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The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.

VEMP (Vestibular Evoked Myogenic Potential) is a short latency response generated either from sternocleidomastoid muscle (cVEMP) or oblique muscle (oVEMP) which is typically evoked by high level acoustic or vibratory stimulation. VEMP is a non-invasive test that is used for diagnosis of vestibular disorders such as superior canal dehiscence, Menier's disease, vestibular neuritis, and, among others. VEMP test can be done in clinics (ENT/audiology) and hospitals provided that the users have adequate knowledge and background about underlying process of VEMP and recording auditory evoked responses. The Integrity V500 is indicated for auditory evoked potential testing. "Integrity with VEMP" (this submission) is the addition of the VEMP test modality to the Integrity V500. The Integrity V500 is an auditory evoked auditory system response and Integrity with VEMP is an auditory evoked vestibular system response. Since the vestibular system is connected to the auditory system, a loud stimulus to the auditory system also simultaneously stimulates the vestibular system. However, the evoked signals are measured at different electrode sites. It is important to note that the methods of stimulation and data acquisition are the same for the VEMP modality as for the ABR modality (one of the Integrity V500's auditory evoked testing modalities), with differences being in electrode montage and patient's physical state. As such, it is possible to also get a VEMP response while testing in the Integrity V500's ABR modality. Integrity with VEMP is a PC based device which uses the same hardware and similar software for evoking the stimulus, collecting the response, processing the data, and displaying the outcome on the screen as does the Integrity V500. The hardware used are: a VivoLink (patient interface device), air and bone conduction transducers (to stimulate the vestibular system), CV-Amp (bio-amplifier), and a computer. The response from the muscle is picked up by a bio-amplifier attached to the neck (for cVEMP) or under eyes (for oVEMP) and forehead with electrodes. The data is the VivoLink for pre-processing and then transferred to the PC via Bluetooth connection for full processing using the algorithm designed for VEMP processing. Through the test, the processed sweeps are filtered using the filter setting defined by the user and the averaged response is shown on the screen. The primary diagnostic component of a VEMP measurement is the comparison of the amplitude of the primary peak of the VEMP response between right and left sides, defined as an asymmetry ratio, where a significant amount of asymmetry is indicative of a vestibular disorder. The amplitude of the vestibular response peaks is also dependent on the contraction level of the muscles involved in the recording. To minimize the muscular response biasing the result, it is important to have equal contraction levels for both sides; this is especially physically challenging to generate equivalent neck contractions needed for cVEMP. To overcome this issue, two key features were added to the Integrity with VEMP compared to Integrity V500: a biofeedback EMG monitor (which displays real-time muscular activity) and VEMP response normalization (scaling based on muscular contraction levels). The EMG monitors can be used as a guidance to the clinicians and patients for the level of muscle contraction. Normalization automatically scales the recorded sweeps based on the energy of the corresponding EMG which helps to compensate for imbalance contraction from the two sides.

The ALGO Pro Newborn Hearing Screener is a mobile, noninvasive instrument used to screen infants for hearing loss. The screener uses Automated Auditory Brainstem Response (AABR®) for automated analysis of Auditory Brainstem Response (ABR) signals recorded from the patient. The screener is intended for babies between the ages of 34 weeks (gestation age) and 6 months. Babies should be well enough to be ready for discharge from the hospital, and should be asleep or in a quiet state at the time of screener is simple to operate. It does not require special technical skills or interpretation of results. Basic training with the equipment is sufficient to learn how to screen infants who are in good health and about to be discharged from the hospital. A typical screening process can be completed in 15 minutes or less. Sites appropriate for screening include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

