510(k) Report

Devices descending from DEN180026

16 later devices reach Bose Hearing Aid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221064Nuheara IQbuds 2 PRO Hearing AidNuheara Limited20221—
+1K220403Vibe SF Self-Fitting Hearing AidWsaud A/S20221—
+1K220303MDHearingAid app, MDHearingAid Smart hearing aidsMdhearingaid20220—
+1K213424Jabra Enhance PlusGN Hearing A/S20221—
+1K211008Bose SoundControl Hearing AidsBose Corporation20218—
+2K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/S20260—
+2K233747Concha Sol Hearing Aids (CL-1001)Concha Labs20240—
+2K233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/S20240—
+2K231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLC20230—
+2K223911Lumen 155-SFIntricon Corporation20230—
+2K221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.20230—
+2K230538All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing AidSonova AG20230—
+2K221698Eargo 5 , Eargo 6Eargo, Inc.20220—
+2K212609BHA100 Series Braun Clear Hearing AidKaz USA, Inc., A Helen of Troy Company20222—
+3K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned, Ltd.20230—
+3K223137Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie ApplicationHearx SA (Pty), Ltd.20230—