Artificial hearing device

CN122582473APending Publication Date: 2026-08-18SHANGHAI WEIWEI TIANLAI MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202611071977.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-07-17
Publication Date
2026-08-18

AI Technical Summary

Technical Problem

然而,听觉脑电测量通常需要额外的第三方设备和时间来完成测试,因此在日常调试中并没有广泛使用

Benefits of technology

[0060] Compared with existing technologies, the artificial hearing device provided by this invention has the following beneficial effects: The artificial hearing device provided by this invention allows users to automatically collect auditory-related electrophysiological signals (target auditory electrical signals) imperceptibly during daily use without the need for additional implantation or wearing of external accessories. Based on the collected target auditory electrical signals, it autonomously adjusts parameters to generate stimulation strategy encoding parameters most suitable for the current state of the auditory nerve and/or auditory cortex, thereby effectively improving the user's hearing experience. Simultaneously, this invention can monitor the user's auditory-related electroencephalogram (EEG) signals daily without the need for additional implantation or wearing of external accessories, objectively evaluating the auditory effect of the adjusted stimulation strategy encoding parameters. Furthermore, the artificial hearing device provided by this invention supports real-time operation and can autonomously identify the current acoustic environment, thereby automatically inducing and collecting target auditory electrical signals without affecting the user's normal listening experience. In addition, by performing closed-loop tuning and evaluation of stimulation strategy coding parameters in a quiet environment, this invention can effectively improve the signal-to-noise ratio of the acquired auditory-related electrophysiological signals, thus laying a good foundation for subsequent tuning of stimulation strategy coding parameters based on target auditory electrical signals.

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Abstract

The application provides an artificial hearing device, comprising: a signal source configured to acquire an external signal; a signal processing module configured to output a closed-loop debugging command when an acoustic environment where a user is located is a quiet environment; a control module configured to output a special test signal and an auditory electrical signal acquisition command based on the closed-loop debugging command; a stimulation module configured to output a test special electrical pulse based on the special test signal; a signal acquisition module configured to acquire a target auditory electrical signal; and the signal processing module is further configured to automatically update a stimulation strategy coding parameter according to the target auditory electrical signal, and evaluate a listening effect of the updated stimulation strategy coding parameter when it is determined that the external signal is suitable for auditory center test evaluation. The application can automatically induce and acquire a target auditory electrical signal for closed-loop parameter adjustment without affecting normal listening experience of a user, and can measure an auditory center response after parameter adjustment to objectively evaluate a listening effect.
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Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an artificial hearing device. Background Technology

[0002] Implantable hearing devices such as cochlear implants and brainstem implants are currently the most effective solution for hearing loss reconstruction in patients with hearing impairment. The working principle of these devices is generally as follows: they pick up external sound signals, process and encode the signals into digital signals, and output electrical stimulation signals. The sound signal processing and stimulation strategy encoding parameters are usually programmed / adjusted by a professional audiologist. Patients use several pre-set encoding parameters during daily listening practice to reconstruct their hearing.

[0003] When audiologists adjust a cochlear implant, patients typically undergo electrophysiological tests first. After the tests, the audiologist uses the results to adjust the parameters. For example, in cochlear implant adjustments, patients will first undergo electrode impedance testing, telemetry of neural responses (electrically-evoked compound action potential, ECAP), electrically evoked stapedius reflex threshold (ESRT) testing, and electrically evoked auditory brainstem responses (EABR) testing. These test results are of significant guiding importance when adjusting the procedure number (stimulation strategy encoding parameters).

[0004] 1) Impedance Testing: Electrode impedance is an indicator of the resistance encountered when current flows through an electrode. It is affected by the electrode contacts, wires, and surrounding media (cochlear lymph, fibrous tissue, bone tissue, electrolytes, proteins, etc.). Impedance testing is performed by sending a small current to each electrode and detecting the returned current or voltage. Based on the impedance results, the audiologist can shut off open-circuit or short-circuit electrodes, preventing them from working during routine stimulation.

[0005] 2) ECAP: ECAP is the electrically evoked nerve fiber electrical response induced by electrical stimulation. It is measured by sending a small current (not necessarily perceptible to the patient) to each electrode and recording the nerve response using adjacent electrodes. It usually occurs within 1 ms after electrical stimulation. ECAP reflects the evoked threshold of the nerve fiber group stimulated by each electrode and can help adjust the T value (minimum threshold) of each electrode to ensure that it does not exceed the ECAP result.

[0006] 3) ESRT: ESRT is the threshold at which the stapedius muscle in both ears reflexively contracts when stimulated by a loud sound. It is measured by sending current to each electrode and measuring the stapedius muscle reflex in the external auditory canal. The ESRT result can help adjust the output current C value (comfort value) of each electrode so that the maximum stimulation current does not exceed the ESRT result.

[0007] 4) EABR: EABR is the response of the auditory nerve and brainstem auditory pathway to sound stimulation, including the response of the cochlear nucleus, superior olivary complex, and hypothalamus. It is usually used to reflect whether the auditory nerve pathway is normal. It occurs about 5ms after electrical stimulation and can also be used to assist in adjusting the T value of each electrode.

[0008] Therefore, the stimulation strategy coding parameters set during device setup are most suitable for the patient's auditory nerve electrophysiological status at the time of setup. However, the patient's auditory nerve electrophysiological status is constantly changing, especially in the early post-implantation activation period. For example, after cochlear implantation, the intracochlear electrode impedance and ECAP threshold change drastically. Due to rejection reactions from electrode insertion, the intracochlear electrodes are rapidly covered by fibrous tissue within one month after implantation, and the electrode impedance rises rapidly. As the cochlear environment gradually stabilizes, the electrode impedance gradually decreases and tends to stabilize 1-3 months after implantation. However, the long-term trend of electrode impedance changes differs between the basal and apical turns of the cochlea. ECAP itself may be related to the electrode impedance value, and therefore its threshold also changes with impedance. In addition, with the stabilization of the cochlear microenvironment and the subsidence of implantation-induced swelling, more auditory nerve fibers can be activated by electrical stimulation, the slope of the ECAP amplitude growth function (AGF) increases, and the electrical stimulation efficiency increases. ECAP results also tend to stabilize 6 months after implantation, and the changes in ECAP thresholds between the basal and apical turns of the cochlea may differ.

[0009] Currently, in-person audiology setups are typically performed once every six months or less. As a result, the parameters set by audiologists during setups (especially for the first time) cannot be adapted to the patient's long-term and rapidly changing auditory nerve electrophysiological condition. On the other hand, more frequent in-person or online setups significantly increase the time cost for audiologists and the expenses for patients, making them unsuitable for widespread adoption.

[0010] In addition, the auditory effect of a set of procedures often needs to be evaluated through the patient's subjective feedback and behavioral response tests; however, a certain number of patients are young prelingual hearing-impaired patients who cannot use language to express themselves or cooperate with the test, and initial users who are not used to artificial hearing electroacoustics. Audiologists also need to combine auditory central response tests to objectively evaluate the auditory effect.

[0011] Auditory electroencephalography (EEG) primarily assesses a patient's initial perception of sound pitch, rhythm, and timbre, as well as higher-level cognitive processing responses such as attention and emotional responses, through simple paradigm-evoked event-related potentials (ERPs) or frequency domain analysis. However, EEG measurements typically require additional third-party equipment and time to complete, and therefore are not widely used in routine consultations. Summary of the Invention

[0012] The purpose of this invention is to provide an artificial hearing device that allows users to automatically collect auditory-related electrophysiological signals during daily use without the need for additional implantation or wearing of accessories outside the artificial hearing device, and to perform autonomous parameter adjustment. Furthermore, auditory central response measurements can be performed after parameter adjustment to evaluate the objective auditory effect after parameter adjustment.

[0013] To achieve the above objectives, the present invention provides an artificial hearing device, comprising a signal source, a signal processing module, a control module, a stimulation module, and a signal acquisition module. The signal source, the control module, and the signal acquisition module are all communicatively connected to the signal processing module, and the stimulation module and the signal acquisition module are both communicatively connected to the control module. The signal source is configured to acquire external signals and transmit them to the signal processing module. The external signals include at least one of external sound signals and external digital audio signals. The signal processing module is configured to output a closed-loop debugging command to the control module when the user's acoustic environment is quiet. The control module is configured to send signals to the stimulation module based on the closed-loop debugging command. The stimulation module outputs at least one dedicated test signal and outputs a corresponding auditory electrical signal acquisition command to the signal acquisition module; the stimulation module is configured to output a dedicated electrical pulse based on the dedicated test signal to stimulate the target nerve; the signal acquisition module is configured to acquire the target auditory electrical signal based on the auditory electrical signal acquisition command and transmit the acquired target auditory electrical signal to the signal processing module; the signal processing module is further configured to automatically update the stimulation strategy coding parameters of the artificial hearing device according to at least one of the target auditory electrical signals, and evaluate the auditory effect of the updated stimulation strategy coding parameters when it is determined that the external signal acquired by the signal source is suitable for auditory center testing and evaluation.

[0014] Optionally, the types of the dedicated test signals include electrically evoked auditory nerve compound action potential test signals, electrically evoked auditory brainstem response test signals, electrically evoked cortical auditory potential test signals, and local evoked potential test signals. The types of the target auditory electrical signals include electrically evoked auditory nerve compound action potential signals induced by the stimulation electrodes of the stimulation module, electrically evoked auditory brainstem response signals induced by the stimulation electrodes of the stimulation module, electrically evoked cortical auditory potential signals induced by the stimulation electrodes of the stimulation module, and local evoked potential signals induced by the stimulation electrodes of the stimulation module.

[0015] Optionally, the type of the dedicated test signal may also include an impedance test signal, and the type of the target auditory electrical signal may also include the current value or voltage value between the stimulation electrode and the ground electrode of the stimulation module; the control module is configured to output the impedance test signal and at least one of the following to the stimulation module in a time-division manner based on the closed-loop debugging command: the electrically evoked auditory nerve compound action potential test signal, the electrically evoked auditory brainstem response test signal, the electrically evoked cortical auditory potential test signal, and the local evoked potential test signal.

[0016] Optionally, when the control module outputs an impedance test signal to the stimulation module, the signal acquisition module is configured to acquire the current or voltage value between the stimulation electrode and the ground electrode based on the auditory electrical signal acquisition command; the signal processing module is configured to: calculate the inter-electrode impedance value corresponding to the stimulation electrode based on the current or voltage value between the stimulation electrode and the ground electrode; determine whether the stimulation electrode is an impedance abnormal electrode based on the inter-electrode impedance value corresponding to the stimulation electrode; if the stimulation electrode is an impedance abnormal electrode and is the selected working electrode, then the stimulation electrode is deactivated and the adjacent impedance normal electrode is used as the new working electrode.

[0017] Optionally, the signal processing module is further configured to: if the number of impedance normal operating electrodes is less than a preset number, redistribute the center frequency of the impedance normal operating electrodes so that the frequency range of the impedance normal operating electrodes can completely cover the preset sound stimulation frequency range.

[0018] Optionally, the signal processing module is further configured to: calculate the maximum output current value or the maximum output voltage value of the stimulation electrode based on the inter-electrode impedance value corresponding to the stimulation electrode; if the maximum output current value of the stimulation electrode is less than the maximum set current value corresponding to the stimulation electrode, or the maximum output voltage value of the stimulation electrode is less than the maximum set voltage value corresponding to the stimulation electrode, then automatically lower the comfort value of the stimulation electrode until the stimulation electrode passes the current or voltage compliance detection.

[0019] Optionally, the signal processing module is further configured to: if the maximum output current value of the stimulation electrode is greater than or equal to the maximum set current value, and the stimulation electrode previously automatically reduced its comfort value because the maximum output current value was less than the maximum set current value, or the maximum output voltage value of the stimulation electrode is greater than or equal to the maximum set voltage value, and the stimulation electrode previously automatically reduced its comfort value because the maximum output voltage value was less than the maximum set voltage value, then automatically increase the comfort value of the stimulation electrode so that the difference between the increased comfort value of the stimulation electrode and the minimum threshold is close to the original difference.

[0020] Optionally, the signal processing module is further configured to: if the inter-electrode impedance value of a previously disabled stimulation electrode due to abnormal inter-electrode impedance value returns to normal, then re-enable the stimulation electrode and perform automatic reallocation of the working electrode and center frequency.

[0021] Optionally, when the control module outputs an electrically evoked auditory nerve compound action potential (EMP) test signal to the stimulation module, the signal acquisition module is configured to use the electrode adjacent to the stimulation electrode of the stimulation module as the acquisition electrode to acquire the EMP signal evoked by the stimulation electrode; the signal processing module is configured to: obtain the test EMP threshold corresponding to the stimulation electrode based on the EMP signal evoked by the stimulation electrode; obtain the amplitude of the change in the EMP threshold corresponding to the stimulation electrode based on the comparison result between the test EMP threshold corresponding to the stimulation electrode and the historical EMP threshold of the stimulation electrode; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of the change in the EMP threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold.

[0022] Optionally, when the control module outputs an electrically evoked auditory brainstem response (EBR) test signal to the stimulation module, the signal acquisition module is configured to use an extracochlear electrode, an extrascalp electrode, or an extrabrain electrode as the acquisition electrode to acquire the EBR signals evoked by the stimulation electrodes of the stimulation module; the signal processing module is configured to: obtain the test EBR threshold corresponding to the stimulation electrode based on the EBR signals evoked by the stimulation electrode under different currents; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the test EBR threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0023] Optionally, adjusting the minimum threshold and comfort value of the stimulation electrode based on the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode includes: obtaining the amplitude of change of the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode based on the comparison result between the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode and the historical electrical evoked auditory brainstem response threshold of the stimulation electrode; and adjusting the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of change of the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode.

[0024] Optionally, the signal processing module is further configured to: obtain the latency of the evoked auditory brainstem response corresponding to the left stimulation electrode based on the evoked auditory brainstem response signals induced by the left stimulation electrode of the stimulation module under different currents; obtain the latency of the evoked auditory brainstem response corresponding to the right stimulation electrode based on the evoked auditory brainstem response signals induced by the right stimulation electrode of the stimulation module under different currents; and perform synchronous processing on the electrical signals of the left stimulation electrode and the right stimulation electrode based on the difference between the evoked auditory brainstem response latencies corresponding to the left stimulation electrode and the right stimulation electrode.

