Is Lexie B2 FDA approved or cleared?
Partly. Lexie B2 belongs to a product family by hearX SA that holds a 510(k) clearance, latest decision in 2023, but this exact variant or app is not named in the FDA record.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
At a glance
| Product | Lexie B2 |
|---|---|
| Maker | hearX SA |
| Care area | Hearing |
| What it does | Self-fitting over-the-counter hearing aids with smartphone app |
| FDA | 510(k), latest decision 2023 (product family) |
| Verification level | Product family authorised; this exact variant or app is not named (checked 18 October 2026) |
| EU (CE) | No CE listing found |
| Website | lexiehearing.com |
| Status | FDA verified |
| Last checked | 6 October 2026 |
Need the evidence behind this entry?
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
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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