FDA 510(k) Applications for Medical Device Product Code: QUH ()

FDA 510(k) Applications for Medical Device Product Code "QUH"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K233747	Concha Labs	Concha Sol Hearing Aids (CL-1001)	03/15/2024
K221698	Eargo, Inc.	Eargo 5 , Eargo 6	12/21/2022
K223137	hearX SA (Pty) Ltd.	Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application	03/14/2023
K221052	Huizhou Jinghao Medical Technology Co., Ltd.	Self-Fitting hearing aids	09/25/2023
K221064	Nuheara Limited	Nuheara IQbuds 2 PRO Hearing Aid	10/30/2022
K230538	Sonova AG	All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid	06/16/2023
K231550	Soundwave Hearing, LLC	Sontro« OTC Hearing Aids (AI)	10/26/2023
K223848	Tuned Ltd	IntrisoundÖ Tuned Lumen« 155 Hearing Aids	09/08/2023
K233464	WSAUD A/S	WSA Self-Fitting Hearing Aid Gen 2	02/09/2024