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Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.

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The Integrity V500 with DPOAE and TEOAE test options is indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function by measuring, recording, and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation. DPOAE and TEOAE tests do not measure hearing per se, but measure whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria. The Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

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The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation. The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria. The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.

Vivo 200 DPS™ Version 2.0 is a diagnostic system that assists clinical professionals in the assessment and screening of cochlear function. The device includes a probe with a disposable tip that fits in the patient's ear canal. The probe contains a tiny speaker for stimulating the patient's ear with sound and a microphone for receiving low-volume otoacoustic emissions (OAEs). The probe is connected to a probe adaptor circuit that generates the acoustic stimuli and amplifies the OAE responses. The probe adaptor circuit initiates stimulus delivery under the control of a dedicated notebook computer. The notebook computer reads the response from the probe adaptor and processes the signal digitally to measure and detect the OAE signal level, estimate the noise and display the results. The Vivo 200 DPS™ Version 2.0 probe adaptor is capable of producing stimuli and eliciting Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). TEOAEs are produced by the cochlea in response to short duration click sounds. DPOAEs are produced in response to two continuous pure tones that are close to each other in frequency. The Vivo 200 DPS™ Version 2.0 software contains digital signal processing algorithms for measuring and detecting responses to both types of OAEs. The DPOAE and TEOAE responses are acquired and detected using the same probe. probe adaptor circuit and computer interface. The stimuli for both types of OAEs use the same probe, amplification circuitry and computer interface but utilize different modules in the probe adaptor circuit to generate their respective waveforms. Software running on the notebook computer under the Windows XP™ operating system incorporates a graphical user interface that allows the user to configure the OAE test protocol, initiate and stop the test, print, save and review test results, and store patient information.