Sound Options Tinnitus Treatments, Inc.
CanadaFDA applicant, unverified
- Devices
- 2
What Sound Options Tinnitus Treatments, Inc. makes
Sound Options Tinnitus Treatments, Inc. develops software applications designed to mask tinnitus symptoms through auditory stimulation. These digital tools generate customizable soundscapes to help users manage perceived ringing or noise in the ears.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) pathway and the Unique Device Identifier (UDI) system. The portfolio is listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
- Registry: GUDID
Sound Options Tinnitus Treatment Ref K161562
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 203087069
- [email protected]
- Phone
- 1-866-688-3772
Frequently asked questions
How many devices does Sound Options Tinnitus Treatments, Inc. have in the registry?
The registry currently lists 2 devices for Sound Options Tinnitus Treatments, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sound Options Tinnitus Treatments, Inc.'s devices?
Among its 2 most recently registered devices, Sound Options Tinnitus Treatments, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sound Options Tinnitus Treatments, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sound Options Tinnitus Treatments, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sound Options Tinnitus Treatments, Inc. in the registry?
The most recently registered devices listed for Sound Options Tinnitus Treatments, Inc. include Sound Options Tinnitus Treatment 2.0 and Sound Options Tinnitus Treatment.