A & M Hearing, Ltd.
GB Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Am Series Hearing Aid Ref K973579
What A & M Hearing, Ltd. makes
A & M Hearing, Ltd. manufactures the AM Series hearing aid, a device designed to amplify sound for individuals with hearing loss.
The AM Series hearing aid is classified as a Class I medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does A & M Hearing, Ltd. manufacture?
A & M Hearing, Ltd. specializes in hearing aids, specifically the AM Series. These devices are designed to amplify sound for individuals experiencing hearing loss, helping them better perceive and understand auditory information in their environment.
Where is A & M Hearing, Ltd. based?
A & M Hearing, Ltd. is headquartered in the United States. The company’s location in the US may influence its regulatory compliance and distribution networks, particularly for devices marketed in North America.
How are the devices manufactured by A & M Hearing, Ltd. classified under medical device regulations?
The AM Series hearing aid produced by A & M Hearing, Ltd. is classified as a Class I medical device. This classification typically applies to devices posing minimal risk to users, such as many hearing aids, which are generally considered safe and effective for their intended purpose without requiring stringent pre-market approval.
Which regulatory registries or pathways list the devices made by A & M Hearing, Ltd.?
The AM Series hearing aid from A & M Hearing, Ltd. is listed under the FDA’s 510(k) pathway. This pathway is used for devices that are substantially equivalent to a legally marketed predicate device, allowing manufacturers to demonstrate safety and effectiveness through comparative analysis rather than full pre-market approval.
Information
- Country
- GB