Search Results

The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function. The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. The AuDX Pro system includes optional software selections distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations. The test consists of measuring and recording transient (clickevoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing pure tones. The same ear probe is used for both types of tests. For transient otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes appear on the LCD display on the front of the AuDX Pro unit. For distortion product otoacoustic emissions (DPOAEs), the DPOAE and noise floor amplitudes appear on the LCD. A pass or refer result is assigned at the end of the test based on a comparison of the patient's OAE response to normalized data. Additionally, a graphic display of the data is presented on the LCD allowing users to view and/or analyze the results. The data collected by the AuDX system can be sent to a host computer where it can be saved or placed in a database. Optional Natus software programs are available for that function. Natus software programs provide a mechanism for users to define their own specific test protocols and download them to the AuDX Pro device. The AuDX Pro Otoacoustic Emissions Measurement System expands upon the capabilities of the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function [K111618]. The AuDX Pro System provides the following enhancements over the AuDX System: - Protocol Setup utilities to load expanded frequency protocols to the AuDX Pro: - Options to upload data to a PC based Patient and Test Information Database (P&TI); - Options to graphically review data from a PC based Hearing Assessment & Tracking System (HATS) software utility linked with the P&TI Database; and. - A Graphical User Interface (GUI) on an enhanced LCD screen for testing, patient information, and data review.

The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests. Scout Sport is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function. The device can be used for patients of all ages, from infants through adults, to include geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests. The Scout Sport Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the Scout Sport system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters. DPOAE I/O is a software option. The standard DPOAE test measures otoacoustic response to a series of frequencypairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The DPOAE I/O software option enables the Scout Sport device user to perform DPOAE testing at different stimulus intensities in order to obtain the DPOAE Input / Output (I/O) function for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE response. The functionality of the Scout Sport system has been enhanced by addition of the following Scout software program modules: the Patient and Test Information database (P&TI), the BLReports application, and additional peripheral software utilities. The Patient and Test Information database (P&TI) is used to store, display, and manage patient and test information records. The database stores the following: - Patient demographic information such as Patient Name, . Patient ID, Doctor Information, and comments; and, - Test demographic information such as ID. Test Dates. . and Test Results The standalone BLReports application provides customizable reporting for Scout. The Scout application must invoke BLReports directly, passing the data necessary to create and use report templates. The report templates are made up of template components that can be added, modified or removed by the user. The additional peripheral software utilities consist of the Feedback utility and the database Repair utility. The Feedback utility enables users to create an archive containing recent logs, databases, registry data and system information to be copied on a CD and provide to Natus Technical Support to assist in troubleshooting. The database Repair utility enables the repair and compaction of databases.

The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.

Master II Evoked Response System is a Windows® based software application for use with the Navigator Pro hardware platform using Auditory Steady State Response Modality for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of audiovestibular and hearing related disorders.

1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs. 2 The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses. 3. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants. 4. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.

The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/SleepScan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological data relating the electrical activity of the brain, by attaching multiple electrodes at various locations on the body. The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients. The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Netlink Traveler patient connection module (headbox) consists of a molded plastic enclosure approximately 5.75 x 3.9 x 1.75 in size and weighing approximately 1 lb. The Netlink Traveler can be configured to perform up to 40 channel data recordings, having 32 AC channels, and an external 8 DC channels (oximetry, body position, etc.), and additional special channels. Power to the box is supplied by an internal battery, and an external medical-grade power supply/charger may also be connected. There are two primary modes of operation: "Ambulatory Mode" (no power or Ethernet) where data is stored to internal flash memory and "Headbox Mode" (data communicated to host computer via Ethernet). External power is not required in Ambulatory Mode because the Netlink Traveler always derives its power from the battery. However, connecting the Netlink Traveler to external power supply/charger is recommended when longer tests are required in order to extend battery capacity. The AC channel electrodes are connected to safety touch-proof jacks on either of the 2 optional electrode connection accessories, the quick-disconnect box and the Netlink Traveler Electrode Block. These are connected to the Netlink Traveler box via a 68-pin cable and connector. The DC channels connect on a separate 8-pin connector. Other connectors (Ethernet, photic strobe out, Netlink) are located on the side of the Netlink Traveler box. The Netlink Traveler consists of a digital board, an analog board and an LCD display board. The analog board is very similar in function to the analog board marketed in the Netlink Predicate Device. This board provides signal amplification and conversion of the data from the 32 channel electrodes to digital. The 68-pin electrode array connector allows the use of existing patient connection hardware, such as the 32-channel electrode connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The Electrode Block may be configured for several arrays and is especially designed to be worn comfortably by the patient. The digital board contains a microprocessor along with program and data memory, and provides control functions for reading and processing of the analog data, converting it to digital, and communicating it to the host computer and/or to the compact flash memory card. Additional features of the Netlink Traveler include the color LCD display to facilitate functions such as electrode impedance collection, setup and impedance features.

The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

The Bio-logic Insert Earphones are transducers that convert electrical stimulus, provided by the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and display of human physiological data for auditory testing purposes and to assist in determining possible auditory and hearing-related disorders. The predicate device referenced above is the latest in a series of systems of this type marketed by Bio-logic. The Navigator Pro Evoked Potential Predicate Device performs ABR recording functions with two channels of simultaneous data recording. The software for the Navigator Pro implements the standard Auditory Brainstem Response (ABR) functions common to most similar systems on the market for many years. One of these functions is the testing for auditory nervous system abnormalities but these measures are only effective once the abnormality has sufficiently progressed so as to affect a large number of fibers in the auditory nerve. The Stacked ABR for Navigator Pro device provides software additions to the Predicate Device for the purpose of displaying ABR activity affecting a subset of the nerve. These additional features include automated masking, filtering and data manipulation functions, which allow the observation of ABR test results for frequency band subsets of the nerve fibers in addition to the fibers as a whole.

