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The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes. (Prescription Use).

The MADSEN Zodiac Type 1096 device is designed to measure and evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals at different frequencies and with temporal characteristics. MADSEN Zodiac is a compact device for immittance testing. You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immittance software module, you can operate Zodiac using the PC's keyboard and mouse with the OTOsuite Immittance module acting as the display. MADSEN Zodiac supports the following probes: - The hand-held Quick Check probe - The two diagnostic probe types, Classic and Comfort - A contralateral insert phone or TDH-39. Supported tests: Depending on the configuration, Zodiac supports the following tests and functionalities: - Tympanometry - Reflex Screening - Reflex Threshold - Reflex Decay - ETF-I (Eustachian Tube Function - Intact) - ETF-P (Eustachian Tube Function -Perforated) - Admittance Recording (multiple uses, e.g. patulous Eustachian Tube evaluation, acoustic reflexes with external stimulus) - Manual Tympanometry This is a MODIFIED version of our previous model, the predicate device.

The ICS Impulse System Model 1085 is used in the assessment of the vestibular-ocular reflex (VOR) and nystagmus by measuring, recording, displaying, and analyzing eye and head movements.

The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, USB video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test". The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eye. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. The software also records and displays the information obtained during Positional and Oculomotor tests. A Positional test is performed by moving that patient from one position to another position. In the example of Dix-Hallpike, the patient is sitting and the patient's head is turned 45 degrees to one side and then the patient is moved from the sitting position to the supine position. An Oculomotor test is performed by having the patient stare in various directions or under various environments. In the example of Gaze, the patient is sitting and the patient is asked to stare left, right, up, down or center. The Gaze test can be performed with vision or with vision denied. For both Positional and Oculomotor the goggles collect head and eye data. The accelerometer in the small sensor measures where the head is in space. That information is taken and the patient's head position or any movement during testing is displayed in the software. The high speed camera captures the image of the eye. The OTOsuite Vestibular software processes the eye velocity data (the response). The eye movement is analyzed to determine the slow phase velocities (SPV). The head data is only used during collection to display if the patient's head is moving and to guide the tester to position the patient's head appropriately for the test. This is what we refer to as "Head Position Feedback". Tests where slow phase velocity is measured display the eve position trace and slow phase velocity beats in a graph. In Oculomotor there are 2 tests VOR and Skew Deviation that are not SPV tests. VOR (vestibular ocular reflex) which allows for both visual VOR (VVOR) and VOR suppression (VORS). This test is very similar to the head impulse test but the head movement is slow (0.5 Hz) and small (10 degrees). In VVOR the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a fixed target. In VORS the patient is sitting and the examiner moves the head from side to side (like a sinusoid) while the patient stares at a moving dot projected from the goggle using one of the lasers. The analysis is similar to head impulse, simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not. In Skew Deviation (also known as cover test or alternate cover test) the patient is sitting and the tester covers and uncovers. The OTOsuite Vestibular software measures the eye position trace during the cover and uncover environments and displays an average eye position shift.

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 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.

The ICS Impulse System is used in the assessment of the vestibular-ocular reflex (VOR) by measuring, recording, displaying, and analyzing eye and head movements. (Prescription use).

The device is a combination of hardware and software. The patient wears a pair of lightweight, tightly-fitting goggles on which is mounted a very small, very light, very fast, fire-wire video camera and a half silvered mirror. This transparent mirror reflects the image of the patient's eye into the camera. The eye is illuminated by a low-level infra-red light emitting diode which is not visible to the patients. A small sensor on the goggles measures the head movement. The whole goggle system is lightweight but it must be secured tightly to the head to minimize goggle slippage. The software records and displays the information obtained during what is known as a "head impulse test" The basic head impulse test starts with the tester standing behind the patient who is wearing the goggles. While the patient is asked to stare at the fixation dot placed on a projection surface in front of them, the tester rotates the patient's head horizontally through a small angle (about 10-20 degrees) in a brief, abrupt and unpredictable manner, varying the direction and the velocity. The goggles collect both head and eye data. The gyroscope measures the velocity of the head movement (the stimulus). The high-speed camera captures the image of the eve. The OTOsuite Vestibular software processes the head velocity data and velocity data for eye movement (the response). Simultaneous displays of the data for head movement and for eye movement allow the clinician to determine if the response is within normal limits or not.

The Aurical HIT Type 1082 is intended to be used by audiologists, technicians, and other professionals who perform hearing instrument testing. Used in conjunction with the OTOSuite software, the Type 1082 permits presentation of acoustic sounds and magnetic field stimuli in order to assess the audio processing and telecoil functionality of the hearing instrument.

AURICAL HIT is designed for Hearing Instrument Testing and Coupler-Based Fitting. AURICAL HIT connects via USB to a computer running the OTOsuite software. With the OTOsuite HIT Module one can perform traditional hearing instrument testing according to either the ANSI or IEC test protocols, and obtain a consistent picture of every hearing instrument, regardless of manufacturer or type. With the OTOsuite PMM Module one can perform Probe Microphone Measurements in a coupler for pre-programming and pre-fitting hearing instruments without the client being present. It is easy to position hearing instruments on snap-on couplers inside the AURICAL HIT test chamber and it is easy to access the hearing instruments in the test chamber during test without disturbing the test setup. The battery pill types are recognized automatically, and the reference microphone ensures reliable positioning in the test chamber.

