App icon of Sontro® Self-Fitting OTC Hearing Aid, from the App Store

Is Sontro® Self-Fitting OTC Hearing Aid FDA approved or cleared?

Yes. Sontro® Self-Fitting OTC Hearing Aid by Soundwave Hearing, LLC is named in the FDA register with a 510(k) clearance, latest decision in 2023.

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

At a glance

Product	Sontro® Self-Fitting OTC Hearing Aid
Maker	Soundwave Hearing, LLC
Care area	Hearing
What it does	Self-fitting over-the-counter hearing aid with smartphone app customization
FDA	510(k), latest decision 2023
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	hearsoundwave.com
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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