510(k) Report

Devices descending from K212609

2 later devices reach BHA100 Series Braun Clear Hearing Aid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd.20230—
+1K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty), Ltd.20230—