Sound Crafters Hearing Instruments
Country not established
- Devices
- 1
What Sound Crafters Hearing Instruments makes
Sound Crafters Hearing Instruments manufactures all-in-the-ear hearing aids designed for discreet, custom-fitted placement within the ear canal. These devices are intended to amplify sound for individuals with mild to moderate hearing loss, offering solutions tailored for daily wear.
The company’s products fall under FDA Class I devices and are listed via the 510(k) pathway. Registration records are maintained in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Hearing Aid (All In The Ear) Ref K872995
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sound Crafters Hearing Instruments have in the registry?
The registry currently lists 1 device for Sound Crafters Hearing Instruments. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sound Crafters Hearing Instruments's devices?
Among its 1 most recently registered device, Sound Crafters Hearing Instruments has devices listed in FDA 510(k) (1 device).
What risk classes do Sound Crafters Hearing Instruments's devices fall under?
Among its 1 most recently registered device, the classes recorded for Sound Crafters Hearing Instruments's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Sound Crafters Hearing Instruments in the registry?
The most recently registered devices listed for Sound Crafters Hearing Instruments include HEARING AID (ALL IN THE EAR).