[0025] Optionally, when the control module outputs an electrically evoked cortical auditory potential (EAP) test signal to the stimulation module, the signal acquisition module is configured to use an extracochlear electrode, an extrascalp electrode, or an extrabrainstem electrode as the acquisition electrode to acquire the EAP signal evoked by the stimulation electrode of the stimulation module; the signal processing module is configured to: obtain the test EAP threshold corresponding to the stimulation electrode based on the amplitude difference between the P200 waveform and the N100 waveform in the EAP signal evoked by the stimulation electrode under different currents; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the test EAP threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0026] Optionally, adjusting the minimum threshold and comfort value of the stimulation electrode based on the test electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode includes: obtaining the amplitude of the change in the electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode based on a comparison between the test electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode and the historical electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode; adjusting the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of the change in the electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0027] Optionally, the signal processing module is further configured to: obtain the electrical evoked cortical response latency corresponding to the left stimulation electrode based on the electrical evoked cortical auditory potential signals induced by the left stimulation electrode of the stimulation module under different currents; obtain the electrical evoked cortical response latency corresponding to the right stimulation electrode based on the electrical evoked cortical auditory potential signals induced by the right stimulation electrode of the stimulation module under different currents; and perform synchronous processing on the electrical signals of the left stimulation electrode and the right stimulation electrode based on the difference between the electrical evoked cortical response latencies corresponding to the left stimulation electrode and the right stimulation electrode.

[0028] Optionally, when the control module outputs a local evoked potential test signal to the stimulation module, the signal acquisition module is configured to use the electrode adjacent to the stimulation electrode of the stimulation module as the acquisition electrode to acquire the local evoked potential signal induced by the stimulation electrode; the signal processing module is configured to: obtain the test local evoked potential threshold corresponding to the stimulation electrode based on the local evoked potential signal induced by the stimulation electrode; obtain the change amplitude of the local evoked potential threshold corresponding to the stimulation electrode based on the comparison result between the test local evoked potential threshold corresponding to the stimulation electrode and the historical local evoked potential threshold of the stimulation electrode; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the change amplitude of the local evoked potential threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0029] Optionally, the signal processing module is configured to encode external signals suitable for auditory central nervous system (ANS) testing and evaluation into corresponding electrical stimulation signals using updated stimulation strategy encoding parameters, and transmit these signals to the control module, and send an ANS signal acquisition command to the control module; the control module is further configured to control the stimulation module to output corresponding ANS evaluation electrical pulses based on the electrical stimulation signal, and control the signal acquisition module to acquire target ANS signals based on the ANS signal acquisition command; the signal processing module is further configured to evaluate the auditory effect of the updated stimulation strategy encoding parameters based on the target ANS signals.

[0030] Optionally, the signal processing module is configured to: if the external signal is an external sound signal and the external sound signal meets preset sound conditions, then determine that the external signal is suitable for auditory central nervous system testing and evaluation, wherein the preset sound conditions include the external sound signal being a speech signal in a quiet environment, a speech signal in a noisy environment, or a music signal; if the external signal is an external digital audio signal, and the external digital audio signal is an auditory event-related potential paradigm test digital signal or an auditory brainwave paradigm test digital signal, then determine that the external signal is suitable for auditory central nervous system testing and evaluation, wherein the auditory event-related potential paradigm test digital signal includes a passive spherical paradigm test digital signal used to induce mismatch negative waves. The system includes at least one of the following: an active spherical paradigm test digital signal for inducing P300 waves and an auditory semantic misalignment paradigm test digital signal for inducing N400 waves; the auditory EEG paradigm test digital signal includes at least one of a speech stimulation paradigm test digital signal and a music stimulation paradigm test digital signal; when the external signal is an auditory event-related potential paradigm test digital signal, the target auditory center signal acquired by the signal acquisition module is an event-related potential signal; when the external signal is a speech signal in a quiet environment, a speech signal in a noisy environment, a music signal, or an auditory EEG paradigm test digital signal, the target auditory center signal acquired by the signal acquisition module is an EEG signal.

[0031] Optionally, when the external signal is a passive spherical paradigm test digital signal used to induce mismatch negative waves, the signal acquisition module is configured to mark the time point of stimulus occurrence when acquiring event-related potential signals; the signal processing module is configured to determine the amplitude and latency of the mismatch negative waves based on the event-related potential signals acquired by the signal acquisition module, and calculate the first speech discrimination ability score based on the amplitude and latency of the mismatch negative waves.

[0032] Optionally, calculating the first speech discrimination ability score based on the amplitude and latency of the mismatched negative wave includes: calculating the first speech discrimination ability score using the following formula:

[0033]

[0034] In the formula, Score_MMN is the first speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_MMN A represents the amplitude of the mismatched negative wave obtained from the current measurement. baseline_MMN A is the amplitude of the mismatch negative waveform recorded during the user's initial device setup. target_MMN For the target mismatch negative wave amplitude, L current_MMN L represents the currently measured latency of the mismatched negative wave. baseline_MMNL is the latency period of the mismatch negative wave recorded during the user's first implantation and tuning. target_MMN For the target mismatch negative wave latency, w A_MMN For the mismatched negative wave amplitude weight, w L_MMN For mismatched negative wave latent options, 0 < w A_MMN <1, 0 <w L_MMN <1, and w A_MMN +w L_MMN =1.

[0035] Optionally, when the external signal is an active spherical paradigm test digital signal used to induce the P300 wave, the signal acquisition module is configured to mark the time point of stimulus occurrence when acquiring event-related potential signals; the signal processing module is configured to determine the P300 wave amplitude and P300 wave latency based on the event-related potential signals acquired by the signal acquisition module, and calculate a second speech discrimination ability score based on the P300 wave amplitude, the P300 wave latency, and the user's behavioral response accuracy.

[0036] Optionally, the calculation of the second speech discrimination ability score based on the P300 wave amplitude, the P300 wave latency, and the user's behavioral response accuracy includes: calculating the second speech discrimination ability score using the following formula:

[0037]

[0038] In the formula, Score_P300 is the second speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_P300 For the currently measured P300 wave amplitude, A baseline_P300 The P300 waveform amplitude recorded during the user's initial device setup, A target_P300 For the target P300 wave amplitude, L current_P300 L represents the currently measured latency of the P300 wave. baseline_P300 The latency of the P300 wave recorded during the user's initial device setup, L target_P300 For the target P300 wave latency period, w A_P300 For the P300 wave amplitude weight, w L_P300 For P300 wave latent options, P be For the accuracy of user behavior response, w B_P300 For behavioral response weights, 0 < w A_P300 <1, 0 <w L_P300 <1, 0 <w B_P300 <1, and w A_P300 +w L_P300 +w B_P300 =1.

[0039] Optionally, when the external signal is a digital signal used to induce the N400 wave in an auditory semantic misalignment paradigm test, the signal acquisition module is configured to mark the occurrence time of key ending words in each trial when acquiring event-related potential signals; the signal processing module is configured to determine the N400 wave latency under the conditions of N400 difference wave amplitude and semantic inconsistency based on the event-related potential signals acquired by the signal acquisition module, and to evaluate semantic understanding ability based on the N400 difference wave amplitude and the N400 wave latency.

[0040] Optionally, when the external signal is a speech stimulus paradigm test digital signal, a speech signal in a quiet environment, or a speech signal in a noisy environment, the signal processing module is configured to: extract the Delta wave actual speech envelope and the Theta wave actual speech envelope based on the speech stimulus paradigm test digital signal, the speech signal in a quiet environment, or the speech signal in a noisy environment; extract Delta wave data and Theta wave data based on the EEG signals acquired by the signal acquisition module; reconstruct the Delta wave reconstructed speech envelope and the Theta wave reconstructed speech envelope based on the extracted Delta wave data and Theta wave data; and calculate a third speech discrimination ability score based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope.

[0041] Optionally, calculating the third speech discrimination ability score based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope, includes: calculating the third speech discrimination ability score using the following formula:

[0042]

[0043] In the formula, Score_EEG is the third speech discrimination ability score, and C Delta C is the correlation coefficient between the reconstructed speech envelope of the Delta wave and the actual speech envelope of the Delta wave. Theta The correlation coefficient between the reconstructed speech envelope of the Theta wave and the actual speech envelope of the Theta wave. For Theta wave weights, and .

[0044] Optionally, when the external signal is a music signal or a digital signal from a music stimulation paradigm test, the signal processing module is configured to: extract baseline Beta wave data and baseline Gamma wave data based on the EEG signals acquired by the signal acquisition module before music stimulation; perform time-frequency analysis on the baseline Beta wave data and the baseline Gamma wave data respectively to obtain corresponding baseline Beta wave time-frequency data and baseline Gamma wave time-frequency data; obtain baseline Beta wave time-frequency energy based on the baseline Beta wave time-frequency data, and obtain baseline Gamma wave time-frequency energy based on the baseline Gamma wave time-frequency data; and extract music-period Beta wave data and music-period Gamma wave data based on the EEG signals acquired by the signal acquisition module during music stimulation. Time-frequency analysis is performed on the music period Beta wave data and the music period Gamma wave data to obtain the corresponding music period Beta wave time-frequency data and music period Gamma wave time-frequency data. Based on the music period Beta wave time-frequency data, the music period Beta wave time-frequency energy is obtained, and based on the music period Gamma wave time-frequency data, the music period Gamma wave time-frequency energy is obtained. Based on the music period Beta wave time-frequency energy and the baseline period Beta wave time-frequency energy, the percentage change in Beta wave time-frequency energy is obtained, and based on the music period Gamma wave time-frequency energy and the baseline period Gamma wave time-frequency energy, the percentage change in Gamma wave time-frequency energy is obtained. Based on the percentage change in Beta wave time-frequency energy and the percentage change in Gamma wave time-frequency energy, a music appreciation ability assessment value is calculated.

[0045] Optionally, calculating the music appreciation ability assessment value based on the percentage change in the time-frequency energy of the Beta wave and the percentage change in the time-frequency energy of the Gamma wave includes: calculating the music appreciation ability assessment value using the following formula:

[0046]

[0047] In the formula, P out P is the assessment value for music appreciation ability. Beta P represents the percentage change in time-frequency energy of the Beta wave. Gamma The percentage change in time-frequency energy of the Gamma wave. For Beta wave weights, and .

[0048] Optionally, the signal processing module is further configured to evaluate the speech discrimination ability under digital signal and / or external sound signal stimulation based on speech stimulation paradigms of speech scenarios with different levels of signal-to-noise ratio, and to comprehensively evaluate the listening effect of the updated stimulation strategy encoding parameters. The different levels of signal-to-noise ratio speech scenarios include quiet speech scenarios, slightly noisy speech scenarios, moderately noisy speech scenarios, and highly noisy speech scenarios.

[0049] Optionally, the evaluation results of speech discrimination ability under digital signal and / or external sound signal stimulation based on speech stimulus paradigms with different signal-to-noise ratios are used to comprehensively evaluate the listening effect of the updated stimulus strategy encoding parameters, including: using the following formula to comprehensively evaluate the listening effect of the updated stimulus strategy encoding parameters:

[0050]

[0051] In the formula, Score_EEG_synthetic represents the comprehensive speech discrimination ability score based on EEG signals; Score_EEG_silent represents the speech discrimination ability score in quiet speech scenarios; Score_EEG_mild represents the speech discrimination ability score in mildly noisy speech scenarios; Score_EEG_medium represents the speech discrimination ability score in moderately noisy speech scenarios; and Score_EEG_intense represents the speech discrimination ability score in highly noisy speech scenarios. silent For quiet speech scenarios, w mild For weighting in mildly noisy speech scenarios, w medium For moderately noisy speech scenarios, w intense For weights in highly noisy speech scenarios, 0 < w silent <1, 0 <w mild <1, 0 <w medium <1, 0 <w intense <1, and w silent +w mild +w medium +w intense =1.

[0052] Optionally, the signal processing module is further configured to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters based on the speech discrimination ability assessment results under the stimulation of the passive monster ball paradigm test digital signal used to induce mismatch negative waves and the active monster ball paradigm test digital signal used to induce P300 waves.

[0053] Optionally, the comprehensive evaluation of the auditory performance of the updated stimulus strategy coding parameters based on the speech discrimination ability assessment results under the stimulation of the passive monster ball paradigm test digital signal used to induce mismatch negative waves and the active monster ball paradigm test digital signal used to induce P300 waves includes: comprehensively evaluating the auditory performance of the updated stimulus strategy coding parameters using the following formula:

[0054]

[0055] In the formula, Score_ERP is the comprehensive speech discrimination ability score based on event-related potential signals, Score_MMN is the speech discrimination ability assessment result under digital signal stimulation of the passive spherical paradigm test used to induce mismatch negative waves, and Score_P300 is the speech discrimination ability assessment result under digital signal stimulation of the active spherical paradigm test used to induce P300 waves. MMN For the mismatched negative wave weights, w P300 For P300 wave weights, 0 < w MMN <1, 0 <w P300 <1, and w MMN +w P300 =1.

[0056] Optionally, the signal processing module is further configured to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters based on the evaluation results of speech discrimination ability stimulated by the digital signals of the auditory event-related potential paradigm test and the digital signals of the auditory brainwave paradigm test.

[0057] Optionally, the assessment of speech discrimination ability based on the digital signals from the auditory event-related potential paradigm test and the auditory EEG paradigm test, and the comprehensive evaluation of the auditory effect of the updated stimulus strategy encoding parameters, includes: using the following formula to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters:

[0058]

[0059] In the formula, Score_ is the comprehensive speech discrimination ability score that integrates event-related potential signals and EEG signals; Score_ERP is the comprehensive speech discrimination ability score based on event-related potential signals; Score_EEG_ is the comprehensive speech discrimination ability score based on EEG signals; and w ERP For event-related potential weights, w EEG For brainwave weights, 0 < w ERP <1, 0 <w EEG <1, and w ERP +w EEG =1.

