510(k) Report

Devices descending from K080955

5 later devices reach Zen Program (Mind 440 Hearing Aid) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110973IE-Zen (in Clear Series Hearing Aid)Widex USA20114—
+2K123450Phonak Tinnitus BalancePhonak, LLC20133—
+3K133308Tinnitus SoundsupportOticon A/S20142—
+4K151719REVE134Kw Ear Lab, Inc.20151—
+5K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.20230—