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WO2013183009A2 - Système de dépistage de la détérioration auditive - Google Patents

Système de dépistage de la détérioration auditive Download PDF

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Publication number
WO2013183009A2
WO2013183009A2 PCT/IB2013/054624 IB2013054624W WO2013183009A2 WO 2013183009 A2 WO2013183009 A2 WO 2013183009A2 IB 2013054624 W IB2013054624 W IB 2013054624W WO 2013183009 A2 WO2013183009 A2 WO 2013183009A2
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WO
WIPO (PCT)
Prior art keywords
electrodes
head frame
head
electrode
screening
Prior art date
Application number
PCT/IB2013/054624
Other languages
English (en)
Other versions
WO2013183009A4 (fr
WO2013183009A3 (fr
WO2013183009A9 (fr
Inventor
Nitin SISODIA
Pragun GOYAL
Mayank Kumar
Rakesh LODHA
Ramesh Agarwal
Shouri Chatterjee
Gita HANDA
Ritu KAMAL
Pushkar V INGALE
Original Assignee
Secretary, Department Of Biotechnology
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Secretary, Department Of Biotechnology filed Critical Secretary, Department Of Biotechnology
Publication of WO2013183009A2 publication Critical patent/WO2013183009A2/fr
Publication of WO2013183009A3 publication Critical patent/WO2013183009A3/fr
Publication of WO2013183009A9 publication Critical patent/WO2013183009A9/fr
Publication of WO2013183009A4 publication Critical patent/WO2013183009A4/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/12Audiometering
    • A61B5/121Audiometering evaluating hearing capacity
    • A61B5/125Audiometering evaluating hearing capacity objective methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316Modalities, i.e. specific diagnostic methods
    • A61B5/369Electroencephalography [EEG]
    • A61B5/377Electroencephalography [EEG] using evoked responses
    • A61B5/38Acoustic or auditory stimuli
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6803Head-worn items, e.g. helmets, masks, headphones or goggles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6814Head

