App icon of Meta Hearing Assist, from the App Store

Is Meta Hearing Assist FDA approved or cleared?

Yes. Meta Hearing Assist by Meta Platform Technologies, LLC is named in the FDA register with a 510(k) clearance, latest decision in 2026.

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

At a glance

Product	Meta Hearing Assist
Maker	Meta Platform Technologies, LLC
Care area	Hearing
What it does	Hearing assistance software for Meta smart glasses
FDA	510(k), latest decision 2026
Verification level	Exact product named in the FDA record (checked 18 October 2026)
EU (CE)	No CE listing found
Website	meta.com
Status	FDA verified
Last checked	7 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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