[0060] Compared with existing technologies, the artificial hearing device provided by this invention has the following beneficial effects: The artificial hearing device provided by this invention allows users to automatically collect auditory-related electrophysiological signals (target auditory electrical signals) imperceptibly during daily use without the need for additional implantation or wearing of external accessories. Based on the collected target auditory electrical signals, it autonomously adjusts parameters to generate stimulation strategy encoding parameters most suitable for the current state of the auditory nerve and / or auditory cortex, thereby effectively improving the user's hearing experience. Simultaneously, this invention can monitor the user's auditory-related electroencephalogram (EEG) signals daily without the need for additional implantation or wearing of external accessories, objectively evaluating the auditory effect of the adjusted stimulation strategy encoding parameters. Furthermore, the artificial hearing device provided by this invention supports real-time operation and can autonomously identify the current acoustic environment, thereby automatically inducing and collecting target auditory electrical signals without affecting the user's normal listening experience. In addition, by performing closed-loop tuning and evaluation of stimulation strategy coding parameters in a quiet environment, this invention can effectively improve the signal-to-noise ratio of the acquired auditory-related electrophysiological signals, thus laying a good foundation for subsequent tuning of stimulation strategy coding parameters based on target auditory electrical signals. Attached Figure Description

[0061] Figure 1 This is a block diagram of an artificial hearing device provided in one embodiment of the present invention.

[0062] Figure 2 This is a dedicated test + closed-loop control link diagram provided for one embodiment of the present invention.

[0063] Figure 3 An external signal stimulation link diagram provided for one embodiment of the present invention.

[0064] Figure 4 This is a schematic diagram of an auditory central nervous system testing and evaluation link provided in one embodiment of the present invention.

[0065] Figure 5 This is a schematic diagram of the rectangular structure of a fully implanted cochlear implant.

[0066] Figure 6 This is a schematic diagram of the box structure of a semi-implanted cochlear implant.

[0067] Figure 7 A schematic diagram of the block structure of an auditory brainstem implantation device.

[0068] The reference numerals in the attached diagrams are explained as follows: Signal source - 110; Signal processing module - 120; Control module - 130; Stimulation module - 140; Signal acquisition module - 150; Implantable sound processor - 210; Stimulator - 220; Acquisition device - 230; External cochlear electrode array - 240; Internal cochlear electrode array - 250; Mobile terminal software - 260; External sound processor - 310; External scalp electrode array - 320; External brainstem electrode array - 330; Cochlear nucleus electrode array - 340. Detailed Implementation

[0069] The artificial hearing device proposed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0070] To facilitate understanding, a brief explanation of the research background of this invention will be given first.

[0071] Because ECAP is only the neural response threshold of the most peripheral auditory pathway and has a weak correlation with T-values ​​(minimum threshold) and C-values ​​(comfort value), audiologists usually need to combine the patient's subjective feedback and behavioral responses to determine the adjustment parameters. However, a certain number of patients are young prelingual hearing-impaired patients who cannot use language, initial users who are not accustomed to artificial auditory electroacoustics, and other patients who cannot provide subjective feedback or judge the hearing effect. In these cases, audiologists usually need to combine objective assessments such as EABR and central auditory response to determine how to adjust the parameters. Among these, the early electrically-evoked cortical auditory evoked potentials (eCAEPs) such as P50, N100, and P200 can be evoked by initial auditory perception. They are exogenous responses that do not require cognitive processing in higher-level centers and can quickly and directly objectively assess auditory thresholds and loudness perception. Specifically, they are manifested as follows:

[0072] 1) P50 is a positive wave that occurs about 50 ms after an auditory stimulus and reflects the brain’s early pre-attentive processing of the stimulus. P50 is generated in the auditory cortex and is most prominent when detected by the central electrode (Cz). It is usually induced by the paired-stimulus paradigm and detects the brain’s sensory gating function for repetitive stimuli.

[0073] 2) N100 is a negative wave induced approximately 100 ms after auditory stimulation. It is also a waveform induced by pre-attentional processing, but it varies with the loudness, interval, predictability, and voice onset time (VOT) of the auditory stimulus, and also with an individual's ability to perceive pitch. N100 is generated in the auditory cortex and is associated with occipital and prefrontal cortex activity. It can be detected by electrodes in the central (Cz), frontal (Fz, FCz), and temporal (T7 / 8, more pronounced at T8) regions.

[0074] 3) P200 is a positive wave evoked about 200ms after auditory stimulation. It is usually used together with N100 (and sometimes P100 and N200) as an evoked marker of auditory perception. However, it can also change independently with auditory attention, type of auditory stimulus, memory relevance, etc. It is usually used as an objective auditory threshold marker for patients who cannot provide subjective feedback or conduct behavioral tests (such as schizophrenia, stuttering, cognitive impairment, etc.).

[0075] However, EABR and EEG measurements typically require additional third-party equipment and time to complete the tests, and therefore are not widely used in routine setup. On the other hand, for patients with implanted auditory neuromodulation devices, the devices themselves have electrodes that fit the auditory nerve pathway or are close to the cortex, which can better support the measurement of auditory pathway-related responses, including EABR, auditory cortical evoked potentials, and auditory homeostasis. Nevertheless, most studies still rely on some external devices (such as external grounding electrodes), and this method has not been practically translated into applications for artificial hearing products.

[0076] The inventors discovered through investigation that the function of collecting auditory-related neural signals using artificial hearing devices has not yet been applied to commercial products, and its application in the laboratory is mostly limited to specific testing stages, not directly used for device adjustment, and not integrated into daily use.

[0077] Furthermore, as described in the background section, auditory EEG primarily assesses a patient's initial perception of sound pitch, rhythm, timbre, etc., and higher cognitive processing feedback such as attention and emotional response to sound through simple paradigm-evoked event-related potentials (ERPs) or band frequency domain analysis.

[0078] Auditory-related ERPs, in terms of the evoked temporal sequence, reflect different levels of auditory cognitive processing:

[0079] 1) P50 is a positive wave that occurs about 50 ms after auditory stimulation, reflecting the brain's early pre-attentive processing of the stimulus. P50 is generated in the auditory cortex and is most prominently detected at the central electrode (Cz). It is usually induced by the paired-stimulus paradigm and detects the brain's sensory gating function for repetitive stimuli.

[0080] 2) N100 is a negative wave induced approximately 100 ms after auditory stimulation. It is also a waveform induced by pre-attentional processing, but it varies with the loudness, frequency, interval, predictability, and voice onset time (VOT) of the auditory stimulus, and also with an individual's ability to perceive pitch. N100 is generated in the auditory cortex and is associated with occipital and prefrontal cortex activity. It can be detected by electrodes in the central (Cz), frontal (Fz, FCz), and temporal (T7 / 8, more pronounced at T8) regions.

[0081] 3) P200 is a positive wave evoked about 200ms after auditory stimulation. It is usually used together with N100 (and sometimes P100 and N200) as an evoked marker of auditory perception. However, it can also change independently with auditory attention, type of auditory stimulus, memory relevance, etc. It is usually used as an objective auditory threshold marker for patients who cannot provide subjective feedback or conduct behavioral tests (such as schizophrenia, stuttering, cognitive impairment, etc.).

[0082] 4) MMN is a mismatched negative waveform induced by the Oddball paradigm. 100ms-250ms after the abnormal stimulus, a negative waveform larger than the standard stimulus waveform can be induced, and the difference in amplitude between the two is the MMN. MMN can reflect auditory perception processing disorders and is related to perceptual memory and attention, originating from neural network activity in the temporal lobe and prefrontal lobe.

[0083] 5) P300 is a positive wave induced approximately 300 ms after stimulation. It is induced by decision processing and is related to attention and cognitive load. The elicitation source is also related to the aforementioned cognitive networks. P300 is most prominent in the parietal bone (P) and central electrode (C), and is usually induced by the Oddball paradigm.

[0084] 6) N400 is induced approximately 400ms after speech stimulation, reflecting the brain's semantic processing. N400 can be detected at the central (C) and top (P) electrodes, and unfamiliar words and illogical statements will induce a larger amplitude of N400.

[0085] Different types of brainwaves, in terms of frequency domain speed, also reflect different levels of auditory cognition:

[0086] 1) Delta wave (0.5-4Hz): related to speech processing, it can reflect speech comprehension in noisy environments.

[0087] 2) Theta waves (4-8Hz): are associated with sound imagery and primary auditory cognition, and can reflect higher cognitive functions such as attention to sound, clarity of speech perception in noise, and emotional response to sound.

[0088] 3) Alpha waves (8-12Hz): are usually associated with higher cognitive processes such as filtering out unnecessary information and emotional responses to sound.

[0089] 4) Beta wave (12-30Hz): related to objective characteristics such as sound loudness and frequency.

[0090] 5) Gamma waves (>30Hz): Related to advanced speech processing, such as the subjective comfort and naturalness of speech, as well as the subjective aesthetic appreciation of music.

[0091] However, EEG measurements typically require additional third-party equipment and time to complete the tests, thus limiting their widespread use in routine testing. On the other hand, for patients with implanted auditory neuromodulation devices, the devices themselves have electrodes located close to the cortex, providing better support for measuring auditory pathway-related responses, and some studies have preliminarily demonstrated the feasibility of this method. Nevertheless, most studies still rely on some external devices (such as external grounding electrodes), and this method has not yet been practically translated into applications for artificial hearing products.

[0092] Based on this, the core idea of ​​this invention is to provide an artificial hearing device that allows users to automatically collect auditory-related electrophysiological signals during daily use without the need for additional implantation or wearing of accessories. The device can also perform autonomous parameter tuning and, after tuning, measure auditory central response to evaluate the objective auditory effect. It should be noted that the artificial hearing device can be a fully implanted cochlear implant, a partially implanted cochlear implant, or an auditory brainstem implant.

[0093] To achieve the above-mentioned goals, this invention provides an artificial hearing device, please refer to [reference needed]. Figure 1 This is a block diagram of the artificial hearing device provided in one embodiment of the present invention. Figure 1As shown, the artificial hearing device provided by the present invention includes a signal source 110, a signal processing module 120, a control module 130, a stimulation module 140, and a signal acquisition module 150. The signal source 110, control module 130, and signal acquisition module 150 are all communicatively connected to the signal processing module 120, and the stimulation module 140 and signal acquisition module 150 are all communicatively connected to the control module 130. The signal source 110 is configured to acquire external signals and transmit them to the signal processing module 120. The external signals include at least one of external sound signals and external digital audio signals. The signal processing module 120 is configured to output closed-loop debugging commands to the control module 130 when the user's acoustic environment is quiet. The control module 130 is configured to... The ring debugging command outputs at least one dedicated test signal to the stimulation module 140 and outputs a corresponding auditory electrical signal acquisition command to the signal acquisition module 150; the stimulation module 140 is configured to output a dedicated electrical pulse based on the dedicated test signal to stimulate the target nerve; the signal acquisition module 150 is configured to acquire the target auditory electrical signal based on the auditory electrical signal and transmit the acquired target auditory electrical signal to the signal processing module 120; the signal processing module 120 is also configured to automatically update the stimulation strategy coding parameters of the artificial hearing device according to at least one target auditory electrical signal, and evaluate the auditory effect of the updated stimulation strategy coding parameters when it is determined that the external signal acquired by the signal source is suitable for auditory center testing and evaluation.

[0094] The artificial hearing device provided by this invention allows users to automatically collect auditory-related electrophysiological signals (target auditory electrical signals) seamlessly during daily use without the need for additional implants or external accessories. Based on the collected target auditory electrical signals, the device autonomously adjusts parameters to generate stimulation strategy encoding parameters best suited to the current state of the auditory nerve and / or auditory cortex, thereby effectively improving the user's hearing experience. Simultaneously, this invention allows for daily monitoring of the user's auditory-related electroencephalogram (EEG) signals without the need for additional implants or external accessories, objectively evaluating the auditory effect of the adjusted stimulation strategy encoding parameters. Furthermore, the artificial hearing device provided by this invention supports real-time operation and can autonomously recognize the current acoustic environment, automatically inducing and collecting target auditory electrical signals without affecting the user's normal listening experience. Additionally, by performing closed-loop tuning and evaluation of stimulation strategy encoding parameters in a quiet environment, this invention effectively improves the signal-to-noise ratio of the collected auditory-related electrophysiological signals, thus laying a solid foundation for subsequent tuning of stimulation strategy encoding parameters based on the target auditory electrical signals.

[0095] It should be noted that, as those skilled in the art will understand, if the energy of the external signal acquired by the signal source 110 is less than a preset threshold, the current acoustic environment is determined to be a quiet environment. It should also be noted that, as those skilled in the art will understand, the update of the stimulus strategy encoding parameters can be performed after a single continuous acquisition of the target auditory electrical signal, or it can be performed after multiple intermittent signal acquisitions until sufficient data is available (i.e., the signal processing module 120 is configured to automatically update the stimulus strategy encoding parameters after the number of target auditory electrical signal data reaches a preset number). This ensures that the updated stimulus strategy encoding parameters better match the user's current auditory nerve and / or auditory cortex state.

[0096] Specifically, the stimulation module 140 is responsible for outputting stimulation and forming a stimulation circuit, which includes stimulation electrodes and ground electrodes. The stimulation electrodes are distributed around the target nerve to be stimulated, and the ground electrodes are distributed around the target nerve and / or the surface of the skull. The electrode combination is determined by the stimulation mode (monopolar mode, bipolar mode, multipolar mode, common ground mode, etc.) and the stimulation signal. The same electrode can be switched as a stimulation electrode or a ground electrode, but it will not be used as both a stimulation electrode and a ground electrode at the same time.

[0097] The signal acquisition module 150 is responsible for acquiring auditory-related electrical signals. When acquiring current or voltage values, the signal acquisition module 150 automatically reads the current or voltage value between the stimulation electrode and the ground electrode in the stimulation module 140. When acquiring neural electrical signals, the module includes acquisition electrodes, reference electrodes, and ground electrodes; the electrode combination is determined by the type of neural electrical signal to be acquired. Further, the acquisition electrodes are distributed around the stimulated target nerve, on the surface of the skull, and / or the scalp, while the reference and ground electrodes are also distributed around the target nerve, on the surface of the skull, and / or the scalp; the electrode combination is determined by the type of neural electrical signal to be acquired. The same electrode can be switched between being an acquisition electrode, a reference electrode, or a ground electrode; when serving as an acquisition electrode, it will not simultaneously serve as another functional electrode.

[0098] It should be noted that the stimulation module 140 and the signal acquisition module 150 can be the same component or different components in the system; the same electrode generally will not be used as part of both the stimulation module 140 and the signal acquisition module 150 at the same time.

