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

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - an optional, external part of the med-el ci system, audiolink is intended to be used as a wireless connection between compatible med-el audio processors and electronic devices (mobile phones, smartphones, tablets, etc.) equipped with bluetooth? wireless technology. in combination with a mobile or smartphone, audiolink provides the functionality of a bluetooth? headset where the incoming audio signal is wirelessly streamed to the ap(s). audiolink is intended to be used to wirelessly stream audio signals from an audio source featuring bluetooth? wireless technology or an analog audio source to the ap(s). it is intended to be used as a wireless remote microphone. audiolink provides a general communication and data pathway between a compatible electronic device featuring bluetooth? wireless technology and the ap(s).

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

med-el implant systems australasia pty ltd - 57885 - hearing aid remote control - an external part of the med-el ci system, the device is intended to be used as a remote control for recipients having received a compatible med-el audio processor (ap). it is intended to be used as an ap test device for easy recognition of the working status and the most common functional problems such as defective coil cables, defective microphones or weak batteries of med-el aps. it is intended to be used by a patient all day long during waking hours, there are no restrictions in the frequency of use. it is intended to be used in typical everyday environments (e.g. home, office, outdoor, etc.) and also in a clinical environment (e.g. audiologist's office).

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.

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

averroes pharmaceuticals sdn. bhd. - v.cholerae inaba 48 classical biotype,; v.cholerae inaba 6973 el tor biotype,; v.cholerae ogawa 50 classical biotype,; v.cholerae ogawa 50 classical biotype,; vibrio cholerae 0139, strain 4260 b, inactivated -

Singapore - English - HSA (Health Sciences Authority)

medel pte. ltd. - ear, nose & throat - the maestro software is a part of the med-el cochlear implant system. the med-el cochlear implant (ci) 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. max programming interface is to offer a hardware platform for different clinical applications with the med-el implant system.

Singapore - English - HSA (Health Sciences Authority)

medel pte. ltd. - ear, nose & throat - the sonnet 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.

Singapore - English - HSA (Health Sciences Authority)

medel pte. ltd. - ear, nose & throat - the cochlear implant mi1200 synchrony is intended to evoke auditory sensations 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. additional the med-el cochlear implant system used in combination with the implant variant syndhrony flex24 and +flex20 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.

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

med-el implant systems australasia pty ltd - 58776 - surgical screwdriver, single-use, sterile - a terminally sterilized single-use device intended to be used by surgeons for tightening/untightening cross-headed bone screws, e.g. for med-el implant fixation.

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

med-el implant systems australasia pty ltd - 63366 - nerve location/function operative test pulse generator - the stimulator box generates stimulation pulses controlled by the med-el hardware interface system. the selector switch permits the selection of the electrode configuration when coupled with different med-el systems (eg abi placing system, ants, promstim system). the stimulator box is used outside the sterile patient environment and is intended to be used multiple times. the stimulator box test device is used in the pre-use check of the stimulator box.