Device and method for joint treatment through sound and ear vagus nerve electric pulse stimulation

Abstract

The invention discloses a device and method for joint treatment through sound and ear vagus nerve electric pulse stimulation. The device comprises an energy supply receiving device (10), an audio treatment device (20) and a pulse treatment device (30), wherein the audio treatment device (20) and the pulse treatment device (30) are rotationally connected with the energy supply receiving device (10). A treatment packet corresponding to the condition of a patient is selected from mobile phone software, the treatment packet comprises audio data and pulse data corresponding to the condition, and after receiving wireless signals of the audio data and the pulse data of the treatment packet, the device converts the wireless signals into an audio data electric signal and a pulse data electric signal through a wireless signal processing chip; then the signals are respectively transmitted to the audio decoder and the pulse generator, finally, corresponding sound electric signals and pulse signals are generated, the sound electric signals output sound through the loudspeaker to carry out sound treatment on the cochlea, and meanwhile, the pulse signals carry out pulse stimulation treatment on the earlobe through the electrode slice.

Description

Technical Field

[0001] The invention relates to a device and method for joint treatment by sound and ear vagus nerve electric pulse stimulation, belonging to the technical field of medical devices. Background Art

[0002] Sound therapy is a method of relieving stress, promoting relaxation and improving health by producing specific sound frequencies and rhythms. This therapy can stimulate certain areas of the brain through specific sound frequencies and rhythms, thereby affecting the body's physiological and psychological state to achieve the purpose of treating diseases. Auricular vagus nerve electrical pulse stimulation is a method of using electrical pulse signals to stimulate the ear nerves, regulate the autonomic nervous system, balance the neuroendocrine system in the body, and affect certain areas of the brain to achieve the purpose of improving and regulating physical and psychological states.

[0003] Both sound therapy and ear vagus nerve pulse stimulation are auxiliary treatment methods, and both have certain therapeutic effects on insomnia, anxiety, depression, fatigue, nerve regulation, tinnitus and other symptoms. The two treatment methods can be combined with drugs, psychology, physics, acupuncture and other treatment methods to improve human health.

[0004] The invention patent with application number 5023116994622 proposes a device and method for joint treatment of sound and ear vagus nerve electrical pulse stimulation, including mobile phone software and a therapeutic device; the mobile phone software exchanges data with the therapeutic device in a contactless communication manner through wireless communication to achieve communication of audio data and control data with the therapeutic device; the therapeutic device includes a Bluetooth voice processing chip, a stimulation circuit, an electrode sheet, a load detection circuit and a speaker; the Bluetooth voice processing chip receives the voice signal of the mobile phone APP and processes it with a treatment algorithm to form a sound electrical signal, and transmits it to the speaker; the Bluetooth voice processing chip also communicates with the stimulation circuit through a serial interface; the stimulation circuit receives commands from the Bluetooth processing chip and generates a stimulation current signal according to the command; the electrode sheet transmits the stimulation current signal generated by the stimulation circuit to the human body; sound therapy and ear vagus nerve electrical stimulation are combined.

[0005] This invention patent uses a combination of sound therapy and ear vagus nerve electrical stimulation to treat the human body. However, from the structure and method, it is known that when using ear vagus nerve electrical stimulation for treatment, a load detection circuit is required for control, because it cannot be guaranteed that the electrical signal received each time is within the treatment range. Once the load detection circuit is out of control, not only will the treatment effect not be achieved, but it is more likely to cause damage to the human body. In addition, the method disclosed in this invention does not include the establishment of an algorithm.

[0006] Therefore, the present application proposes a device and method for combined treatment of sound and ear vagus nerve electrical pulse stimulation. Summary of the invention

[0007] In order to solve the above-mentioned technical problems, the present invention discloses a device and method for combined treatment of sound and ear vagus nerve electrical pulse stimulation.

[0008] The technical solution adopted by the present invention is: to provide a device for joint treatment of sound and ear vagus nerve electric pulse stimulation, including an energy supply receiving device, an audio treatment device and a pulse treatment device which are respectively rotatably connected to the energy supply receiving device.