Definitions

  • the present invention relates to the field of hearing impairment screening and in particular to a hearing impairment screening system having fast screening test for neonates.
  • Congenital hearing loss is the most common disorder at birth. The ability to hear is also essential in developing language. A child develops significant auditory perception skills before the age of six months. However, it may take four years before he starts to speak clear sentences. In certain cases, a child may suffer from congenital hearing impairment which can have devastating, detrimental impact on their development. Early detection and intervention can save the child from speech and linguistic loss, can avoid cognitive impairment and difficulties in education and employment.
  • AABR Automated Auditory Brainstem response
  • Auditory evoked potential are very small electrical voltage potentials originating from the brain recorded from the scalp in response to an auditory stimulus (such as different tones, speech sounds etc.) the AEPs that are recorded from the top of the head originate from structures within the brain (e.g. the auditory cortex, the auditory brain stem structures, the auditory VIII cranial nerve). They are very low in voltage: from 0.1 microvolt to 1 microvolt. Their low voltage combined with relatively high background electrical noise requires the use of highly sensitive amplifiers and computer averaging component.
  • test time which comprises subject preparation, data acquisition and algorithm time is prohibitively high in many contemporary devices which hinders their widespread use in non-institutional setups such as vaccination camps due to demand-supply inequality.
  • the present invention provides a system which enables the hearing testing to be achieved very quickly and accurately.
  • the present invention allows hearing test to be performed in the brief periods when an infant is sleeping and allows many infants to be tested in a short time.
  • the present invention significantly reduces the time for screening.
  • the test time is reduced by reducing time to place the electrode.
  • the placement of electrodes is crucial in deciding the time it takes to test the baby.
  • the placement of electrodes involves positioning of electrode at the right place and position stability of electrodes in one place.
  • the present invention electrode system helps the caregiver to position the electrode accurately and in less time and provides better position stability to it.
  • the impedance is reduced and balanced by providing contact stability, effectively increasing the electrode surface area.
  • the present invention relates to a hearing impairment screening system having fast test screening for neonates.
  • the system comprises of a head frame (17) having microphone (13), audio transducer and at least three surface electrodes, a signal amplification unit (10), a signal filtering unit (11), an analog to digital converter (12) and fed to a digital processing and control unit (15).
  • a display unit (16) can display the ABR in digital format which can be evaluated by an expert.
  • the head frame (17) which comprises of integrated speaker and at least three electrodes to get a good contact on the above forehead (on the vertical axis) and on mastoid behind the ear (horizontal axis) and a convenient point on the baby which provides a good ground source on the body to detect waveform recordings.
  • the head frame of the system enables quick and stable positioning of the electrodes, reduced length of the connecting wires from the electrodes to the signal amplification unit (10) reduces the impedance, and the loop formed between inverting electrode with ground and non- inverting electrode with ground being same balances the impedance which reduces the noise.
  • This system provides pillow- shaped head frame, head frame with extendable electrodes, head frame with adjustable electrodes, head frame which fits different head sizes, head frame shaped as flexible bands and caps.
  • Figure 1 is a block diagram of one of the embodiments of the present invention.
  • Figure 2 is the ABR signal acquired from the preferred embodiment of the present invention.
  • FIG. 3 shows disposable electrodes of prior art.
  • Figure 4 shows reusable electrodes of prior art and messy placement of such electrodes in prior art.
  • Figure 5 shows pillow shaped head frame as one of the embodiment of the present invention.
  • Figure 6 shows head frame with extendable electrodes and integrated speakers in one of the embodiment of the present invention.
  • Figure 7 shows head frame with adjustable electrodes in one of the embodiment of the present invention.
  • Figure 8 shows head frame which fits different head sizes in one of the embodiment of the present invention.
  • Figure 9 shows knob adjustment (modification) details in head frame to fit different head sizes in one of the embodiment of the present invention.
  • Figure 10 shows head frame as flexible bands and flexible caps with flexible electrodes in one of the embodiment of the present invention.
  • Figure 11 shows detail structure of head frame with extendable electrodes and integrated speaker.
  • Figure 12 shows electrode of the present invention which are worn on the fingers and enables healthcare provider to control the impedance value by applying pressure and changing position of his fingers.
  • Figure 13 shows complete device configuration as one of the embodiment of the present invention.
  • the present invention relates to a hearing impairment screening system having fast test screening for neonates.
  • the system comprises of a head frame (17) having microphone (13), audio transducer and at least three surface electrodes, a signal amplification unit (10), a signal filtering unit (11), an analog to digital converter (12) and fed to a digital processing and control unit (15).
  • a display unit (16) can display the ABR in digital format which can be evaluated by an expert.
  • the head frame (17) which comprises of integrated speaker and at least three electrodes to get a good contact on the above forehead (on the vertical axis) and on mastoid behind the ear (horizontal axis) and a convenient point on the baby which provides a good ground source on the body to detect waveform recordings.
  • the head frame of the system enables quick and stable positioning of the electrodes, reduced length of the connecting wires from the electrodes to the signal amplification unit (10) reduces the impedance, and the loop formed between inverting electrode with ground and non- inverting electrode with ground being same balances the impedance which reduces the noise.
  • the present invention provides a system which enables the hearing testing to be achieved very quickly and accurately.
  • the present invention allows hearing test to be performed in the brief periods when an infant is sleeping and allows many infants to be tested in a short time.
  • This system provides pillow- shaped head frame, head frame with extendable electrodes, head frame with adjustable electrodes, head frame which fits different head sizes, head frame shaped as flexible bands and caps.
  • a hearing impairment screening system having fast test screening for neonates comprising:
  • a head frame (17) comprising a microphone (13) for providing auditory stimulus, an audio transducer (14) and at least three surface electrodes placed above forehead on vertical axis and on mastoid behind the ear on horizontal axis and on a convenient point on the baby for providing ground source on the body and said surface electrodes sense auditory brainstem responses (ABR in response to the auditory stimulus;
  • ABR auditory brainstem responses
