Data / Medical devices / Denmark / GN Hearing A/S

GN Hearing A/S: FDA-registered device maker in BALLERUP Hovedstaden, Denmark, 3 510(k) clearances

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

GN Hearing A/S is registered with the FDA (registration 3005650109) in BALLERUP Hovedstaden, Denmark. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 25, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005650109
Address: Lautrupbjerg 7, BALLERUP Hovedstaden, Denmark, DK-2750
Owner or operator: GN Hearing A/S (2182204)
Roles: Contract manufacturer, Manufacturer, 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
Face Plate Hearing Aid	LRB	1	Specification developer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	QUG	2	Specification developer	accessdata.fda.gov
Hearing Aid, Air-Conduction With Wireless Technology, Prescription	OSM	2	Contract manufacturer, Specification developer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Contract manufacturer, Specification developer	accessdata.fda.gov
Masker, Tinnitus	KLW	2	Manufacturer, Specification developer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Over The Counter	QUH	2	Specification developer	accessdata.fda.gov
Self-Fitting Air-Conduction Hearing Aid, Prescription	QDD	2	Specification developer	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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 18, 2019	83906	Class II	Terminated	Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-D	GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users resid	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.