[0009] Preferably, the energy supply receiving device includes a sleeve, a rotating shaft inserted into the sleeve, a shell for mounting the rotating shaft, an energy supply device arranged in the shell, and a wireless signal processing chip electrically connected to the energy supply device.

[0010] Preferably, the energy supply device includes a power adapter, a charging circuit connected to the power adapter, a lithium battery connected to the charging circuit, and a control circuit for controlling the lithium battery to deliver electrical energy; the energy supply device is electrically connected to the wireless signal processing chip through the control circuit.

[0011] Preferably, the audio therapy device includes an ear cap, a front cavity connected to the ear cap, a rear cavity connected to the front cavity, an audio decoder arranged in the rear cavity, and a speaker electrically connected to the audio decoder; the audio decoder is electrically connected to the control circuit via a wire.

[0012] Preferably, the pulse treatment device includes a pulse generating device, a shaping hose connected to the pulse generating device, and a pulse output device connected to the shaping hose.

[0013] Preferably, the pulse generating device comprises a massage protrusion, a generating shell for mounting the massage protrusion, and a pulse generator mounted in the generating shell; the pulse generator is electrically connected to the control circuit via a wire.

[0014] Preferably, the pulse output device comprises an output shell, an electrode sheet installed in the output shell, and a stimulation needle installed on the electrode sheet; the electrode sheet is electrically connected to the pulse generator via a wire.

[0015] The present invention further provides a method for combined treatment of sound and ear vagus nerve electrical pulse stimulation, comprising the following steps:

[0016] S1. Establish a knowledge base of sound and ear vagus nerve electrical pulse stimulation to generate a treatment package for a common treatment device;

[0017] S2. Wear the device, fit the pulse generator in the device to the vagus nerve of the ear, then bend the pulse output device through the shaping hose to match it with the pulse generator, clamp it to the vagus nerve of the ear, and then insert the ear cap in the audio therapy device into the external auditory canal to complete the wearing;

[0018] S3, start the mobile phone treatment software, select a suitable treatment package from the software according to the patient's condition, and click on the treatment package, the treatment package contains audio data and pulse data, and each treatment package has audio data and pulse data for at least one condition;

[0019] S4, the device receives the wireless signal of the treatment package through the wireless signal processing chip, and converts the wireless signal of the treatment package into an electrical signal of the treatment package, and transmits the electrical signal of the treatment package to the audio decoder and the pulse generator respectively after processing;

[0020] S5, after the audio decoder and the pulse generator simultaneously receive the electrical signal of the treatment package, they generate sound and electrical pulse stimulation through the speaker and the electrode sheet respectively, so as to perform sound therapy and ear vagus nerve therapy on the patient;

[0021] S6. Adjust the treatment plan according to the treatment effect of tinnitus patients and optimize the device parameters.

[0022] Preferably, S1 comprises the following sub-steps:

[0023] S11. Collect initial case data of tinnitus patients;

[0024] S12. Preliminary selection of treatment parameters;

[0025] S13, generating sound and ear vagus nerve electrical pulse stimulation signals;

[0026] S14. Study the effects of sound and electrical stimulation of the vagus nerve, and continuously optimize after evaluation and feedback;

[0027] S15. Complete the establishment of the knowledge base of sound and ear vagus nerve electrical pulse stimulation.

[0028] Preferably, the S13 comprises:

[0029] 1) Perform Fourier transform on the collected tinnitus signal to analyze its frequency components;

[0030] 2) Set the masking frequency and establish the masking model;

[0031] 3) Establish an electrical pulse stimulation regulation model;

[0032] 4) Synthesize sound and electrical pulse signals.

