PMA · Approved
Recalled · Class II · 2018Esteem 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 Mar 17, 2010 through premarket approval, which rests on the device’s own clinical evidence after a 225-day review. It has been recalled 2 times.
- Decided
- Mar 17, 2010
- Review
- 225 days
- Class
- Class III
- Product code
- OAF
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P090018 has 40 supplements since 2010: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2010 | 6 |
| 2011 | 6 |
| 2012 | 3 |
| 2013 | 6 |
| 2014 | 3 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 4 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2026 | 3 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2018 | Class II | Z-2590-2018 | Packaging process control | Sterile Wipes packed in these four Esteem II Sound Processors had an earlier expiration date than the final pack and the Esteem II Sound Processors. The Sterile Wipes expired prior to the date labeled on the final pack. |
| Jan 9, 2013 | Class II | Z-0750-2013 | Software design | Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference. |
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. 2010, 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 · printed Nov 6, 2026
Cite this page
510(k) Report. “P090018: 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
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026