FDA.reportPublic FDA data

Head-worn bone-conduction hearing aid implantable magnet

Definition
A sterile implantable magnetized device intended to be used to magnetically hold in place a head-worn bone-conduction hearing aid (against the skin on the side of the head), usually using a base plate. It is metallic, typically flat-disc- or dual-disc-shaped, and permanently implanted with screws in the mastoid process or parietal bone of the skull. Disposable devices associated with implantation may be included.
GUDID devices
11
Last updated
2019-03-30 04:26:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00643169644625Otomag™ Alpha 2 Sound ProcessorMEDTRONIC XOMED, INC.S0521-002016-04-15
00643169644632Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0521-012016-04-15
00643169644649Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0521-022016-04-15
00643169645301Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0263-002016-04-15
00643169645318Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0263-012016-04-15
00643169645325Otomag™ Alpha 2 Sound ProcessorMEDTRONIC XOMED, INC.S0521-002016-04-15
00643169645332Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0521-012016-04-15
00643169645349Otomag™ Alpha (M) Magnetic ImplantMEDTRONIC XOMED, INC.S0521-022016-04-15
00643169649071NAMEDTRONIC XOMED, INC.S0585-002016-04-15
00643169719958NAMEDTRONIC XOMED, INC.S0585-002017-10-02
00643169868854Sophono™MEDTRONIC XOMED, INC.S1000-002017-10-02