Data / Medical devices / United States / GN Hearing Care Corporation
GN Hearing Care Corporation: FDA-registered device maker in Shakopee, MN, United States, 3 510(k) clearances
GN Hearing Care Corporation is registered with the FDA (registration 2182204) in Shakopee, MN, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2182204
- Address
- 5005 Dean Lakes Blvd, Shakopee, MN, United States, 55379
- Owner or operator
- GN Hearing A/S (2182204)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 31, 1989
- Registered through
- 2027
- Brand names listed
- AGXR-E, AGXR-H, AGXR-L, AGXR-N, AGXR-Q, AGXR-T, AGXR-XB, AGXR-XC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Contract manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Masker, Tinnitus | KLW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Over The Counter | QUH | 2 | Complaint file establishment | accessdata.fda.gov |
| Self-Fitting Air-Conduction Hearing Aid, Prescription | QDD | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 25, 2026 | K254108 | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | QUH | Substantially Equivalent | GN Hearing A/S | accessdata.fda.gov |
| January 19, 2022 | K213424 | Jabra Enhance Plus | QDD | Substantially Equivalent | GN Hearing A/S | accessdata.fda.gov |
| February 20, 2020 | K193303 | Tinnitus Sound Generator Module | KLW | Substantially Equivalent | GN Hearing A/S | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- All makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Masker, Tinnitus
- All makers of Self-Fitting Air-Conduction Hearing Aid, Prescription
- All makers of Hearing Aid, Air-Conduction, Prescription
Updated June 25, 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.