  • processing control unit for receiving the digitized signals from analog to digital converter and processing these signals to enhance signal-to-noise ratio by averaging method
  • any one or more of units selected from signal amplification unit (10), signal filtering unit (11), analog to digital converter (12), processing control unit (15) and display unit (16) can be housed in the head frame (17) of the system.
  • Figure 1 of the present invention illustrates a block diagram of auditory impairment screening system.
  • the system comprises of a data acquisition unit and an auditory stimulus device.
  • a processing and control unit is connected to the data acquisition unit and the auditory stimulus device.
  • the processing and control unit may further be connected to a user interface unit which can comprise of a display unit.
  • the head frame (17) comprises of a microphone (13) for providing auditory stimulus, an audio transducer (14) and at least three electrodes which are placed above forehead on vertical axis and on mastoid behind the ear on horizontal axis and on a convenient point on the baby for providing ground source on the body and said surface electrodes sense auditory brainstem responses (ABR in response to the auditory stimulus.
  • the surface electrodes sense signals which are in response to the auditory stimulus provided by a microphone (13) placed in the subject's ears.
  • various stimulus types like click, tone, chirp, pip etc. are used to generate responses, but click evoked Auditory Brainstem Response (ABR) is generally considered as a standard.
  • ABR Auditory Brainstem Response
  • a click sound stimulus is repetitively applied to subject's ears through a transducer earphone. Screening ABR requires 3 to 27 minutes of testing.
  • the head frame (17) records a very weak signal from the surface electrodes.
  • the signals are fed to a signal amplification unit (10) for amplification.
  • the signals are then filtered by a signal filtering unit (11) to remove any background noise and those signals which are not applicable to the ABR such as power line noise and RF noise.
  • These analog signals are then digitized by an analog to digital converter (12) and fed to a digital processing and control unit (15).
  • ABR elicited by a single acoustic stimulus has very small amplitude. It cannot be detected in the presence of huge EEG background noise which also is recorded from the scalp electrodes.
  • averaging method is implemented in the digital processing and control unit (15). In this method a large number of stimuli are applied in a short period of time, and the post stimulus responses are averaged synchronously to enhance signal-to-noise ratio. As the interfering EEG noise has random characteristics, its contribution become smaller and smaller with progressive averaging.
  • the preferred embodiment described herein could be used to acquire ABR response of patients by placing the electrode system onto the head and connecting it to the ABR acquisition hardware.
  • the digital processing and control unit (15) helps in processing and representation of ABR in digital format.
  • a display unit (16) can display the ABR in digital format which can be evaluated by an expert.
  • the resultant ABR can be sent to an expert over a communication channel.
  • a report can be generated which will help the specialist to re-analyze the subjects hearing condition.
  • the present invention uses a signal acquisition system, and an application with reduced processing time, that saves time, requires less skill and expertise to detect hearing loss in newborns in a resource constrained environment
  • the screening ABR utilizes click stimuli ranging from 70 db to 35 db and below.
  • At least three surface electrodes are placed to get a good contact on the above forehead (on the vertical axis) and on mastoid behind the ear (horizontal axis) and a convenient point on the baby which provides a good ground source on the body to detect waveform recordings generated by the auditory brainstem response to the click stimuli.
  • the characteristics of the waveform (morphology, latency, energy, spectral information) are compared to normal or analyzed independently for the presence of brainstem evoked signal. Delayed or absent waves suggest a neurologic or cochlear deficit.
  • the system is easy to clean, and the system can be dis-assembled and re-assembled again.
  • head frame is shaped as pillow-like structure
  • the speaker is integrated in the pillow structure which provides the stimuli and there will be flexible electrodes which can get attached to the forehead mastoid and earlobe of the subject.
  • the head frame is pillow shaped and the head frame provides stability to the baby' s head, stable positioning of the electrodes and reduced motion artifacts.
  • This pillow frame comprises of hardware electronics assembled inside the pillow structure.
  • any one or more of units selected from signal amplification unit (10), signal filtering unit (1 1), analog to digital converter (12), processing control unit (15) and display unit (16) can be housed in the head frame (17) of the system.
  • this pillow shaped head frame with electrodes provides cushion and is comfortable to neonates. A small display unit will give indication about the impedance match and starting/completion of the test.
  • Figure 5 shows pillow structure embodiment of the present invention.
  • head frame is provided with extendable electrodes and integrated speaker.
  • the mechanism will allow it to extend or compress.
  • the electrodes system is integrated with the speaker.
  • the surface electrodes of the head frame are extendable, at least one electrode (top electrode) is capable of extending to come on forehead and said electrode is flexible to be pressed on the forehead.
  • At least two electrodes are extendable to the earlobes.
  • There are two extendable clips shown in figure 6 which can be clipped to the earlobes. These two clips will act as electrode, it is very easy to apply them and maintain their stability while conducting the test.
  • This unit may also enclose hardware/ software or combination of hardware and software electronics.
  • Figure 6 shows head structure with extendable electrodes and integrated speakers of the present invention.
  • the electrodes are extendable and spring action or any other suitable mechanism makes it fit different head sizes.
  • Figure 11 shows detail structure of head frame with extendable electrodes and integrated speaker. Hence, the electrodes can comfortably fit to different head sizes of the neonates which save time, efforts and require less skill while conducting hearing impairment screening test.
  • head structure is provided with adjustable electrodes.
  • the head frame is having groove for the movement of the surface electrodes.
  • the electrodes will move along the grove to adjust to different head sizes and also the get the best impedance match.
  • the top unit which is compact in size and comprises of hardware/ software or combination of hardware and software electronics.
  • the display and processing is performed by a wireless display unit and data is transmitted via bluetooth or other means.
  • Figure 7 shows head structure with adjustable electrodes in one of the embodiment of the present invention.
  • head frame is able to fit different head sizes.
  • Figure 8 shows head structure which fits different head sizes in one of the embodiment of the present invention. As shown in figure 8, knobs are provided to change the pressure of the sensor and grooves are provided to adjust the size of the structure to ensure better fit and stability.
