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This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

OtoNova is a compact, portable battery-powered electronic device which records physiological responses to sound for the purpose of hearing testing. It Is controlled wirelessly from a local controlling device. OtoNova has two hardware variants: OtoNova and OtoNova Pro. Both the OtoNova and OtoNova Pro devices have been directly engineered from Otodynamics' currently marketed Otoport OAE+ABR device, retaining all the testing algorithms of the Otoport OAE+ABR device. The primary aim of the development was to physically separate the control console from the testing device while maintaining the same performance and effectiveness. Like the predicate Otoport OAE+ABR device, both OtoNova devices can record two different physiological indicators of a functioning auditory system's peripheral response to sound namely a) Otoacoustic emission (OAEs), which are small sounds made by the inner ear in response to acoustic stimulation, and b) Auditory brainstem responses (ABRs) are tiny electrical signals emanating from the auditory brainstem in response to sound. Automatic recognition of an ABR response is referred to as AABR. During ABR or OAE testing, low-level sounds are delivered to the ear. The responses to multiple presentations of these sounds (either acoustic or electrical responses) are recorded digitally and added together to enhance repeated responses with respect to the random/ noise signals that are always present. The averaged signal is automatically analysed by the device to identify and quantify true physiological response component and to assess the degree of noise contamination. This allows the quality/ accuracy of the recording to be determined for evidence of response validity. The processed data is reported to and displayed on the controlling device.

The Otoport Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening. Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery. The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required. Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.

hearOAE is intended to be used by hearing healthcare professionals in the audiologic evaluation and documentation of ear function and ear disorders using Transient Evoked Otoacoustic Emissions (TEOAEs) and Distortion Product Otoacoustic Emissions (DPOAEs). The target population for the hearOAE includes all ages.

Per 21 CFR 874.1050, the hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission technologies. The hearOAE device may be configured to support one or any combination of TEOAE or DPOAE. Otoacoustic Emission devices are class II medical devices. hearOAE consists of three main components listed below: - hearOAE Application (available on supported Android devices supplied by i hearX) - hearOAE Codec - hearOAE Probe The hearOAE Application: - is operated on an Android smart device that uses Bluetooth connectivity to communicate with the hearOAE Codec. - enables the user to choose and set up testing protocols for both TEOAE and DPOAE. - enables the checking of the probe functionality, namely "Probe Check". - controls the start and stop of a TEOAE and DPOAE test including pre-test functions such as Probe Check and in-ear calibration. - provides feedback during and after the test in the form of tables, figures, and graphs. The hearOAE Codec: - consists of hardware and software for generating the test signals and measuring the responses. - has the ability to generate, measure and process signals. - contains a rechargeable lithium-ion battery to power the device. - uses three light indicators to provide a visual display of the status of the hearOAE Codec to the user. A push button (signified by a Power symbol) is located on the case of the hearOAE Codec to allow the user to switch it on or off. - communicates the test results via Bluetooth to the hearOAE smart device which will be displayed on the Smart device screen to the user within the application. The hearOAE Probe: - houses the speakers (drivers), and a microphone that produces the test stimuli and measures the sound pressure level (SPL) present in the ear canal. - has a removable probe coupler with ear tips which fit onto the probe coupler.

Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only), Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.

Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. These accessories can be connected to Sentiero based on a special plug, which holds the information about the connected transducer / cable. Therefore, the firmware can make use of this information and adapt the measurement procedures accordingly or provide information to the user via its display. Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple. 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 (if available for the test method). Besides that, wave forms and result information are displayed for the user's evaluation. The patient/test data can be transferred from the device to a PC via a USB connection and the accompanied data management and archiving software MRA. Patient/test data on the PC software can be password- protected so that unauthorized access is prohibited. Compared to the original 510(k) submission of the Sentiero in its predicate state, the Sentiero now offers a VEMP test module. Vestibular evoked myogenic potential (VEMP) is a short latency muscle reflex driven by otolithic organs that play a major role for detecting the orientation, static balance and linear acceleration of the head. Vestibular dysfunctions arise from various different regions along the vestibular pathway. Vestibular neuritis, vestibular schwannoma, multiple sclerosis or Meniere's disease will be indicated by the decrease or absence of VEMP responses.

The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE includes all ages. The Lyra with TEOAE is intended for use in the audiologic evaluation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages. The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

The device is audiometric equipment used for assisting of inner ear abnormalities. Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. The PC software provides a user interface designed to integrate in the standard Microsoft Windows environment. Lyra can be purchased with various licenses allowing you to perform different hearing screening tests. Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. Transient otoacoustic emissions (TEOAE) technology uses a short duration stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.

The GSI Corti series is indicated for testing of cochlear function in infants, children and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal-hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAEs. is an indication that the outer hair cells are vidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40 dB HL). The majority of hearing-impaired individuals will be identified by a simple OAE test.