[0099] Please continue to refer to this. Figure 2 This is a dedicated test + closed-loop control link diagram provided by one embodiment of the present invention. For example... Figure 2As shown, when the current acoustic environment is determined to be quiet, the signal processing module 120 outputs a closed-loop debugging command to the control module 130. The control module 130 outputs a dedicated test signal (dedicated stimulation signal) to the stimulation module 140 and an acquisition command to the signal acquisition module 150. The signal acquisition module 150, according to the specific requirements of the acquisition command, adjusts the signal acquisition array and acquisition parameters required for acquiring specific signals (e.g., voltage or current values ​​around the stimulation array, response threshold of the stimulated nerve, other auditory-related nerve signals in the auditory pathway). The acquired target auditory electrical signal is returned to the signal processing module 120, which decodes the target auditory electrical signal in real time and compares it with historical data, automatically updating the stimulation strategy encoding parameters; simultaneously, the updated stimulation strategy encoding parameters are also stored in the signal processing module 120.

[0100] In some exemplary embodiments, the signal processing module 120 is further configured to encode the external signal into a corresponding electrical stimulation signal according to the currently selected stimulation strategy encoding parameters when the current acoustic environment is determined to be a non-quiet environment, and transmit the electrical stimulation signal to the control module 130; the control module 130 is configured to transmit the electrical stimulation signal to the stimulation module 140; the stimulation module 140 is configured to output electrical pulses through the selected working electrode for hearing reconstruction.

[0101] Therefore, by encoding external signals into electrical stimulation signals when there is sound in the environment, and outputting electrical pulse signals through the stimulation module 140 to stimulate target nerves, users can continuously and uninterruptedly perceive external sounds, thereby ensuring the continuity and real-time nature of users' daily auditory reconstruction.

[0102] It should be noted that, as those skilled in the art will understand, the signal acquisition module 150 is not activated during hearing reconstruction, and the user can manually select a set of stimulation strategy coding parameters.

[0103] Please continue to refer to this. Figure 3 This is an external signal stimulation link diagram provided in one embodiment of the present invention. For example... Figure 3 As shown, when the current acoustic environment is determined to be not quiet, the signal processing module 120 performs strategy encoding on the external signal and outputs the encoded signal to the control module 130. The stimulation module 140 then outputs an electrical pulse signal, while the signal acquisition module 150 remains off. Under this linkage, the user can perform hearing reconstruction. The external signal is encoded into an electrical signal by the system and transmitted to the stimulation target nerve. The stimulation strategy encoding parameters are fixed (the user manually selects a set of stimulation strategy encoding parameters stored in the signal processing module 120).

[0104] In some exemplary embodiments, the signal processing module 120 is further configured to store multiple sets of stimulus strategy encoding parameters for the user to select. Thus, by pre-storing multiple sets of stimulus strategy encoding parameters in the signal processing module 120, common usage scenarios of artificial hearing devices can be covered, thereby meeting the personalized listening needs of users in different acoustic environments and effectively improving the user's auditory comfort.

[0105] In some exemplary embodiments, the types of dedicated test signals include electrically evoked auditory nerve compound action potential test signals, electrically evoked auditory brainstem response test signals, electrically evoked cortical auditory potential test signals, and local evoked potential test signals. The types of target auditory electrical signals include electrically evoked auditory nerve compound action potential signals evoked by the stimulating electrodes of the stimulating module 140, electrically evoked auditory brainstem response signals evoked by the stimulating electrodes of the stimulating module 140, electrically evoked cortical auditory potential signals evoked by the stimulating electrodes of the stimulating module 140, and local evoked potential signals evoked by the stimulating electrodes of the stimulating module 140.

[0106] Since ECAP (Electrically Evoked Auditory Compound Action Potential) directly reflects the synchronous discharge response of auditory nerve fibers to electrical stimulation, acquiring ECAP signals allows for objective and automated tracking of changes in auditory nerve excitability, facilitating precise adaptive adjustment of stimulation strategy coding parameters. Because EABR (Electrically Evoked Auditory Brainstem Response) signals can assess the integrity and temporal synchronicity of neural conduction from the auditory nerve to the auditory nuclei in the brainstem (cochlear nucleus, superior olivary nucleus, inferior colliculus), acquiring EABR signals allows for objective assessment of the functional state of the brainstem auditory pathway, compensating for the limitations of peripheral testing and contributing to precise adaptive adjustment of stimulation strategy coding parameters. Since eCAEP (Electrically Evoked Cortical Auditory Potential) signals directly reflect the neural activity of the auditory cortex, representing the highest level of sound perception, acquiring eCAEP signals allows for stimulation parameter optimization to extend beyond the periphery and brainstem, truly serving cortical perception and achieving closed-loop parameter tuning at the highest level (cortex). Since the stimulation target of auditory brainstem implants is the cochlear nucleus, and the local evoked potential (LEP) signal is the sum of postsynaptic potentials generated by local neurons in the cochlear nucleus under electrical stimulation, it directly reflects whether the stimulation current has effectively activated the target neural cluster. Therefore, for auditory brainstem implants, by collecting LEP signals, it is possible to dynamically track changes in local neural excitability, thereby enabling better adaptive closed-loop parameter tuning of the auditory brainstem implants to ensure that the stimulation intensity always matches the current sensitivity of the brainstem nuclei.

[0107] In some exemplary embodiments, when the control module 130 outputs an electrically evoked auditory nerve compound action potential (EMP) test signal to the stimulation module 140, the signal acquisition module 150 is configured to use the electrode adjacent to the stimulation electrode as the acquisition electrode to acquire the EMP signal evoked by the stimulation electrode; the signal processing module 120 is configured to: obtain the test EMP threshold corresponding to the stimulation electrode based on the EMP signal evoked by the stimulation electrode; obtain the amplitude of the change in the EMP threshold corresponding to the stimulation electrode based on the comparison result between the test EMP threshold corresponding to the stimulation electrode and the historical EMP threshold of the stimulation electrode; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of the change in the EMP threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold.

[0108] Therefore, by calculating the amplitude of the threshold change of electrically evoked auditory nerve compound action potentials and adjusting the minimum threshold and comfort value accordingly, the user's current neural state can be dynamically tracked and adapted to ensure that the stimulation strategy parameters always match the user's actual physiological conditions. By setting the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode to be equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode, the stability of the user's auditory dynamic range can be maintained, avoiding abrupt changes in loudness perception.

[0109] Specifically, for each stimulation electrode, the minimum threshold (T value) of that stimulation electrode can be adjusted using the following formula (1):

[0110] (1)

[0111] in, The adjusted minimum threshold (T value) for the i-th stimulation electrode. This represents the lowest threshold value before adjustment for the i-th stimulation electrode. The threshold for the electrically evoked auditory nerve compound action potential (ECAP threshold obtained from the current test) is the threshold value of the i-th stimulating electrode. The historical ECAP threshold is the threshold value of the auditory nerve compound action potential evoked by the i-th stimulating electrode. It is the first regulatory factor, and .

[0112] It should be noted that this invention relates to the first regulatory factor. The specific value is not limited, the first regulatory factor The specific value can be set according to actual needs, such as the first regulatory factor. The value can be 0.5. It should also be noted that... This refers to the amplitude of the threshold change of the electrically evoked auditory nerve compound action potential corresponding to the i-th stimulating electrode.

[0113] Furthermore, for each stimulation electrode, the comfort value (C value) of that stimulation electrode can be adjusted using the following formula (2):

[0114] (2)

[0115] in, Let be the adjusted comfort value for the i-th stimulation electrode. This represents the comfort value before adjustment for the i-th stimulation electrode.

[0116] Furthermore, during ECAP testing, the stimulation mode can be either monopolar or bipolar. Specifically, when the artificial hearing device is a fully implanted or partially implanted cochlear implant, in monopolar mode, the stimulating electrode is a specific intracochlear electrode, and the grounding electrode is a specific extracochlear electrode or a combination of multiple extracochlear electrodes; in bipolar mode, the stimulating electrode is a specific intracochlear electrode, and the grounding electrode is any non-stimulating intracochlear electrode.

[0117] Furthermore, the ECAP-specific test signal is a preset set of signal sequences with the current gradually increasing; the current range can be, but is not limited to, 300μA-500μA, the step size can be, but is not limited to, 5μA; the pulse width can be, but is not limited to, 20μs, the pulse gap can be, but is not limited to, 5μs, and the stimulation frequency can be, but is not limited to, 30Hz.

[0118] Furthermore, the signal acquisition module 150 can acquire ECAP signals using a common ECAP measurement method. The signal acquisition module 150 acquires ECAP signals through an acquisition electrode, a reference electrode, and a ground electrode. The same electrode can be switched between being an acquisition electrode, a reference electrode, or a ground electrode, but when serving as an acquisition electrode, it will not simultaneously serve as another functional electrode. Furthermore, when the artificial hearing device is a fully implanted or partially implanted cochlear implant, the acquisition electrode can be an intracochlear electrode separated from the stimulating electrode by one electrode, the reference electrode can be any extracochlear electrode (not used as a stimulating or acquisition electrode), and the ground electrode can be any intracochlear or extracochlear electrode (not used as a stimulating or acquisition electrode).

[0119] Furthermore, the acquisition accuracy of the ECAP signal can be, but is not limited to, 12 bits, the sampling frequency can be, but is not limited to, 20KHz, the sampling gain can be, but is not limited to, 50dB, and the number of acquisitions can be, but is not limited to, 50 times.

[0120] Furthermore, the amplitude of the ECAP signal appears within 1 ms after stimulation and consists of a negative wave (N1) and a positive wave (P1). To reduce the interference of the ECAP-specific test signal on ECAP signal acquisition, methods such as forward-masking subtraction, alternating polarity stimulation, or artefact template subtraction can be used to remove artifacts.

[0121] Furthermore, ECAP signal acquisition can be performed on each stimulating electrode, or on a small number of electrodes with relatively even spacing (such as 5 out of 24 electrodes), and the results can be estimated for all remaining stimulating electrodes through interpolation. The signal processing module 120 can use common methods such as coherent superposition, low-pass filtering, and linear fitting to calculate the ECAP threshold of the auditory nerve fiber bundle stimulated by the stimulating electrodes.

[0122] In some exemplary embodiments, when the control module 130 outputs an electrically evoked auditory brainstem response test signal to the stimulation module 140, the signal acquisition module 150 is configured to use an extracochlear electrode, an extrascalp electrode, or an extrabrain electrode as the acquisition electrode to acquire the electrically evoked auditory brainstem response signal induced by the stimulation electrode of the stimulation module 140; the signal processing module 120 is configured to: obtain the test electrically evoked auditory brainstem response threshold corresponding to the stimulation electrode based on the electrically evoked auditory brainstem response signals induced by the stimulation electrode under different currents; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the test electrically evoked auditory brainstem response threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0123] Therefore, by adjusting the minimum threshold and comfort value accordingly based on the threshold of electrically evoked auditory brainstem response, it can be ensured that the stimulation strategy parameters always match the user's actual physiological conditions. Furthermore, for each stimulation electrode, by setting the difference between the adjusted comfort value and the adjusted minimum threshold of that electrode to be equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of that electrode, the stability of the user's auditory dynamic range can be maintained, avoiding abrupt changes in loudness perception.

[0124] Furthermore, when the artificial hearing device is a fully implanted or partially implanted cochlear implant, the EABR-specific test signal is output through the intracochlear stimulation electrodes; when the artificial hearing device is an auditory brainstem implant, the EABR-specific test signal is output through the cochlear nuclear electrodes. The stimulation mode can be monopolar or bipolar. The EABR-specific test signal is a preset sequence of signals with gradually increasing current; the current range can be, but is not limited to, 300μA-500μA, the step size can be, but is not limited to, 5μA; the pulse width can be, but is not limited to, 20μs, the pulse interval can be, but is not limited to, 5μs, and the stimulation frequency can be, but is not limited to, 80Hz.

[0125] Furthermore, when the artificial hearing device is a fully implanted cochlear implant, the EABR signal acquisition electrode can be any external cochlear electrode, the reference electrode can be any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode can be any internal cochlear electrode or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is a partially implanted cochlear implant, the EABR signal acquisition electrode can be any external cochlear electrode or any external scalp electrode, the reference electrode can be any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode or external scalp electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode can be any internal cochlear electrode or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is an auditory brainstem implantation device, the EABR signal acquisition electrode can be any external brainstem electrode, the reference electrode can be any cochlear nucleus electrode (not used as a stimulation electrode) or any external brainstem electrode (not used as an acquisition electrode, and is at a certain distance from the acquisition electrode so that it can detect the effective waveform), and the ground electrode can be any cochlear nucleus electrode or external brainstem electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode).

[0126] Furthermore, the acquisition accuracy of the EABR signal can be, but is not limited to, 12 bits, the sampling frequency can be, but is not limited to, 10KHz, the acquisition gain can be, but is not limited to, 60dB, and the number of acquisitions can be, but is not limited to, 200.

[0127] Furthermore, the amplitude of the EABR signal appears approximately 1-5 ms after stimulation, with the most prominent waveforms being wave III (around 2 ms) and wave V (around 4 ms). To reduce interference from the EABR-specific test signal on EABR signal acquisition, methods such as coherent superposition and low-pass filtering can be used to remove artifacts.

[0128] Furthermore, EABR signals can be acquired for each stimulation electrode, or for a small number of electrodes with relatively even spacing, and the results can be estimated for all remaining stimulation electrodes by interpolation.

[0129] Furthermore, for each stimulation electrode, the signal processing module 120 can calculate the EABR threshold and latency induced by the stimulation electrode by statistically analyzing the waveforms and latencies of wave III and wave V induced under different currents and using common methods such as low-pass filtering and linear fitting.

[0130] In some exemplary embodiments, for each stimulation electrode, the amplitude of the change in the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode is obtained based on the comparison between the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode and the historical electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode; and the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly based on the amplitude of the change in the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode.

[0131] Therefore, for each stimulation electrode, by adjusting the minimum threshold and comfort value of the stimulation electrode according to the amplitude of the EABR threshold change obtained by comparing the test EABR threshold corresponding to the stimulation electrode with the historical EABR threshold, dynamic tracking of the user's auditory pathway can be achieved, which can further help to achieve precise adaptive adjustment of stimulation strategy coding parameters.