  • the head frame is having knobs and grooves to adjust the size of the head frame structure to fit with head size of the neonate for stable positioning of the electrodes.
  • Figure 9 shows details about the modifications possible in the head frame which fits different head sizes in one of the embodiment of the present invention.
  • flexible bands and caps are provided with integrated electrodes. The flexible bands and caps are made from combination of hard and soft materials.
  • Figure 10 shows flexible bands and caps with integrated electrodes in one of the embodiment of the present invention.
  • Figure 10(c) shows material property of the electrode system and head frame.
  • the material of the head frame and electrodes are such that it is comfortable, can be stretched and can fit different head sizes.
  • Material of the structure is such that it can be stretched to fit different head sizes, it is gelly type so won't give discomfort and can mould and fit different head sizes to form like a cap or band. It also has the capability of enclosing a circuitry and provides a display for the test results.
  • electrode of the present invention are worn on the fingers and enables healthcare provider to control the impedance value by applying pressure and changing position of his fingers.
  • Figure 12 shows electrode points in the hand of healthcare provider/mother.
  • Figure 13 shows complete device configuration as one of the embodiment of the present invention.
  • Figure 13 shows easily adjustable electrodes, preamplifier, processor and display in one of the embodiment of the present invention.
  • the present invention significantly reduces the time for screening.
  • the test time is reduced by reducing time to place the electrode.
  • the placement of electrodes is crucial in deciding the time it takes to test the baby.
  • the placement of electrodes involves: a) Positioning of electrode at the right place:
  • the head frame of the system as claimed in the present invention enables positioning of electrodes at right place in less time and requires less skill. This avoids repetition of testes and also prevents false results.
  • This system provides pillow- shaped head frame, head frame with extendable electrodes, head frame with adjustable electrodes, head frame which fits different head sizes, head frame shaped as flexible bands and caps.
  • Figures 5 to 10 shows embodiments of the head frame of the system of the present invention.
  • the head frame of the system as claimed in the present invention enables stable positioning of electrodes.
  • Our electrode system helps the caregiver to position the electrode accurately and in less time and provides better position stability to it. The difficulties arising due to movement of baby or movement of electrode wires are avoided.
  • This system provides pillow- shaped head frame, head frame with extendable electrodes, head frame with adjustable electrodes, head frame which fits different head sizes, head frame shaped as flexible bands and caps.
  • Figures 5 to 10 shows embodiments of the head frame of the system of the present invention.
  • the impedance is reduced and balanced by:
  • An electrolyte gel, paste or cream is applied to improve the conductivity of the dead skin layer which also reduces time of placing the electrode.
  • testing of both the ears at same time reduces testing time by half. Hence, this results in reducing time to collect data.
  • Quick data analysis In the present invention, data acquisition and processing boards are used.
  • the hardware devices which can be used are mobile phones, laptops, tablets and other processing devices.
  • Enhancement in signal to noise ratio provides enhancement in signal to noise ratio.
  • the algorithm constitutes of selecting the separate sweeps and averaging them to improve the SNR. This technique helps in improving the signal to noise ratio (S/N ratio) of weak signals buried in noise. Averaging N data samples improves the S/N ratio by a factor of root of N. This value is obtained if each of the data samples contain a signal and additive noise and if the noise samples are zero mean, uncorre!ated and have identical variances. In some applications, however, these conditions are not met. This is especially true for electric response audiometry (ERA), where the superimposed noise is generally non-stationary, due to changing EEG and myogenic activities.
  • ERA electric response audiometry
  • the processing control unit (15) of the screening device is configured for enhancing signal -to-noise ratio by selective data rejection and averaging techniques.
  • the averaging techniques employed by the processing control unit (15) comprises of one or more of the weighted averaging, latency corrected averaging, and techniques for deciding when to stop averaging.
  • AGC automatic gain control
  • Weighted averaging weighted averaging techniques have been introduced to improve the signal to noise ratio by taking into account the non-stationarity of the EEG.
  • Latency corrected averaging techniques have been employed to overcome some BAEP non-stationarity. Other method is focused on the decision of when to stop averaging i.e. stopping criterion or on the development of high speed stimulation techniques in order to reduce the acquisition time necessary to extract the BAEPs. Signal stationarity is used for detection of signal.
  • the system may be based on statistical methods to detect the presence or absence of ABR, therefore removing the discrepancies arising due to the judgment of the person conducting the test procedure.
  • the present invention provides a method of conducting hearing screening Test in Neonates and this method saves time and requires less skill and less expertise to detect hearing loss in newborns in a resource constrained environment.
  • the skin is prepared by applying the gel and at least three electrodes are placed to get a good contact on the above forehead (on the vertical axis) and on mastoid behind the ear (horizontal axis) and a convenient point on the baby which provides a good ground source on the body to detect waveform recordings.
  • Click stimuli ranging from 70 db to 35 db or below is provided to the neonates and ABR signal is generated by the auditory brainstem response to the click stimuli.
  • a display unit (16) can display the ABR in digital format which can be evaluated by an expert.
  • the resultant ABR can be sent to an expert over a communication channel.
  • a report can be generated which will help the specialist to reanalyze the subject's hearing condition.
  • the various illustrative logical blocks, modules, circuits, elements, and/or components described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, or other programmable logic component, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.
  • the methods described in connection with the embodiments disclosed herein may be embodied directly in hardware, in one or more instructions executed by a processor, or in a combination of the two.
  • the software may reside as one or more instructions in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art.
  • a storage medium may be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor.
  • This system has reduced screening time by quick placement of electrodes at correct position and by stable positioning of electrodes.
  • This system provides head frame comprising at least three surface electrodes with integrated speaker in the shape of pillow, head frame with extendable electrodes, head frame with adjustable electrodes to fit different head sizes and head frame shaped as flexible bands and flexible caps.
  • This system is easy to clean, and the system can be dis-assembled and reassembled again