[0033] Beneficial effects of the present invention:

[0034] The present invention combines mobile phone software and therapeutic apparatus, which is small in size and convenient to carry. At the same time, the wireless signal generated by the mobile phone software is converted into a sound electric signal and an electric pulse signal through the device, and the human body is treated by sound and electric pulse stimulation through the cochlea and the vagus nerve of the ear respectively; specifically, a treatment package corresponding to the patient's condition is selected from the mobile phone software, and the treatment package contains audio data and pulse data corresponding to the condition. After the device receives the audio data and pulse data wireless signals of the treatment package, it is converted into audio data electric signals and pulse data electric signals through a wireless signal processing chip, and then transmitted to an audio decoder and a pulse generator respectively, and finally generates corresponding sound electric signals and pulse signals. The sound electric signal outputs sound through a speaker to perform sound treatment on the cochlea, and at the same time, the pulse signal performs pulse stimulation treatment on the vagus nerve of the ear through an electrode sheet. The method provided by the present invention also includes how to establish a treatment algorithm for continuous improvement. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 A schematic diagram of a device for combined treatment of sound and ear vagus nerve electrical pulse stimulation;

[0036] Figure 2 yes Figure 1 The left view structural diagram of ;

[0037] Figure 3 yes Figure 2 A schematic diagram of the structure of the energy receiving device;

[0038] Figure 4 yes Figure 2 A schematic diagram of the structure of the medium-frequency treatment device;

[0039] Figure 5 yes Figure 2 A schematic diagram of the structure of the pulse generating device;

[0040] Figure 6 yes Figure 2 The schematic diagram of the structure of the pulse output device;

[0041] Figure 7 yes Figure 1 Schematic diagram of the wiring arrangement. DETAILED DESCRIPTION

[0042] The present invention will be further described below in conjunction with specific drawings.

[0043] Specifically, a device for combined treatment of sound and ear vagus nerve electrical pulse stimulation is provided, comprising an energy supply receiving device 10, an audio treatment device 20 and a pulse treatment device 30 which are rotatably connected to the energy supply receiving device 10 respectively.

[0044] like Figure 1 and Figure 2 As shown, a connecting tube is provided between the energy receiving device 10 and the audio therapy device 20 and the pulse therapy device 30. The angles of the two connecting tubes can be adjusted by rotating on the energy receiving device 10. A wire passes through the connecting tube for power supply and signal transmission between the energy receiving device 10 and the audio therapy device 20 and the pulse therapy device 30.

[0045] By rotating on the energy receiving device 10, the audio therapy device 20 and the pulse therapy device 30 are adjusted to the external auditory canal and the vagus nerve of the ear respectively, and then worn accordingly.

[0046] Furthermore, the energy supply receiving device 10 includes a sleeve 11, a rotating shaft 12 inserted into the sleeve 11, a shell 13 for mounting the rotating shaft 12, an energy supply device 14 disposed in the shell 13, and a wireless signal processing chip 15 electrically connected to the energy supply device 14.

[0047] like Figure 3 As shown, a rotating shaft 12 is installed on each of the left and right sides of the shell 13, and the shaft sleeve 11 is sleeved on the rotating shaft 12 and can be rotated to adjust the audio treatment device 20 and the pulse treatment device 30 accordingly.

[0048] The energy supply device 14 can be charged by magnetic induction or by wired charging, and includes a power adapter 141, a charging circuit 142 connected to the power adapter 141, a lithium battery 143 connected to the charging circuit 142, and a control circuit 144 for controlling the lithium battery 143 to deliver electrical energy; the energy supply device 14 is electrically connected to the wireless signal processing chip 15 via the control circuit 144.

[0049] like Figure 4 As shown, the audio therapy device 20 includes an ear cap 21, a front cavity 22 connected to the ear cap 21, a rear cavity 23 connected to the front cavity 22, an audio decoder 24 arranged in the rear cavity 23, and a speaker 25 electrically connected to the audio decoder 24; the audio decoder 24 is electrically connected to the control circuit 144 via a wire.

[0050] Furthermore, the pulse treatment device 30 includes a pulse generating device 31 , a shaping hose 32 connected to the pulse generating device 31 , and a pulse output device 33 connected to the shaping hose 32 .

[0051] Furthermore, the pulse generating device 31 includes a massage protrusion 311, a generating shell 312 for mounting the massage protrusion 311, and a pulse generator 313 installed in the generating shell 312; the pulse generator 313 is electrically connected to the control circuit 144 via a wire.

[0052] Furthermore, the pulse output device 33 includes an output shell 331, an electrode sheet 332 installed in the output shell 331, and a stimulation needle 333 installed on the electrode sheet 332; the electrode sheet 332 is electrically connected to the pulse generator 313 through a wire.

