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The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.

The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable. QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible. The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).

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 ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.

ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded 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 ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible. Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station. The ALGO 7i offers hearing screening using AABR technology. 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. Besides that, result information is displayed as PASS/REFER/INCOMPLETE. The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.

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 Ear Probe is intended to be an accessory to auditory testing equipment that use evoked responses (e.g. DPOAE, ABR) to assess hearing function. · The Ear Probe is capable of both generating and recording sounds in the ear canal. · The Ear Probe is intended for use in all ages. The interface to the patient's ear is provided by means of disposable standard eartips, which are available as separate consumables.

The Earprobes EP-DP and EP-TE are passive Transducers, which are used to covert electrical stimulus into acoustical stimulus. The electrical stimuli are provided by otoacoustic emissions devices or auditory evoked responses stimulators (afterwards referred as interfacing instruments). The acoustical stimulus is then coupled into the patient's ear. The probe comprises of four sections: a) Electrical transmission path b) speaker and microphone c) acoustic transmission path d) transducer case

The Ear Probe is intended to be an accessory to auditory testing equipment that use evoked responses (e.g. DPOAE, ABR) to assess hearing function. • The Ear Probe is capable of both generating and recording sounds in the ear canal. · The Ear Probe is intended for use in infants from 34% week (gestational age) up to 6 months of age. The interface to the patient's ear is provided by means of disposable standard eartips, which are available as separate consumables.

The Earprobes EP-DP and EP-TE are passive Transducers, which are used to covert electrical stimulus into acoustical stimulus. The electrical stimuli are provided by otoacoustic emissions devices or auditory evoked responses stimulators (afterwards referred as interfacing instruments). The acoustical stimulus is then coupled into the patient's ear. The probe comprises of four sections: a) Electrical transmission path - b) speaker and microphone - c) acoustic transmission path - d) transducer case a) The electrical transmission path is connected to the interfacing instrument by a connector, which is connected to a shielded cable. The other end of the cable is attached to the microphone and speaker svstem. Within the connector, an EEPROM is placed to store calibration data of the probe and to enable an interfacing device to identify the attached probe. b) Each of the two speakers (in case of EP-DP) or the only speaker (in case of EP-TE) converts the electrical stimulus into an acoustic stimulus. The acoustic stimulus is delivered to the patient's ear by means of the acoustic transmission path. One microphone in the probe is used to pick up the acoustical stimulus (which is delivered by the acoustical transmission path) and convert it to an electrical stimulus. c) The acoustic transmission path is separated for each speaker and microphone. It consists of a silicone sealing which contains the speaker and microphones and connects to the acoustic ducts, which are implemented within the probe tip. The ducts are separated from each other and are used to smooth the acoustic output at the probe tip. Ear tips, which is not part of the probe, are put onto the tip of the probe tip in order to interface to the patient's ear. d) The transducer case is the housing of the speaker and microphone and acts as the bridge between electrical and acoustical transmission path. It also provides means of handling.