510(k) Report

Devices descending from K132278

11 later devices reach Cochlear Baha 4 Sound Processor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171088Cochlear Baha SoundArcCochlear Americas20170—
+1K142907Baha 5 Sound ProcessorCochlear Americas2015101
+2K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH20181—
+2K161123Baha 5 Power Sound ProcessorCochlear Americas20166—
+2K153245Baha 5 Super Power Sound ProcessorCochlear Americas20161—
+3K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…Shokz Health Global Limited20260—
+3K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd.20260—
+3K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…Cochlear Americas20213—
+4K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…Cochlear20250—
+4K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas20211—
+5K254296Ossiclear (Ossiclear System)Sounduct20260—