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510(k) Data Aggregation

    K Number
    K143670
    Device Name
    ICS CHARTR EP 200 WITH VEMP
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2015-10-23

    (303 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    "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.
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    K Number
    K110286
    Device Name
    GN OTOMETRICS TYPE 1053 FREEFIT
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2011-04-28

    (87 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K083399
    Device Name
    ICS CHARTR EP 200
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2009-02-20

    (95 days)

    Product Code
    GWJ, EWO
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K061791
    Device Name
    FOCUS VNG/ENG TYPE 1068
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2006-07-11

    (15 days)

    Product Code
    GWN
    Regulation Number
    882.1460
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Focus VNG/ENG is a nystagmograph that is intended to measure, record, and display involuntary movements (nystagmus) of the eyeball.
    Device Description
    The Focus VNG/ENG is a PC-based system, which consist of software modules for installation on a PC, an isolation transformer, a hardware platform, a mains adapter, stimulation devices and recording devices. The stimulation and recording devices are connected to the hardware platform, which is connected to the PC via a USB cable - no hardware installation inside the PC is required.
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    K Number
    K061104
    Device Name
    SPEECHLINK 100 TYPE 1053
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2006-05-03

    (13 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpeechLink 100 is a hearing aid calibrator and analysis system that is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid.
    Device Description
    The SpeechLink is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from self-contained software modules installed on a common software platform. The following applications are available: Audio fitting system and Simulator system. The fitting system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC 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 simulator consists of software for installation on a PC and hardware for connection to a PC.
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    K Number
    K033645
    Device Name
    OTOFLEX 100 TYE 1012
    Manufacturer
    GN OTOMETRICS A/S
    Date Cleared
    2004-03-31

    (132 days)

    Product Code
    ETY
    Regulation Number
    874.1090
    Why did this record match?
    Applicant Name (Manufacturer) :

    GN OTOMETRICS A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTOflex 100 type 1012 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.
    Device Description
    The OTOflex system consists of a charger unit, a handheld unit with built-in Bluetooth interface, a probe, a contra earphone, and software for installation on a PC. The probe and contra earphone is connected to the handheld unit. The handheld unit can be operated as a standalone device, as a desktop device when placed in the charger, or as a PC-based system from the software via a Bluetooth radio link. The handheld unit is powered from batteries that are recharged when the unit is placed in the mains powered charger unit and two transducers for contra stimulus presentation are available: Probe and Insert phone.
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