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GN Consumer Hearing Corporation: FDA-registered device maker in Shakopee, MN, United States, 1 510(k) clearance

Name: GN Consumer Hearing Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GN Consumer Hearing Corporation is registered with the FDA (registration 3017995697) in Shakopee, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 25, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017995697
Address: 5005 Dean Lakes Blvd, Shakopee, MN, United States, 55379
Owner or operator: GN Consumer Hearing Corporation (10084532)
Roles: Complaint file establishment, Manufacturer
First device listed: March 3, 2022
Registered through: 2026
Brand names listed: Jabra Enhance Select (App), Jabra Enhance Select (app)

Devices it lists

Device	Product code	Class	Role	Source
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	2	Complaint file establishment, Manufacturer	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

Compare with other makers

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.