[0053] like Figures 1 to 7 As shown, the pulse generating device 31 and the pulse output device 33 can be freely bent through the shaping hose 32. After bending, the bent shape can be maintained. If the two are put together, they will have a certain clamping effect on the object.

[0054] When the device is worn, because the earlobe is below the external auditory canal, the adjusted energy supply receiving device 10, audio therapy device 20 and pulse therapy device 30 form a triangle state, the audio therapy device 20 is inserted into the external auditory canal by the ear cap 21 for fixation, and the pulse therapy device 30 is bent by the pulse generating device 31 and the pulse output device 33 to clamp and fix the earlobe; after the audio therapy device 20 and the pulse therapy device 30 are fixed on the ear respectively, they form a stable triangle with the energy supply receiving device 10 to prevent the device from falling off during the treatment process.

[0055] The audio therapy device 20 plays therapeutic music through the audio decoder 24 and the speaker 25 to treat the external auditory canal. At the same time, the pulse therapy device 30 outputs pulse signals through the pulse generating device 31 and the pulse output device 33 to stimulate the vagus nerve at the ear vagus nerve for treatment.

[0056] During vagus nerve treatment, the stimulation needle 333 releases a pulse signal, which generates a slight vibration, and cooperates with the massage protrusion 311 to stimulate the vagus nerve while also initiating a certain massage and dredging effect.

[0057] Non-invasive neuromodulation acoustic and ear vagus nerve electrical pulse stimulation coordinated resetting is a promising treatment method that aims to regulate the nervous system through acoustic signals and ear vagus nerve electrical pulse stimulation signals to alleviate or treat a series of nervous system-related diseases and symptoms. This technology usually combines acoustic stimulation with neuromodulation principles, and is mainly used to improve nerve function and promote physical recovery. An embodiment of the present invention provides a method for joint treatment of sound and ear vagus nerve electrical pulse stimulation, using the aforementioned device for joint treatment of sound and ear vagus nerve electrical pulse stimulation, including the following steps:

[0058] S1. Establish a knowledge base of sound and ear vagus nerve electrical pulse stimulation for generating treatment packages for common treatment devices.

[0059] First, it is necessary to establish a knowledge base of sound and ear vagus nerve electrical pulse stimulation based on a large number of case studies to select the treatment plan of the device. This step includes the following sub-steps:

[0060] S11. Collect initial case data of tinnitus patients.

[0061] Initial case data collection for tinnitus patients includes the following aspects:

[0062] 1) Patient assessment. First, conduct a comprehensive assessment of tinnitus patients, including the nature, intensity, frequency, and impact of tinnitus on the patient's quality of life. Questionnaires, hearing tests, and other methods can be used to obtain relevant data.

[0063] 2) Physiological signal monitoring: Collect the patient's physiological signals, such as electroencephalogram (EEG), heart rate variability (HRV), etc., to help understand the patient's physiological state and the characteristics of tinnitus, and collect information on tinnitus signals.

[0064] S12. Preliminary selection of treatment parameters.

[0065] The human ear can usually hear sounds from 20Hz to 20,000Hz. Sounds of different frequencies have different therapeutic effects. The selected frequency range can be selected according to different goals. Lower frequencies below 1000Hz can promote deep relaxation and meditation, and high frequencies above 1000Hz can be used for stimulation. For example, 432Hz audio can be used to help relaxation and meditation, and 528Hz audio has a certain effect in relieving pain.

[0066] The initial selection of treatment parameters, including frequency and other parameters, can be based on historical experience and previous research results to make full use of existing technologies, narrow the scope of research attempts, shorten the research time, and accelerate the establishment of models and knowledge bases.

[0067] S13, generating sound and ear vagus nerve electrical pulse stimulation signals.

[0068] Based on the analysis of patient data, algorithms are used to generate specific sounds and electrical pulse stimulation signals of the vagus nerve. These signals include music or other modulated signals, which are designed to mask tinnitus or directly affect neuronal activity to achieve the purpose of treating tinnitus.

[0069] During the signal generation process, the following methods are used:

[0070] 1) Perform Fourier transform on the collected tinnitus signal and analyze its frequency components.

