GN Hearing Care Corporation (other, Shakopee, MN): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter
GN Hearing Care Corporation (Shakopee, Minnesota): 2 new FDA device listings, incl. self-fitting air-conduction hearing aid, over the counter. Its amount of 2 is above the median of 1 (69th percentile). Dated 79 days ago, it serves as a historical benchmark. Score 50/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 15 published fields of this record are shown below. Locked: 42 related MN DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (43 MN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-17
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: GN Hearing Care Corporation and 43 Minnesota peers
- Minnesota DeviceEstablishmentPulse records like this one: 43
- GN Hearing Care Corporation's amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $8,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
50 / 100 Score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for GN Hearing Care Corporation in Shakopee, Minnesota?
GN Hearing Care Corporation (Shakopee, MN), a other, added 2 FDA device listings on 2026-08-17.
How does GN Hearing Care Corporation compare to other Minnesota DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 79 days old; check the official source for later updates before acting.
GN Hearing Care Corporation vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| GN Hearing Care Corporation | Shakopee, MN | 2 | 69th | 2026-08-17 |
| Conmed Corporation | Utica, NY | 3 | 77th | 2026-09-14 |
| Euroimmun Us Inc. | Mountain Lakes, NJ | 3 | 77th | 2026-09-10 |
| Rohrer Aesthetics, Inc. | Homewood, AL | 3 | 77th | 2026-09-09 |
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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.