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

ge healthcare australia pty ltd - 35368 - stimulator, evoked response, auditory - this device is a stimulator intended to produce an adequate stimulus to stimulate the auditory system. it can be used, e.g. for evoked response measurement or electroencephalogram (eeg) activation.

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

ge healthcare australia pty ltd - 35373 - stimulator, evoked response, visual - this stimulator is intended to apply a photic stimuli, e.g. shifting patterns, to patient?s eyes. this stimulator typically presents either light to the eye through an optical system (optical stimulator) or light is viewed directly from an illuminated screen (direct- view stimulators). most visual stimulators are used as a component of several other devices, e.g. refractors, scanning ophthalmoscopes, visual evoked potential recorders, or electroretinographs.

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

ge healthcare australia pty ltd - 35373 - stimulator, evoked response, visual - this device is intended to be a stimulator that applies a photic stimuli, e.g. shifting patterns, to patient?s eyes. this stimulator typically presents either light to the eye through an optical system (optical stimulator) or light is viewed directly from an illuminated screen (direct- view stimulators). most visual stimulators are used as a component of several other devices, e.g. refractors, scanning ophthalmoscopes, visual evoked potential recorders, or electroretinographs.

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

cochlear ltd - 35643 - stimulator, electrical, auditory, cochlea - the intended purpose of the nucleus ci422 cochlear implant with staright electrode is the restoration of hearing sensation via electrical stimulation of the auditory nerve to subjects with moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies, suitable for adults and children over the age of 12 months.

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

cochlear ltd - 35643 - stimulator, electrical, auditory, cochlea - the nucleus 24 cochlear implant ci24re(st) is intended to restore a level of auditory sensation via electrical stimulation of the auditory nerve in adults and children. the cochlear implant is part of a system, connected to a receiver-stimulator that is implanted in the skull near the ear, and a speech processor that is worn externally which converts sound into electrical signals to be transmitted to the receiver-stimulator.

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

cochlear ltd - 35643 - stimulator, electrical, auditory, cochlea - the nucleus 24 cochlear implant ci24re(ca) is intended to restore a level of auditory sensation via electrical stimulation of the auditory nerve in adults and children. the cochlear implant is part of a system, consisting of an implant, connected to a receiver-stimulator that is implanted in the skull near the ear, and a speech processor that is worn externally which converts sound into electrical signals to be transmitted to the receiver-stimulator.

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

cochlear ltd - 35368 - stimulator, evoked response, auditory - restoration of hearing sensation via the digital processing of sound to deliver through a cochlear implant electrical stimulation of the auditory nerve.

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

cochlear ltd - 35368 - stimulator, evoked response, auditory - restoration of hearing sensation via the digital processing of sound to deliver through a cochlear implant electrical stimulation of the auditory nerve.

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

emergo asia pacific pty ltd t/a emergo australia - 35729 - stimulator, electrical, neuromuscular, diagnostic - disposable monopolar stimulating probe intended for ionm (intraoperative neurophysiological monitoring).

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

cochlear ltd - 35643 - stimulator, electrical, auditory, cochlea - the cochlear implant model ci512 with pedestal is prescription only, single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. the cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve. the cochlear implant is intended for use in: adults 18 years of age or older who have bilateral, pre, peri, or postlinguistic sensorineural hearing impairment and obtain limited benefit from appropriate binaural hearing aids. these individual have moderate to profound hearing loss in the low frequencies and profound (?90 db hl) hearing loss in the mid to high speech frequencies. limited benefit from amplification is defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided listening condition) on tape-recorded tests of open set sentence recognition, children, 12 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate limited benefit from appropriate binaural hearing aids, children, two years of age or older may demonstrate severe to profound hearing loss bilaterally. in younger children, limited benefit is defined as lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six month period. it is recommended that limited benefit be quantified on a measure such as the meaningful auditory integration scale or the early speech perception test. in older children, limited benefit is defined as ? 30% correct on the open set multisyllabic lexical neighborhood test (mlnt) or lexical neighborhood test (lnt), depending upon the child?s cognitive and linguistic skills. a three to six month hearing aid trial is recommended for children without previous aided experience.