Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - ear, nose & throat - the hearing aid is intended to amplify and transmit sound to the ear. indications for minirite / minirite t: bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a slight (16 db hl) to profound (95 db hl) degree of hearing loss, with an individual frequency configuration. indications for bte / bte pp: bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a slight (16 db hl) to severe (85 db hl) degree of hearing loss, with an individual frequency configuration. meant for adults and children older than 36 months. tinnitus soundsupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program.

Singapore - English - HSA (Health Sciences Authority)

demant singapore pte ltd - ear, nose & throat - the hearing aid is intended to amplify and transmit sound to the ear. for bilateral or unilateral impaired hearing of sensorineural, conductive, or mixed type ranging from a slight (25 db hl) to severe (80 db hl) degree of hearing loss, with an individual frequency configuration. meant for adults only.

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

oticon medical a division of audmet australia - 44796 - clinical measurer, ruler - the ruler is a reusable instrument to be used when installing the implant components of oticon medical bone anchored hearing system, intended to measure the soft tissue thickness and provide indication for choice of abutment length.

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

oticon medical a division of audmet australia - 12143 - tray, instrument - the oticon medical sterilization cassette is intended to organize and protect non-disposable medical device instrumentation during handling and use in hearing health care surgery. it is intended to be sterilized and stored with non-disposable medical device instrumentation. the sterilization cassette is intended to be used in conjunction with a legally marketed sterilization wrap in order to maintain sterility of the enclosed instruments until use. the sterilization cassette is intended for washing, either manually or in an automated process in a washer disinfector, and for sterilization in a pre-vacuum steam sterilizer (min. three pulse, standard) utilizing either of the following cycles: temperature 132?c (270?f) ? exposure time 4 minutes minimum ? dry for 20 minutes minimum. temperature 134-137?c (273-278?f) ? exposure time 3 minutes minimum ? dry for 16 minutes minimum.

Nigeria - English - NAFDAC (National Agency for Food and Drugs Administration and Control)

microphant, receiver, amplifer, battery-compartment m - 1- 0 switch hook

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

oticon medical a division of audmet australia - 46638 - craniofacial bone screw, non-biodegradable - the ponto implant is anchored (osseointegrated) to the skull bone behind the ear and connected to a skin penetrating abutment in order to retain a sound processor and transmit bone conduction vibrations from the sound processor directly into the cochlea.

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

oticon medical a division of audmet australia - 61745 - head-worn bone-conduction hearing aid base plate - hearing aid accessories are intended to be used in combination with the sound processor.

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

oticon medical a division of audmet australia - 34180 - hearing aid, bone-anchored - the ponto bone anchored hearing system is designed to give patients improved hearing through direct bone conduction. the ponto sound processor converts sound into vibrations that are transmitted via an abutment and implant (or softband/headband/testband) through the skull bone directly to the cochlea.

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

oticon medical a division of audmet australia - 12440 - marker, - the sound processor indicator is inteded to be used to mark the correct implant position on the skin.

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

oticon medical a division of audmet australia - 13369 - retainer, bandage - the healing cap is intended to hold a dressing in place after bone anchored surgery.