Data / Medical devices / Implant, Auditory Brainstem
Implant, Auditory Brainstem (MHE): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Implant, Auditory Brainstem (product code MHE, Class 3). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MHE
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| Australia | 3 |
| United States | 1 |
| Malaysia | 1 |
| Mexico | 1 |
| China | 1 |
| Switzerland | 1 |
Makers of Implant, Auditory Brainstem
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cochlear Ltd. | LANE COVE New South Wales, Australia | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cochlear Americas Warehouse | Centennial, CO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cochlear Limited - Brisbane | Newstead Queensland, Australia | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cochlear Ltd | Macquarie University New South Wales, Australia | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cochlear Malaysia Sdn Bhd | Kuala Lumpur, Malaysia | Complaint file establishment, Exporter to the US, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Greatbatch Medical S. de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wyon AG | Appenzell Steinegg Appenzell Innerrhoden, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.