[0071] The frequency characteristics of the tinnitus signal are analyzed using the Fast Fourier Transform (FFT) algorithm to determine the fundamental frequency and other frequencies of the tinnitus.

[0072] 2) Set the masking frequency and establish the masking model.

[0073] Tinnitus patients usually hear certain specific frequencies of sound, which generates sounds or stimulation signals close to the tinnitus frequency. By playing and applying antagonistic sounds and stimulation models of these frequencies, part of the tinnitus can be masked and the perception of tinnitus can be reduced. The establishment of the masking model can be achieved by comparing the intensity of the tinnitus frequency and the background signal, which can usually be expressed by the following formula:

[0074] M(f)=S(f)+∑Ri(f)

[0075] Among them, M(f) is the masking sound intensity, S(f) is the background sound intensity, and Ri(f) is the masking signal related to tinnitus. These parameters are all functions of frequency f.

[0076] 3) Establish an electrical pulse stimulation regulation model.

[0077] The electrical pulse stimulation signal can be recycled or synthesized to study and test the response of several basic electrical pulse signals and establish an electrical pulse stimulation regulation model. The basic electrical pulse signals include:

[0078] 1) Continuous wave. Continuous wave refers to a combination of different ways of generating a single pulse to form a waveform with different frequencies, without a pause in the middle, and the frequency is continuously adjustable. The frequency of the continuous wave is continuously adjustable, and the appropriate frequency can be selected for treatment as needed.

[0079] 2) Sparse-dense wave. Sparse-dense wave is a form of electric current in which sparse waves and dense waves appear automatically alternately. Its frequency alternates between high and low. Usually, the electric pulse with a lower frequency is called sparse wave, and the one with a higher frequency is called dense wave. There are various combinations of sparse-dense wave frequencies, and the appropriate combination of sparse and dense wave frequencies can be selected according to the treatment needs.

[0080] 3) Intermittent waves. Intermittent waves refer to rhythmic, intermittent, and automatically occurring waveforms. Intermittent waves are pulse wave sequences obtained by modulating continuous waves with rectangular pulses. Intermittent waves have a strong tremor effect on the human body and have a strong excitatory effect on nerves and muscles.

[0081] In the model establishment research, a variety of waveforms are selected for treatment research according to the patient's specific condition and treatment effect, and an electric pulse stimulation regulation model is established.

[0082] 4) Synthesize sound and electrical pulse signals;

[0083] The synthesis of the generated acoustic and electrical pulse stimulation signals can be achieved by superimposing sine waves of different frequencies and amplitudes, as expressed by the formula:

[0084] s(t)=∑Aisin(2πfit+i)

[0085] Where s(t) is the synthesized signal, Ai is the amplitude, fi is the frequency, i is the phase, and t is the time.

[0086] It should be noted that step S13 shows the basic method of establishing sound and electrical pulse signals. In practical applications, different algorithms and models can be combined to make adjustments and optimizations based on treatment needs and patient responses.

[0087] S14. Study the effects of sound and electrical stimulation of the vagus nerve, and continuously optimize after evaluation and feedback.

[0088] The sound and vagus nerve electrical pulse stimulation signals obtained in step S13 are applied to the treatment research of tinnitus patients. According to the needs and reactions of patients, acoustic and stimulation schemes are formulated, including different types of sounds and signals, playback and stimulation time, and optimization and adjustment of intensity. During the treatment process, the changes in the patient's tinnitus symptoms are regularly evaluated. Standardized questionnaires can be used to evaluate the effect of intervention treatment, and physiological parameters can be monitored through physiological signal monitoring tools, including heart rate, electroencephalogram, skin galvanic response and other indicators to evaluate the effect of intervention treatment. Record the patient's tinnitus symptoms, frequency, intensity, duration and other improvement information, and record the sound and electrical pulse stimulation parameters during the treatment. According to the results of the effect evaluation, the parameters of the signal, including frequency, intensity, duration, etc., are dynamically adjusted to observe the treatment effect. Based on this, the algorithm and the generation process of acoustic and vagus nerve electrical pulse stimulation signals are further optimized to achieve continuous improvement.