[0132] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (3):

[0133] (3)

[0134] in, This represents the adjusted minimum threshold for the i-th stimulation electrode. This represents the lowest threshold value before adjustment for the i-th stimulation electrode. The threshold for the electrically evoked auditory brainstem response (EABR threshold obtained from the current test) is the threshold value of the i-th stimulating electrode. The historical evoked auditory brainstem response threshold (historical EABR threshold) is the threshold value of the i-th stimulating electrode. It is the second regulatory factor, and .

[0135] It should be noted that this invention relates to the second regulatory factor. The specific value is not limited, the second regulatory factor The specific value can be set according to actual needs, such as the second regulatory factor. The value can be 0.5. It should also be noted that... This is the amplitude of the EABR threshold change corresponding to the i-th stimulation electrode.

[0136] Furthermore, it should be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold of that stimulating electrode is calculated using the above formula (3). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0137] In some other exemplary embodiments, for each stimulating electrode, the minimum threshold of that stimulating electrode is adjusted using the following formula (4):

[0138] (4)

[0139] in, It is the third regulatory factor, and C1 is the first preset constant.

[0140] It should be noted that this invention addresses the third regulatory factor. The specific value is not limited; the third regulatory factor The specific value can be set according to actual needs, such as the third regulatory factor. The value can be 0.5. Similarly, the present invention does not limit the specific value of the first preset constant C1. The specific value of the first preset constant C1 can be set according to actual needs. For example, the value of the first preset constant C1 can be 10CU.

[0141] It should also be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold of the stimulating electrode is calculated using the above formula (4). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0142] In some exemplary embodiments, the signal processing module 120 is further configured to: acquire the latency of the evoked auditory brainstem response corresponding to the left stimulation electrode based on the evoked auditory brainstem response signals induced by the left stimulation electrode of the stimulation module 140 under different currents; acquire the latency of the evoked auditory brainstem response corresponding to the right stimulation electrode based on the evoked auditory brainstem response signals induced by the right stimulation electrode of the stimulation module 140 under different currents; and perform synchronous processing on the electrical signals of the left and right stimulation electrodes based on the difference between the evoked auditory brainstem response latencies corresponding to the left and right stimulation electrodes.

[0143] Since the bilateral auditory nerves initially converge in the brainstem, for users with bilateral implants, the EABR signal can reflect the objective neural response under bilateral stimulation. By comparing the EABR latency after stimulation on both sides, the difference in neural electrical signal delay between the left and right sides can be compared. By synchronizing the signals on the left and right sides based on this difference, the arrival time of the stimulation signals from both sides to the brainstem can be synchronized, thereby restoring natural binaural time perception and improving the accuracy of sound source localization.

[0144] Specifically, the electrical signals of the left and right stimulation electrodes can be synchronized according to the following formula (5):

[0145] (5)

[0146] in, This is a time series of stimulation signals from the left stimulation electrode. This is a time series of stimulation signals from the right-side stimulation electrode. This represents the EABR latency corresponding to the left stimulation electrode. This represents the EABR latency corresponding to the right-side stimulating electrode. This represents the difference (delay time difference) between the EABR latencies corresponding to the left and right stimulating electrodes. To enhance the time series of the stimulation signal from the right-side stimulation electrode after the delay, To increase the stimulation signal time series of the left stimulation electrode after delay.

[0147] In some exemplary embodiments, when the control module 130 outputs an electrically evoked cortical auditory potential (EAP) test signal to the stimulation module 140, the signal acquisition module 150 is configured to use an extracochlear electrode, an extrascalp electrode, or an extrabrainstem electrode as the acquisition electrode to acquire the EAP signal evoked by the stimulation electrode of the stimulation module 140; the signal processing module 120 is configured to: obtain the test EAP threshold corresponding to the stimulation electrode based on the amplitude difference between the P200 waveform and the N100 waveform in the EAP signal evoked by the stimulation electrode under different currents; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the test EAP threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0148] Therefore, by adjusting the minimum threshold and comfort value accordingly based on the threshold of the electrically evoked cortical auditory potential, it can be ensured that the stimulation strategy parameters always match the user's actual physiological conditions. Furthermore, for each stimulation electrode, by setting the difference between the adjusted comfort value and the adjusted minimum threshold of that electrode to be equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of that electrode, the stability of the user's auditory dynamic range can be maintained, avoiding abrupt changes in loudness perception.

[0149] Furthermore, when the artificial hearing device is a fully implanted or partially implanted cochlear implant, the eCAEP-specific test signal is output through the cochlear stimulation electrodes; when the artificial hearing device is an auditory brainstem implant, the eCAEP-specific test signal is output through the cochlear nuclear electrodes. The stimulation mode can be unipolar or bipolar. The eCAEP-specific test signal is a preset sequence of signals with gradually increasing current: the current range can be, but is not limited to, 300-500 μA; the step size can be, but is not limited to, 5 μA; the pulse width can be, but is not limited to, 20 μs; the pulse interval can be, but is not limited to, 5 μs; and the stimulation frequency can be, but is not limited to, 80 Hz.

[0150] Furthermore, when the artificial hearing device is a fully implanted cochlear implant, the eCAEP signal acquisition electrode can be any external cochlear electrode, the reference electrode can be any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode can be any internal cochlear electrode or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is a semi-implanted cochlear implant, the eCAEP signal acquisition electrode can be any external cochlear electrode or any external scalp electrode, the reference electrode can be any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode or external scalp electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode can be any internal cochlear electrode or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is an auditory brainstem implantation device, the acquisition electrode of the eCAEP signal can be any external brainstem electrode, the reference electrode can be any cochlear nucleus electrode (not used as a stimulation electrode) or any external brainstem electrode (not used as an acquisition electrode, and is at a certain distance from the acquisition electrode so that it can detect the effective waveform), and the ground electrode can be any cochlear nucleus electrode or external brainstem electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode).

[0151] Furthermore, the acquisition accuracy of the eCAEP signal can be, but is not limited to, 12 bits; the sampling frequency can be, but is not limited to, 10 kHz; the acquisition gain can be, but is not limited to, 80 dB; and the number of acquisitions can be, but is not limited to, 50.

[0152] Furthermore, the eCAEP signal amplitude appears approximately 50ms-250ms after stimulation, consisting of P50 / P100, N100, P200, and N200 waveforms, with N100 and P200 being the most prominent. To reduce interference from the dedicated eCAEP test signal on eCAEP signal acquisition, methods such as coherent superposition and low-pass filtering can be used to reduce signal interference.

[0153] Furthermore, eCAEP signal acquisition can be performed on each stimulation electrode, or on a small number of electrodes with relatively even spacing, and the results can be estimated for all remaining stimulation electrodes by interpolation.

[0154] Furthermore, for each stimulation electrode, the signal processing module 120 can calculate the eCAEP threshold and latency induced by the stimulation electrode by calculating the amplitude difference between the P200 waveform and the N100 waveform induced under different currents, and using a general method such as linear regression or a preset exponential regression method.

[0155] In some exemplary embodiments, for each stimulation electrode, the amplitude of the change in the electrical evoked cortical auditory potential threshold corresponding to the stimulation electrode is obtained based on the comparison between the test electrical evoked cortical auditory potential threshold corresponding to the stimulation electrode and the historical electrical evoked cortical auditory potential threshold corresponding to the stimulation electrode; and the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly based on the amplitude of the change in the electrical evoked cortical auditory potential threshold corresponding to the stimulation electrode.

[0156] Therefore, for each stimulation electrode, by adjusting the minimum threshold and comfort value of the stimulation electrode according to the amplitude of the eCAEP threshold change obtained by comparing the test eCAEP threshold corresponding to the stimulation electrode with the historical eCAEP threshold, dynamic tracking of the user's cortical auditory function can be achieved, which is more conducive to the accurate adaptive adjustment of stimulation strategy coding parameters.

[0157] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (6):

[0158] (6)

[0159] in, This represents the adjusted minimum threshold for the i-th stimulation electrode. This represents the lowest threshold value before adjustment for the i-th stimulation electrode. The test electroevoked auditory potential threshold (eCAEP threshold obtained from the current test) is the threshold value of the i-th stimulation electrode. The historical electroevoked cortical auditory potential threshold (historical eCAEP threshold) is the threshold value of the i-th stimulating electrode. It is the fourth regulatory factor, and .

[0160] It should be noted that this invention addresses the fourth regulatory factor. The specific value is not limited; the fourth regulatory factor The specific value can be set according to actual needs, such as the fourth regulatory factor. The value can be 0.5. It should also be noted that... This is the amplitude of the eCAEP threshold change corresponding to the i-th stimulation electrode.

[0161] Furthermore, it should be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold of that stimulating electrode is calculated using the above formula (6). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0162] In some other exemplary embodiments, for each stimulating electrode, the minimum threshold of that stimulating electrode is adjusted using the following formula (7):

[0163] (7)

[0164] in, It is the fifth regulatory factor, and C2 is the second preset constant.

[0165] It should be noted that this invention relates to the fifth regulatory factor. The specific value is not limited; the fifth regulatory factor The specific value can be set according to actual needs, such as the fifth regulatory factor. The value can be 0.5. Similarly, the present invention does not limit the specific value of the second preset constant C2. The specific value of the second preset constant C2 can be set according to actual needs. For example, the value of the second preset constant C2 can be 15CU.

[0166] It should also be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold of that stimulating electrode is calculated using the above formula (7). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0167] In some exemplary embodiments, the signal processing module 120 is further configured to: obtain the electrical evoked cortical response latency corresponding to the left stimulation electrode based on the amplitude difference between the P200 and N100 waveforms in the electrical evoked cortical auditory potential signals induced by the left stimulation electrode of the stimulation module 140 under different currents; obtain the electrical evoked cortical response latency corresponding to the right stimulation electrode based on the amplitude difference between the P200 and N100 waveforms in the electrical evoked cortical auditory potential signals induced by the right stimulation electrode of the stimulation module 140 under different currents; and perform synchronous processing on the electrical signals of the left and right stimulation electrodes based on the difference between the electrical evoked cortical response latencies corresponding to the left and right stimulation electrodes.

[0168] Since the bilateral auditory nerves initially converge in the brainstem, bilateral auditory perception has been integrated at the cortical level. Therefore, for users with bilateral implantation, eCAEP can reflect the objective response to bilateral stimulation. By comparing the eCAEP latency after bilateral stimulation, the difference in neural electrical signal delay between the left and right sides can be compared. By synchronizing the signals between the left and right sides based on this difference, the arrival time of the stimulation signals from both sides in the cortex can be synchronized, thereby restoring natural binaural time perception and improving the accuracy of sound source localization.

[0169] It should be noted that, as those skilled in the art will understand, the electrical signals of the left and right stimulation electrodes can be processed synchronously using the formula (5) above.

[0170] In some exemplary embodiments, when the control module 130 outputs a local evoked potential test signal to the stimulation module 140, the signal acquisition module 150 is configured to use the electrode adjacent to the stimulation electrode of the stimulation module 140 as the acquisition electrode to acquire the local evoked potential signal induced by the stimulation electrode; the signal processing module 120 is configured to: obtain the test local evoked potential threshold corresponding to the stimulation electrode based on the local evoked potential signal induced by the stimulation electrode; obtain the change amplitude of the local evoked potential threshold corresponding to the stimulation electrode based on the comparison result of the test local evoked potential threshold corresponding to the stimulation electrode and the historical local evoked potential threshold of the stimulation electrode; and adjust the minimum threshold and comfort value of the stimulation electrode accordingly based on the change amplitude of the local evoked potential threshold corresponding to the stimulation electrode, wherein the difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0171] Therefore, by calculating the amplitude of local evoked potential threshold changes and adjusting the minimum threshold and comfort value accordingly, the user's current neural state can be dynamically tracked and adapted to ensure that the stimulation strategy parameters always match the user's actual physiological conditions. Furthermore, for each stimulation electrode, by setting the difference between the adjusted comfort value and the adjusted minimum threshold of that electrode to be equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of that electrode, the stability of the user's auditory dynamic range can be maintained, avoiding abrupt changes in loudness perception.

[0172] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (8):

[0173] (8)

[0174] in, This represents the adjusted minimum threshold for the i-th stimulation electrode. This represents the lowest threshold value before adjustment for the i-th stimulation electrode. The threshold value for the local evoked potential (LEP threshold obtained from the current test) is the threshold value for the i-th stimulation electrode. The historical local evoked potential threshold (historical LEP threshold) is the threshold value of the i-th stimulating electrode. It is the sixth regulatory factor, and .

[0175] It should be noted that this invention relates to the sixth regulatory factor. The specific value is not limited; the sixth regulatory factor The specific value can be set according to actual needs, such as the sixth regulatory factor. The value can be 0.5. It should also be noted that... This is the amplitude of the local evoked potential threshold change corresponding to the i-th stimulation electrode.

[0176] Furthermore, it should be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold of that stimulating electrode is calculated using the above formula (8). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0177] Furthermore, during LEP testing, the stimulation mode can be either monopolar or bipolar. In monopolar mode, the stimulating electrode is a specific cochlear nucleus electrode, and the grounding electrode is a specific brainstem electrode or a combination of multiple brainstem electrodes. In bipolar mode, the stimulating electrode is a specific cochlear nucleus electrode, and the grounding electrode is any of the non-stimulating cochlear nucleus electrodes.

[0178] It should be noted that the specific parameters of the LEP dedicated test signal, as well as the specific acquisition and processing methods of the LEP signal, can be understood by referring to the specific parameters of the ECAP dedicated test signal and the specific acquisition and processing methods of the ECAP signal mentioned above. They will not be elaborated on here.

[0179] In some exemplary embodiments, when the artificial hearing device is a fully implanted cochlear implant or a partially implanted cochlear implant, the control module 130 is configured to output electrically evoked auditory nerve compound action potential test signal, electrically evoked auditory brainstem response test signal, and electrically evoked cortical auditory potential test signal to the stimulation module 140 in a time-division manner based on closed-loop debugging commands. The signal processing module 120 is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module 140 according to the electrically evoked auditory nerve compound action potential signal, electrically evoked auditory brainstem response signal, and electrically evoked cortical auditory potential signal evoked by the stimulation electrode. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0180] Since ECAP signals can reflect the synchronous firing of auditory nerve fibers, EABR signals can assess the integrity of the brainstem auditory conduction pathway, and eCAEP signals can reflect the final processing function of the auditory cortex, for fully implanted and semi-implanted cochlear implants, collecting ECAP, EABR, and eCAEP signals in a time-sequential manner during a single parameter tuning process can achieve information complementarity and realize objective assessment of the entire pathway from the periphery to the auditory cortex. Furthermore, through the fusion and parameter tuning of multimodal target auditory electrical signals, the adjustment accuracy of stimulation strategy coding parameters can be effectively improved, significantly enhancing the accuracy, safety, robustness, and long-term stability of auditory reconstruction.

