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The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a "normal" or "abnormal" determination. If the decision is "abnormal", the software can make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and may be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.

The Hearing Healthcare (HHC) Pro is software designed to be used by healthcare providers (HCP) either trained and experienced in hearing, audiology, or otology, such as Ear, Nose, and Throat (ENT) doctors or not, such as primary care providers. The HHC Pro software is not intended to make a clinical diagnosis. The HHC Pro software is a screening product. The software aggregates the inputted data and determines whether the person's hearing is considered normal or abnormal. If the results are abnormal, the software can either provide a recommendation for further clinical consultation with a licensed physician with expertise in Ear, Nose and Throat (ENT), or allow for an ENT-trained physician to enter their own recommendation in a blank text field. Further, the software can distinguish between symmetrical and asymmetrical sensorineural hearing loss; the former would be recommended to see an audiologist or an otolaryngologist who works with an audiogist, the latter would be recommended to an ENT clinical specialist. The HHC Pro software compiles the hearing information previously available to physicians, classifies the data as normal or abnormal with respect to any measureable hearing loss, and identifies the presence of asymmetric hearing results. dB Diagnostics has chosen to validate the algorithm determining the difference between the symmetry and asymmetry of hearing loss as a greater that 20 dB difference between two ears at any test frequency (which are 250, 500, 1000, 2000, 6000, and 8000 Hz). The health care provider uses the HHC Pro to enter hand-held tympanometry results, limited clinical history, and limited physical examination findings, including a Rinne tuning fork test at 512Hz, to further identify patients who would benefit from an ENT evaluation. The HHC Pro device comprises the HHC Pro Software. With the HHC Pro Software, dB Diagnostic Systems distributes the Amplitude T4 audiometer or the OTOpod audiometer, both manufactured by Auditdata A/S and collectively known as a "digital audiometer", a 512Hz Rinne tuning fork, and the Microsoft Surface Pro tablet preloaded with the Microsoft Windows 10 operating system and the HHC Pro Software. An Amplivox Otowave 102 Tympanometer may also be distributed with the HHC Pro software.

The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a "normal" or "abnormal" determination. If the decision is "abnormal", the software will make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and is intended to be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.

The Hearing Healthcare (HHC) Pro is software designed to be used by healthcare providers (HCP) not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The HHC Pro software is not intended to make a clinical diagnosis. The HHC Pro software is a screening product. The software aggregates the inputted data and determines whether the person's hearing is considered normal or abnormal. If the results are abnormal, the software provides a recommendation for further clinical consultation with a licensed physician with expertise in Ear, Nose and Throat (ENT). The HHC Pro software compiles the hearing information previously available to physicians, classifies the data as normal or abnormal with respect to any measureable hearing loss, and identifies the presence of asymmetric hearing results. The health care provider uses the HHC Pro to enter hand-held tympanometry results, limited clinical history, and limited physical examination findings, including a Rinne tuning fork test at 512Hz, to further identify patients who would benefit from an ENT evaluation. The HHC Pro device comprises the HHC Pro Software. With the HHC Pro Software. dB Diagnostic Systems distributes the Auditdata/Otovation Amplitude T4 audiometer manufactured by Auditdata A/S, a 512Hz Rinne tuning fork, and the Microsoft Surface Pro 4 tablet preloaded with the Microsoft Windows 10 operating system and the HHC Pro Software. An Amplivox Otowave 102 Tympanometer may also be distributed with the HHC Pro software.

The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflex audiometry.

The touchTymp is an auditory impedance analyser. The device 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. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers.

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 Interacoustics AT235 Impedance Audiometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry, acoustic reflex and air conduction audiometry.

AT235 is an auditory impedance analyser. The device 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. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The uncomfortable loudness level is useful when providing rehabilitative amplification methods and determining the correct management process for the patient. The AT235 also includes basic audiometry functions. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator (There are no interpretations of results in the device). The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers

The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.

