Is Kalmeda Tinnitus certified as a medical device?
Kalmeda Tinnitus by Pohl-Boskamp Digital Health 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 | Kalmeda Tinnitus |
|---|---|
| Maker | Pohl-Boskamp Digital Health GmbH |
| Care area | Hearing |
| What it does | Digital tinnitus therapy based on CBT |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| German DiGA | permanent |
| Website | kalmeda.de |
| Status | EU DiGA |
| Last checked | 1 October 2026 |
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Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
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