Data / Medical devices / Self-Fitting Air-Conduction Hearing Aid, Over The Counter / United States
FDA-registered makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Self-Fitting Air-Conduction Hearing Aid, Over The Counter (product code QUH). 7 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
- Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- Product code
- QUH
- Country
- United States
Makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Audicon Corporation | Ontario, CA, United States | Complaint file establishment, Specification developer | 1 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Concha Inc. | San Mateo, CA, United States | Complaint file establishment, Specification developer | 1 | March 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Eargo Inc | San Jose, CA, United States | Complaint file establishment, Manufacturer | 1 | December 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| GN Consumer Hearing Corporation | Shakopee, MN, United States | Complaint file establishment, Manufacturer | 1 | June 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Novidan, Inc. | Golden Valley, MN, United States | Contract manufacturer, Manufacturer | 1 | September 8, 2023 | 0 | 0 | 0 | api.fda.gov |
| Oricle Hearing LLC | San Diego, CA, United States | Manufacturer | 1 | September 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Soundwave Hearing, LLC | Oak Brook, IL, United States | Specification developer | 1 | October 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| MDHearing Warehouse | Chicago, IL, United States | 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.