154-day review.
- Decided
- Aug 24, 2022
- Review
- 154 days
- Class
- Class III
- Product code
- OAF
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OAF devicesOAF Implant, Hearing, Active, Middle Ear, Totally Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OAF
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OAF
Too few OAF 510(k)s in any year since 2007 to give a median.
Recalls per year · OAF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAF
11in 2025
MAUDE reports naming product code OAF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 7 | — | 0 | 0 |
| 2011 | 6 | — | 0 | 0 |
| 2012 | 3 | — | 0 | 61 |
| 2013 | 6 | — | 1 | 65 |
| 2014 | 3 | — | 0 | 18 |
| 2015 | 2 | — | 0 | 9 |
| 2016 | 3 | — | 0 | 0 |
| 2017 | 4 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 36 |
| 2019 | 1 | — | 0 | 8 |
| 2020 | 1 | — | 0 | 9 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P090018/S041 · printed Nov 6, 2026
Cite this page
510(k) Report. “P090018/S041: Esteem® Totally Implantable Hearing System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P090018/S041
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026