Is Nuheara IQbuds 2 PRO certified as a medical device?
Nuheara IQbuds 2 PRO by Nuheara Limited has a 510(k) clearance, latest decision in 2022, but it is on our watchlist: the product appears to be discontinued or no longer supported.
In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.
This product appears to be discontinued or no longer supported by its maker.
At a glance
| Product | Nuheara IQbuds 2 PRO |
|---|---|
| Maker | Nuheara Limited |
| Care area | Hearing |
| What it does | Wireless earbuds cleared as a self-fitting hearing aid |
| FDA | 510(k), latest decision 2022 |
| EU (CE) | No CE listing found |
| Website | nuheara.com |
| Status | Watchlist |
| Last checked | 8 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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