510(k) Report

Devices descending from K955713

45 later devices reach Nobelpharma Bone Anchored Hearing Aid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042017Baha DivinoEntific Medical Systems, Inc.200439—
+1K021837Branenmark Bone-Anchored-Hearing Aid (Baha)Entific Medical Systems, Inc.200240—
+1K992872Branemark Bone-Anchored Hearing Aid (Baha) Cordelle IIEntific Medical Systems, Inc.199936—
+1K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc.199943—
+2K100649Soundbite Hearing System by SonitusSonitus Medical, Inc.20111—
+2K090996Ponto ProOticon Medical AB200918—
+2K090720Cochlear Baha BP100Cochlear Bone Anchored Systems AB200933—
+2K082108Obc Bone Anchored Hearing Aid SystemOticon Medical AB200819—
+2K081606Baha IntensoCochlear Americas200835—
+2K080363Baha Cordelle IICochlear Bone Anchored Systems AB200835—
+2K050653Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc.20052—
+3K171088Cochlear Baha SoundArcCochlear Americas20170—
+3K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerOticon Medical AB20165—
+3K150751Cordelle II Sound ProcessorCochlear Americas20152—
+3K132775Ponto Plus and Ponto Plus PowerOticon Medical AB201310—
+3K132278Cochlear Baha 4 Sound ProcessorCochlear Americas201311—
+3K121228Ponto Bone Anchored Hearing SystemOticon Medical AB20124—
+3K110831Soundbite Hearing System by Sonitus MedicalSonitus Medical, Inc.201105
+3K103594Ponto Pro PowerOticon Medical AB201111—
+3K110996Baha 3 Power Sound ProcessorCochlear Americas20117—
+3K100193Otomag Bone Conduction Hearing SystemSophono, Inc.20105—
+4K213733Ponto 5 SuperPowerOticon Medical AB20211—
+4K190540Ponto 4Oticon Medical AB20193—
+4K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas20180—
+4K161123Baha 5 Power Sound ProcessorCochlear Americas20166—
+4K153245Baha 5 Super Power Sound ProcessorCochlear Americas20161—
+4K152067Ponto bone anchored hearing systemOticon Medical AB20151—
+4K142907Baha 5 Sound ProcessorCochlear Americas2015101
+4K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System /…Oticon Medical AB20153—
+4K102199Otomag Bone Conduction Hearing System Model Alpha 1 (S) and Alpha 1 (M)Sophono, Inc.20114—
+5K261142Ponto 5 Mini; Ponto 5 SuperpowerOticon Medical AB20260—
+5K253431Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN…Shokz Health Global Limited20260—
+5K211640Ponto 5 MiniOticon Medical AB20212—
+5K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical AB20210—
+5K202048Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…Cochlear Americas20213—
+5K172460ADHEAR SystemMed-El Elektromedizinische Geraete GmbH20181—
+5K152820Ponto Bone Anchored Hearing SystemOticon Medical AB20160—
+5K132189Otomag Bone Conducation Hearing SystemSophono, Inc.20132—
+5K123962Otomag Bone Conduction Hearing SystemSophono, Inc.20130—
+6K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153…Zdeer Technology (Henan) Co., Ltd.20260—
+6K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…Cochlear20250—
+6K212136Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppCochlear Americas20211—
+6K153391Sophono Bone Conduction Systems (S) Configuration and (M) ConfigurationSophono, Inc.20161—
+7K254296Ossiclear (Ossiclear System)Sounduct20260—
+7K243041contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh20250—