The ALGO® Pro is a fully automated hearing screening device used to screen infants for hearing loss. It provides consistent, objective pass/refer results. The ALGO Pro device utilizes Auditory Brainstem Response (ABR) as the hearing screening technology, which allows the screening of the entire hearing pathway from outer ear to the brainstem. The ABR signal is evoked by a series of acoustic broadband transient stimulus (clicks) presented to a subject's ears using acoustic transducers and recorded by sensors placed on the skin of the patient. The ALGO Pro generates each click stimulus and presents to the patient's ear using acoustic transducers attached to disposable acoustic earphones. The click stimulus elicits a sequence of distinguishable electrophysiological signals produced as a result of signal transmission and neural responses within the auditory nerve and brainstem of the infant. Disposable sensors applied to the infant's skin pick up this evoked response, and the signal is transmitted to the screener via the patient electrode leads. The device employs advanced signal processing technology such as amplification, digital filtering, artifact rejection, noise monitoring and noise-weighted averaging, to separate the ABR from background noise and from other brain activity. The ALGO Pro uses a statistical algorithm based on binomial statistics to determine if there is a response to the stimulus that matches to the ABR template of a normal hearing newborn. If a response is detected that is consistent with the ABR template derived from normal hearing infants (automated auditory brainstem response technology, AABR), the device provides an automated 'Pass' result. A 'Refer' result is automatically generated if the device cannot detect an ABR response with sufficient statistical confidence or one that is consistent with the template.

The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.

The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable. QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible. The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).

The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.

ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded plug-in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible. Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station. The ALGO 7i offers hearing screening using AABR technology. The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics. Besides that, result information is displayed as PASS/REFER/INCOMPLETE. The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.

The Audera Pro is intended to be used for the stimulation, recording and measurement of auditory evoked potentials, vestibular evoked myogenic potentials, auditory steady state responses and otoacoustic emissions. The device is indicated for use in the evaluation, identification, documentation and diagnosis of auditory and vestibular disorders. The device is intended to be used on patients of any age. The Audera Pro is intended to be used by qualified medical personnel such as an audiologist, physician, hearing healthcare professional, or trained technician. The Audera Pro is intended to be used in a hospital, clinic, or other healthcare facility with a suitable quiet testing environment. The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's scalp and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for vestibular evoked myogenic potential (VEMP) testing are the patient's ear canal (with the contact object being a sound delivery eartip or headphone, or an ear probe and eartip) and the patient's head and neck and possibly other body sites (with the contact object being a bone transducer or electrodes that are capable of measuring bio-potentials). The anatomical sites of contact for otoacoustic emission (DPOAE, TEOAE) testing are the patient's ear canal (with the contact object being an ear probe and eartip).

The device is a configurable platform used to aid in the screening and diagnosis of sensory-neural and hearing conditions. It is capable of performing the following procedures: Auditory Evoked Potentials (EP), Auditory Steady-State Response (ASSR), Distortion Products Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE), and vestibular evoked myogenic potentials (VEMP). The device system consists of a laptop PC with Windows 10 Pro, placed on top of or beside a specialized hardware implementation interface (i.e. platform) for the procedures. Software in the laptop controls the specialized hardware and collects and analyzes the resulting signals. Transducers and various accessories connect to the specialized hardware via connectors on the back of the hardware package.

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 Eclipse with VEMP (Vestibular Evoked Myogenic Potential) is intended for vestibular evoked myogenic potential testing to assist in the assessment of vestibular function. The target population for Eclipse with VEMP includes patients aged from 8 years and up. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

The Eclipse with VEMP is audiometric equipment intended to perform various Otoacoustic Emissions (OAEs) and Auditory Evoked Potential evaluations. The Eclipse is operated solely from PC based software modules. The Eclipse platform performs the physical measurements. The protocols are created in the software modules. The Eclipse consists of a hardware platform, a preamplifier, stimulation transducers and recording electrodes. VEMP evaluations are tests of the vestibular portion of the inner ear and acoustic nerve, evoked with an auditory stimulation. The evoked response results in a potential recorded from the sternocleidomastoid (neck) muscles or the inferior oblique (eye) muscles. VEMP is not a test of the neck or eye musculature directly; the clinician is interested in the vestibular anatomy which triggers the response. The cervical Vestibular Evoked Myogenic Potential (cVEMP) is an evoked potential measured from the sternocleidomastiod (SCM) muscle and the ocular VEMP (oVEMP) is an evoked potential measured from the inferior oblique muscle. Both tests are used to assess the otolith organs (saccule and utricle) of the vestibular system and their afferent pathways and assist medical practitioners in the diagnosis of various balance disorders. Summary: VEMP is Auditory Evoked Potentials like ABR obtained using any commercially available EP system. The addition of the VEMP module to Eclipse will make it possible for clinicians to conduct VEMP tests while using EMG (electromyography) monitoring and scaling. The VEMP function of the Eclipse with VEMP does not make a diagnosis. It only assists the medical professional.

