Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182204

FEI Number

2182204

Entity Name

GN Hearing Care Corporation

City/State/Country

Shakopee, MN, US

Establishment Address

5005 Dean Lakes Blvd, Shakopee, MN 55379, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GN Hearing A/S (Owner Number: 2182204)

Owner / Operator Contact Address

Lautrupbjerg 7, Ballerup, DK-84 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150171

PMA Number

N/A

All Registered Proprietary Names

Tinnitus Sound Generator Module Enhance Select 500 SureFit,sport lock Multi Mic Enhance Select 700 Enhance Select 200 Enhance Select 50R TV Streamer 2 Enhance Select 300 Phone Clip Plus Enhance Select 100 Enhance Select 50 Enhance Plus Tinnitus Sound Generator Module Tinnitus Sound Generator Module Tinnitus Sound Generator Module Enhance Plus Tinnitus Sound Generator Module

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2008-06-23
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2023-04-11
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-02-10
QDD	Self-Fitting Air-Conduction Hearing Aid, Prescription	Ear, Nose, Throat	Class 2	874.3325	2022-02-10
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2019-02-27
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2011-11-22
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2022-04-28
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2022-10-21
KLW	Masker, Tinnitus	Ear, Nose, Throat	Class 2	874.3400	2015-11-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GN Hearing A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005650109	GN Hearing A/S	BALLERUP Hovedstaden, DK
3026048380	GN ReSound (Malaysia) Sdn. Bhd	Senai Johor, MY
3011927597	GN ReSound (Malaysia) Sdn Bhd.	Kulai Johor, MY
3003303986	GN RESOUND CHINA, LTD.	XIAMEN Fujian, CN

Similar Registrations

Registration Number	Establishment Name	Location
3026390997	AURELIYM GMBH	Bad Neuenahr-Ahrweiler Rhineland-Palatinate, DE
3002808415	Unitron Hearing, a division of National Hearing Services Inc.	KITCHENER Ontario, CA
3005019184	Sivantos GmbH	Erlangen Bavaria, DE
3004929038	Sonova Hearing (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3019622583	Starkey Global Distribution Center	Plainfield, IN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182204. Last updated year: 2026. Please use registration number 2182204 when referencing this establishment in official correspondence.