Determining cochlear fluid based on recorded electro-physiological responses

Abstract

The present application discloses determining cochlear fluid based on recorded electro-physiological responses, wherein a system for diagnosing cochlear fluid in a human or animal comprises: an acoustic stimulus generation unit comprising a stimulus generator and an output transducer, wherein the acoustic stimulus generation unit is configured to provide an audio stimulus to at least one ear of the human or animal via the output transducer by means of the stimulus generator, wherein the acoustic stimulus generation unit is configured to provide a plurality of audio stimuli comprising at least a first click audio stimulus and a first chirp audio stimulus or comprising at least a first and a second chirp audio stimulus; a recording unit configured to record one or more electro-physiological responses of the human or animal in response to one or more audio stimuli provided to at least one ear of the human or animal by means of the acoustic stimulus generation unit; and a diagnostic unit configured to process the recorded electro-physiological responses.

Description

Technical Field

[0001] This application relates to a system for diagnosing cochlear effusion in humans or animals.

[0002] This application also relates to methods for recording auditory electrophysiological responses in humans or animals. Background Technology

[0003] Meniere's disease is currently diagnosed by observing symptoms such as episodic vertigo, tinnitus, pulsatile hearing loss, and a feeling of pressure or fullness in the ears. In addition, sometimes the diagnosis can be combined with CT or MRI scans to rule out any other causes of these symptoms.

[0004] Not all patients will exhibit all of the above symptoms, especially in the early stages of Meniere's disease, where only some symptoms may be present.

[0005] The etiology of Meniere's disease has not been fully elucidated. However, the etiology of Meniere's disease has been proposed to be endolymphatic (or cochlear) effusion. Endolymphatic effusion is a condition in which the endolymphatic system is dilated[1].

[0006] Several methods have been proposed to definitively diagnose symptoms caused by Meniere's disease, such as:

[0007] -Vestibular evoked myogenic potentials;

[0008] - Cochlear electrodialysis;

[0009] - Cochlear Hydrops Analysis Masking Procedure (CHAMP) [2].

[0010] However, each of these methods presents its own challenges. For example, while CHAMP has been reported to achieve high sensitivity and specificity in patients with fully developed Meniere's disease, it has been found to have lower sensitivity and specificity in patients with early-stage Meniere's disease, resulting in diagnostic indeterminate outcomes. Furthermore, CHAMP is time-consuming and labor-intensive.

[0011] In addition, the process of determining whether the symptoms are caused by Meniere's disease is time-consuming and uncomfortable for patients.

[0012] Therefore, there is a great need for a simple and rapid objective test to determine whether the symptoms are caused by Meniere's disease. Summary of the Invention

[0013] System for diagnosing cochlear effusion

[0014] In one aspect of this application, a system for diagnosing cochlear effusion in humans or animals is provided.

[0015] The system may include an acoustic stimulus generation unit containing a stimulus generator and an output converter.

[0016] The system may include a speaker.

[0017] For example, the loudspeaker may include an output converter that allows audio from the acoustic stimulus generation unit to be output in the environment of a person or animal.

[0018] The system may include headphones.

[0019] For example, headphones may include an output converter that allows audio from the acoustic stimulus generation unit to be output from the headphones at the ear of a person or animal.

[0020] The system may include an ear contact part.

[0021] For example, the ear contact portion can be an earpiece suitable for insertion into the ear canal of a person or animal. The earpiece may include a soft material, such as a dome or earmold, configured to conform to the shape of the ear canal wall of a person or animal. The earpiece may also include an earmold whose shape substantially conforms to the shape of the ear canal wall of a person or animal.

[0022] For example, the output transducer can be positioned in the ear contact portion so that the output transducer is properly located in the ear canal and outputs acoustic stimuli correctly toward the inner ear of a person or animal.

[0023] The stimulus generator can be connected to the output converter (and, for example, an ear contact, speaker, or headphones, if present) via wired or wireless means.

[0024] The acoustic stimulus generation unit can be configured to provide one or more audio stimuli to at least one ear of a human or animal via an output transducer through a stimulus generator. For example, the acoustic stimulus generation unit can be configured to automatically provide an audio stimulus by the stimulus generator, thereby providing simple audio stimulus generation.

[0025] The acoustic stimulus generation unit can be configured to provide multiple audio stimuli.

[0026] For example, the acoustic stimulus generation unit can be configured to provide two or more different types of audio stimuli, so that the responses of humans or animals to different audio stimuli can be monitored and compared to obtain more data for human or animal evaluation.

[0027] Multiple audio stimuli may include providing at least a first click audio stimulus and at least a first chirp audio stimulus.

[0028] Multiple audio stimuli may include providing at least a first chirping audio stimulus and at least a second chirping audio stimulus.

[0029] For example, chirping audio stimuli may include CE chirping [4].

[0030] The system may include a recording unit configured to record one or more auditory electrophysiological responses in a person or animal.

[0031] One or more auditory electrophysiological responses may be recorded in response to audio stimuli provided to at least one ear of a human or animal by an acoustic stimulus generation unit.

