510(k) Report

Devices descending from DEN230081

4 later devices reach Hearing Aid Feature (HAF) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261187Hearing Aid FeatureSamsung Electronics Co., Ltd.20260—
+1K254044Hearing assistMeta Platform Technologies, LLC20260—
+1K251208Tuned Self-Fitting Mobile AppTuned, Ltd.20250—
+1K243150Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.20250—