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SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, visual, and vestibular evoked myogenic potential data, as well as providing nerve stimulation and monitoring. The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual, and vestibular) and in surgical procedures for inter-operative nerve monitoring. The SmartEP system is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.

The SmartEP device records evoked potentials by using delivery of auditory, somatosensory, visual, or nerve sensory stimuli and using signal averaging techniques to extract the evoked potential from the uncorrelated electrical activity of the brain (electroencephalography or EEG) and muscles (electromyography or EMG). The device has options for Auditory Evoked Potentials (AEPs), Somatosensory Evoked Potentials (SEPs), Visual Evoked Potentials (VEPs), Vestibular Evoked Myogenic Potentials (VEMPs), and nerve stimulation and monitoring. The SEP, VEP, and nerve stimulation and monitoring functionality. operating principles, and intended uses are the same as on the predicate SmartEP device. On the SmartEP device with VEMP modality, the AEP modality has been modified to facilitate VEMP recording and analysis with optional biofeedback. The VEMP features added are comparable to those found in the ICS Chartr 200 predicate device. The VEMP modality does not provide a diagnosis. Diagnosis is made by a medical professional. The SmartEP device is a Windows OS personal computer (PC) based system composed of software modules, an external main hardware unit, an optional biofeedback box, and peripheral stimulus delivery and recording components and accessories. The biofeedback box, stimulation, and recording devices are connected to the main hardware unit which is connected to the PC via a Universal Serial Bus cable. Software on the computer is used for the user interface to facilitate test parameter specification and for data display and analysis purposes. The SmartEP with VEMP device has an optional biofeedback hardware accessory (VEMP feedback box) or uses a computer monitor for indicating EMG levels during VEMP testing. The VEMP feedback box has LEDs that indicate that the measured EMG level is either below the minimum value set by the user (Low - orange LED), or is between the minimum and maximum values set by the user (Satisfactory green LED), or is above the maximum value as set by the user (High – orange LED). The computer monitor displays a bar graph and pictorial face that indicates that the measured EMG level is either below the minimum value set by the user (Low - small pink bar and sad face), or is between the minimum and maximum values set by the user (Satisfactory - medium green bar and happy face), or is above the maximum value as set by the user (High - large pink bar and sad face). Recording of VEMPs can be set to occur when the EMG level is within the user programmed satisfactory range.

The SmartScreener-Plus2 device is indicated for use in the recording and automated analysis of human physiological data (auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearingrelated disorders. The device is especially indicated for use in the screening of infants to determine hearing loss. Sites appropriate for use include the well-baby nursery, neonatal intensive care unit (NICU), mother's bedside, outpatient clinic, audiologist's office, or doctor's office. The device is simple to operate. It does not require special technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how to operate it. The SmartScreener-Plus2 device can be used for patients of all ages, from children to adults, including infants and geriatric patients. It 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 possible anatomical sites of contact are the patient's ear, ear canal, and/or external skin surrounding the ear (with the contact object being a sound delivery eartip, headphone cushion, or an acoustic ear coupler such as a circumaural ear cup, intra-aural ear bud, or supra-aural ear patch), the patient's head (with the contact object being a bone vibrator), and the patient's head, nape of the neck and shoulder (with the contact object being electrodes that are capable of measuring biopotentials). The SmartScreener-Plus2 device is for prescription use.