[0181] Specifically, for each stimulation electrode in a fully implanted or partially implanted cochlear implant, the minimum threshold of that stimulation electrode can be adjusted using the following formula (9):

[0182] (9)

[0183] in, This represents the adjusted minimum threshold for the i-th stimulation electrode. This is the lowest threshold for the i-th stimulating electrode after adjustment based on the ECAP signal. This is the lowest threshold value of the i-th stimulating electrode after adjustment based on the EABR signal. This is the lowest threshold for the i-th stimulation electrode after adjustment based on the eCAEP signal. As the first weight, As the second weight, As the third weight, , and 0 < <1, 0< <1, 0< <1.

[0184] It should be noted that this invention applies to the first weight. Second weight and third weight The specific value is not limited, the first weight Second weight and third weight The specific value can be set according to actual needs. For example, the first weight The value can be 0.5, the second weight. The value can be 0.3, the third weight. The value can be 0.2. Furthermore, it should be noted that, as those skilled in the art will understand, for each stimulating electrode, the adjusted minimum threshold value of that stimulating electrode is calculated using the above formula (9). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0185] In some exemplary embodiments, when the artificial hearing device is an auditory brainstem implant, the control module 130 is configured to output local evoked potential test signals, electrically evoked auditory brainstem response test signals, and electrically evoked cortical auditory potential test signals to the stimulation module 140 in a time-sharing manner based on closed-loop debugging commands. The signal processing module 120 is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module 140 according to the local evoked potential signal, electrically evoked auditory brainstem response signal, and electrically evoked cortical auditory potential signal evoked by the stimulation electrode. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the unadjusted comfort value and the unadjusted minimum threshold of the stimulation electrode.

[0186] Therefore, for auditory brainstem implanted devices, the acquisition of LEP, EABR, and eCAEP signals in a time-separated manner during a single parameter tuning process can achieve information complementarity and realize objective evaluation of the entire pathway from the periphery to the auditory cortex. Furthermore, through the fusion and parameter tuning of multimodal target auditory electrical signals, the adjustment accuracy of stimulation strategy coding parameters can be effectively improved, significantly enhancing the accuracy, safety, robustness, and long-term stability of auditory reconstruction.

[0187] Specifically, for each stimulation electrode in the auditory brainstem implant, the minimum threshold of that stimulation electrode can be fused and adjusted using the following formula (10):

[0188] (10)

[0189] in, This represents the adjusted minimum threshold for the i-th stimulation electrode. This is the lowest threshold for the i-th stimulating electrode after adjustment based on the LEP signal. This is the lowest threshold value of the i-th stimulating electrode after adjustment based on the EABR signal. The minimum threshold for the i-th stimulation electrode after adjustment based on the eCAEP signal.

[0190] It should be noted that, as those skilled in the art will understand, for each stimulation electrode, the adjusted minimum threshold of that stimulation electrode is calculated using the above formula (10). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0191] In some exemplary embodiments, the types of dedicated test signals also include impedance test signals, and the types of target auditory electrical signals also include current or voltage values ​​between the stimulation electrode and the ground electrode of the stimulation module 140; the control module 130 is configured to output impedance test signals and at least one of electrically evoked auditory nerve compound action potential test signals, electrically evoked auditory brainstem response test signals, electrically evoked cortical auditory potential test signals, and local evoked potential test signals to the stimulation module 140 in a time-sharing manner based on closed-loop debugging commands.

[0192] Therefore, impedance testing can guide electrode selection and current / voltage compliance adjustment, thereby effectively improving the reliability and robustness of closed-loop tuning of stimulation strategy encoding parameters.

[0193] In some exemplary embodiments, when the control module 130 outputs an impedance test signal to the stimulation module 140, the signal acquisition module 150 is configured to acquire the current or voltage value between the stimulation electrode and the ground electrode based on an auditory electrical signal acquisition command; the signal processing module 120 is configured to: calculate the inter-electrode impedance value corresponding to the stimulation electrode based on the current or voltage value between the stimulation electrode and the ground electrode; determine whether the stimulation electrode is an impedance-abnormal electrode based on the inter-electrode impedance value corresponding to the stimulation electrode; if the stimulation electrode is an impedance-abnormal electrode and is the selected working electrode, then the stimulation electrode is deactivated and the adjacent impedance-normal electrode is used as the new working electrode.

[0194] Therefore, by identifying and disabling electrodes with abnormal impedance values ​​(abnormal electrodes), unsafe pathways can be cut off, potential damage can be avoided, and stimulation safety can be effectively improved. By replacing the working electrode with an abnormal impedance value with an adjacent electrode with a normal impedance value, not only can the number of effective stimulation channels remain unchanged and auditory coverage be kept intact, but the frequency coverage offset can also be reduced, effectively reducing auditory distortion.

[0195] Specifically, for each stimulation electrode, if the impedance between the electrode pair and the ground electrode is less than a first preset impedance value (e.g., 0.5kΩ), the stimulation electrode is determined to be in a short-circuit state (abnormal electrode); if the impedance between the electrode pair and the ground electrode is greater than a second preset impedance value (e.g., 30kΩ), the stimulation electrode is determined to be in an open-circuit state (abnormal electrode). If the selected electrodes corresponding to the speech strategy (e.g., 6 out of 24 electrodes) are abnormal and deactivated, they are automatically replaced by adjacent normally functioning impedance electrodes. It should be noted that impedance testing can be performed before ECAP, EABR, eCAEP, and LEP tests. Subsequently, based on the impedance test results, ECAP, EABR, eCAEP, and LEP tests can be performed only on electrodes with normal impedance, thereby improving testing efficiency and avoiding invalid tests. It should also be noted that for a new working electrode, the dynamic range (the difference between the C value and the original T value) of the old working electrode replaced by the new working electrode can be used as the original dynamic range corresponding to the new working electrode.

[0196] Furthermore, during impedance testing, either a monopolar or common-ground stimulation mode is used. Specifically, when the artificial hearing device is a fully implanted or partially implanted cochlear implant, in monopolar mode, the stimulating electrode is a specific intracochlear electrode, and the grounding electrode is a specific extracochlear electrode or a combination of multiple extracochlear electrodes; in common-ground mode, the stimulating electrode is a specific intracochlear electrode, and the grounding electrode is all remaining intracochlear electrodes. When the artificial hearing device is an auditory brainstem implant, in monopolar mode, the stimulating electrode is a specific cochlear nucleus electrode, and the grounding electrode is a specific brainstem extracorporeal electrode or a combination of multiple brainstem extracorporeal electrodes; in common-ground mode, the stimulating electrode is a specific cochlear nucleus electrode, and the grounding electrode is all remaining cochlear nucleus electrodes.

[0197] Furthermore, the stimulating electrode outputs a pulse (e.g., 70 μA, 25 μs) based on the impedance test signal. The signal acquisition module 150 uses a common impedance measurement method to read the current value (constant voltage source) or voltage value (constant current source) between the stimulating electrode and the ground electrode and transmits it to the signal processing module 120. The signal processing module 120 calculates the impedance value between the electrode pairs based on Ohm's law. It should also be noted that, as those skilled in the art will understand, impedance testing must be performed on all stimulating electrodes, except for those electrodes that are manually turned off by the audiologist during linearization.

[0198] In some exemplary embodiments, the signal processing module 120 is further configured to: if the number of impedance normal operating electrodes is less than a preset number, redistribute the center frequencies of the impedance normal operating electrodes so that the frequency range of the impedance normal operating electrodes can completely cover the preset sound stimulation frequency range.

[0199] Therefore, by automatically redistributing the center frequency of the electrodes when the number of working electrodes is less than the originally set number (preset number), it can be ensured that the frequency range of the normally operating electrodes can completely cover the original sound stimulation frequency range, thereby ensuring that each frequency component has corresponding electrical stimulation, and thus keeping the overall auditory perception intact.

[0200] In some exemplary embodiments, the signal processing module 120 is further configured to: for each stimulation electrode, calculate the maximum output current value or the maximum output voltage value of the stimulation electrode based on the inter-electrode impedance value corresponding to the stimulation electrode; if the maximum output current value of the stimulation electrode is less than the maximum set current value corresponding to the stimulation electrode, or the maximum output voltage value of the stimulation electrode is less than the maximum set voltage value corresponding to the stimulation electrode, then automatically lower the comfort value of the stimulation electrode until the stimulation electrode passes the current or voltage compliance detection.

[0201] Therefore, for each stimulation electrode, the maximum output current value (constant current source) of the stimulation electrode is calculated based on the inter-electrode impedance value and the maximum operating voltage of the stimulation driving chip in the stimulation module 140. This value is then compared with the maximum set current value corresponding to the stimulation electrode to perform current compliance detection. If the current compliance detection fails (the maximum output current value of the stimulation electrode is less than the maximum set current value), the comfort value of the stimulation electrode is automatically lowered. This ensures that the maximum operating voltage of the stimulation driving chip can support the output current of the stimulation electrode to reach the originally set maximum upper limit (maximum set current value). For each stimulation electrode, the maximum output voltage value (constant voltage source) of the stimulation electrode is calculated based on the inter-electrode impedance value and the maximum operating current of the stimulation driving chip in the stimulation module 140. This value is then compared with the maximum set voltage value corresponding to the stimulation electrode to perform voltage compliance detection. If the voltage compliance detection fails (the maximum output voltage value of the stimulation electrode is less than the maximum set voltage value), the comfort value of the stimulation electrode is automatically lowered. This ensures that the maximum operating current of the stimulation driving chip can support the output voltage of the stimulation electrode to reach the originally set maximum upper limit (maximum set voltage value).

[0202] It should be noted that, as those skilled in the art will understand, for each stimulation electrode, the maximum set current value and the maximum set voltage value corresponding to that stimulation electrode are related to the comfort value of that stimulation electrode. It should also be noted that, as those skilled in the art will understand, for each stimulation electrode, the adjusted comfort value of that stimulation electrode is obtained based on at least one of the following: electrically evoked auditory nerve complex action potential signal, electrically evoked auditory brainstem response signal, electrically evoked cortical auditory potential signal, and local evoked potential signal evoked by that stimulation electrode. Subsequently, the current / voltage compliance of the stimulation electrode was detected by impedance testing.

[0203] In some exemplary embodiments, the signal processing module 120 is further configured to: for each stimulation electrode, if the maximum output current value of the stimulation electrode is greater than or equal to the maximum set current value, and the stimulation electrode previously automatically reduced its comfort value because the maximum output current value was less than the maximum set current value, or the maximum output voltage value of the stimulation electrode is greater than or equal to the maximum set voltage value, and the stimulation electrode previously automatically reduced its comfort value because the maximum output voltage value was less than the maximum set voltage value, then automatically increase the comfort value of the stimulation electrode so that the difference between the increased comfort value of the stimulation electrode and the minimum threshold value is close to the original difference value.

[0204] Therefore, by increasing the comfort value of the stimulation electrode, which was previously automatically reduced due to failure of current compliance testing or voltage compliance testing, but now passes current compliance testing or voltage compliance testing, to a level close to the original dynamic range (the difference between the original C value and the original T value), the original auditory dynamic range can be restored, effectively improving auditory quality.

[0205] In some exemplary embodiments, the signal processing module 120 is also configured to reactivate the stimulating electrode and perform automatic redistribution of the working electrode and center frequency if the inter-electrode impedance value of the stimulating electrode that was previously disabled due to abnormal inter-electrode impedance value returns to normal.

[0206] Therefore, by automatically reactivating electrodes that were previously deactivated due to abnormal impedance values ​​and automatically redistributing the working electrodes and center frequency, complete frequency coverage can be restored, thus improving hearing quality.

[0207] In some exemplary embodiments, the signal processing module 120 is configured to encode external signals suitable for auditory central nervous system (ANS) testing and evaluation into corresponding electrical stimulation signals using updated stimulation strategy encoding parameters, and transmit these signals to the control module 130. It also sends an auditory central nervous system (ANS) signal acquisition command to the control module 130. The control module 130 is further configured to control the stimulation module 140 to output corresponding auditory central nervous system (ANS) evaluation electrical pulses based on the electrical stimulation signals, and to control the signal acquisition module 150 to acquire target ANS signals based on the ANS signal acquisition command. The signal processing module 120 is also configured to evaluate the auditory effect of the updated stimulation strategy encoding parameters based on the target ANS signals. Therefore, this setup allows for routine monitoring of the user's auditory-related EEG signals, effectively reducing the cost of manual device adjustments and improving user rehabilitation efficiency.

[0208] It should be noted that comparative analysis can be performed once sufficient auditory central signal data has been collected. The collected auditory central signals can be used to compare the objective auditory effects under different stimulus strategy coding parameters. After comparison, the user can choose to enable automatic coding parameter application. The signal processing module 120 identifies the current acoustic scene through external signal analysis and applies the stimulus strategy coding parameters that provide the best auditory effect under that scene.

[0209] Please continue to refer to this. Figure 4 This is a schematic diagram of the auditory central nervous system testing and evaluation chain provided in one embodiment of the present invention. Figure 4 As shown, the signal processing module 120 performs strategy encoding on external signals suitable for auditory central nervous system testing and evaluation, and outputs the encoded signal to the control module 130, which then outputs a current pulse signal via the stimulation module 140. Simultaneously, the signal processing module 120 sends an auditory central nervous system signal acquisition command to the control module 130, and the control module 130 outputs an acquisition command to the signal acquisition module 150. The signal acquisition module 150, according to the specific requirements of the acquisition command, activates the acquisition array and acquisition parameters required for acquiring specific auditory central nervous system signals (including auditory ERP (Event-Related Potential) signals and auditory EEG (Electroencephalogram) signals). The acquired auditory central nervous system signals are returned to the signal processing module 120, which performs real-time decoding to objectively evaluate the auditory effect.

