510(k) Report

Devices descending from K211008

8 later devices reach Bose SoundControl Hearing Aids through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233747Concha Sol Hearing Aids (CL-1001)Concha Labs20240—
+1K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC20230—
+1K221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.20230—
+1K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG20230—
+1K221698Eargo 5 , Eargo 6Eargo, Inc.20220—
+1K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company20222—
+2K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd.20230—
+2K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty), Ltd.20230—