FDA.reportPublic FDA data

Cochlear implant system, external-microphone

Definition
A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulator implanted near the ear; and an externally worn microphone-sound processor, battery pack, coil cable, and coil (transmitter). Sound waves are converted into electrical signals by the sound processor (transducer) and sent to the coil (transmitter) via the coil cable. The coil transmits the signals to the receiver-stimulator and ultimately to the cochlea via the electrode array. Implantation instruments may be packaged with the system.
GUDID devices
34
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840094406513Electrode Claw ToolAdvanced Bionics, LLCCI-42522022-12-09
00840094406520Recess Gauge for HiRes 90K™Advanced Bionics, LLCCI-43302022-12-09
00840094406780HiFocus MS Electrode Insertion Tool KitAdvanced Bionics, LLCCI-45072022-12-09
00840094407138HiRes™ Ultra Replacement MagnetAdvanced Bionics, LLCCI-14132022-12-09
00840094454293Electrode Insertion ToolAdvanced Bionics, LLCMMT-61112022-12-09
00840094454309Slotted ICS Electrode Insertion TubeAdvanced Bionics, LLCMMT-61352022-12-09
00840094454323Metal Insertion TubeAdvanced Bionics, LLCAB-61352022-12-09
00840094454361Coil Gauge for HiRes 90K™Advanced Bionics, LLCCI-43402022-12-09
00840094454378BTE-ICS Template for HiRes 90K™Advanced Bionics, LLCCI-44202022-12-09
00840094454408HiRes 90K™ Surgical Tool KitAdvanced Bionics, LLCCI-45002022-12-09
00840094454415HiRes 90K™ HiFocus™ 1J Electrode Instrument KitAdvanced Bionics, LLCCI-45042022-12-09
00840094455795Insertion Gauge PlasticAdvanced Bionics, LLCAB-71202022-12-09
00840094456150HiRes 90K™ Magnet Insert DummyAdvanced Bionics, LLCCI-14102023-01-13
00840094456815HiRes 90K™ Magnet InsertAdvanced Bionics, LLCCI-14102022-12-09
07630016809606Electrode Insertion ToolAdvanced Bionics, LLCMMT-61112015-10-08
07630016809927Electrode Claw ToolAdvanced Bionics, LLCCI-42522015-10-14
07630016809934Recess Gauge for HiRes 90K™Advanced Bionics, LLCCI-43302015-10-08
07630016809941Coil Gauge for HiRes 90K™Advanced Bionics, LLCCI-43402015-10-08
07630016809958Helix Cochleostomy Sizing GaugeAdvanced Bionics, LLCCI-43452015-10-14
07630016809965BTE-ICS Template for HiRes 90KAdvanced Bionics, LLCCI-44202015-10-08
07630016809989Recess Marking Template for HiRes 90K™Advanced Bionics, LLCCI-44302015-10-08
00840094406742HiRes™ Ultra Mock UpAdvanced Bionics, LLCCI-44262022-12-09
00840094406766HiFocus MS Electrode Insertion ToolAdvanced Bionics, LLCCI-42072022-12-09
00840094407626HiRes™ Ultra 3D Temporary Non-Magnetic PlugAdvanced Bionics, LLCCI-14202022-12-09
00840094454385HiRes 90K™ Mock UpAdvanced Bionics, LLCCI-44252022-12-09
00840094454392Recess Marking Template for HiRes 90K™Advanced Bionics, LLCCI-44302022-12-09
00840094454569HiFocus Mid-Scala Electrode Instrument KitAdvanced Bionics, LLCCI-45082022-12-09
00840094454644HiRes™ Ultra Temporary Non Magnetic PlugAdvanced Bionics, LLCCI-14112022-12-09
00840094455382AB RemoteAdvanced Bionics, LLCCI-6058-0012023-01-13
00840094456518HiFocus Mid-Scala Electrode Instrument KitAdvanced Bionics, LLCCI-45082022-12-09
00840094456525HiRes 90K™ Replacement MagnetAdvanced Bionics, LLCCI-14122022-12-09
07630016809798Insertion Gauge PlasticAdvanced Bionics, LLCAB-71202015-10-08
07630016841668Metal Insertion TubeAdvanced Bionics, LLCAB-61352022-12-09
07630016841682Slotted ICS Electrode Insertion TubeAdvanced Bionics, LLCMMT-61352022-12-09