Club Hearing Instruments A/S
Denmark(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 5
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Itc Hearing Aid Club Model LM50H Ref K923293
Itc Hearing Aid Club Model LM40 Ref K923295
Itc Hearing Aid Club Model LM50 Ref K923292
Bte Hearing Aid Club Model ST70 Ref K923296
Bte Hearing Aid Club Model: ST60 Ref K923294
What Club Hearing Instruments A/S makes
Club Hearing Instruments A/S makes in-the-canal (ITC) and behind-the-ear (BTE) hearing aids, including models such as the ITC HEARING AID CLUB MODEL LM50H, ITC HEARING AID CLUB MODEL LM40, ITC HEARING AID CLUB MODEL LM50, BTE HEARING AID CLUB MODEL ST70, and BTE HEARING AID CLUB MODEL ST60.
The company's devices are listed in the FDA 510(k) registry and are classified as Class I medical devices. Club Hearing Instruments A/S is based in the US.
Frequently asked questions
What does Club Hearing Instruments A/S manufacture?
Club Hearing Instruments A/S produces in-the-canal (ITC) and behind-the-ear (BTE) hearing aids, including specific models like the ITC HEARING AID CLUB MODEL LM50H, ITC HEARING AID CLUB MODEL LM40, ITC HEARING AID CLUB MODEL LM50, BTE HEARING AID CLUB MODEL ST70, and BTE HEARING AID CLUB MODEL ST60.
Where is Club Hearing Instruments A/S based?
Club Hearing Instruments A/S is based in the United States, as indicated in the provided device data.
Which regulatory registries list Club Hearing Instruments A/S devices?
Club Hearing Instruments A/S devices are listed in the FDA 510(k) registry, which is a premarket notification database for medical devices in the United States.
How are Club Hearing Instruments A/S devices classified?
Club Hearing Instruments A/S devices are classified as Class I medical devices, which are considered low-risk devices and subject to general controls to ensure safety and effectiveness.
Information
- Country
- Denmark