All apps · Sleep & breathing

Is Sonu FDA approved or cleared?

Yes. Sonu by Sound Health Systems, Inc. is named in the FDA register with a De Novo authorisation, first authorised in 2023, latest decision in 2025.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

At a glance

Product	Sonu
Maker	Sound Health Systems, Inc.
Care area	Sleep & breathing
What it does	Wearable headband that uses acoustic vibration to relieve nasal congestion from allergies
FDA	De Novo, latest decision 2025
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	soundhealth.life
Status	FDA verified
Last checked	6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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