Cochlear implant assessment system

Definition
An assembly of non-sterile portable electronic devices designed to perform an integrity test on the implantable portion of a cochlear implant (CI) system in situ; the test is intended to provide objective data on implant function and aid in the assessment of implant failure/fault modes. It typically includes hardware (e.g., biological signal amplifier, sound processor, coils, sign cables, magnets, leads) and software, with consumables (e.g., skin electrodes/gel, swabs/wipes, tapes), to provide implant stimulation to the patient and acquire skin surface potential waveforms from the patient. It is powered via a computer USB port. This is a multi-patient reusable device.
GUDID devices
5
Last updated
2020-12-30 08:41:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09321502033770Cochlear Integrity Test UnitCOCHLEAR LIMITEDS4281632020-12-22
09321502044059Cochlearâ„¢ Research PlatformCOCHLEAR LIMITEDP14796942019-06-14
07630016809705Clinician's Programming InterfaceAdvanced Bionics, LLCAB-65002015-10-08
07630016817137CPI-3 Clinical Programming InterfaceAdvanced Bionics, LLCCI-61012015-10-24
07630016841552CPI-3 Clinical Programming InterfaceAdvanced Bionics, LLCCI-61012015-10-24