Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137)
Description
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application by Hearx SA (Pty) , Ltd., an FDA 510(k) cleared ear, nose, throat device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223137
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212609 | BHA100 Series Braun Clear Hearing Aid | Kaz USA, Inc., A Helen of Troy Company | 2022 |
Trace the full predicate network for K223137
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.