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

advanced bionics australia pty ltd - 61603 - cochlear electrode array depth gauge - the device is intended to be used by the surgeon to determine the patency of suspected obstructed cochlea prior to insertion of the electrode.

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

advanced bionics australia pty ltd - 62901 - cochlear implant system sound processor speaker - the sound processor speaker coupled with the sound processor is intended to provide acoustic amplification and electrical stimulation, respectively, for unilateral or bilateral use patients with aidable low frequency hearing sensitivity and severe-to-profound sensorineural hearing loss.

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

advanced bionics australia pty ltd - 42500 - dressing/utility forceps, tweezers-like, reusable - this kit contains two identical optional tools intended to assist the surgeon during the insertion of the cochlear implant electrode.

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

advanced bionics australia pty ltd - 62601 - cochlear implant implantable magnet - small, sterile, magnetic device within the implantable component of a cochlear implant system (cis) that couples with a magnet in the cis external component, to hold implantable and external components in alignment. it is a magnetized metal disc contained within a non-reactive titanium case. magnet within the implanted receiver used to hold and secure the external headpiece in alignment with the receiver so that signals can be transmitted to the cochlear implant.

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 - 62602 - cochlear implant dummy magnet - the ultra 3d temporary non-magnetic plug is intended to be installed in the hires ultra 3d 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.

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

advanced bionics australia pty ltd - 30109 - fixation aid, magnet/magnetic strip/clamp - a device intended to be used for the purpose of ensuring retention between the cochlear implant and the headpiece.

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

advanced bionics australia pty ltd - 61242 - cochlear implant system coil cover/spacer - a color cap is intended to securely cover the headpiece magnet well and microphone on the headpiece. a foam spacer is affixed to the magnet to ensure a secure fit inside the headpiece magnet well.

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 - 62601 - cochlear implant implantable magnet - the hires ultra 3d replacement magnet is a non-reusable, single-use sterile component of the hires ultra 3d cochlear implant. the replacement magnet fits within the magnet pocket of the hires ultra 3d cochlear implant. the ultra 3d replacement magnet is intended to be installed in the hires ultra 3d cochlear implant magnet pocket as a replacement magnet following the removal of the temporary non-magnetic plug to couple with a magnet in the external component to hold implantable and external components in place.