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

med-el implant systems australasia pty ltd - 47374 - cochlear implant system sound processor - external component of the ci system supporting electrical & acoustic stimulation. battery powered bte processor includes control unit with earhook attached, battery pack, coil & coil cable. the coil connects processor with implant. the integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems installed in some public buildings & converts them into audible signals. finetuner facilitates access to various audio processor function. multiple color options available the sonnet 2 audio processor is an external part of the med?el cochlear implant system. the med?el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med?el cochlear implant system used in combination with the flex24 or flex20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med?el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single-sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. the auditory brainstem implant (abi) is used for electrical stimulation of the cochlear nucleus (cn) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.

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

med-el implant systems australasia pty ltd - 47374 - cochlear implant system sound processor - an external component of the ci system supports electrical stimulation only. battery powered bte processor includes control unit with earhook attached, battery pack, coil & coil cable. the coil connects the processor with the implant. the integrated telecoil picks up magnetic sound signals from telephone receivers or loop systems installed in some public buildings & converts them into audible signals. finetuner facilitates access to various processor functions. multiple colour options available. the sonnet 2 audio processor is an external part of the med?el cochlear implant system. the med?el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med?el cochlear implant system used in combination with the flex24 or flex20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med?el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single-sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. the auditory brainstem implant (abi) is used for electrical stimulation of the cochlear nucleus (cn) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.

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

med-el implant systems australasia pty ltd - 58734 - cochlear implant system evaluation application software - the software provides an interface for the programming interface hardware. electrode and implant telemetry is established via this interface. the maestro software is part of the med-el cochlear implant system which is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profound hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition; additionally for partially deaf individuals who obtain benefit from acoustic amplification in the lower frequencies only, and individuals with single-sided deafness (defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear). the software supports the implants and processors in combination with programming interface hardware.

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

med-el implant systems australasia pty ltd - 58794 - cochlear implant assessment system - the max programming interface (pi) is pc controlled connected through usb cable, therefore its entire functionality is software based. the coil allows connection to the implant for clinical evaluations. the programming cable allows connection to the audio processor during fitting. the external coil, programming cables and usb cable are included with the pi. the max programming interface is part of the med-el implant system. together with the external host software, it is intended for the configuration and testing of med el hearing implant systems and med el neuro-prosthesis systems. the device is used for: ? programming of med-el system devices ? conducting a functional implant check (impedance and field telemetry mode) ? triggered stimulation in connection with a suitable recording system to record electrically evoked auditory brainstem responses (eabr) ? triggered stimulation in connection with a suitable recording system to record the electrically evoked stapedius reflex threshold (esrt) ? recording eap

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

med-el implant systems australasia pty ltd - 64479 - surgical implant handling forceps - the device is intended to be used to grip, hold and insert an electrode array into the cochlea during med-el hearing implant surgeries.

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

med-el implant systems australasia pty ltd - 61176 - implantable vibrator bone-conduction hearing implant system - the bone conduction implant is the implantable part of the bonebridge system. the device is a direct-drive implantable hearing prosthesis, intended to provide a useful level of sound perception for individuals with chl and mhl, as well as for those suffering from single sided deafness. the bci 602 is surgically implanted into the temporal bone. the kit contains one bci 602 implant, 1 single-use screwdriver, 2 self-drilling cortical screws (silver surface) and 1 emergency screw (blue surface). the bonebridge system with the bone conduction implant bci 602 is intended to treat patients with either conductive or mixed hearing loss or patients suffering from single sided sensorineural deafness. the bonebridge with the bci 602 augments hearing by providing acoustic information to the inner ear via bone conduction. this is achieved by actuating a vibratory transducer, which is implanted in the temporal bone. the bci 602 is for patients 5 (five) years of age or older.

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

med-el implant systems australasia pty ltd - 61176 - implantable vibrator bone-conduction hearing implant system - the bone conduction implant is the implantable part of the bonebridge system. the device is a direct-drive implantable hearing prosthesis, intended to provide a useful level of sound perception for individuals with chl and mhl, as well as for those suffering from single sided deafness. the bci 602 is surgically implanted into the temporal bone. the kit contains 1 bci 602 implant kit and 1 bci 602 sizer kit. the bonebridge system with the bone conduction implant bci 602 is intended to treat patients with either conductive or mixed hearing loss or patients suffering from single sided sensorineural deafness. the bonebridge with the bci 602 augments hearing by providing acoustic information to the inner ear via bone conduction. this is achieved by actuating a vibratory transducer, which is implanted in the temporal bone. the bci 602 is for patients 5 (five) years of age or older.

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

med-el implant systems australasia pty ltd - 47374 - cochlear implant system sound processor - the rondo 2 ap, an external component of the med-el ci system converts acoustic signals into electric signals. the hermetically sealed ap contains the electronics and rechargeable battery which powers the external and the implanted electronics. magnetic attraction holds the ap in place over the implant. the finetuner facilitates access to various ap functions. accessories assist with programming, alternate power source, troubleshooting & customisation. the rondo 2 is an audio processor and an external part of the med - el cochlear implant system. the med - el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med - el cochlear implant system used in combination with the flex24 or flex20 electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med - el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single-sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. the auditory brainstem implant (abi) is used for electrical stimulation of the cochlear nucleus (cn) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.

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

med-el implant systems australasia pty ltd - 47374 - cochlear implant system sound processor - the rondo 3 ap, an external component of the med-el ci system, converts acoustic signals into electric signals. worn off-the-ear over the implant site, the ap is held in place by magnetic attraction. the ap contains the electronics and rechargeable battery which powers the external and the implanted electronics. the telecoil adapter enables magnetic sound signals to be picked up from telephone receivers or loop systems. accessories assist with programming, alternate power source & customisation. the rondo 3 is an audio processor and an external part of the med-el cochlear implant system. the med-el cochlear implant system is intended to evoke auditory sensation via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. additionally, the med-el cochlear implant system used in combination with the (+)flex24, +flex20, +flex20w electrode is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (eas) of the auditory pathways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the med-el cochlear implant system is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single-sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. the auditory brainstem implant (abi) is used for electrical stimulation of the cochlear nucleus (cn) via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non-functional cochlear nerves.

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

med-el implant systems australasia pty ltd - 58184 - cochlear implant system coil - the coil connects the audio processor with the implant. it sends both energy and the coded audio signal through the skin to the implant.