Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi pello is intended to be used for the identification and etiology of hearing loss in patients of any age. it is intended to be used by an audiologist, ent, hearing healthcare professional, or trained technician in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in ansi s3.1 or equivalent.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - can be used as part of an audiometric test battery. it can be used to assess the status of cochlear function. it can be used to enable estimation of behavioral hearing threshold by evoking auditory brainstem response (abr) or steady state brainstem response (ssep). it can be used to aid in the detection of lesions in the auditory pathway. it can be applied to neonates, infants, children and adults

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi 18 audiometer is a single channel, pure tone, air conduction, portable instrument designed to provide basic audiometric screening capability for physician's office, schools and industry.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the audioscreener oae and abr may be used for patients of all ages, from newborn infants through adults. the distortion product otoacoustics emission (dpoae), transient evoked otoacoustics emission (teoae), and auditory brainstem response (abr) tests are indicated for use in screening individuals for hearing loss for whom behavioral audiometric responses are deemed to be unreliable, such as in infants, young children, and uncooperative or cognitively impaired adults.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - gsi 39 is an audiometric screening product. it offers basic pure tone audiometry and tympanometry with reflex. the gsi 39 is also an audiotory impedance tester that is intended to change air pressure in the external auditory canal and measure and graph the mobility characteristic of the tympanic membrane to evaluate the functional conditions of the middle ear.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi audiostar pro audiometer is intended to be used for the identification and etiology of hearing loss in patients of any age. it is intended to be use by an audiologist, ent, hearing healthcare professional, or trained technician in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in ansi s3.1 or equivalent. the gsi audiostar pro is intended to be used for the purposes of determining patient hearing sensitivity. it is intended to quantify the patient's level of hearing by presenting pure tones stimuli through specific transducers at different frequencies and at different sound pressure levels. gsi amtas pro software is intended to be used to obtain diagnostic audiometric data through a gsi audiometer. it is intended to be used for routine clinical testing in any environment in which pure-tone audiometry and speech recognition testing is performed.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi corti oae test instrument is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (oaes).

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi tympstar pro is intended to be used for the measurement of acoustic impedance/admittance and otoacoustic emissions within the human external ear canal. these measures are useful in the evaluation, identification, documentation and diagnosis of ear disorders. the gsi tympstar pro is intended to be used by an audiologist, ear nose and throat physician (ent), hearing healthcare professional, or trained technician. gsi tympstar pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment.

Singapore - English - HSA (Health Sciences Authority)

hearlife pte. ltd. - ear, nose & throat - the gsi allegro is intended to be used for the measurement of acoustic impedance/admittance within the human external ear canal. these measures are useful in the evaluation, identification, documentation and diagnosis of ear disorders. the device is intended to be used on patients of any age.

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

adler ortho australia pty ltd - 35661 - acetabulum prosthesis - the cross-linked pe/pe insert is fitted into the acetabular cup (acetabular shell) and is blocked inside the cup through a locking system present of the acetabular cup in the same group size with which the insert is coupled (i.e. equatorial teeth). it is available in different internal diameters and it articulates with the ceramic femoral head or the co-cr femoral head of the same internal diameter of the insert, permitting to restore the physiological motion of the hip joint. the cross-linked pe/pe insert is designed to be used in total hip arthroplasty (tha), as an articulating surface, and to interface with a ceramic femoral head or a co-cr femoral head, after insertion into an acetabulum prosthesis shell (acetabular cup).