FDA product code · Ear, nose and throat
Implant, Auditory Brainstem
1 FDA decision since 2000. No recall names this code.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of MHE 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 · MHE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHE
Too few MHE 510(k)s in any year since 2007 to give a median.
Recalls per year · MHE
No recall names MHE since 2007.
Adverse event reports per year · MHE
5in 2025
MAUDE reports naming product code MHE, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 5 | — | 0 | 9 |
| 2017 | 8 | — | 0 | 7 |
| 2018 | 8 | — | 0 | 1 |
| 2019 | 7 | — | 0 | 11 |
| 2020 | 4 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 4 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 7 |
| 2025 | 1 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
Planning a device in MHE? 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