[0032] For example, an acoustic stimulus generation unit can provide multiple audio stimuli to the inner ear of a person or animal via an output converter and can record one or more auditory electrophysiological responses of the person or animal to each provided audio stimulus.

[0033] For example, the system can be configured to record auditory electrophysiological responses of a person or animal in response to one or more audio stimuli provided by an acoustic stimulus generation unit (e.g., automatically), thereby providing a simple recording of auditory electrophysiological responses.

[0034] For example, one or more auditory electrophysiological responses can be measured using electrodes placed on the skin of a person or animal.

[0035] For example, one or more auditory electrophysiological responses can be measured using electrodes positioned at the ear contact portion of the acoustic stimulus generation unit.

[0036] The system may include a diagnostic unit.

[0037] The diagnostic unit can be configured to process the recorded auditory electrophysiological responses.

[0038] For example, processing recorded auditory electrophysiological responses may include categorizing the recorded auditory electrophysiological responses according to, for example, the type and magnitude of multiple audio stimuli.

[0039] For example, processing recorded auditory electrophysiological responses may include analyzing the recorded auditory electrophysiological responses, such as determining parameters of the auditory electrophysiological responses (e.g., magnitude) or the amplitude of the recorded auditory electrophysiological responses.

[0040] The diagnostic unit can be configured to provide a diagnosis of cochlear effusion in a human or animal based on one or more audio stimuli.

[0041] For example, providing a diagnosis of cochlear effusion may include determining whether a person or animal has cochlear effusion. The diagnosis may be based on analysis of auditory electrophysiological responses recorded in response to at least a first click audio stimulus and at least a first chirp audio stimulus, or in response to at least a first and a second chirp audio stimulus.

[0042] Therefore, endothelial effusion can be diagnosed based on the auditory electrophysiological response obtained by providing at least a first click audio stimulus and at least a first chirp audio stimulus, or by providing at least a first and a second chirp audio stimulus and recording and processing the results. This is faster, easier, and more comfortable for humans or animals than existing technologies.

[0043] The recorded auditory electrophysiological responses can be auditory brain-stem responses (ABR).

[0044] The system may include recording units configured to record one or more ABRs of humans or animals.

[0045] The diagnostic unit configured to process one or more recorded auditory electrophysiological responses may include being configured to compare response characteristics (e.g., in the time domain or frequency domain) of one or more auditory electrophysiological responses recorded based on at least a first click audio stimulus and at least a first chirp audio stimulus, or based on at least a first and a second chirp audio stimulus.

[0046] The diagnostic unit may be configured to process one or more recorded auditory electrophysiological responses and provide a diagnosis of cochlear effusion. The diagnostic unit may be configured to compare response characteristics (e.g., in the time domain or frequency domain) of one or more auditory electrophysiological responses recorded based on at least a first click audio stimulus and at least a first chirp audio stimulus or based on at least a first and a second chirp audio stimulus.

[0047] In the CHAMP technique mentioned above, suprathreshold click audio stimuli are generated. The resulting auditory electrophysiological responses are then measured using different masking levels, and their effect on the V-wave latency is examined.

[0048] Therefore, the CHAMP technique involves recording auditory electrophysiological responses to moderate-level clicking sounds and simultaneously to high-pass masking noise on the same side of the body. Responses to a standalone clicking audio stimulus and responses to clicking audio stimuli with masking noise filtered at 8, 4, 2, 1, and 0.5 kHz are recorded.

[0049] In typical, normal-hearing subjects without cochlear effusion, the effect of masking is clearly visible. Here, the V-wave latency in the auditory electrophysiological response was observed to increase as the cutoff frequency of the high-pass masking noise decreased. Typically, the highest unmasked frequency range dominates the V-wave latency. Therefore, as the cochlea is continuously masked from 8 kHz down to 0.5 kHz, the peak latency of the V-wave increases.

[0050] As the high-pass masking noise cutoff frequency decreases with each reduction, the response to the clicking audio stimulus shifts from a lower frequency range to a predominantly lower frequency range, leading to an expected increase in the V-wave latency. Therefore, due to factors related to the delay in cochlear propagation waves, the measured V-wave latency of the auditory electrophysiological response increases as the unmasked cochlear regions are successively restricted to lower frequencies.

[0051] Conversely, CHAMP measurements in people or animals with Meniere's disease showed that masking had no substantial effect on V-wave latency, since an increase in V-wave latency was not observed through high-pass masking noise [2].

[0052] The diagnostic unit may be configured to compare and determine a ratio between corresponding response characteristics of one or more auditory electrophysiological responses recorded based on at least a first click audio stimulus and a first chirp audio stimulus.

[0053] The diagnostic unit is configured to include a comparison that may include determining a ratio between corresponding response characteristics of one or more auditory electrophysiological responses based on at least first and second chirped audio stimulus recordings.

[0054] For example, the diagnostic unit may be configured to receive auditory electrophysiological responses recorded in response to at least a first click-like audio stimulus being provided to the ear of a person or animal, and to determine the corresponding response characteristics. Furthermore, the diagnostic unit may be configured to receive auditory electrophysiological responses recorded in response to at least a first chirped audio stimulus being provided to the ear of a person or animal, and to determine the corresponding response characteristics. Additionally, the diagnostic unit may be configured to receive auditory electrophysiological responses recorded in response to at least a second chirped audio stimulus being provided to the ear of a person or animal, and to determine the corresponding response characteristics. The diagnostic unit may be configured to determine the ratio between the response characteristics of the separately determined click-like and chirped audio stimuli.

[0055] In normal cochlea, it has been found that higher V-wave amplitudes are obtained when chirping audio stimuli, such as CE chirping, replace traditional clicking audio stimuli[3][4]. This increased amplitude is due to the average wave propagation time in a healthy cochlea, which is aligned with the spread of chirping audio stimuli to produce optimal synchronous stimulation, resulting in higher V-wave amplitudes compared to clicking audio stimuli.

[0056] CHAMP measurements indicate that the normal cochlear propagation time is significantly reduced in the ears of individuals or animals with endocochlear effusion. For individuals with normal hearing, audio stimuli typically take approximately 10 ms to propagate through the cochlea. Furthermore, there is a propagation time difference of, for example, 10 ms between low and high frequencies in the cochlea (depending on the exact frequency). This suggests that the V-wave amplitude advantage of chirping audio stimuli compared to clicking audio stimuli observed in the ears of individuals or animals with normal hearing will be replaced by the disadvantage in the ears of individuals or animals with endocochlear effusion.

[0057] At least one first chirping audio stimulus may be different from at least one second chirping audio stimulus.

[0058] For example, the first chirping audio stimulus may have a longer or shorter duration than the second chirping audio stimulus.

[0059] For example, the first chirped audio stimulus may have a higher or lower sound pressure level than the second chirped audio stimulus.

[0060] By designing a first chirping audio stimulus based on the average delay profile of the cochlea affected by water accumulation and a second chirping audio stimulus based on the average delay profile of the healthy cochlea, improved discrimination ability can be obtained compared to the click and chirping-based methods described above.

[0061] The first chirping audio stimulus may have a time delay distribution (duration) that conforms to the average time delay distribution of the cochlea affected by endolymphatic hydrops.

[0062] The second chirping audio stimulus can have a time delay distribution (duration) that conforms to the average time delay distribution of a healthy cochlea.

[0063] It can be foreseen that the time delay distribution of the first and second chirping audio stimuli can be reversed.

[0064] By taking measurements sequentially across different sound pressure levels, a wider range of data can be obtained for comparison, potentially leading to a more accurate diagnosis. It should be understood that at each sound pressure level, comparisons can be made between click and chirp responses or between the first and second chirp audio stimulus responses.

[0065] This effect can be used for a simpler diagnosis of cochlear effusion.

[0066] Simplicity comes from two aspects:

[0067] For example, compared to the six conditions specified in the fully implemented CHAMP, only two measurement conditions are required;

[0068] The two measurements required by the proposed technique are unmasked, which means that the averaging time required is shorter compared to the masking conditions of CHAMP.

[0069] The diagnostic unit can be configured to compare the determined ratio with a predetermined ratio.

[0070] For example, the diagnostic unit can be configured to determine whether the response characteristics based on chirped audio stimuli are higher than those based on clicked audio stimuli. If so, the person or animal is diagnosed as having normal hearing.

[0071] For example, the diagnostic unit can be configured to determine whether the response characteristics based on click-based audio stimuli are higher than those based on chirp-based audio stimuli. If so, the person or animal is diagnosed with endolymphatic hydrops.

[0072] The acoustic stimulus generation unit can be configured to provide at least a first click audio stimulus and at least a first chirp audio stimulus at a fixed suprathreshold level.

[0073] The acoustic stimulus generation unit can be configured to provide at least a first chirped audio stimulus and at least a second chirped audio stimulus at a fixed suprathreshold level.

[0074] For example, click and chirp audio stimuli can be provided at 60 dB.

[0075] Clicking audio stimuli can be frequency shaped.

[0076] Click-like audio stimuli can be frequency-shaped based on the hearing threshold level (HTL) of humans or animals.

[0077] (First and / or second) chirping audio stimuli can be frequency shaped.

[0078] Chirping audio stimuli can be frequency-shaped based on the human or animal HTL.

[0079] HTL can be determined based on audiograms taken in humans or animals at an early stage. For example, "early" could be a stage just before or even earlier than when the system was used in humans or animals.

[0080] Click audio stimuli and / or (first and / or second) chirping audio stimuli can be provided at a fixed sensory level (SL).

[0081] Click audio stimuli and / or (first and / or second) chirping audio stimuli may be provided across the stimulation frequency range at a fixed SL higher than the HTL of humans or animals.

[0082] For example, click audio stimuli and / or (first and / or second) chirp audio stimuli can be provided across the stimulation frequency range at a SL of 20 dB above the HTL of humans or animals.

[0083] The acoustic stimulus generation unit can be configured to provide multiple click and chirp audio stimuli.

[0084] The acoustic stimulus generation unit can be configured to provide multiple chirped audio stimuli.

[0085] The acoustic stimulus generation unit can be configured to provide multiple clicking audio stimuli.

[0086] The acoustic stimulus generation unit can be configured to provide multiple click and / or chirp audio stimuli to at least one ear of a human or animal in an alternating manner.

[0087] The acoustic stimulus generation unit can be configured to provide alternating click and / or chirp audio stimuli to at least one ear of a human or animal.

[0088] The acoustic stimulus generation unit can be configured to provide multiple click and / or chirp audio stimuli to both ears of a human or animal in an alternating manner.

[0089] The acoustic stimulus generation unit can be configured to provide alternating clicking and / or chirping audio stimuli to both ears of a human or animal.

[0090] For example, multiple audio stimuli can be delivered to both ears of a person or animal simultaneously in an alternating manner.

[0091] For example, the acoustic stimulus generation unit can be configured to provide alternating first click audio stimuli and first chirp audio stimuli.

[0092] For example, the acoustic stimulus generation unit can be configured to provide alternating first chirped audio stimuli and second chirped audio stimuli.

[0093] This allows for more accurate diagnoses in humans or animals, as measurements can be taken simultaneously at both ears under similar conditions.

[0094] The acoustic stimulus generation unit can be configured to provide multiple click-like audio stimuli at multiple sound pressure levels to at least one ear of a human or animal.

[0095] The acoustic stimulus generation unit can be configured to provide multiple chirped audio stimuli of multiple sound pressure levels to at least one ear of a human or animal.

[0096] For example, multiple click and / or chirp audio stimuli can be simultaneously delivered to both ears of a human or animal at similar sound pressure levels, enabling the retrieval of ear-specific information. This simplifies the delivery of audio stimuli and the subsequent recording of auditory electrophysiological responses.

[0097] For example, auditory electrophysiological response recordings can be performed in response to multiple click and / or chirp audio stimuli provided in succession to facilitate subsequent recording analysis.

[0098] For example, auditory electrophysiological response recordings can be performed alternately.

[0099] The diagnostic unit can be configured to provide corresponding average values ​​of response characteristics of one or more auditory electrophysiological responses recorded based on at least a first click audio stimulus and a first chirp audio stimulus, or based on at least a first and a second chirp audio stimulus.

[0100] The diagnostic unit can be configured to provide a corresponding average value of the response characteristics of the auditory electrophysiological response based on the recording of the first click audio stimulus.

[0101] The diagnostic unit can be configured to provide a corresponding average value of the response characteristics of the auditory electrophysiological response based on the recording of the first chirped audio stimulus or the second chirped audio stimulus.

[0102] The diagnostic unit can be configured to process the recorded auditory electrophysiological responses, including providing corresponding average response characteristics; and configured to provide a diagnosis of cochlear effusion in humans or animals based on corresponding average first click audio stimulation and average chirp audio stimulation or based on corresponding average first chirp audio stimulation and average second chirp audio stimulation.

[0103] The system can be configured to make diagnoses based on simultaneous measurements in both ears of a person or animal in order to retrieve ear-specific information.

[0104] For example, the acoustic stimulus generation unit of the system may include a loudspeaker containing an output converter.

[0105] For example, the acoustic stimulus generation unit of the system may include headphones and two output converters.

[0106] For example, the acoustic stimulus generation unit of the system may include two ear contact portions and two output transducers. One ear contact portion may be placed in the left ear of a person or animal, and the other ear contact portion may be placed in the right ear. One output transducer may be placed in one ear contact portion, and the other output transducer may be placed in the other ear contact portion.

[0107] Thus, the acoustic stimulus generation unit can be configured to simultaneously or alternately provide one or more audio stimuli to both ears of a person or animal via an output converter through a stimulus generator.

[0108] When there is only one output converter, the measurement can be performed first at one ear and then at the second ear.

[0109] Response characteristics may include the V-wave amplitude of one or more recorded auditory electrophysiological responses.

[0110] One or more auditory electrophysiological responses can be one or more auditory brainstem responses (ABR).

[0111] The system can be or form part of a portable device, such as a device that includes a local power source, such as a battery, for example a rechargeable battery.

[0112] application

[0113] On the one hand, it provides the application of the system described above, in detail in the "Detailed Description" section, and as defined in the claims.

[0114] method

[0115] On the one hand, the present invention further provides a method for recording auditory electrophysiological responses in humans or animals.

[0116] This method may include providing audio stimuli.

[0117] Audio stimuli may include at least the first click audio stimulus.

[0118] Audio stimuli may include at least the first chirping audio stimulus.

[0119] The audio stimulus may include at least a second chirping audio stimulus.

[0120] At least the first click audio stimulus and / or at least the first chirp audio stimulus may be provided by the stimulus generator of the acoustic stimulus generation unit.

[0121] At least the first chirped audio stimulus and / or at least the second chirped audio stimulus may be provided by the stimulus generator of the acoustic stimulus generation unit.

[0122] At least a first click audio stimulus and / or at least a first chirp audio stimulus may be provided to at least one ear of a human or animal via the output transducer of the acoustic stimulus generation unit.

[0123] At least a first chirped audio stimulus and / or at least a second chirped audio stimulus may be provided to at least one ear of a human or animal via the output transducer of the acoustic stimulus generation unit.

[0124] The method may include recording one or more auditory electrophysiological responses of a person or animal through a recording unit.

[0125] The method may include recording one or more auditory electrophysiological responses of a person or animal in response to one or more audio stimuli provided to at least one ear of a person or animal by a recording unit.

[0126] The method may include processing one or more recorded auditory electrophysiological responses.

[0127] This method may include providing a diagnosis of cochlear effusion in a person or animal via a diagnostic unit.

[0128] The method may include processing recorded auditory electrophysiological responses based on at least a first click audio stimulus and at least a first chirp audio stimulus via a diagnostic unit.

[0129] The method may include processing recorded auditory electrophysiological responses based on at least a first click audio stimulus and at least a first chirp audio stimulus via a diagnostic unit to provide a diagnosis of cochlear effusion in a human or animal.

[0130] The method may include processing recorded auditory electrophysiological responses based on at least a first chirped audio stimulus and at least a second chirped audio stimulus via a diagnostic unit.

[0131] The method may include processing recorded auditory electrophysiological responses based on at least a first chirped audio stimulus and at least a second chirped audio stimulus via a diagnostic unit to provide a diagnosis of cochlear effusion in a human or animal.

[0132] The method may include measuring the hearing threshold level (HTL) of at least one ear of a person or animal.

[0133] The steps of processing one or more recorded auditory electrophysiological responses and providing a diagnosis of cochlear effusion in a human or animal may include comparing the characteristics (e.g., V wave amplitude) of one or more recorded auditory electrophysiological responses based on at least a first click audio stimulus and a first chirp audio stimulus.

[0134] The steps of processing one or more recorded auditory electrophysiological responses and providing a diagnosis of cochlear effusion in a human or animal may include comparing the characteristics of the recorded auditory electrophysiological responses (such as V wave amplitude) based on at least first and second chirped audio stimuli.

[0135] The comparison step may include determining the ratio between corresponding response characteristics of one or more recorded auditory electrophysiological responses based on at least the first click audio stimulus and the first chirp audio stimulus.

[0136] The comparison step may include determining the ratio between corresponding response characteristics of one or more recorded auditory electrophysiological responses based on at least first and second chirped audio stimuli.

[0137] Other methods for evaluating response characteristics can be used instead of measuring the V-wave amplitude of the response. For example, the responses or their differences in the frequency domain can be evaluated.

[0138] The acoustic stimulus generation unit can provide multiple clicking audio stimuli to at least one ear of a human or animal.

[0139] The acoustic stimulus generation unit can provide multiple chirping audio stimuli to at least one ear of a human or animal.

[0140] For the assessments described herein, the V-wave response may provide the most robust response component clinically, but other response components may also be used, either alone or in combination, where the combination may or may not include the V-wave.

[0141] The acoustic stimulus generation unit can alternately deliver multiple click and / or chirp audio stimuli to at least one ear of a human or animal.

[0142] Audio stimuli can have a specified frequency bandwidth.

[0143] Audio stimuli can have a specified presentation rate.

[0144] Audio stimuli can have a specified amplitude.

[0145] Audio stimuli can have a specified spectral content.

[0146] Audio stimuli can have specified frequency bandwidth, presentation rate, amplitude, and spectral content.

[0147] When appropriately replaced by a corresponding process, some or all of the structural features of the system described above, in detail in the "Detailed Description," or as defined in the claims can be combined with the implementation of the method of the present invention, and vice versa. The implementation of the method has the same advantages as the corresponding apparatus.

[0148] Computer-readable media or data carrier

[0149] The present invention further provides a tangible computer-readable medium (data carrier) storing a computer program including program code (instructions), which, when the computer program is run on a data processing system (computer), causes the data processing system to perform (implement) at least some (such as most or all) of the steps of the methods described above, in detail in the "Detailed Description" and as defined in the claims.

[0150] By way of example, but not limitation, the aforementioned tangible computer-readable media may include RAM, ROM, EEPROM, CD-ROM or other optical disc storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to execute or store required program code in the form of instructions or data structures and is accessible by a computer. As used herein, disks include compact discs (CDs), laser discs, optical discs, digital multipurpose discs (DVDs), floppy disks, and Blu-ray discs, wherein these disks typically magnetically copy data while simultaneously being optically copied using lasers. Other storage media include those stored in DNA (e.g., in synthetic DNA strands). Combinations of the aforementioned disks should also be included within the scope of computer-readable media. In addition to being stored on tangible media, computer programs may also be transmitted via transmission media such as wired or wireless links or networks such as the Internet and loaded into data processing systems to run at locations other than tangible media.

[0151] Computer program

[0152] In addition, this application provides a computer program (product) including instructions that, when run by a computer, cause the computer to perform the steps of the methods (methods) described above, in detail in the "Detailed Description" section, and as defined in the claims.

[0153] Data processing system

[0154] In one aspect, the present invention further provides a data processing system, including a processor and program code, the program code causing the processor to perform at least some (such as most or all) of the steps of the methods described above, in detail in the "Detailed Description" section, and as defined in the claims.

[0155] Auxiliary devices

[0156] This system is adapted to establish a communication link between the system and auxiliary devices so that information (such as control and status signals, and possibly audio signals) can be exchanged or forwarded from one device to another.

[0157] The auxiliary device may include a remote control or other portable electronic device.

[0158] The auxiliary device may consist of or include a remote controller, which is used, for example, to control the functions and operation of the system via a user interface.

[0159] APP

[0160] On the other hand, the present invention also provides a non-transitory application called an APP. An APP includes executable instructions configured to run on an auxiliary device to implement a user interface for the system described above, in detail in the "Detailed Description," and as defined in the claims. The APP can be configured to run on a mobile phone, such as a smartphone, or another portable device enabled to communicate with said system. Attached Figure Description

[0161] Various aspects of the invention will be best understood from the following detailed description taken in conjunction with the accompanying drawings. For clarity, these drawings are schematic and simplified, showing only the details necessary for understanding the invention while omitting other details. Throughout the specification, the same reference numerals are used for the same or corresponding parts. Features of each aspect may be combined with any or all features of other aspects. These and other aspects, features, and / or technical effects will be apparent from and illustrated in the following figures, wherein:

[0162] Figure 1 Exemplary application scenarios of the system according to the present invention are shown;

[0163] Figure 2 Exemplary click and chirp audio stimuli according to the present invention are shown;

[0164] Figure 3 An exemplary flowchart is shown for a method of recording auditory electrophysiological responses in humans or animals.

[0165] The further applicability of the invention will become apparent from the detailed description given below. However, it should be understood that while the detailed description and specific examples illustrate preferred embodiments of the invention, they are given for illustrative purposes only. Other embodiments of the invention will become apparent to those skilled in the art based on the following detailed description. Detailed Implementation

[0166] The detailed description below, taken in conjunction with the accompanying drawings, serves as a description of various different configurations. This detailed description includes specific details to provide a thorough understanding of several different concepts. However, it will be apparent to those skilled in the art that these concepts can be implemented without these specific details. Several aspects of the system and method are described by various different blocks, functional units, modules, elements, circuits, steps, processes, algorithms, etc. (collectively, “elements”). Depending on the specific application, design constraints, or other reasons, these elements may be implemented using electronic hardware, computer programs, or any combination thereof.

[0167] Electronic hardware may include microelectromechanical systems (MEMS), (e.g., application-specific integrated circuits), microprocessors, microcontrollers, digital signal processors (DSPs), field-programmable gate arrays (FPGAs), programmable logic devices (PLDs), gating logic, discrete hardware circuits, printed circuit boards (PCBs) (e.g., flexible PCBs), and other suitable hardware configured to perform the various functions described in this specification, such as sensors for sensing and / or recording the physical properties of the environment, devices, users, etc. Computer programs should be interpreted broadly as instructions, instruction sets, code, code segments, program code, programs, subroutines, software modules, applications, software applications, software packages, routines, subroutines, objects, executables, threads of execution, programs, functions, etc., whether referred to as software, firmware, middleware, microcode, hardware description languages, or other names.

[0168] Figure 1 An exemplary application scenario of the system according to the present invention is shown.

[0169] exist Figure 1 The image shows a system 1 for diagnosing cochlear effusion in a person 2.

[0170] System 1 may include an acoustic stimulus generation unit. The acoustic stimulus generation unit may be configured to provide audio stimuli to at least one ear of a person 2. Figure 1 The image shows that audio stimuli can be delivered to a person's first ear 3 and second ear 4.

[0171] The acoustic stimulus generation unit may include a stimulus generator 5. The stimulus generator 5 can provide audio stimuli.

[0172] The acoustic stimulus generation unit may include an ear contact portion 6 and an output transducer 7. Alternatively, the acoustic stimulus generation unit may include a speaker or headphones. The output transducer 7 may be disposed in the ear contact portion 6. The ear contact portion 6 may have an outer surface whose shape conforms to the surface of the ear canal of the person 2. The ear contact portion 6 may include a soft material such that the ear contact portion 6 can be securely placed within the ear canal of the person 2.

[0173] The acoustic stimulus generation unit can provide audio stimulation to the first ear 3 and / or the second ear 4 of the person 2 via the stimulus generator 5 and the output converter 7 located in the ear contact part 6.

[0174] exist Figure 1 In this configuration, the stimulus generator 5 can be connected to the output converter 7 via a wired connection (e.g., during operation), such as via a first wired connection 8 and a second wired connection 9. Alternatively, the stimulus generator 5 can be connected to the output converter 7 via a wireless connection.

[0175] The stimulus generator 5 of the acoustic stimulus generation unit can be configured to provide multiple audio stimuli to the first ear 3 and / or the second ear 4 of a person 2, for example, in an alternating manner. The multiple audio stimuli include at least one click audio stimulus and at least one chirp audio stimulus. Alternatively, the multiple audio stimuli may include at least a first chirp audio stimulus and at least a second chirp audio stimulus.

[0176] System 1 may include a recording unit 10. The recording unit 10 may be configured to record one or more auditory electrophysiological responses (such as ABR) of person 2 in response to audio stimuli or multiple audio stimuli provided to at least one ear of person 2 by an acoustic stimulus generation unit. The recording of the auditory electrophysiological responses may be performed automatically by the recording unit 10 and / or manually by a second person operating the system on person 2.

[0177] System 1 may include a diagnostic unit 11. Diagnostic unit 11 may be configured to process recorded auditory electrophysiological responses. Diagnostic unit 11 may be configured to provide a diagnosis of cochlear effusion in person 2 based on at least one click audio stimulus and at least one chirp audio stimulus provided by stimulus generator 5 to the first ear 3 and / or the second ear 4 of person 2, or based on at least one first chirp audio stimulus and at least one second chirp audio stimulus.

[0178] exist Figure 1 The diagram illustrates that the stimulus generator 5, recording unit 10, and diagnostic unit 11 can be housed in the same device 12, thereby enabling the generation of audio stimuli, measurement of the resulting auditory electrophysiological response, and diagnosis of cochlear effusion using a single device 12. This provides a faster and easier diagnosis of cochlear effusion.

[0179] Figure 2 Exemplary click and chirp audio stimuli according to the present invention are shown.

[0180] exist Figure 2 In the diagram, the curve above shows the waveform of a chirped audio stimulus, such as the CE chirped audio stimulus. The amplitude of the chirped audio stimulus is shown as a function of time in milliseconds.

[0181] exist Figure 2 In the diagram below, the curve shows the waveform of the clicking audio stimulus. The amplitude of the clicking audio stimulus is shown as a function of time in milliseconds.

[0182] Figure 3 An exemplary flowchart illustrates a method for recording one or more auditory electrophysiological responses in a human or animal.

[0183] exist Figure 3 In this context, the recording of auditory electrophysiological responses in humans or animals can be performed in response to the provision of at least one audio stimulus to at least one ear of the human or animal.

[0184] This method may include providing audio stimulation at S1.

[0185] The audio stimulus may include at least one click audio stimulus and at least one chirp audio stimulus, or may include at least one first chirp audio stimulus and at least one second chirp audio stimulus. The audio stimulus may be provided by the stimulus generator of the acoustic stimulus generation unit. The audio stimulus may be provided to at least one ear (e.g., both ears) of a human or animal via the output transducer of the acoustic stimulus generation unit.

[0186] This method may include recording one or more auditory electrophysiological responses in a human or animal at S2.

[0187] Auditory electrophysiological responses can be recorded by a recording unit in response to audio stimuli provided to at least one ear of a human or animal by an acoustic stimulus generation unit.

[0188] The method may include processing one or more recorded auditory electrophysiological responses in S3.

[0189] The auditory electrophysiological responses recorded during the S3 treatment can be analyzed via a diagnostic unit.

[0190] This method may include providing a diagnosis of cochlear effusion in a person or animal at S4.

[0191] Diagnosis of cochlear effusion in S4 can be performed via a diagnostic unit. The diagnostic unit can provide a diagnosis based on audio stimulation. The diagnostic unit can also provide a diagnosis based on recorded auditory electrophysiological responses.

[0192] When appropriately replaced by a corresponding process, the structural features of the apparatus described above, in detail in the "Detailed Description" section, and as defined in the claims can be combined with the steps of the method of the present invention.

[0193] Unless explicitly stated otherwise, the singular forms “a” and “the” used herein include the plural forms (i.e., meaning “at least one”). It should be further understood that the terms “having,” “comprising,” and / or “including” as used in the specification indicate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or combinations thereof. It should be understood that, unless explicitly stated otherwise, when an element is referred to as “connected” or “coupled” to another element, it may be a direct connection or coupling to the other element, or there may be intermediate inserting elements. The term “and / or” as used herein includes any and all combinations of one or more of the listed related items. Unless explicitly stated otherwise, the steps of any method disclosed herein do not necessarily have to be performed in the exact order disclosed.

[0194] It should be understood that references to "an embodiment," "an embodiment," "an aspect," or "may" in this specification mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the invention. Furthermore, particular features, structures, or characteristics may be suitably combined in one or more embodiments of the invention. The foregoing description is provided to enable those skilled in the art to implement the various aspects described herein. Various modifications will be apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects.

[0195] The claims are not limited to the aspects shown herein, but encompass the full scope consistent with the language of the claims, wherein, unless expressly stated, an element referred to in the singular does not mean "one and only one," but rather "one or more." Unless expressly stated, the term "some" means one or more.

[0196] Therefore, the scope of this invention should be determined based on the claims.

[0197] References

[0198] [1]Roeser,RJ,Valente,M.,&Hosford-Dunn,H.(2007).Audiology:Diagnosis(Second edition).Thieme.

[0199] [2]Don,M.,Kwong,B.,&Tanaka,C.(2005).A Diagnostic test for Ménière'sdisease and cochlear hydrops:Impaired high-pass noise masking of auditorybrainstem responses.Otology&Neurotology,26,711–722.

