Data / Medical devices / Hearing Aid, Bone Conduction / United States
FDA-registered makers of Hearing Aid, Bone Conduction in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Hearing Aid, Bone Conduction (product code LXB). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Hearing Aid, Bone Conduction
- Product code
- LXB
- Country
- United States
Makers of Hearing Aid, Bone Conduction in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cochlear Americas Warehouse | Centennial, CO, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 11 | May 29, 2025 | 0 | 0 | 0 | api.fda.gov |
| Osypka Medtec Inc. | Longmont, CO, United States | Contract manufacturer, Repackager or relabeler | 2 | June 16, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Xomed, Inc. | Jacksonville, FL, United States | Manufacturer | 1 | May 18, 2010 | 0 | 0 | 0 | api.fda.gov |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | 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.