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Audiology, Speech & Language Pathology (AREA)
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  • Psychiatry (AREA)
  • Otolaryngology (AREA)
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

La présente invention concerne un système de dépistage de la détérioration auditive comprenant un test rapide pour nouveau-nés. Ledit système inclut un cadre de tête (17) comportant un microphone (13), un transducteur audio et au moins trois électrodes de surface, une unité d'amplification de signal (10), une unité de filtrage de signal (11), et un convertisseur analogique-numérique (12) relié à une unité de commande et de traitement numérique (15). Une unité d'affichage (16) permet d'afficher l'ABR (réponse évoquée auditive du tronc cérébral) dans un format numérique qui peut être évalué par un spécialiste. Le cadre de tête (17) comprend un haut-parleur intégré, et au moins trois électrodes de surface destinées à procurer un bon contact sur le front supérieur (axe vertical), sur la mastoïde derrière l'oreille (axe horizontal), et au niveau d'un point pratique sur le bébé, qui constitue une bonne source de terre sur le corps pour détecter des enregistrements de forme d'onde. Le cadre de tête du système permet un positionnement rapide et stable des électrodes, la longueur réduite des fils de raccordement entre les électrodes et l'unité d'amplification de signal (10) réduit l'impédance, et la boucle formée entre l'électrode d'inversion avec la terre et l'électrode de non-inversion avec la même terre équilibre l'impédance qui réduit le bruit.
PCT/IB2013/054624 2012-06-05 2013-06-05 Système de dépistage de la détérioration auditive WO2013183009A2 (fr)

Applications Claiming Priority (2)

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IN3524DE2011 2012-06-05
IN3524/DEL/2011 2012-06-05

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN118614910A (zh) * 2024-08-12 2024-09-10 中国人民解放军空军特色医学中心 一种听力筛查装置

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JP4833202B2 (ja) * 2004-06-18 2011-12-07 ニューロントリックス インコーポレイテッド 神経学的疾患のための誘発反応試験システム
JP5589593B2 (ja) * 2009-06-29 2014-09-17 ソニー株式会社 生体信号測定用装具
US20110301486A1 (en) * 2010-06-03 2011-12-08 Cordial Medical Europe Measurement of auditory evoked responses

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118614910A (zh) * 2024-08-12 2024-09-10 中国人民解放军空军特色医学中心 一种听力筛查装置

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WO2013183009A3 (fr) 2014-02-06
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