Data / Medical devices / Hearing Aid, Air-Conduction With Wireless Technology, Prescription / United States
FDA-registered makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription in the United States: 17 establishments
17 establishments in the United States are registered with the FDA to make Hearing Aid, Air-Conduction With Wireless Technology, Prescription (product code OSM). 0 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, Air-Conduction With Wireless Technology, Prescription
- Product code
- OSM
- Country
- United States
Makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eargo Inc | San Jose, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Etymotic Research, Inc. | Schaumburg, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortell Research Inc. | New York, NY, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortell Research Manufacturing | Danbury, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Consumer Hearing Corporation | Shakopee, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Hearing Care Corporation | Shakopee, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hearing Lab Technology, LLC | Fort Worth, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hearing Lab Technology, LLC. | West Bristol, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isuniye LLC | Milpitas, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magnatone Hearing Aid Corp. dba Persona Medical | Casselberry, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sound Hearing Lab Inc | Aurora, IL, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starkey Glencoe | Glencoe, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sonova USA Inc. | Aurora, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starkey Global Distribution Center | Plainfield, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Starkey Laboratories, Inc. | Eden Prairie, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WS Audiology USA, Inc. | Hauppauge, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WeHear USA | Little Rock, AR, United States | Specification developer | 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.