Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 47373 - cochlear implant system electrode array assembly - the implant is comprised of a receiver and an electrode array that are implanted surgically under the skin behind the ear. the electrode array has 16 contacts and is connected to the implant through the electrode lead. the antenna coil allows for forward and backward communication between the implant and the external parts. the system converts sound into electrical energy that activates the auditory nerve. the auditory nerve then sends information to the brain, where it is interpreted as sound. the hires ultra ci hifocus ms electrode (model number: ci-1600-04) is a component of the hiresolution bionic ear system, a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of the auditory nerve. the hiresolution bionic ear system is intended to restore a level of auditory sensation.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 47373 - cochlear implant system electrode array assembly - the implant is comprised of a receiver and an electrode array that are implanted surgically under the skin behind the ear. the electrode array has 16 contacts and is connected to the implant through the electrode lead. the antenna coil allows for forward and backward communication between the implant and the external parts. the system converts sound into electrical energy that activates the auditory nerve. the auditory nerve then sends information to the brain, where it is interpreted as sound. the hires ultra ci hifocus slimj electrode (model number: ci-1600-05) is a component of the hiresolution bionic ear system, a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of the auditory nerve. the hiresolution bionic ear system is intended to restore a level of auditory sensation.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 47373 - cochlear implant system electrode array assembly - the implant includes a receiver and electrode array. the electrode array has 16 contacts and is connected to the implant through the electrode lead. the receiver stimulator titanium case houses the electronics. the antenna coil allows bidirectional communication between the implant and external parts. a magnet assists retention of the external headpiece. the hiresolution bionic ear system is a cochlear implant system designed to provide useful hearing to individuals with severe-to-profound hearing loss via electrical stimulation of the auditory nerve. the hiresolution bionic ear system is intended to restore a level of auditory sensation.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 62564 - cochlear implant magnet inserter/remover - a hand-held manual surgical instrument designed to aid insertion or removal of the subcutaneous magnet component of a cochlear implant system. this is a reusable device intended to be sterilized prior to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 58186 - cochlear implant system coil cable - a device that provides a connection between two or more devices for the purpose of transmitting an energy and/or information signals. within a hearing system, this may include, but not be limited to, cables between sound processors, devices with microphones and sensors.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 62564 - cochlear implant magnet inserter/remover - a hand-held manual surgical instrument designed to aid insertion, reinsertion and/or removal of the subcutaneous magnet component of a cochlear implant system. it is made of high-grade stainless steel and is in a form suited for its application. this is a reusable device intended to be sterilized prior to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 62901 - cochlear implant system sound processor speaker - a small device designed to be attached to a cochlear implant system sound processor to function as a microphone, an audio jack, room loop receiver/booster, and/or a wireless connection receiver. it may be hook-shaped to facilitate wearing behind-the-ear (earhook), or another configuration. this is a reusable device.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 46479 - surgical implant template, reusable - gauges and templates used to facilitate accurate introduction of medical devices and to insure the exact positioning of incisions, cuts or medical devices. this is a reusable device intended to be sterilized prior to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 44067 - surgical procedure kit, ent, reusable - a collection of various hand-held manual surgical instruments, for example sizing gauges, templates, guides, forceps and other tools to perform an ear surgical procedure. these are reusable devices intended to be sterilized prior to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

advanced bionics australia pty ltd - 62602 - cochlear implant dummy magnet - the device is intended to be installed in the cochlear implant magnet pocket, temporarily, to avoid tissue growth in the pocket following the removal of the cochlear implant magnet. this is a sterile single-use device.