[0089] S15. Complete the establishment of the knowledge base of sound and ear vagus nerve electrical pulse stimulation.

[0090] Through the implementation of the above steps S11-S14, the knowledge base of sound and ear vagus nerve electrical pulse stimulation is finally established. The establishment of the knowledge base provides a solid theoretical basis for the treatment method. The knowledge base can be used as a reference guide for the common treatment device to help the common treatment device formulate personalized treatment plans according to the specific conditions of the patient and generate treatment packages for the common treatment device. A treatment package is a set of treatment plans, which is an optimized treatment plan to maximize the effect of the treatment.

[0091] S2. Wear the device, fit the pulse generating device 31 in the device to the vagus nerve of the ear, then bend the pulse output device 33 through the shaping hose 32 to cooperate with the pulse generating device 31, clamp it to the vagus nerve of the ear, and then insert the ear cap 21 in the audio therapy device 20 into the external auditory canal to complete the wearing.

[0092] S3. Start the mobile phone treatment software, select a suitable treatment package from the software according to the patient's condition, and click on the treatment package. The treatment package contains audio data and pulse data. Each treatment package has audio data and pulse data for at least one condition.

[0093] In S3, each treatment package has audio data and pulse data for a disease. Taking the treatment of tinnitus as an example, the audio data is a set of parameters calculated based on the sound therapy most suitable for treating tinnitus, and the audio data is input into the audio decoder 22 to form the sound electrical signal most suitable for treating tinnitus; similarly, the pulse data is also a set of parameters calculated based on the vagus nerve pulse stimulation therapy most suitable for treating tinnitus, and the pulse data is input into the pulse generator 24 to form the pulse signal most suitable for treating tinnitus.

[0094] S4, the device receives the treatment package wireless signal through the wireless signal processing chip 15, and converts the treatment package wireless signal into a treatment package electrical signal, and transmits the treatment package electrical signal to the audio decoder 24 and the pulse generator 313 after processing.

[0095] S5, after the audio decoder 24 and the pulse generator 313 simultaneously receive the electrical signal of the treatment package, they generate sound and electrical pulse stimulation through the speaker 25 and the electrode 333 respectively, to perform sound therapy and ear vagus nerve therapy on the patient.

[0096] In S5, after receiving the audio data electrical signal, the audio decoder 24 converts it into a sound signal and transmits it to the speaker 25, which then converts it into sound and outputs it into the cochlea to perform sound therapy on the patient. At the same time, after receiving the pulse data electrical signal, the pulse generator 313 forms a pulse frequency having the pulse data and outputs it to the vagus nerve of the ear through the electrode sheet 333, thereby stimulating the vagus nerve on the earlobe to perform vagus nerve therapy on the patient.

[0097] S6. Adjust the treatment plan according to the treatment effect of tinnitus patients and optimize the device parameters.

[0098] The physician evaluates or the patient self-evaluates the improvement of tinnitus symptoms to analyze whether the treatment effect is significant and whether there are parameters that need to be adjusted. For example, the frequency, loudness, and duration of the sound can be adjusted to better match the characteristics of tinnitus and improve the treatment effect. You can try different sound types, such as pure tone, white noise, or music, to find the sound stimulation that best suits the patient.

[0099] For electrical pulse stimulation, the frequency, intensity and duration of the electrical pulses can be changed to observe the improvement effect on tinnitus symptoms. The intensity of the electrical pulse stimulation is adjusted according to the patient's tolerance and comfort to ensure the safety and effectiveness of the treatment process.

[0100] Tinnitus patients or physicians can adjust treatment plans and optimize device parameters based on the treatment effects, thereby further improving the treatment effects and patient comfort.

[0101] The above description is only a preferred embodiment of the present invention, which is only illustrative and not restrictive of the present invention. Those skilled in the art understand that many changes, modifications, and even equivalences may be made to the present invention within the spirit and scope defined by the claims of the present invention, but all of them will fall within the scope of protection of the present invention.

Claims

1. A device for combined treatment of sound and ear vagus nerve electrical pulse stimulation, characterized in that: The invention comprises an energy supply receiving device (10), an audio treatment device (20) and a pulse treatment device (30) which are respectively rotatably connected to the energy supply receiving device (10).

2. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 1, characterized in that: The energy supply receiving device (10) comprises a shaft sleeve (11), a rotating shaft (12) inserted into the shaft sleeve (11), a housing (13) for mounting the rotating shaft (12), an energy supply device (14) disposed in the housing (13), and a wireless signal processing chip (15) electrically connected to the energy supply device (14).

3. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 2, characterized in that: The energy supply device (14) comprises a power supply adapter (141), a charging circuit (142) connected to the power supply adapter (141), a lithium battery (143) connected to the charging circuit (142), and a control circuit (144) for controlling the lithium battery (143) to transmit electric energy; the energy supply device (14) is electrically connected to the wireless signal processing chip (15) via the control circuit (144).

4. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 1, characterized in that: The audio therapy device (20) comprises an ear cap (21), a front cavity (22) connected to the ear cap (21), a rear cavity (23) connected to the front cavity (22), an audio decoder (24) arranged in the rear cavity (23), and a speaker (25) electrically connected to the audio decoder (24); the audio decoder (24) is electrically connected to a control circuit (144) via a wire.

5. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 1, characterized in that: The pulse treatment device (30) comprises a pulse generating device (31), a shaping hose (32) connected to the pulse generating device (31), and a pulse output device (33) connected to the shaping hose (32).

6. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 5, characterized in that: The pulse generating device (31) comprises a massage protrusion (311), a generating shell (312) for mounting the massage protrusion (311), and a pulse generator (313) mounted in the generating shell (312); the pulse generator (313) is electrically connected to a control circuit (144) via a wire.

7. The device for combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 5, characterized in that: The pulse output device (33) comprises an output shell (331), an electrode sheet (332) installed in the output shell (331), and a stimulation needle (333) installed on the electrode sheet (332); the electrode sheet (332) is electrically connected to the pulse generator (313) via a wire.

8. The method of combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 7, characterized in that: The following steps are involved: S1. Establish a knowledge base of sound and ear vagus nerve electrical pulse stimulation to generate a treatment package for a common treatment device; S2, wearing the device, fitting the pulse generating device (31) in the device to the vagus nerve of the ear, then bending the pulse output device (33) through the shaping hose (32) to cooperate with the pulse generating device (31), clamping it to the vagus nerve of the ear, and then inserting the ear cap (21) in the audio therapy device (20) into the external auditory canal to complete the wearing; S3, start the mobile phone treatment software, select a suitable treatment package from the software according to the patient's condition, and click on the treatment package, the treatment package contains audio data and pulse data, and each treatment package has audio data and pulse data for at least one condition; S4, the device receives the treatment package wireless signal through the wireless signal processing chip (15), converts the treatment package wireless signal into a treatment package electrical signal, and transmits the treatment package electrical signal to the audio decoder (24) and the pulse generator (313) respectively after processing; After receiving the electrical signal of the treatment package at the same time, S5, the audio decoder (24) and the pulse generator (313) respectively generate sound and electrical pulse stimulation through the speaker (25) and the electrode sheet (333), so as to perform sound therapy and ear vagus nerve therapy on the patient; S6. Adjust the treatment plan according to the treatment effect of tinnitus patients and optimize the device parameters.

9. The method of combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 8, characterized in that: The S1 comprises the following sub-steps: S11. Collect initial case data of tinnitus patients; S12. Preliminary selection of treatment parameters; S13, generating sound and ear vagus nerve electrical pulse stimulation signals; S14. Study the effects of sound and electrical stimulation of the vagus nerve, and continuously optimize after evaluation and feedback; S15. Complete the establishment of the knowledge base of sound and ear vagus nerve electrical pulse stimulation.

10. The method of combined treatment of sound and ear vagus nerve electrical pulse stimulation according to claim 9, characterized in that: The S13 includes: 1) Perform Fourier transform on the collected tinnitus signal to analyze its frequency components; 2) Set the masking frequency and establish the masking model; 3) Establish an electrical pulse stimulation regulation model; 4) Synthesize sound and electrical pulse signals.

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