The Otowave 202 relies heavily on long-established practice in the clinical area of middle-ear measurements, and implements tympanometer functionality in a small desk-top device that may be powered from the mains (via a d.c. adapter) or by internal batteries. Stimuli are applied to the patient by means of a probe mounted on a flexible connecting lead for ease of use (especially with neonates) and additional contralateral stimuli are available if required via a separate plug-in transducer. Operation is via an intuitive menu-driven user interface, with test data displayed on the integral screen and capable of download to a PC via a USB connection and to a printer via an infrared communications (IrDA) interface. Tympanometers work by measuring the admittance of the tympanic membrane while the pressure in the ear canal is varied. The admittance is at a maximum when the air pressure across the tympanic membrane is balanced.

Sentiero is a portable instrument to diagnose all ages or hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as: · Distortion Product Otoacoustic Emissions (DPOAE) · Transient Evoked Otoacoustic Emissions (TEOAE) · Auditory Brainstem Response (ABR) · Auditory Steady State Response (ASSR) · Auditory Impedance and acoustic reflex (TYMP) Additionally if offers standard audiometry (psycho-acoustical). All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the function of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists. pediatricians. ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician. Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other 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 designed for: 1. Diagnostics, monitoring and follow-up after newborn hearing screening 2. Pre-school, school, and adult hearing screening 3. ENT diagnostics based on measurement of a) Otoacoustic emissions b) Tympanometry and acoustic reflex c) Auditory Brainstem Responses d) Auditory Steady State Responses Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer.

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. All connectors and transducers have a special 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 Sentiero instrument can be connected flexibly to different kind of transducers while enabling the instrument to 'know' the features of the connected transducer. This information is used within the different modules (test methods which are configured) to guide the user (feedback via display) and help to ensure correct performance of the test methods. Sentiero is available in two different models: handheld or desktop version. The desktop version is labeled Sentiero (Type Desktop). Both versions are standalone examination platforms and can be connected to a personal computer (PC) via USB for data review and management. The handheld version is portable and is meant to be mainly used as mobile device. The desktop version is portable as well but is meant to be mainly used as stationary device. Both models base on a common hardware platform (printed circuit board, PCB) but with different configurations. Materials in contact with humans are selected to be biocompatible. 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 of modules described in the following intended use. The measurement application is controlled from a self-contained firmware (software installed on the instrument). 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 is displayed for the user's evaluation.

The Inventis Middle Ear Analyzers, Flute and Viola, are intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The Inventis Middle Ear Analyzers are intended for use on individuals six months of age or older. Flute is a tympanometer. Viola is a combination of audiometer and tympanometer, which reduces the amount of necessary equipment.

Flute is stand-alone tympanometry / reflex diagnostic device. Viola is a stand-alone combined unit, integrating a screening middle ear analyzer and a diagnostic audiometer capable of performing air and bone conduction threshold and speech exams. Flute and Viola are available with or without the integrated thermal printer.

The Titan Impedance System is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. The Titan Impedance System measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance, reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume. These measures allow the evaluation of the functional condition of the middle and outer ear. The Titan Impedance System is suitable for all populations including new-born infants. The Titan Impedance 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 instrument is audiometric equipment used for measuring aural acoustic impedance and admittance (According to ANSI S3.39). The Titan is a platform with multi functions depending of licensing. The license function for this submission is IMP440 (IMP) for measurement of aural acoustic impedance and admittance. The Titan IMP test 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. The IMP test function is already cleared by FDA 510(k) premarket notification K083861 (04/09/2009) The instrument is a diagnostic/clinical instrument (as defined in IEC60645-5), but provides normative data for guidance. Titan consists of a handheld unit named Titan, Titan Cradle (cleared by FDA 510(k) premarket notification K083861) and PC software (Titan Suite/IMP440). The measurements are controlled by the handheld unit. A connection box (shoulder box) enables different types of accessories to be connected to the platform The Titan platform can connect to PC software via a Bluetooth connection.

The ER35 ERO•SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex.

The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions, tympanic membrane performance, and acoustic reflex. Test information is stored in memory, displayed on a graphic LCD, and can be printed by a printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices.