Audiometry system

The hearing test system allows for real-time assessment of hearing improvements during otological surgery through auditory evoked responses and cartilage conduction vibrators, addressing the challenge of post-operative hearing assessments and potentially reducing the need for repeat surgeries.

JP2025095001APending Publication Date: 2025-06-26NARA MEDICAL UNIVERSITY +1
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Patent Information

Application Number
JP2023210750
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-12-14
Publication Date
2025-06-26

AI Technical Summary

Technical Problem

Current otological surgeries lack the capability to assess the effectiveness of ossicular chain reconstruction during the procedure, leading to potential need for repeat surgeries if post-operative hearing tests are unsatisfactory.

Method used

A hearing test system that utilizes auditory evoked responses, incorporating a cartilage conduction vibrator sealed in a sterilizable case, which can be worn on the patient's ear during surgery to assess hearing improvements in real-time.

Benefits of technology

Enables immediate assessment of hearing improvements during otological surgery, allowing for adjustments to the reconstruction site as needed, thereby reducing the burden on patients and surgeons by potentially eliminating the need for additional surgeries.

✦ Generated by Eureka AI based on patent content.

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Abstract

To provide a technology capable of performing audiometry during an ear surgery.SOLUTION: In an audiometry system 1, a cartilage conduction oscillator 10 gives vibrations in accordance with a stimulus sound signal transmitted by a sound signal transmission part 40 to the ear cartilage and presents an auditory stimulation sound, and an analysis part 60 analyzes a brain wave signal synchronously transmitted by an electrode 20. The cartilage conduction oscillator 10 is sealed in a case whose vibration part can be sterilized or the like, so that when processing such as sterilization is performed, it is possible to fit the same to a patient's ear and to perform an evoked response examination after reconstruction of a part to be reconstructed, that is, during an ear surgery, and to confirm during the surgery whether a desired effect has been obtained by reconstruction. Also, the audiometry system 1 compares results of the evoked response examination before and after the reconstruction of the part to be reconstructed, and evaluates whether or not hearing has been improved relatively, but does not need to obtain hearing threshold accurately, so that it can be more easily dealt with than equipment such as an audiometer requiring rigid calibration and management.SELECTED DRAWING: Figure 1
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Description

Technical Field

[0001] The present invention relates to an auditory examination system capable of confirming whether hearing has been improved by otological surgery before the completion of the surgery.

Background Art

[0002] When there is an abnormality in the ossicles due to otitis media, cholesteatoma, etc., or when a stapedectomy is performed as a treatment for otosclerosis, a reconstruction surgery of the ossicular chain is performed. In general, the reconstruction surgery of the ossicular chain is performed based on the experience and speculation of a doctor. Whether the location, size, and effectiveness of the material to be reconstructed are appropriate cannot currently be determined without performing a hearing test after the completion of the surgery and looking at the results. Therefore, if the result of the hearing test performed after the completion of the surgery is not satisfactory, the surgery has to be performed again, which is a heavy burden for both the patient and the doctor.

[0003] Here, in neurosurgery, conventionally, an insertion-type earphone and electrodes are attached to a patient during surgery, and while emitting a stimulating sound from the earphone during the surgery and confirming that the electroencephalogram of the patient obtained from the electrodes responds to the stimulating sound, the surgery is performed so that the response does not decrease, that is, so as not to damage the auditory nerve or the like (see, for example, Non-Patent Document 1).

Prior Art Documents

Non-Patent Documents

[0004]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] In neurosurgery, since it is not necessary to touch the ear, as described above, an earphone can be inserted during the operation to observe the patient's reaction to the stimulating sound presented from the earphone. However, in otological surgery, since the operation cannot be performed without touching the ear, it is impossible to keep an insert type earphone or an air conduction receiver attached. In addition, a bone conduction vibrator transmits sound by directly shaking the cochlea by applying vibration to the skull, and since the vibration does not pass through the reconstructed ossicular chain, the effect of reconstructing the ossicular chain cannot be confirmed.

[0006] Originally, if one tries to wear something during the operation, processes such as sterilization, disinfection, and antisepsis according to the situation are essential. For that purpose, the wearable must have a structure that can perform such processes and must be in a method that can be used immediately after the process. For example, ethylene oxide gas (EOG) sterilization using EOG is difficult to use immediately after sterilization because EOG itself is toxic to the human body and removal of the residual gas after sterilization is also necessary. Thus, although there are various difficulties in obtaining the patient's auditory response during otological surgery, in order to reduce the burden on the patient and the doctor, it is desirable to be able to obtain the patient's auditory response during otological surgery and improve the hearing ability in a single operation without performing the operation again.

[0007] Therefore, an object of the present invention is to provide a technique enabling a hearing test to be performed during otological surgery.

Means for Solving the Problems

[0008] To solve the above problems, the present invention employs the following hearing test system. Note that the words in the following parentheses are merely examples, and the present invention is not limited thereto.

[0009] That is, the hearing test system of the present invention is a hearing test system that performs tests using auditory evoked responses, and includes a sound signal output unit that outputs a stimulus sound signal corresponding to a predetermined stimulus sound, and a case that can be sealed in a case where predetermined processing including dealing with microorganisms (processing for dealing with microorganisms or processing for dealing with the attachment of substances harmful to the human body) is possible, and is worn on the patient's ear, and a cartilage conduction vibrator that gives vibrations corresponding to the stimulus sound signal to the auricular cartilage, an electrode that converts the brain waves detected from the patient into electrical signals and outputs them, and an analysis unit that determines the presence or absence of the patient's response to the stimulus sound based on the electrical signals.

[0010] In the hearing test system of this aspect, the cartilage conduction vibrator is sealed in the case, and since this case can be processed such as sterilization, it can be worn on the patient's ear during surgery (after reconstruction of the reconstruction target site) if processed according to the cleanliness level required in the operating room. Therefore, according to the hearing test system of this aspect, the hearing of the patient can be tested during surgery.

[0011] Preferably, in the hearing test system of the above-described aspect, the analysis unit analyzes the patient's hearing ability based on the electrical signals, and compares the analysis result in the test performed before the reconstruction of the reconstruction target site of the ear (for example, the ossicular chain) with the analysis result in the test performed after the reconstruction, and analyzes how much the hearing ability has changed relatively before and after the reconstruction of the reconstruction target site.

[0012] According to the hearing test system of this aspect, it is possible to know how much the hearing ability has been relatively improved by the reconstruction of the reconstruction target site from the analysis result by the analysis unit. Therefore, the doctor can judge whether adjustment of the reconstruction target site is necessary during the surgery based on this analysis result. And by repeating the adjustment and test as necessary, the hearing ability can be improved to a desired state during a single surgery. Therefore, compared with the conventional method in which a hearing test is performed after the surgery and a new surgery has to be performed if the result is not satisfactory, the burden on the patient and the doctor can be significantly reduced.

[0013] More preferably, in the hearing test system according to any of the above-described aspects, the cartilage conduction vibrator has a structure (for example, a clip) that is attached to the ear with a force within a predetermined range. Alternatively, the cartilage conduction vibrator is pressed against the ear with a force within a predetermined range.

[0014] According to the hearing test system of this aspect, since the cartilage conduction vibrator is attached to or pressed against the patient's ear with a force within a predetermined range, the cartilage conduction vibrator can be worn in the same wearing manner in each test performed before and after reconstruction, and variations in test results that may occur due to differences in the wearing manner can be suppressed.

[0015] Even more preferably, in the hearing test system according to any of the above-described aspects, the system further includes an electroencephalogram signal receiving unit that receives an electrical signal from the electrode, and at least one of the communication between the cartilage conduction vibrator and the sound signal output unit and the communication between the electrode and the electroencephalogram signal receiving unit is performed wirelessly.

[0016] According to the hearing test system of this aspect, since at least one of the connection forms of the cartilage conduction vibrator and the electrode is wireless, the number of wires routed around the patient is smaller than when all are wired, making it easier to handle and wear, and reducing or eliminating the occurrence of an unexpected situation where the cartilage conduction vibrator or the electrode becomes detached when something catches on the wire.

Advantages of the Invention

[0017] As described above, according to the present invention, a hearing test can be performed during otological surgery. Also, by comparing the test results before (before surgery) and after (during surgery) reconstruction of the reconstruction target site, it is possible for the doctor to confirm the improvement status of the hearing ability during surgery in order to show how much the hearing ability has relatively changed before and after reconstruction.

Brief Description of the Drawings

[0018]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Embodiments for Carrying Out the Invention

[0019] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that the following embodiments are preferred examples, and the present invention is not limited to this example.

[0020] 〔Configuration of Auditory Examination System〕 FIG. 1 is a block diagram showing the auditory examination system 1 of one embodiment. The auditory examination system 1 is a system that examines hearing using auditory evoked responses, and the cartilage conduction method is adopted as the auditory stimulation means. The auditory examination system 1 includes a cartilage conduction vibrator 10 that applies vibrations for giving auditory stimulation to the auricular cartilage, an electrode 20 that detects potential changes generated in a patient, a control unit 30, a sound signal transmission unit 40, an electroencephalogram signal relay unit 50, an analysis unit 60, a storage area 70, and a display 80. At the time of the examination, the cartilage conduction vibrator 10 is attached to a location with cartilage in the outer ear of the patient, and the electrode 20 is attached to the lower parts of the left and right ears, the top of the head, and the forehead.

[0021] In the illustrated example, the control unit 30, the analysis unit 60, the storage area 70, and the display 80 are implemented in the computer 2 for control / analysis, and the processor of the computer 2 serves as the operating entity of the control unit 30 and the analysis unit 60. Also, the sound signal transmission unit 40 and the electroencephalogram signal relay unit 50 are implemented in the signal transceiver 3, and the processor of the signal transceiver 3 serves as the operating entity of the sound signal transmission unit 40 and the electroencephalogram signal relay unit 50. The cartilage conduction oscillator 10 and the electrode 20 are both connected to the signal transceiver 3 either wired or wirelessly. Also, the signal transceiver 3 is connected to the computer 2 either wired or wirelessly.

[0022] The control unit 30 is responsible for overall control of the examination, and instructs the sound signal transmission unit 40 regarding the type and output timing of the auditory stimulus sound. The sound signal transmission unit 40 outputs a signal corresponding to the auditory stimulus sound of the type instructed by the control unit 30 (hereinafter referred to as the "stimulus sound signal") at the instructed timing and sends it to the cartilage conduction oscillator 10. The cartilage conduction oscillator 10 generates vibrations corresponding to the stimulus sound signal and vibrates the auricular cartilage. Thereby, the auditory stimulus sound is presented through the cartilage conduction pathway (cartilage air conduction pathway, direct air conduction pathway, cartilage bone conduction pathway).

[0023] When the auditory stimulus sound is heard, the patient reacts to this and a change occurs in the electroencephalogram. The electrode 20 detects the potential change generated in the patient as an electroencephalogram, converts it into an electrical signal (hereinafter referred to as the "electroencephalogram signal"), and outputs it to the electroencephalogram signal relay unit 50. The electroencephalogram signal relay unit 50 receives the electroencephalogram signal sent from the electrode 20 and transfers it as it is to the computer 2 (analysis unit 60). The analysis unit 60 synchronously adds and analyzes the electroencephalogram signal received from the electroencephalogram signal relay unit 50 to determine the presence or absence of a reaction to the auditory stimulus sound. Also, the analysis unit 60 compares the analysis results in the examinations conducted before and after the reconstruction of the reconstruction target site of the ear. The storage area 70 is an HDD, RAM, etc., and stores the time history data of the electroencephalogram signal, the data of its analysis results, etc. The display 80 displays the operation menu regarding the examination, the analysis results, etc. on the screen.

[0024] 〔Structure of the cartilage conduction oscillator〕 Figure 2 is a diagram showing the cartilage conduction oscillator 10. As shown in (A) of FIG. 2, the cartilage conduction vibrator 10 is roughly composed of a vibration unit 11 incorporating an electromechanical transducer that converts an electrical signal into a mechanical vibration, a cable 12 having one end connected to the vibration unit 11, and a case 13 that seals the entire vibration unit 11. The cable 12 is composed of a lead wire and a coating material that covers the outside thereof. The vibration unit 11 generates vibrations corresponding to the stimulation sound signal sent from the sound signal transmission unit 40 via the cable 12.

[0025] When the other end of the cable 12 is connected to the signal transceiver 3 in the case of a wired connection between the cartilage conduction vibrator 10 and the signal transceiver 3, or is connected to a wireless communication unit (not shown) provided outside the case 13 in the case of a wireless connection. Note that the wireless communication unit may be provided inside the case 13, and in such a configuration, the cable 12 becomes unnecessary.

[0026] The case 13 and the coating material of the cable 12 are formed of a material (for example, resin) that can be processed such as sterilization necessary for use in the operating room. Here, the "processing such as sterilization" (predetermined processing) refers to processing for dealing with microorganisms and processing for dealing with the attachment of substances harmful to the human body. For example, sterilization that kills or removes all microorganisms, disinfection that kills microorganisms, and disinfection that reduces microorganisms or loses their infectivity are assumed.

[0027] When the cartilage conduction vibrator 10 is worn during the operation (after reconstruction of the reconstruction target site), an optimal treatment corresponding to the required cleanliness level at that time is selected, and the base portions of the case 13 and the cable 12 are treated with alcohol, gas, etc. each time. In this way, since the entire outer surface of the vibration unit 11 of the cartilage conduction vibrator 10 is covered with the case 13, it can be worn on the patient's ear even during the operation if a treatment such as sterilization is performed.

[0028] As shown in (B) of FIG. 2, the cartilage conduction vibrator 10 is attached to the concha so as to be inserted, for example, inside the tragus and antitragus. In the illustrated example, the ear canal is visible behind the attached cartilage conduction vibrator 10. Note that, taking into account individual differences in the outer ear shape and the incision site in surgery, etc., it may be attached in a manner different from the illustrated example. During the examination, the cartilage conduction vibrator 10 can be pressed by hand with a substantially constant force as needed, or fixed in a certain position by taping. In any case, according to the cartilage conduction vibrator 10, auditory stimulation can be given without affecting the surgical site.

[0029] When the cartilage conduction vibrator 10 is pressed against the ear by hand, it can be pressed with a substantially constant force by visually checking the magnitude of the force applied to the ear using a force gauge or the like. Also, the force for pressing the cartilage conduction vibrator 10 against the ear does not have to be substantially constant, and it may be pressed with a force within a range having a somewhat wide margin above and below (a force within a predetermined range).

[0030] 〔Flow before and after reconstruction〕 FIG. 3 is a flowchart showing the flow of an examination accompanying a reconstruction surgery of the ossicular chain as an example of an examination for evaluating the effect of otological surgery. For convenience of explanation, in FIG. 3, the flow when the examination before reconstruction is performed after entering the operating room will be described as an example. The steps shown in double frames correspond to the reconstruction surgery. Note that during the surgery, the control / analysis computer 2 and the signal transceiver 3 do not necessarily have to be arranged in the operating room, and may be arranged in another room.

[0031] Step S10: Attach the cartilage conduction vibrator 10 and the electrodes 20 to the patient. The cartilage conduction vibrator 10 is attached so as to surely touch the ear cartilage. The electrodes 20 are attached to a total of four locations: the lower parts of the left and right ears, the top of the head, and the forehead.

[0032] Step S12: When the start button for the pre-reconstruction inspection is pressed (including clicking, tapping, etc.; the same applies hereinafter) from the operation menu displayed on the screen of the display 80, the evoked response inspection process is executed. The results of this inspection are stored in the storage area 70 as the pre-reconstruction inspection results. Note that the detailed content of the evoked response inspection process will be described in detail later with reference to another drawing.

[0033] Step S14: In preparation for the subsequent reconstruction surgery, the cartilage conduction vibrator 10 is removed from the patient, and the electrode 20 remains attached.

[0034] Note that the above-described pre-reconstruction procedures (Steps S10 to S14) may be performed before entering the operating room (for example, during outpatient medical treatment). In that case, in Step S14, the electrode 20 is also removed together with the cartilage conduction vibrator 10, and after entering the operating room, the electrode 20 is reattached to the patient to proceed with the surgery.

[0035] Step S20: The doctor reconstructs the ossicular chain.

[0036] Step S22: After performing a treatment such as sterilization on the cartilage conduction vibrator 10, the cartilage conduction vibrator 10 is reattached to the patient.

[0037] Step S24: When the start button for the post-reconstruction inspection is pressed from the operation menu displayed on the screen of the display 80, the evoked response inspection process is executed. The results of this inspection are stored in the storage area 70 as the post-reconstruction inspection results.

[0038] Step S26: When the evoked response inspection process ends, the inspection result comparison process is executed. In the inspection result comparison process, the analysis unit 60 compares the pre-reconstruction inspection results obtained in Step S12 with the post-reconstruction inspection results obtained in the immediately preceding Step S24, and analyzes how much the hearing ability has changed relatively before and after the reconstruction. The analysis results are displayed on the screen of the display 80.

[0039] Steps S28, S30: Based on the above analysis results, the doctor determines whether an acceptable improvement effect has been obtained (step S28). If no acceptable improvement effect has been obtained (step S28: No), the doctor determines whether there is room for improvement (step S30). If there is room for improvement (step S30: Yes), the process proceeds to step S32. On the other hand, if an acceptable improvement effect has been obtained (step S28: Yes), or if no acceptable improvement effect has been obtained (step S28: No) and no further improvement is expected (step S30: No), the process proceeds to step S36.

[0040] Steps S32, S34: If there is room for improvement, the doctor removes the cartilage conduction vibrator 10 from the patient (step S32) and adjusts the ossicular chain (step S34). Then, the process returns to step S22 and the subsequent steps are executed again.

[0041] Step S36: The doctor removes the cartilage conduction vibrator 10 and the electrode 20 from the patient.

[0042] Following the above process, during the reconstruction surgery, the adjustment of the ossicular chain and the evoked response test after adjustment are repeated until the doctor determines that an acceptable improvement effect has been obtained, or until the doctor determines that no acceptable improvement effect has been obtained but no further improvement is expected. Then, in the test result comparison process (step S26), the test result before reconstruction is compared with the test result after adjustment (the latest test result after reconstruction).

[0043] In this way, in this embodiment, the evoked response test is performed after the reconstruction (during the surgery) to confirm whether the hearing has been improved by the reconstruction. If it has not been improved, the adjustment is made and then it is confirmed again whether the hearing has been improved. Therefore, compared with the conventional method of repeating the process of performing a hearing test after the completion of the surgery and performing the surgery again if the result is not satisfactory, the burden on the patient and the doctor can be significantly reduced.

[0044] In addition, in this embodiment, as described above, a doctor determines whether a desired effect is obtained based on a relative value obtained by comparing the inspection result before reconstruction and the inspection result after reconstruction (after adjustment). That is, in the auditory inspection system 1, it is only necessary to obtain a relative value of hearing based on the inspection results before and after reconstruction, and it is not necessary to accurately obtain a hearing threshold in each evoked response inspection process (steps S12 and S24). Therefore, calibration according to standards such as an audiometer and equipment management are not required. Therefore, the auditory inspection system 1 can be handled more easily than equipment that requires strict management.

[0045] Note that due to differences in the wearing mode of the cartilage conduction vibrator 10 (such as the wearing position and the degree of contact with the auricular cartilage), there may be variations in the inspection results, and thus in the relative values obtained from the inspection results before and after reconstruction. Therefore, a mark may be made on the wearing position of the cartilage conduction vibrator 10 during the inspection before reconstruction, and during the inspection after reconstruction (after adjustment), the cartilage conduction vibrator 10 may be worn in the same manner as before reconstruction in accordance with this mark. Alternatively, an inspection may be performed by wearing a cartilage conduction vibrator having a shape that can be worn in a certain manner. Specific examples of such a cartilage conduction vibrator will be further described later with reference to other drawings.

[0046] 〔Evoked Response Inspection Process〕 FIG. 4 is a flowchart showing an example of the procedure of the evoked response inspection process. The evoked response inspection process is a process for objectively inspecting hearing using an auditory evoked response, and is executed before (step S12 in FIG. 3) and after (step S24 in FIG. 3) the reconstruction of the ossicular chain in the auditory inspection system 1. In this embodiment, an auditory brainstem response (ABR) is used as the auditory evoked response. The following will be described along with an example of the procedure.

[0047] Step S50: The control unit 30 instructs the sound signal transmission unit 40 to start the evoked response inspection. At the start of the evoked response inspection, an initial value of "0" is set in the inspection count counter N.

[0048] Step S52: In response to an instruction from the control unit 30, the sound signal transmission unit 40 outputs a stimulation sound signal of a predetermined type and sound pressure level, and sends it to the cartilage conduction oscillator 10. Generally, a click sound is set as the type of the stimulation sound signal, but a tone pip sound, a tone burst sound, or a pure sound may also be set. In addition, the lowest sound pressure level in the inspection target range is set as the initial value of the sound pressure level of the stimulation sound signal.

[0049] Step S54: The cartilage conduction oscillator 10 generates vibrations corresponding to the stimulation sound signal sent from the sound signal transmission unit 40, vibrates the auricular cartilage, and thereby presents an auditory stimulation sound.

[0050] Step S56: The electroencephalogram signal relay unit 50 receives the electroencephalogram signal sent from the electrode 20 in synchronization with the presentation of the auditory stimulation sound, and transfers it to the analysis unit 60 as it is. The analysis unit 60 temporarily holds the received electroencephalogram signal data in the storage area 70.

[0051] Steps S58, S60: The control unit 30 adds "1" to the inspection count counter N (Step S58), and checks whether the inspection count counter N after the addition is less than a certain value (for example, "1000") (Step S60). As a result of the check, if the inspection count counter N is less than the certain value, that is, if the number of inspections at the current sound pressure level has not yet reached a certain number (Step S60: Yes), the control unit 30 returns the control to Step S52 and repeats the subsequent procedures.

[0052] Step S62: On the other hand, if the inspection count counter N is equal to or greater than the certain value, that is, if the number of inspections at the current sound pressure level has reached a certain number (Step S60: No), the analysis unit 60 synchronously adds and analyzes the electroencephalogram signals transferred in Step S56 for the inspections performed a certain number of times at the current sound pressure level, and records the analysis result (the inspection result for the current sound pressure level) indicating the state of the auditory nerve transmission system with respect to the auditory stimulation sound at the current sound pressure level in the storage area 70.

[0053] Steps S64 to S68: The control unit 30 checks whether the current sound pressure level has reached the upper limit within the inspection target range (step S64). If the sound pressure level has not yet reached the upper limit (step S64: No), the control unit 30 increases the sound pressure level in predetermined steps (for example, 10 dB) (step S66), resets the inspection count counter N to "0" (step S68), returns the control to step S52, and repeats the subsequent procedures to proceed with the inspection at the sound pressure level after a constant step increase. On the other hand, if the sound pressure level has reached the upper limit (step S64: Yes), the control unit 30 terminates the evoked response inspection process.

[0054] Note that the procedure example shown in FIG. 4 is merely an example and can be appropriately changed according to the situation without being limited thereto. In the above procedure example, the inspection is performed by gradually increasing the sound pressure level. Instead of this, the inspection may be performed only at a specific sound pressure level.

[0055] 〔Modification Example〕 FIG. 5 is a block diagram showing an auditory inspection system 101 of a modification example. In the auditory inspection system 1 (see FIG. 1) of the above-described embodiment, the sound signal transmission unit 40 and the electroencephalogram signal relay unit 50 were implemented in a device different from the control / analysis computer 2 called the signal transceiver 3. In contrast, in the auditory inspection system 101 of the modification example, there is no signal transceiver, and the sound signal transmission unit 40 and the electroencephalogram signal reception unit 51 are implemented in the control / analysis computer 102.

[0056] Therefore, in the auditory inspection system 101, a stimulus sound signal is directly sent from the computer 102 to the cartilage conduction vibrator 10, and the electroencephalogram signal output by the electrode 20 is directly received by the computer 102. Even with such a configuration, the same operational effects as those of the auditory inspection system 1 of the embodiment can be produced.

[0057] FIG. 6 is a diagram showing various modified examples of a cartilage conduction oscillator. The left side in the figure shows the modified cartilage conduction oscillator alone, and the right side shows an example of the wearing state of the cartilage conduction oscillator. All of the modified cartilage conduction oscillators shown below are common to the above-described cartilage conduction oscillator 10 in that the entire vibration part is sealed in a case that can be processed such as sterilization, but each has different characteristics in terms of its outer shape.

[0058] (A) in FIG. 6 shows a cartilage conduction oscillator 110 of the first modified example. In the cartilage conduction oscillator 110, a support part 114 extends from a vibration part 111 having a substantially spherical shape, and a cable 112 is connected to the end of the support part 114. And the entire outer surface of the vibration part 111 and the support part 114 is covered with a material that can be processed such as sterilization. The cartilage conduction oscillator 110 can be stably mounted at a fixed position by placing the vibration part 111 between the tragus and the antitragus with the base of the support part 114 aligned with the intertragal notch and fitting it into the concha cavity.

[0059] (B) in FIG. 6 shows a cartilage conduction oscillator 210 of the second modified example. The cartilage conduction oscillator 210 is roughly composed of a vibration part 211 and a vibration transmission part 215. The vibration part 211 is composed of a rod-shaped part 211a and a semi-ring part 211b that branches into two branches from one end of the rod-shaped part 211a and extends in an arc shape, and the entire outer surface is covered with a material that can be processed such as sterilization. Further, the vibration transmission part 215 is formed in a ring shape with a material that can be processed such as sterilization and is adhered to the semi-ring part 211b. A cable 212 is connected to the other end of the rod-shaped part 211a. The cartilage conduction oscillator 210 can be stably mounted at a fixed position, for example, by aligning the rod-shaped part 211a along the intertragal notch, placing a part of the semi-ring part 211b inside the tragus and the antitragus, and fitting it into the concha cavity while pressing the upper end of the vibration transmission part 215 against the antihelical crus.

[0060] In Fig. 6(C), the cartilage conduction oscillator 310 of the third modification is shown. The cartilage conduction oscillator 310 is obtained by adding a clip to the cartilage conduction oscillator 10 of the above-described embodiment, and a clip 316 formed of a material capable of being processed such as sterilization is provided on one side thereof. The cartilage conduction oscillator 310 can be stably attached to a fixed position with a certain force, for example, by sandwiching and fixing the tragus and the peripheral portion of the concha cavity while housing a part thereof in the concha cavity with the clip 316.

[0061] 〔Advantages of the present invention〕 As described above, according to the auditory examination system and the cartilage conduction oscillator in any of the above-described forms, the following effects can be obtained.

[0062] (1) Since the vibration part and its peripheral part of the cartilage conduction oscillators 10, 110, 210, and 310 are sealed in a case capable of being processed such as sterilization, they can be attached to the patient's ear during surgery after being processed such as sterilization. Therefore, according to the auditory examination system 1, 101 provided with such a cartilage conduction oscillator, the hearing ability of the patient can be examined after the reconstruction of the reconstruction target site (during surgery).

[0063] (2) According to the auditory examination system 1, 101, based on the relative value obtained by comparing the results of the evoked response tests performed before reconstruction (before surgery) and after reconstruction (during surgery), the doctor can confirm whether the hearing ability has been improved by the reconstruction, and if necessary, repeatedly adjust the reconstruction target site. Therefore, it is possible to improve the hearing ability to a desired state during one surgery. Therefore, the burden on the patient and the doctor can be significantly reduced compared to the conventional method of repeating the process of performing a hearing test after the surgery and performing the surgery again if the result is not satisfactory.

[0064] (3) In the auditory examination system 1, 101, the relative value of the hearing ability may be obtained by comparing the examination result before the reconstruction of the reconstruction target site with the examination result after the reconstruction (after adjustment). Since it is not necessary to accurately obtain the hearing threshold value, it can be handled more easily than a device that requires calibration and device management according to standards such as an audiometer.

[0065] (4) The cartilage conduction vibrators 110, 210, and 310 of the modified examples can be worn on the outer ear in a certain manner (fixed at a certain position with a certain force). Therefore, variations that may occur in the test results due to differences in the wearing manner of the cartilage conduction vibrator can be suppressed, and the relative value of hearing ability based on the test results before and after reconstruction can be accurately obtained.

[0066] The present invention can be variously modified and implemented without being restricted by the above-described embodiments and modified examples.

[0067] In the above-described embodiment, the hearing test before and after the reconstruction of the ossicular chain was taken as an example for explanation. However, it is naturally necessary to relatively evaluate the hearing ability before and after the reconstruction of other parts (for example, before and after tympanoplasty). That is, the hearing test system of the embodiment or the modified example is not limited to the time of reconstructing the ossicular chain and can be used at the time of reconstructing various parts of the middle ear.

[0068] The computer for control / analysis in the above-described embodiments and modified examples may be one in which necessary functional parts are implemented on a general-purpose computer equipped with a CPU, RAM, HDD, various I / Fs, a display, etc., or may be one designed and implemented as a device dedicated to the hearing test system.

[0069] In the above-described embodiment, the analysis result by the analysis unit 60 (the result of comparing the test results before and after reconstruction) is displayed on the display 80. However, instead of this, the analysis result may be output to a printer or output to other devices connected to the computer for control / analysis.

[0070] In the above-described embodiments and modifications, a cartilage conduction vibrator is used. However, instead of the cartilage conduction vibrator, it is also possible to perform the examination using a small vibrator. FIG. 7 shows a wearing mode in a modification using a small vibrator 410, using a cross-sectional view of the left ear cut at a position passing through the tragus and antitragus. The vibrating part 411 is sealed in a case that can be processed such as sterilization, and one end of a cable 412 is connected to the vibrating part 411. Such a vibrator 410 may be inserted into the external auditory canal and brought into contact with the eardrum, and an auditory stimulus sound may be presented by directly vibrating the eardrum.

[0071] In this modification, after determining the position of the vibrating part 411, a part of the cable 412 is fixed to the ear with a tape TP or the like. When the cable 412 is hard, the vibrating part 411 can be brought into contact with the eardrum with a force within a predetermined range by pressing the cable 412 by hand, or the vibrating part 411 can be pressed against the eardrum with a force within a predetermined range while checking the magnitude of the force with a force gauge or the like.

[0072] In addition, the configurations, numerical values, etc. mentioned in the process of explaining the auditory examination system of the embodiments and modifications, and the cartilage conduction vibrator of the embodiments and modifications are merely examples, and it goes without saying that they can be appropriately modified in the implementation of the present invention.

Explanation of symbols

[0073] 1 Auditory examination system 10 Cartilage conduction vibrator 20 Electrode 30 Control unit 40 Sound signal transmission unit (sound signal output unit) 50 Electroencephalogram signal relay unit (electroencephalogram signal reception unit) 60 Analysis unit 70 Memory area 80 Display

Claims

1. An auditory examination system that performs an examination using an auditory evoked response, comprising: a sound signal output unit that outputs a stimulus sound signal corresponding to a predetermined stimulus sound; a cartilage conduction vibrator that is sealed in a case capable of performing a predetermined process including dealing with microorganisms, is attached to a patient's ear, and applies vibration corresponding to the stimulus sound signal to the auricular cartilage; an electrode that converts an electroencephalogram detected from a patient into an electrical signal and outputs it; an analysis unit that determines the presence or absence of a patient's response to the stimulus sound based on the electrical signal An auditory examination system comprising.

2. In the auditory examination system according to Claim 1, the analysis unit analyzes the patient's hearing ability based on the electrical signal, compares the analysis result in the examination performed before the reconstruction of the reconstruction target site of the ear with the analysis result in the examination performed after the reconstruction, and analyzes how much the hearing ability has changed relatively before and after the reconstruction of the reconstruction target site. An auditory examination system characterized by that.

3. In the auditory examination system according to Claim 1 or 2, the cartilage conduction vibrator has a structure that is attached to the ear with a force within a predetermined range. An auditory examination system characterized by that.

4. In the auditory examination system according to Claim 1 or 2, the cartilage conduction vibrator is pressed against the ear with a force within a predetermined range. An auditory examination system characterized by that.

5. In the auditory examination system according to Claim 1 or 2, further comprising an electroencephalogram signal receiving unit that receives the electrical signal from the electrode, Among the communication between the cartilage conduction vibrator and the sound signal output unit and the communication between the electrode and the electroencephalogram signal receiving unit, at least one is performed wirelessly. An auditory examination system characterized by that.

6. In the auditory examination system according to Claim 1 or 2, the sound signal output unit is mounted on a first device, the analysis unit is mounted on a second device different from the first device. An auditory examination system characterized by that.