[0210] In some exemplary embodiments, the signal processing module 120 is configured to: if the external signal is an external sound signal and the external sound signal meets preset sound conditions, then determine that the external signal is suitable for auditory central nervous system testing and evaluation; the preset sound conditions include the external sound signal being a speech signal in a quiet environment, a speech signal in a noisy environment, or a music signal; if the external signal is an external digital audio signal, and the external digital audio signal is an auditory event-related potential paradigm test digital signal or an auditory brainwave paradigm test digital signal, then determine that the external signal is suitable for auditory central nervous system testing and evaluation; the auditory event-related potential paradigm test digital signal includes a passive spherical paradigm test digital signal used to induce mismatch negative waves. The signal acquisition module 150 acquires at least one of the following: an active spherical paradigm test digital signal for inducing P300 waves and an auditory semantic misalignment paradigm test digital signal for inducing N400 waves; the auditory EEG paradigm test digital signal includes at least one of a speech stimulation paradigm test digital signal and a music stimulation paradigm test digital signal; when the external signal is an auditory event-related potential paradigm test digital signal, the target auditory center signal acquired by the signal acquisition module 150 is an event-related potential signal; when the external signal is a speech signal in a quiet environment, a speech signal in a noisy environment, a music signal, or an auditory EEG paradigm test digital signal, the target auditory center signal acquired by the signal acquisition module 150 is an EEG signal.

[0211] Therefore, by automatically using real-life sound signals from daily life as auditory central response measurement stimuli when external signals are identified as speech signals in quiet environments, speech signals in noisy environments, or music signals, the user's real auditory responses in actual scenarios can be collected. By automatically using standardized paradigm test digital signals (ERP or EEG) as auditory central response measurement stimuli when external signals are identified as auditory event-related potential (ERP) or auditory brainwave (EEG) paradigm test digital signals, the authenticity of daily assessments and the accuracy of professional tests can be balanced.

[0212] In some exemplary embodiments, when the external signal is a digital signal from a passive spherical paradigm test used to induce a mismatch negative wave, the signal acquisition module 150 is configured to mark the time point of the stimulus occurrence when acquiring the event-related potential signal; the signal processing module 120 is configured to determine the amplitude and latency of the mismatch negative wave based on the event-related potential signal acquired by the signal acquisition module 150, and to calculate a first speech discrimination ability score based on the amplitude and latency of the mismatch negative wave.

[0213] Therefore, by calculating the first speech discrimination ability score based on MMN amplitude and MMN latency, an objective assessment of auditory performance can be achieved. Furthermore, by marking the time points of stimulus occurrence, the ERP signal under each stimulus type (standard stimulus or deviated stimulus) can be accurately distinguished.

[0214] It should be noted that because the passive odddball paradigm requires patients to remain resting, or even watch silent videos to ignore sound, this approach is particularly suitable for young infants who are unable or unwilling to cooperate with subjective testing, and initial users who have difficulty adapting to cochlear implant electrical stimulation.

[0215] Specifically, the passive skewer paradigm test digital signal contains two types of sound stimuli: standard stimuli (80%-85%) and biased stimuli (15%-20%). Standard and biased stimuli differ in a certain acoustic dimension, including the four tones of Mandarin (e.g., first tone vs. third tone), initial consonants of monosyllabic words (e.g., bo vs. po), final vowels (e.g., ba vs. bo), and sound frequencies (e.g., / a / vs. / i / in the "Lin's Six Tones"). There are 200-500 sound stimuli in total, each lasting 50ms-200ms, with intervals of 500ms-1500ms. The sound stimuli are played continuously in a random order, while biased stimuli cannot appear consecutively (at least two standard stimuli must be present at the interval). Users do not need to respond to the sounds but must remain silent and watch a silent video provided by the mobile software, ignoring the sound stimuli.

[0216] Furthermore, when the artificial hearing device is a fully implanted cochlear implant, the acquisition electrode is any external cochlear electrode (preferably close to the central brain region), the reference electrode is any internal cochlear electrode (not used as a stimulation electrode or acquisition electrode) or any external cochlear electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that effective waveforms can be detected), and the ground electrode is any internal or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is a semi-implanted cochlear implant, the acquisition electrode can be any external cochlear electrode or any external scalp electrode, the reference electrode is any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode or external scalp electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that effective waveforms can be detected), and the ground electrode is any internal or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is an auditory brainstem implantation device, the acquisition electrode is any external brainstem electrode, the reference electrode is any cochlear nucleus electrode or any external brainstem electrode (not used as an acquisition electrode, and is at a certain distance from the acquisition electrode so that it can detect an effective waveform), and the ground electrode is any cochlear nucleus electrode or any external brainstem electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode).

[0217] Furthermore, the acquisition precision of the event-related potential (ERP) signal can be, but is not limited to, 12 bits, the sampling frequency can be, but is not limited to, 500 Hz, and the gain can be, but is not limited to, 80 dB. The time points of stimulus occurrence need to be marked during acquisition. To reduce interference from the digital signal of the passive glitch ball paradigm test on the ERP signal acquisition, methods such as coherent superposition and low-pass filtering can be used to remove artifacts.

[0218] Furthermore, for each sound stimulus, the signal processing module 120 takes the instant the stimulus begins as the zero point and extracts the ERP signal from 200ms before the stimulus to 500ms after the stimulus, as a complete analysis time history. Then, the extracted ERP signal is sequentially bandpass filtered (filtering frequency from 1Hz to 30Hz), followed by artifact removal, baseline correction, and reference electrode correction.

[0219] Furthermore, the MMN waveform equals the average ERP evoked by the deviated stimulus minus the average ERP evoked by the standard stimulus. Since the MMN latency is 100ms-250ms, the MMN amplitude and latency can be measured by finding the most prominent negative peak within this window in the MMN waveform. Significantly larger MMN amplitudes and significantly shorter MMN latencies reflect stronger auditory perception differences and faster perception and processing speeds between the standard and deviated stimuli, respectively. Therefore, stimulus strategy encoding parameters with larger MMN amplitudes and / or shorter MMN latencies for the same paradigm within the same time period are better in speech contexts.

[0220] In some exemplary embodiments, the calculation of the first speech discrimination ability score based on the mismatch negative wave amplitude and the mismatch negative wave latency includes: calculating the first speech discrimination ability score using the following formula (11):

[0221] (11)

[0222] In the formula, Score_MMN is the first speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_MMN A represents the amplitude of the mismatched negative wave obtained from the current measurement. baseline_MMN A is the amplitude of the mismatch negative waveform recorded during the user's initial device setup. target_MMN For the target mismatch negative wave amplitude, L current_MMN L represents the currently measured latency of the mismatched negative wave. baseline_MMN L is the latency period of the mismatch negative wave recorded during the user's first implantation and tuning. target_MMN For the target mismatch negative wave latency, w A_MMN For the mismatched negative wave amplitude weight, w L_MMN For mismatched negative wave latent options, 0 < w A_MMN<1, 0 <w L_MMN <1, and w A_MMN +w L_MMN =1.

[0223] Therefore, by using the above formula (11) to calculate the first speech discrimination ability score Score_MMN, not only can the two different physical quantities, MMN amplitude and MMN latency, be weighted and fused on the same scale, thus enabling a more accurate assessment of speech discrimination ability, but it can also help to achieve a precise assessment of individualized and dynamic speech discrimination ability. At the same time, it can also ensure that the calculated first speech discrimination ability score Score_MMN is a score between 0 and 1. The closer the score is to 1, the better the speech discrimination ability (the better the listening effect); the closer the score is to 0, the worse the speech discrimination ability (the worse the listening effect).

[0224] It should be noted that this invention relates to w A_MMN and w L_MMN The specific value is not limited, for example, w A_MMN The value of w can be 0.6. L_MMN The value can be 0.4.

[0225] In some exemplary implementations, when the external signal is an active spherical paradigm test digital signal used to induce the P300 wave, the signal acquisition module 150 is configured to mark the time point of the stimulus occurrence when acquiring the event-related potential signal; the signal processing module 120 is configured to determine the P300 wave amplitude and P300 wave latency based on the event-related potential signal acquired by the signal acquisition module 150, and calculate a second speech discrimination ability score based on the P300 wave amplitude, P300 wave latency, and the user's behavioral response accuracy.

[0226] Therefore, by calculating the second speech discrimination ability score based on the P300 wave amplitude, P300 wave latency, and the accuracy of the user's behavioral response, a dual-modal verification of neural and behavioral aspects can be achieved, effectively improving the accuracy of speech discrimination ability assessment results.

[0227] Specifically, the digital signal of the active skewer paradigm test is the same as that of the passive skewer paradigm test mentioned above, but the user needs to respond to the sound, such as pressing a button on the mobile software interface when hearing the skewer stimulus.

[0228] Furthermore, the acquisition method of ERP signals under active quagmire ball paradigm test digital signal stimulation is the same as that under passive quagmire ball paradigm test digital signal stimulation, but the acquisition electrodes are preferably selected from those located near the central or parietal brain regions.

[0229] Furthermore, for each sound stimulus, the signal processing module 120 takes the instant the stimulus begins as the zero point and extracts the ERP signal from 200ms before the stimulus to 600ms after the stimulus, as a complete analysis time history. Then, the extracted ERP signal is sequentially bandpass filtered (filtering frequency from 1Hz to 30Hz), followed by artifact removal, baseline correction, and reference electrode correction.

[0230] Furthermore, the P300 waveform equals the average ERP evoked by the biased stimulus minus the average ERP evoked by the standard stimulus. Since the P300 wave latency is 250ms-500ms, the P300 wave amplitude and latency can be measured by finding the most prominent positive peak within this window in the P300 waveform. Significantly larger P300 wave amplitudes, significantly shorter P300 wave latencies, and higher accuracy in behavioral responses all reflect a user's stronger ability to distinguish between standard and biased stimuli. Furthermore, higher accuracy in user behavioral responses indicates stronger cognitive abilities. Therefore, for the same paradigm within the same time period, stimulus strategy encoding parameters with larger P300 wave amplitudes and / or shorter P300 wave latencies are better in verbal contexts.

[0231] In some exemplary implementations, the calculation of the second speech discrimination score based on P300 wave amplitude, P300 wave latency, and user behavioral response accuracy includes: calculating the second speech discrimination score using the following formula (12):

[0232] (12)

[0233] In the formula, Score_P300 is the second speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_P300 For the currently measured P300 wave amplitude, A baseline_P300 The P300 waveform amplitude recorded during the user's initial device setup, A target_P300 For the target P300 wave amplitude, L current_P300 L represents the currently measured latency of the P300 wave. baseline_P300 The latency of the P300 wave recorded during the user's initial device setup, L target_P300 For the target P300 wave latency period, w A_P300 For the P300 wave amplitude weight, w L_P300 For P300 wave latent options, P be For the accuracy of user behavior response, w B_P300 For behavioral response weights, 0 < w A_P300 <1, 0 <w L_P300 <1, 0 <w B_P300 <1, and wA_P300 +w L_P300 +w B_P300 =1.

[0234] Therefore, by using the above formula (12) to calculate the second speech discrimination ability score Score_P300, not only can the three different physical quantities of P300 wave amplitude, P300 wave latency and behavioral response accuracy be weighted and fused on the same scale, so as to more accurately assess speech discrimination ability, but also can help to achieve individualized and dynamic accurate assessment of speech discrimination ability.

[0235] It should be noted that this invention relates to w A_P300 w L_P300 and w B_P300 The specific value is not limited, for example, w A_P300 The value of w can be 0.5. L_P300 The value of w can be 0.3. B_P300 The value can be 0.2.

[0236] In some exemplary embodiments, the signal processing module 120 is also configured to comprehensively evaluate the auditory performance of the updated stimulus strategy coding parameters based on the speech discrimination ability assessment results under stimulation by the passive skein-the-ball paradigm test digital signal used to induce mismatch negative waves and the active skein-the-ball paradigm test digital signal used to induce P300 waves.

[0237] Therefore, since MMN can assess the brain's ability to keenly capture subtle changes in sound during the unconscious, automatic pre-attentional stage, and P300 can assess the brain's ability to efficiently distinguish and make decisions when consciously paying attention, by integrating the assessment results of speech discrimination ability under the passive Oddball paradigm and the active Oddball paradigm, a two-level complete assessment of auditory function can be achieved, effectively improving the accuracy of the auditory effect assessment results.

[0238] In some exemplary embodiments, the comprehensive evaluation of the auditory performance of the updated stimulus strategy coding parameters based on the speech discrimination ability assessment results under the stimulation of passive monster ball paradigm test digital signals used to induce mismatch negative waves and active monster ball paradigm test digital signals used to induce P300 waves includes: comprehensively evaluating the auditory performance of the updated stimulus strategy coding parameters using the following formula (13):

[0239] (13)

[0240] In the formula, Score_ERP is the comprehensive speech discrimination ability score based on event-related potential signals, Score_MMN is the first speech discrimination ability score (used to assess speech discrimination ability under digital signal stimulation of the passive spherical paradigm test to induce mismatch negative waves), and Score_P300 is the second speech discrimination ability score (used to assess speech discrimination ability under digital signal stimulation of the active spherical paradigm test to induce P300 waves), w MMN For the mismatched negative wave weights, w P300 For P300 wave weights, 0 < w MMN <1, 0 <w P300 <1, and w MMN +w P300 =1.

[0241] It should be noted that the weighting of MMN and P300 waves depends on the user's autonomy. Specifically, for younger or older users, the weighting of MMN (w) is different. MMN ) higher, for example, w MMN The value of w can be 0.7. P300 The value can be 0.3; for teenage or young adult users, the weight of P300 (w) P300 ) higher, for example, w MMN The value of w can be 0.3. P300 The value can be 0.7.

[0242] In some exemplary implementations, when the external signal is a digital signal used to induce the N400 wave in an auditory semantic misalignment paradigm test, the signal acquisition module 150 is configured to mark the occurrence time of key ending words in each trial when acquiring event-related potential signals; the signal processing module 120 is configured to determine the N400 wave latency under the conditions of N400 difference wave amplitude and semantic inconsistency based on the event-related potential signals acquired by the signal acquisition module 150, and to evaluate semantic understanding ability based on the N400 difference wave amplitude and N400 wave latency.

[0243] Therefore, by assessing semantic understanding ability based on N400 difference wave amplitude and N400 wave latency, objective quantification of the highest level of auditory function (semantic understanding) can be achieved, providing a deeper neurological basis for evaluating the auditory effect of stimulus strategy encoding parameters. Furthermore, by marking the occurrence time of key ending words in each trial, accurate classification of ERP signals under semantically consistent and semantically inconsistent conditions can be achieved, thus laying a solid foundation for the extraction of N400 difference waves.

