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Is Meine Tinnitus App certified as a medical device?

Meine Tinnitus App by BAYOOCARE GmbH is listed in the German DiGA directory of reimbursed digital health apps (status: permanent), CE class I. We found no FDA authorisation.

At a glance

Product	Meine Tinnitus App
Maker	BAYOOCARE GmbH
Care area	Hearing
What it does	Digital tinnitus counselling based on CBT
FDA	No FDA authorisation found
EU (CE)	Class I (self-declared)
German DiGA	permanent
Website	meinetinnitusapp.de
Status	EU DiGA
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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