FDA product code MHE: Implant, Auditory Brainstem
MHE is the FDA product code for implant, auditory brainstem. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under MHE reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Auditory Brainstem |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MHE devices
openFDA lists no recalls for product code MHE.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8618 — Transmitter cable for use with cochlear implant device or auditory osseointegrated device, replacement
Frequently asked questions
What is FDA product code MHE?
MHE is the FDA product code for implant, auditory brainstem. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is MHE?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code MHE
- Run a recall and safety report across every MHE manufacturer
- Watch product code MHE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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