[0200] [3]Elberling, C., & Don, M. (2008). Auditory brainstem responses to a chirpstimulus designed from derived-band latencies in normal-hearing subjects. The Journal of the Acoustical Society of America, 124(5), 3022. https: / / doi.org / 10.1121 / 1.2990709.

[0201] [4]Elberling,C.,&Don,M.(2010).A direct approach for the design ofchirp stimuli used for the recording of auditory brainstem responses.TheJournal of the Acoustical Society of America,128(5),2955.https: / / doi.org / 10.1121 / 1.3489111.

Claims

1. A system for diagnosing cochlear effusion in humans or animals, the system comprising: An acoustic stimulus generation unit comprising a stimulus generator and an output converter, wherein the acoustic stimulus generation unit is configured to provide an audio stimulus to at least one ear of a human or animal via the output converter through the stimulus generator, wherein the acoustic stimulus generation unit is configured to provide a plurality of audio stimuli, the plurality of audio stimuli including at least a first click audio stimulus and a first chirp audio stimulus or including at least a first and a second chirp audio stimulus. The recording unit is configured to record one or more auditory electrophysiological responses of a person or animal in response to one or more audio stimuli provided to at least one ear of a person or animal by the acoustic stimulus generation unit. and The diagnostic unit is configured to process the recorded auditory electrophysiological responses; The diagnostic unit is configured to process one or more recorded auditory electrophysiological responses, including comparing response characteristics of one or more recorded auditory electrophysiological responses based on at least a first click audio stimulus and at least a first chirp audio stimulus or based on at least a first and a second chirp audio stimulus, wherein the response characteristics include the V-wave amplitude of the one or more recorded auditory electrophysiological responses.

2. The system of claim 1, wherein the diagnostic unit is configured to compare the following: the diagnostic unit is configured to determine a ratio between corresponding response characteristics of one or more auditory electrophysiological responses recorded based on at least a first click audio stimulus and a first chirp audio stimulus or based on at least a first and a second chirp audio stimulus.

3. The system according to any one of claims 1-2, wherein the acoustic stimulus generation unit is configured to provide at least a first click audio stimulus and a first chirp audio stimulus at a fixed suprathreshold level, or to provide at least first and second chirp audio stimuli.

4. The system according to any one of claims 1-2, wherein at least the first click audio stimulus and / or at least the first chirp audio stimulus or at least the first and second chirp audio stimuli are frequency-shaped based on the hearing threshold level of a human or animal.

5. The system of claim 4, wherein at least a first click audio stimulus and / or at least a first chirp audio stimulus or at least the first and second chirp audio stimuli are provided across a stimulus frequency range at a fixed sensory level higher than the hearing threshold level of a human or animal.

6. The system of claim 1, wherein the acoustic stimulus generation unit is configured to provide a plurality of click and / or chirp audio stimuli to at least one ear of a human or animal in an alternating manner.

7. The system of claim 1, wherein the acoustic stimulus generation unit is configured to provide at least one ear of a human or animal with a plurality of click audio stimuli and / or chirp audio stimuli of a plurality of sound pressure levels.

8. The system of claim 1, wherein the diagnostic unit is configured to provide corresponding average values ​​of response characteristics of one or more auditory electrophysiological responses recorded respectively based on at least a first click audio stimulus and a first chirp audio stimulus or respectively based on at least a first and a second chirp audio stimulus.

9. The system of claim 1, wherein one or more auditory electrophysiological responses are one or more auditory brainstem responses.

10. A method for recording auditory electrophysiological responses in humans or animals, the method comprising: The acoustic stimulus is provided to at least one ear of a human or animal by the stimulus generator of the acoustic stimulus generation unit via the output converter of the acoustic stimulus generation unit. The audio stimulus includes at least a first click audio stimulus and a first chirp audio stimulus, or includes at least a first and a second chirp audio stimulus. Record one or more auditory electrophysiological responses of a human or animal by a recording unit in response to one or more audio stimuli provided to at least one ear of a human or animal by an acoustic stimulus generation unit; and The recorded auditory electrophysiological responses are processed through the diagnostic unit; Processing one or more recorded auditory electrophysiological responses includes comparing the response characteristics of one or more recorded auditory electrophysiological responses based on at least a first click audio stimulus and a first chirp audio stimulus, or based on at least a first and a second chirp audio stimulus, wherein the response characteristics include the V-wave amplitude of the one or more recorded auditory electrophysiological responses.

11. The method of claim 10, wherein the method comprises measuring the hearing threshold level of at least one ear of a person or animal.

12. The method of claim 10, wherein the comparison comprises determining a ratio between corresponding response characteristics of recorded auditory electrophysiological responses based on at least a first click audio stimulus and a first chirp audio stimulus or based on at least a first and at least a second chirp audio stimulus.

13. The method of claim 10, wherein the acoustic stimulus generation unit provides a plurality of click and / or chirp audio stimuli to at least one ear of a human or animal in an alternating manner.

14. The method of claim 10, wherein the audio stimulus has a specified frequency bandwidth, presentation rate, amplitude, and spectral content.

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