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities.

The Bio-logic Auditory Evoked Potential (AEP) family of products is used for the recording, display, computation, and manipulation of human physiological data, for auditory screening purposes and to provide assistance in the neurological assessment and treatment of auditory sensory disorders. The predicate device referenced above is the latest in a series of complete systems of this type marketed by Bio-logic. The Navigator Pro Evoked Potential Predicate Device performs Auditory Brainstem Response (ABR) recording functions with two channels of simultaneous data recording. The software for the Navigator Pro implements the standard ABR functions common to most similar systems on the market for many years. The standard ABR test works on the basis of repeating a stimulus-response cycle. An auditory stimulation (click, tone, etc.) is presented to the patient through the use of an earphone or headphones. The EEG response from the brain is read through the use of one or more scalp electrodes placed on the patient. The response time of interest is approximately from 1 - 20 milliseconds following the stimulus. The response voltage readings for this time period are amplified, digitized and stored in the AEP system computer's memory. The stimulation is then repeated, the EEG response is read again, and this cycle is repeated many times. Each time the response is read, it is averaged together with all previous responses. The final data record is the result of averaging several thousand (usually 2000-3000) responses. This averaging process is necessary because the ABR signal is very small, much lower in voltage than the surrounding EEG "noise" present in the recording. The noise is averaged out over the many readings, because the noise will have a very low average net value. The result from the averaging process will be the signal. The reason for this 510(k) is that the software for the host computer (PC) in the Evoked Potential system has been modified. The host computer software for the Predicate Device is DOS-based, whereas the host software for this modified Bio-logic AEP program is WINDOWS-based. The WINDOWS program has the same features and functionality as that of the predicate device, but with improved user interfaces and overall ease-of-use. The functions of the hardware are the same as those of the Predicate Device (Navigator Pro) hardware. The host computer software for control of the hardware has the same functionality as that of the DOS-based Predicate Device software. Direct hardware control of all Navigator Pro functions is provided from the Digital Signal Processor (DSP) and its program code located inside the Navigator Pro module, instead of directly from the host computer program. (There are no changes to the DSP program code in the Navigator Pro module as a result of this host computer software modification.) By distributing the hardware-specific functions to the DSP, the Windows-based host computer program has fewer real-time demands, and performance and reliability are improved. Together, the hardware and software implement the same functionality and perform the same intended use as the Predicate Device, but with improved ease-of-use and flexibility for the user.

The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies. Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The predicate device referenced above is the latest in a series of diagnostic systems of this type marketed by Bio-logic. Other related diagnostic devices in the Evoked Potential family include: - 510(k) #K803226 Bio-logic Evoked Response Stimulators. 1. - 510(k) #K842543 Bio-logic Evoked Potential System. 2. - 510(k) #K844992 Bio-logic Portable Evoked Response System. 3. - 510(k) #K862690 -- Bio-logic Traveler LT System. 4. - 5. 510(k) #K930328 - Navigator and Traveler Evoked Potential Product. The predicate device, the Bio-logic Evoked Potential system with Navigator Pro hardware, performs Evoked Potential recording and analysis functions, including up to 2 channels of data recording and numerous diagnostic protocols and modalities. This new MASTER Evoked Potential with Navigator Pro device performs many of these same functions in essentially the same ways with a one-channel version of the same hardware, but employs a new software application package with significant new capabilities over those of the predicate device. Through the use of the Auditory Steady State Response (ASSR) modality, which is a variant of the MLR / 40 Hz test modality used in the referenced systems already on the market, hearing threshold levels can quickly and reliably be determined based on physiological rather than behavioral means. The Auditory Steady State Response test is an alternative to tone burst Auditory Brainstem Response (ABR) testing which is used to predict frequency-specific behavioral hearing thresholds particularly for patients who cannot provide a reliable behavioral response. The ASSR technique avoids one of the inherent pitfalls of the tone burst ABR technique which is the problem of "spectral splatter" (distortions in frequency-specific data due to the start/stop actions of the tone burst) of the short duration acoustic stimulus that is required for ABR measurement. The ASSR technique uses a continuous frequency and/or amplitude modulated tone as the stimulus and can combine several stimuli together simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus. Thus, assessment of the response spectrum can yield information about the presence of the response to stimuli of varying intensities in order to determine the response threshold. ASSR thresholds have a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence and degree of hearing loss. The MASTER application software is a modification of software originally designed by and exclusively licensed from researchers at the Rotman Research Institute, Baycrest Centre for Geriatric Care, at The University of Toronto. This software was designed originally for research purposes, and Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety (e.g. presentation of prolonged, intense acoustic stimuli), to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified in terms of operation and information display so that only the relevant operations and data are available. More complex functions that do not have clinical relevance were eliminated from the software. This system will be used to assist in defining the configuration of the hearing loss particularly in populations that are difficult to test using traditional behavioral audiometry. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic QAE and EP Systems 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 results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Biologic OAE and EP families of products is to be performed under the prescription and supervision of other trained health care professional.

The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub. The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub. The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.