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 - 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.

Singapore - English - HSA (Health Sciences Authority)

medel pte. ltd. - ear, nose & throat - the rondo 3 is an audio processor and an external part of the med-el cochlear implant system. the implant system is intended to evoke auditory sensation for: • severely to profoundly hearing impaired individuals who obtain little of no benefit from acoustic amplification in the best aided condition • 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. additionally, the implant system used in combination with the (+)flex24 [2], +flex20, +flex20 w electrode is intended to evoke auditory sensations for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only. the auditory brainstem implant is used for electrical stimulation of the cochlear nucleus via an implanted stimulator and a specially designed electrode array to evoke auditory sensations in patients with non- functional cochlear nerves.

Singapore - English - HSA (Health Sciences Authority)

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

Singapore - English - HSA (Health Sciences Authority)

medel pte. ltd. - ear, nose & throat - the med‑el cochlear implant system 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. additionally, the med‑el cochlear implant system used in combination with the implant variant synchrony 2 pin flex24 and synchrony 2 pin 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. 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.

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

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1200 implant is the implantable part of the med-el cochlear implant system and can only be used together with compatible med-el external components. the device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. also included in this system is an implant template that replicates the outline of the corresponding implant. the med-el cochlear implant system 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony +flex24 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony +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. 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.

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

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1200 pin implant is the implantable part of the med-el cochlear implant system and can only be used together with compatible med-el external components. the device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. also included in this system is an implant template that replicates the outline of the corresponding implant. the med-el cochlear implant system 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony pin +flex24 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony pin +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. 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.

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

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1250 implant is the implantable part of the med-el hearing implant system and can only be used together with compatible med-el external components. the device consists of a stimulator, a coil with a removable magnet within its center, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. also included in this system is an implant template that replicates the outline of the corresponding implant. the med-el cochlear implant system 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony 2 flex24 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. additionally, the med-el cochlear implant system used in combination with the implant variants synchrony 2 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. 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.

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

med-el implant systems australasia pty ltd - 35643 - stimulator, electrical, auditory, cochlea - the mi1250 pin is the implantable part of the med-el hearing implant system and consists of a stimulator, a coil with a removable magnet within its centre, a reference electrode, an eap reference electrode and an active electrode permanently attached to the stimulator. it features titanium fixation pins to secure the placement of the implant for stability. the corresponding implant template is provided with the mi1250 pin. the med-el cochlear implant system 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. additionally the med-el cochlear implant system used in combination with the implant variant synchrony 2 pin flex24 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. additionally, the med-el cochlear implant system used in combination with the implant variants synchrony 2 pin 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. 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.

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

boston scientific pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - momentum el dual chamber icd combines ventricular tachyarrhythmia therapy with ventricular and atrial pacing and sensing. cardioversion or defibrillation therapies include a range of low- and high- energy shocks using a biphasic waveform; and a choice of multiple shock vectors. this device is intended to provide ventricular antitachycardia pacing (atp) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.