510(k) Report

Devices descending from K161123

6 later devices reach Baha 5 Power Sound Processor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…Shokz Health Global Limited20260—
+1K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…Cochlear Americas20213—
+1K171088Cochlear Baha SoundArcCochlear Americas20170—
+2K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…Cochlear20250—
+2K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas20211—
+3K254296Ossiclear (Ossiclear System)Sounduct20260—