# GN Hearing Care Corporation (other, Shakopee, MN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | GN Hearing Care Corporation |
| Owner / operator | GN Hearing A/S |
| Role | Other |
| Establishment types | Complaint File Establishment per 21 CFR 820.198 |
| Location | Shakopee, MN, US |
| New listings | 2 |
| Devices | Self-Fitting Air-Conduction Hearing Aid, Over The Counter; Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Product codes | QUH, OSM |
| Device classes | Class II |
| Medical specialties | Ear, Nose, Throat |
| Brand names | Enhance Select M2; Enhance Select M3; Enhance Select M1; Enhance Select 550 |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 2182204 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.