The ICS Chartr EP 200 with VEMP is indicated for auditory evoked potential testing as an aid in assessing hearing loss and lesions in the auditory pathway. The Vestibular Evoked Myogenic Potential is indicated for vestibular evoked potential testing as an aid in assessing vestibular function in adult patients. The device is to be used only by qualified medical personnel with prior knowledge of the medical and scientific facts underlying the procedure.

"Vestibular Evoked Myogenic Potentials (VEMPs) are short latency electromyograms (EMGs) evoked by high level acoustic stimuli recorded from surface electrodes over the tonically contracted sternocleidomastoid (SCM) muscle." Akin FW & Murnane OD (2001). The ICS Chartr EP 200 with VEMP is used to test the auditory and vestibular functions of children and adults in a hospital, in an Ear, Nose and Throat Clinic or in an Audiology office. The ICS Chartr EP 200 system measures evoked potentials from the patient using repeated auditory stimuli and averaging EEG or EMG activity in order to abstract the response from the noise resulting in an analysis of the auditory/vestibular system functions. The ICS Chartr EP 200 is a PC-based system, which consists of software modules for installation on a PC, an isolation transformer, a hardware platform, pre-amp, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the preamp, which is connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required. The PC and hardware platform are powered from the isolation transformer which is powered from the mains. One added item as compared to the standard EP200 is the VEMP monitor. The Chartr EP (USB) VEMP monitor assesses the level of tonic EMG and displays if the level is adequate or inadequate. The monitor light will display the following based on the EMG level: Low (blue) -EMG level is below the Min value- Good (green) - EMG level is between Min value and the Max value - High (amber) - EMG level is above the Max value Summary: VEMP is an evoked potential (EP) just like ABR obtained using any commercially available EP system. The unique feature with the ICS Chartr EP 200 is the ability to perform EMG monitoring during VEMP data collection. The VEMP function of the EP 200 does not make a diagnosis. The diagnosis is made by a medical professional.

The Echo-Screen III hearing screener models are based upon otoacoustic emission (OAE) and auditory brainstem response (ABR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present. The Echo-Screen III product family consists of handheld, automated OAE and ABR based hearing systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The Echo-Screen III devices are intended to be used by trained personnel in a medical or school environment. The Echo-Screen III models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.

The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies. The device represents the next generation of the Echo-Screen product line with key enhancements over the previously cleared predicate Echo- Screen T, TA, TD, TDA, TC [K013977], hereinafter referred to as the Echo-Screen T series; specifically, use of the Android operating system, programming upgrade to C and Java languages, addition of a color screen and built-in full hardware keyboard plus icons and on-screen touch keyboard, optional barcode scanner, Li-ion rechargeable battery, and inclusion of a docking station for battery charging and data transfer.

The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders. Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module 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 adults. Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age. When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals.

The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests: AccuScreen TE (TEOAE), AccuScreen DP (DPOAE), AccuScreen TE/DP (TEOAE and DPOAE), AccuScreen ABR (ABR), AccuScreen ABR/TE (ABR and TEOAE), AccuScreen ABR/DP (ABR and DPOAE), AccuScreen ABR/TE/DP (ABR, TEOAE and DPOAE). The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device. For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present. When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.