FDA product code · Ear, nose and throat
Implant, Hearing, Active, Middle Ear, Totally Implanted
1 FDA decision since 2010. 1 recall names this code; it is not Class I.
Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OAF at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
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 | — |
Planning a device in OAF? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report