FDA product code · Ear, nose and throat
Hearing Aid, Bone Conduction, Implanted
12 FDA decisions since 1999. 510(k) reviews decided 2021–2025 took a median of 65 days (half between 65 and 65). No recall names this code. The most-cited predicate is K080363, named by 4 later devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MAH 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 · MAH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · MAH
124in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAH
No recall names MAH since 2007.
Adverse event reports per year · MAH
562in 2025
MAUDE reports naming product code MAH, 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 | 9 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 46 |
| 2015 | 3 | 124 | 0 | 52 |
| 2016 | 1 | — | 0 | 309 |
| 2017 | 0 | — | 0 | 614 |
| 2018 | 1 | — | 0 | 629 |
| 2019 | 0 | — | 0 | 635 |
| 2020 | 0 | — | 0 | 692 |
| 2021 | 1 | — | 0 | 709 |
| 2022 | 0 | — | 0 | 711 |
| 2023 | 0 | — | 0 | 742 |
| 2024 | 0 | — | 0 | 621 |
| 2025 | 0 | — | 0 | 562 |
| 2026 | 1 | — | 0 | — |
Planning a device in MAH? 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) ReportRelated product codes
Other codes under 21 CFR 874.3302.