App icon of Jabra Enhance Select Self-fit, from the App Store

Is Jabra Enhance Select Self-fit FDA approved or cleared?

Yes. Jabra Enhance Select Self-fit by GN Hearing A/S 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	Jabra Enhance Select Self-fit
Maker	GN Hearing A/S
Care area	Hearing
What it does	Self-fitting over-the-counter hearing aid with app
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	jabraenhance.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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