The SmartScreener-Plus2 is a noninvasive device used to test for hearing and related neurological abnormalities. The device is especially indicated for use in the screening of infants to determine hearing loss. The SmartScreener-Plus2 device records and detects auditory evoked potentials (AEPs) and otoacoustic emissions (OAEs) which are generated in response to a series of auditory stimuli delivered to the patient. AEPs are electrical signals produced by the patient's nourological activity and are picked up by electrodes attached to the patient's skin. The portion of the AEP that originates from the anatomical structures of the inner ear to the auditory brainstem is commonly called the Auditory Brainstem Response (ABR). Otoacoustic emissions are acoustic signals produced by the patient's inner ear and are picked up by a sensitive microphone located in an OAE probe. The SmartScreener-Plus2 device is capable of recording Transient Evoked OAEs (TEOAEs or TrOAEs), and Distortion Product OAEs (DPOAEs) The SmartScreener-Plus2 uses advanced signal processing technology to separate AEPs and OAEs from background noise and other physiological activity. The device uses proven statistical algorithms to automatically determine if there is an AEP or OAE response present to the auditory stimuli delivered to the patient. A user, with device administrator approved password security clearance, is able to set the output level of the stimulus. AEP stimulus levels between 30 to 40 dB nHL, and TEOAE stimulus level of 85 dB SPL, and DPOAE stimulus levels of 65 and 55 dB SPL are commonly used for newborn hearing screening applications. The SmartScreen-Plus2 device is simple to operate. It does not require any special technical skills or interpretation of results. Basic training is sufficient to learn how to use the device.

The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.

The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device. The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.

SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring. The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory, visual) and in surgical procedures for inter-operative nerve monitoring.

SmartEP is an evoked response system that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation/monitoring. The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for somatosensory evoked potential, visual evoked potential, and nerve stimulation testing to the previously FDA cleared indications for auditory evoked potential testing. Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, and to provide nerve stimulation/monitoring functionality.

The IHS TM-Wick Electrode is intended for non-invasive use in acquiring electrocochleography (ECochG) data on patients of all ages, for the purpose of monitoring and recording in the diagnosis of cochlear and auditory disorders. The electrodes are biocompatible, non-sterile, single patient use, disposable devices.

IHS TM-Wick Electrodes are non-invasive, cutaneous devices used in the acquisition of electrocochleography (ECochG) signals from the tympanic membrane for the purpose of monitoring and recording. These extra-tympanic electrodes are inserted into the ear canal to make contact with the tympanic membrane for acquiring the ECochG data. The electrodes are biocompatible, non-sterile, single patient use, disposable devices. The IHS TM-Wick Electrode is a non-invasive, TM ECochG electrode which is biocompatible, prewired, non-sterile, for single patient use, and disposable. The electrode features a fine Silver/Silver Chloride (Ag/AgCl) wire attached to a soft cotton tip (i.e., wick) pre-soaked in a highly conductive, low impedance electrode gel/saline solution, which is hypoallergenic, non-irritating, bacteriostatic, water soluble, non-staining, and non-gritty. The conductive gel reduces the impedance of the contact between the electrode surface and the skin. The Ag/AgCl wire is encased inside of a thin, soft, flexible silicone tubing which is resilient, stretchable, non-corrosive, and inert. This tubing's small size and characteristics provide for ease of insertion and removal, as well as patient comfort and safety. The other end of the Ag/AgCl wire is permanently adhered to an electrode cable lead wire. The solder joint is then covered by a heat shrink tubing so as not to allow exposure of the lead wire, as well as to provide strain relief. The electrode cable lead is terminated on the opposite end using two industry standard 1.5mm (0.06in) molded DIN safety socket connectors, which are subsequently used to interface to the monitoring device. For electrical safety, these connectors do not allow accidental connection to an A/C wall electrical outlet.

The intended use of the Smart USBLite device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages.

Smart USBLite is an auditory evoked potential and otoacoustic emission system that is capable of recording and measuring auditory evoked potential, otoacoustic emission, and auditory steady-state evoked potential data. The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

The intended use of the Opti-Amp DC-Powered is as a physiological signal amplifier. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

Opti-Amp DC-Powered is a bio-amplifier testing device (made up of a transmitter and receiver) that is capable of acquiring evoked potentials.

The intended use of the SmartEP-ASSR product is for the recording of auditory steadystate evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders and as an adjunctive tool in the estimation of behavioral hearing thresholds.

SmartEP-ASSR is a auditory evoked potential testing device that is capable of measuring auditory steady state responses (ASSR).

The intended use of the SmartTrOAE device is to measure otoacoustic emissions, which allow the operator to get information on cochlear function without requiring a subjective response from the person being tested with the device. It is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

SmartTrOAE is an otoacoustic emissions testing device that is capable of measuring transient and spontaneous otoacoustic emissions produced by the inner ear.

The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

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