AccuScreen is a portable instrument used to screen infants for hearing loss. The instrument uses the Distortion Product Otoacoustic Emissions (DPOAE), Transient Evoked Otoacoustic Emissions (TEOAE) and Auditory Brainstem Response (ABR) technologies. The instrument is intended for screening infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. Infants should be asleep or in a quiet state at the time of screening. AccuScreen is intended for use by audiologists, ENTs and other health care professionals.

GN Otometrics Type 1077 AccuScreen is a handheld examination system based on Otoacoustic Emissions (OAE) and/or Auditory Brainstem Response (ABR). The Type 1077 AccuScreen is designed to be easy to use, and employs automated OAE and/or ABR tests. The measurement flow is menu-guided and evaluation is based upon signal statistics. The Type 1077 AccuScreen is designed for trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) up to 6 months of age that are well enough to be ready for discharge from the hospital. The Type 1077 AccuScreen OAE system consists of the AccuScreen handheld device, a Docking Station with mains adapter, OAE probe with disposable probe- and ear-tips, and AccuLink software for installation on a PC. When ABR is included an optional ear coupler cable and disposable ear couplers can be included in the system, as well. The AccuScreen handheld device comes in two hardware versions; one for OAE screening only and one for both OAE and ABR screening. Both versions are based on a common hardware platform (printed circuit board), but with different configurations. 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 determine whether or not a hearing loss may be present. When the OAE measurement is a DPOAE measurement, the stimulus signal is while and of two pure tone signals, each presented by a speaker in the OAE probe. When the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe. For automated ABR measurements, the device uses the OAE probe, or an ABR ear coupler cable for providing the acoustical stimulus for the patient. When the ABR ear coupler cable is used, its speakers are inserted in the ABR Ear Couplers, which are then placed over the patient's ear with a biocompatible adhesive gel on the ear coupler rim. The stimulus signal is a series of broadband clicks and the AccuScreen device measures the patient's response as an electrical signal from three electrodes placed on the head of the patient. The measured response is processed by the AccuScreen device using statistics to help determine whether or not a hearing loss may be present. The 1077 Docking Station serves as a means of providing power to charge the rechargeable battery in the AccuScreen handheld device. The Docking Station also provides an interface to an optional label printer or to a PC. The label printer is used for printing test results from the AccuScreen handheld device. The PC is used for transferring patient demographical data to the AccuScreen handheld device and for collecting measurement results from the AccuScreen handheld device by using the AccuLink PC software.

Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing Instrument settings.

The GN Otometrics Type 1053 FreeFit is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from selfcontained software modules installed on a common software platform. The following applications are available: Real ear measurement system (i.e., audio fitting system) and Simulator system. As a real ear measurement system, the Type 1053 FreeFit plays calibrated sound files and measures the sound pressure level in the ear canal. The difference between the measured sound level outside the ear and in the ear canal gives the gain from the hearing aid. This allows for adjusting hearing aids and demonstrating hearing aid features like noise suppression. The Type 1053 FreeFit system also shows target curves that the hearing aid dispenser can use as guidelines for adjusting the hearing aid. The real ear measurement system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC (i.e., OTOsuite Probe Microphone Measurements (PMM)) and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link (i.e. no physical connection to the PC). The FreeFit Neckset is the actual measuring device. It contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. Digital signal processing in form of Fast Fourier Transformations takes place inside the device and the obtained frequency spectra are transmitted to the OTOsuite via Bluetooth. The microphones measuring outside the ear are used for calibrating the sound level. Measurements inside the ear canal (near the eardrum) are conducted with a biocompatible silicone tube guiding the sound waves to the microphone. And the probes contain an o-ring also in biocompatible material for fastening at the ear (pinna). The FreeFit Charger is used to charge the FreeFit neckset via an inductive coil system. The charger includes a power adaptor connected to mains and providing DC input to the charger stand. OTOsuite PMM is a software platform required for measuring with the Type 1053 FreeFit, displaying the results and controlling the played sound files and levels. OTOsuite runs on most windows based PCs. The Type 1053 FreeFit also has the capability to act as a hearing loss simulator and a hearing instrument simulator. These applications are commonly used to demonstrate the level of hearing loss suffered by a patient and the degree to which that loss can be overcome by use of a hearing instrument. The simulator consists of software for installation on a PC (i.e., OTOsuite Counseling and Simulation (C&S)) and hardware for connection to a PC (i.e., headphones). OTOsuite C&S is a software application that is required for simulating hearing loss and hearing instruments as part of the counseling process.

The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

The ICS CHARTR EP 200 is a PC-based svstem, 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 pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required. This submission is for a modification to K083399. The same hardware is used but the software has the additional ASSR (Auditory Steady State Response) feature as implemented on the system described in K031986.

The ICS Chartr EP 200 is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

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 pre-amp, which is connected to the hardware platform, which is connected to the PC via USB cable - no hardware installation inside the PC is required.