Corti test system provides rapid measurement and documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies. The system consists of the instrument, probe, printer, single-use eartips replaceable probe tubes and other accessories. The Corti instrument contains the hardware and software for generating the test stimuli, measuring and displaying the OAEs, and storing the results until they are printed. The plastic housing contains circuit boards that provide the signal processing and display the test results. The instrument also contains a rechargeable lithium-ion battery to power the device. The instrument uses a liquid-crystal display (LCD) and three light-emitting diodes (LEDs) to provide a visual display of test status to the operator. Four push buttons located on the keypad of the device allow the user to control testing and printing, and to reset test protocols. The Probe houses the speaker and microphone which produce test stimuli and measure the sound pressure level (SPL) present in the sealed ear canal. Interface of the instrument to the ear canal is accomplished through disposable eartips, which fit onto the probe tube. The disposable eartips are color coded to facilitate easy selection by size. Distortion Product Otoacoustic Emissions (DPOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at the frequency 2f1-f2. The Corti instrument generates a series of test tones, directs them into the ear canal, and then measures the level of the DPOAE tone generated by the cochlea. By using different test frequencies, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies. Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a series of wideband clicks. The Corti instrument generates a series of clicks, directs them into the ear canal, and then analyzes the spectrum of the returning signal, separating the noise and emission. By using band pass filters, the Corti device provides an estimate of outer hair cell function over a wide range of frequencies

The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages. The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages. The Sera™ with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Sera with ABRIS is newborns. The Sera™ System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.

The device is audiometric equipment used for assisting of inner ear and auditory brainstem abnormalities. Sera™ features a touch-screen display and user-friendly software in a compact hardware design. Sera™ can be purchased with various licenses allowing you to perform different hearing screening tests. Sera™ uses auditory brainstem response (ABRIS) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity. Auditory brainstem response (ABRIS) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.

The GSI Novus is intended to be used for the measurement and automated analysis of auditory evoked responses (auditory brainstem responses, ABR) and/or otoacoustic emissions (distortion product, DPOAE and transient evoked, TEOAE). These measures are useful in the screening evaluation, documentation and diagnosis of auditory and hearing related disorders. The auditory evoked response (ABR) measurement is intended for newborns and infants up to 6 months of age. The otoacoustic emissions (DPOAE and/or TEOAE) measurement is intended for use in patients of all ages. The GSI Novus is intended to be used by a healthcare professional such as an ENT doctor, nurse or audiologist or by a trained technician under the supervision of a professional. The device is intended to be used in a hospital, clinic, or other facility with a suitable quiet testing environment.

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities. Novus features a touch-screen display and user-friendly software in a compact hardware design. Novus can be purchased with various licenses allowing you to perform different hearing screening tests. Novus uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity. The EEG is processed and analyzed automatically using the Novus's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned. Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment. The Novus consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth® communication with a label printer for the purpose of printing screening results.

The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages. The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age. The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities. easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests. easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity. The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned. Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment. The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth communication with a label printer for the purpose of printing screening results.

The iHearTest is an air-conduction over the counter hearing screener for profiling your hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. Hearing test results are displayed on the computer screen and stored in our HIPAA-compliant remote server for review anytime using secure online access.

The iHearTest is an over the counter (OTC) hearing screener for profiling hearing ability based on guidelines by the World Health Organization (WHO). The iHearTest is intended for home use by adults of at least 18 years of age. The iHearTest Software System consists of: The iHearUSB device for connection to a personal computer via USB port. Factory calibrated in-ear earphones, marked for right and left ears, with 3 tip sizes. iHearTest software application. Instructions and warranty information provided in the User Guide and online. A quick Install guide to assist in the initial software installation, registering the USB device, and initiating the iHearTest. The iHearTest Software System requires a standard personal computer (PC) with USB port running Microsoft Windows or OS X. The iHearTest software application is a browser-based software application executed from the consumer's personal computer that provides the user interface for a hearing screening test on the PC's monitor, controls the output of test sound signals from an iHearUSB device connected to the PC's USB port, displays hearing test results and sends the results to a remote HIPAA compliant server for review anytime by the consumer using secure online access, and conducts periodic checks of earphone calibration via the calibration tool incorporated into the iHearUSB device. The iHearTest kit is designed to produce air-conducted sounds via the in-ear earphone within the supra-threshold range of 25-85 dB HL at test frequencies of 500, 1000, 2000 and 4000 Hz. The iHearTest software application prompts the user to respond to test sounds and determines the individual's hearing level at each test frequency. The user's overall hearing ability is then computed and displayed for both the right and left ear with a recommendation for potential hearing aid use as per WHO guidelines. The iHearUSB device incorporates a microphone for sensing the background noise during the hearing screening process, and ensuring that the background noise is within an acceptable level range.