FDA.reportPublic FDA data

Cochlear implant system external kit

Definition
A collection of non-sterile devices intended to be given to a cochlear implant patient, typically after the first fitting, as a convenience kit of various external components of a cochlear implant system. It typically includes a cochlear implant sound processor and associated devices such as a coil, coil cable, external magnet, remote control, batteries, and battery holder.
GUDID devices
4
Last updated
2025-03-07 15:57:41

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09008737383015SONNET 3 BabyWear Kit (DL) WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.383012025-02-27
09008737383022SONNET 3 BabyWear Kit (DL) BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.383022025-02-27
09008737383039SONNET 3 BabyWear Kit (DL) Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.383032025-02-27
09008737385842SONNET 3 BabyWear Kit (DL) BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.385842025-02-27