[0244] Specifically, the digital signal used to induce the N400 wave in the auditory semantic misalignment paradigm test comprises trials consisting of two types of stimuli: semantically consistent statements and semantically inconsistent statements, each accounting for 50%. In a trial, the user's semantic expectation is established by first playing the first part of a short sentence (excluding the last keyword) (e.g., "This is too..."), followed by the final keyword. In semantically consistent statements, the final keyword conforms to the contextual expectation (e.g., "Okay"); in semantically inconsistent statements, the final keyword does not conform to the contextual expectation (e.g., "ran away"). The stimulus data can be derived from Mandarin Chinese CMnBio, Mandarin speech audiometry materials (MSTMs), etc. The total number of trials can be, but is not limited to, 200. The stimuli of semantically consistent and semantically inconsistent statements are balanced in terms of key linguistic attributes such as word frequency, length, and abstraction, and are randomly mixed in the experiment to avoid forming a predetermined strategy. The trial interval can be, but is not limited to, 1500 ms. The user does not need to react to the sound but must remain seated.

[0245] Furthermore, the acquisition method for ERP signals under the auditory semantic misalignment paradigm test digital signal is consistent with the acquisition method under the passive quirk ball paradigm test digital signal. During acquisition, the occurrence time of key ending words in each trial needs to be marked.

[0246] Furthermore, for each trial, the signal processing module 120 uses the instant of the key ending word as the time zero point and extracts the ERP signal from 200ms before the stimulus begins to 800ms after the stimulus begins, as a complete analysis time history. Then, the extracted ERP signal is sequentially subjected to bandpass filtering (filtering frequency 0.1Hz-30Hz), artifact removal, baseline correction, and reference electrode correction. Since the N400 wave latency is 250ms-600ms, the N400 wave amplitude and latency can be measured by finding the most prominent negative peak within this window.

[0247] Furthermore, the N400 results under semantically consistent and semantically inconsistent conditions were averaged separately, and the difference waveforms (the amplitude of the N400 waveform under the semantically inconsistent condition minus the amplitude of the N400 waveform under the semantically consistent condition) were analyzed. If the N400 difference waveform amplitude is significant, the user's semantic processing and cognitive abilities are normal; otherwise, under that time period or specific program number encoding, the user cannot correctly distinguish Chinese words, affecting semantic understanding.

[0248] Furthermore, the N400 difference amplitude value can be calculated using the following formula (14):

[0249] (14)

[0250] In the formula, Amp diff The difference amplitude value is N400.incong For the N400 wave amplitude under semantic inconsistency conditions, Amp cong The amplitude of the N400 wave under the condition of semantic consistency.

[0251] Furthermore, if the N400 difference amplitude value Amp diff N400 wave latency less than or equal to a preset differential amplitude value (e.g., -3.5 μV) and under semantically inconsistent conditions. incong If the latency is greater than or equal to the first preset latency (e.g., 400ms) and less than or equal to the second preset latency (e.g., 550ms), it indicates that the user's semantic processing and cognitive abilities are normal, and the updated stimulus strategy encoding parameters pass the test.

[0252] In some exemplary implementations, when the external signal is a speech stimulus paradigm test digital signal, a speech signal in a quiet environment, or a speech signal in a noisy environment, the signal processing module 120 is configured to: extract the Delta wave actual speech envelope and the Theta wave actual speech envelope based on the speech stimulus paradigm test digital signal, the speech signal in a quiet environment, or the speech signal in a noisy environment; extract Delta wave data and Theta wave data based on the EEG signals acquired by the signal acquisition module 150; reconstruct the Delta wave reconstructed speech envelope and the Theta wave reconstructed speech envelope based on the extracted Delta wave data and Theta wave data; and calculate a third speech discrimination ability score based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope.

[0253] Due to the correlation coefficient C between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope... Delta The correlation coefficient C between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope can significantly predict the user's comprehension of the target speech. Theta It can significantly predict speech clarity, thereby through C-based Delta and C Theta Calculating the third speech discrimination ability score can effectively improve the accuracy of speech discrimination ability assessment results.

[0254] It should be noted that C can be calculated using the Pearson product-moment correlation coefficient formula, which is well known to those skilled in the art. Delta and C Theta .

[0255] Specifically, in the auditory semantic misalignment paradigm test digital signal, the target speech stimulus is a Chinese sentence, and the material can be derived from the Mandarin Chinese version of CMnBio, Mandarin speech audiometry materials MSTMs, etc. In the quiet scene paradigm, only the target speech stimulus needs to be played; in the noisy scene paradigm, in addition to playing the target speech stimulus, background noise also needs to be added. The noise material comes from a noise material library of daily life scenes (such as restaurants, roads, subway stations, etc.) (i.e., speech scenes under daily life noise) or the Chinese sentence material library mentioned above (i.e., speech scenes under noise from multiple people communicating), so that the signal-to-noise ratio ranges from 5~10dB (mild noise), 0~5dB (moderate noise), and -5~0dB (high noise).

[0256] Furthermore, when the signal source 110 picks up external sound signals, the signal processing module 120 determines whether the current scene is a speech scene through scene recognition, and evaluates whether the signal-to-noise ratio of the current external sound signal is greater than 10dB (i.e., a quiet scene) or falls within the three signal-to-noise ratio ranges of a noisy scene. If so, the current natural scene can be used for central assessment. One paradigm lasts for about 10 minutes. The user needs to remain in a resting state and does not need to react to the sound, but needs to maintain attention to the target speech stimulus.

[0257] Furthermore, when the artificial hearing device is a fully implanted cochlear implant, the acquisition electrode is any external cochlear electrode (preferably close to the central brain region), the reference electrode is any internal cochlear electrode (not used as a stimulation electrode or acquisition electrode) or any external cochlear electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode is any internal or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is a partially implanted cochlear implant, the acquisition electrode can be any external cochlear electrode or any external scalp electrode, the reference electrode is any internal cochlear electrode (not used as a stimulation electrode) or any external cochlear electrode or external scalp electrode (not used as a acquisition electrode, and at a certain distance from the acquisition electrode so that an effective waveform can be detected), and the ground electrode is any internal or external cochlear electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode). When the artificial hearing device is an auditory brainstem implantation device, the acquisition electrode is any external brainstem electrode, the reference electrode is any cochlear nucleus electrode or any external brainstem electrode (not used as an acquisition electrode, and is at a certain distance from the acquisition electrode so that it can detect an effective waveform), and the ground electrode is any cochlear nucleus electrode or any external brainstem electrode (not used as a stimulation electrode, the ground electrode of the stimulation module 140, or the acquisition electrode).

[0258] Furthermore, the acquisition precision of the electroencephalogram (EEG) signal can be, but is not limited to, 24 bits, the sampling frequency can be, but is not limited to, 500 Hz, and the gain can be, but is not limited to, 80 dB. During the acquisition of the EEG signal, the stimulation module 140 and the signal acquisition module 150 need to operate simultaneously. To avoid the influence of stimulation on signal acquisition artifacts, template subtraction can be used to remove artifacts.

[0259] Furthermore, Delta wave data can be extracted by performing bandpass filtering of the EEG signal at a frequency of 1Hz-4Hz, followed by artifact removal, baseline correction, and reference electrode correction; Theta wave data can be extracted by performing bandpass filtering of the EEG signal at a frequency of 4Hz-8Hz, followed by artifact removal, baseline correction, and reference electrode correction.

[0260] Furthermore, the original external signal (digital signal of speech stimulus paradigm test, speech signal in a quiet environment or speech signal in a noisy environment) can be preprocessed by downsampling and full-wave rectification, and then the preprocessed external signal can be filtered to the target EEG frequency band (1Hz-4Hz, 4Hz-8Hz), and finally downsampled to 50Hz to extract the Delta wave actual speech envelope and Theta wave actual speech envelope.

[0261] Furthermore, an inverse linear model can be used to reconstruct the speech envelope of the extracted Delta and Theta wave data, thereby obtaining the reconstructed Delta and Theta wave speech envelopes. Specifically, regarding how to use an inverse linear model to reconstruct the speech envelope of the extracted Delta and Theta wave data, please refer to relevant materials known to those skilled in the art for an adaptive understanding; further explanation is not provided here.

[0262] In some exemplary embodiments, the calculation of the third speech discrimination ability score based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope, includes: calculating the third speech discrimination ability score using the following formula (15):

[0263] (15)

[0264] In the formula, Score_EEG is the third speech discrimination ability score, and C Delta C represents the correlation coefficient between the reconstructed speech envelope of the Delta wave and the actual speech envelope of the Delta wave. ThetaThe correlation coefficient between the reconstructed speech envelope of the Theta wave and the actual speech envelope of the Theta wave. For Theta wave weights, and .

[0265] Therefore, by using the above formula (15) to calculate the third speech discrimination ability score, the weighted score can be dynamically optimized according to the different auditory rehabilitation stages or hearing impairment types of different patients, thereby providing better data support for the optimization of stimulus strategy coding parameters.

[0266] It should be noted that, within the same time period, for speech stimuli with the same signal-to-noise ratio, a program number (stimulus strategy encoding parameter) with a higher Score_EEG is better in this type of speech environment. It should also be noted that this invention... The specific value is not limited. The value can be, but is not limited to, 0.5.

[0267] In some exemplary embodiments, the signal processing module 120 is also configured to test the speech discrimination ability assessment results under digital signal and / or external sound signal stimulation based on speech stimulation paradigms of different signal-to-noise ratio speech scenarios, and to comprehensively evaluate the listening effect of the updated stimulation strategy coding parameters. The different signal-to-noise ratio speech scenarios include quiet speech scenarios, slightly noisy speech scenarios, moderately noisy speech scenarios, and highly noisy speech fields.

[0268] Therefore, this setup enables full-scene coverage assessment of the real listening world, thus providing better data support for optimizing stimulus strategy encoding parameters.

[0269] Specifically, the speech discrimination ability assessment results under digital signal and / or external sound signal stimulation can be tested based on speech stimulation paradigms of speech scenarios with different signal-to-noise ratios. The listening effect of the updated stimulation strategy encoding parameters can be comprehensively evaluated using the following formula (16):

[0270] (16)

[0271] In the formula, Score_EEG_synthetic represents the comprehensive speech discrimination ability score based on EEG signals; Score_EEG_silent represents the third speech discrimination ability score in quiet speech scenarios; Score_EEG_mild represents the third speech discrimination ability score in mildly noisy speech scenarios; Score_EEG_medium represents the third speech discrimination ability score in moderately noisy speech scenarios; and Score_EEG_intense represents the third speech discrimination ability score in highly noisy speech scenarios. silent For quiet speech scenarios, w mildFor weighting in mildly noisy speech scenarios, w medium For moderately noisy speech scenarios, w intense For weights in highly noisy speech scenarios, 0 < w silent <1, 0 <w mild <1, 0 <w medium <1, 0 <w intense <1, and w silent +w mild +w medium +w intense =1.

[0272] It should be noted that this invention relates to w silent w mild w medium w intense The specific value is not limited, for example, w silent The value of w can be 0.4. mild The value of w can be 0.2. medium The value of w can be 0.2. intense The value can be 0.2.

[0273] In some exemplary embodiments, the signal processing module 120 is also configured to comprehensively evaluate the auditory effect of the updated stimulus strategy coding parameters based on the speech discrimination ability assessment results under the stimulation of auditory event-related potential paradigm test digital signals and auditory brainwave paradigm test digital signals.

[0274] Therefore, this setup enables comprehensive, multi-dimensional assessment across all levels, from the brainstem to the cortex, from automatic perception to active understanding, and from basic discrimination to real-world scene tracking, thereby significantly improving the accuracy and reliability of the assessment results.

[0275] Specifically, the auditory performance of the updated stimulus strategy coding parameters can be comprehensively evaluated using the following formula (17) based on the comprehensive speech discrimination ability score Score_ERP based on event-related potential signals and the comprehensive speech discrimination ability score Score_EEG_comprehensive based on electroencephalogram signals:

[0276] (17)

[0277] In the formula, Score_ is the comprehensive speech discrimination ability score that integrates event-related potential signals and EEG signals, and w ERP For event-related potential weights, w EEG For brainwave weights, 0 < w ERP <1, 0 <w EEG <1, and w ERP +w EEG =1.

[0278] It should be noted that this invention relates to w ERP and w EEG The specific value is not limited, for example, w ERP The value of w can be 0.4. EEG The value can be 0.6.

[0279] In some exemplary embodiments, when the external signal is a music signal or a digital signal from a music stimulation paradigm test, the signal processing module 120 is configured to: extract baseline Beta wave data and baseline Gamma wave data based on the EEG signals acquired by the signal acquisition module 150 before music stimulation; perform time-frequency analysis on the baseline Beta wave data and baseline Gamma wave data respectively to obtain the corresponding baseline Beta wave time-frequency data and baseline Gamma wave time-frequency data; obtain the baseline Beta wave time-frequency energy based on the baseline Beta wave time-frequency data, and obtain the baseline Gamma wave time-frequency energy based on the baseline Gamma wave time-frequency data; and extract the music-period Beta wave data and music-period Gamma wave data based on the EEG signals acquired by the signal acquisition module 150 during music stimulation. The music period Gamma wave data was analyzed. Time-frequency analysis was performed on the music period Beta wave data and music period Gamma wave data to obtain the corresponding music period Beta wave time-frequency data and music period Gamma wave time-frequency data. Based on the music period Beta wave time-frequency data, the music period Beta wave time-frequency energy and music period Gamma wave time-frequency energy were obtained. Based on the music period Beta wave time-frequency energy and the baseline period Beta wave time-frequency energy, the percentage change in Beta wave time-frequency energy and the percentage change in Gamma wave time-frequency energy were obtained. Based on the percentage changes in Beta wave time-frequency energy and Gamma wave time-frequency energy, the music appreciation ability assessment value was calculated.

[0280] Therefore, this setting can eliminate the influence of individual differences, thus providing an objective basis for optimizing the coding parameters of the stimulus strategy in music scenarios. Furthermore, since the energy enhancement of Beta waves is generally associated with music-induced attentional engagement, alertness, and rhythmic perception, and the energy enhancement of Gamma waves is closely related to higher-level perceptual integration, subjective pleasure, and the aesthetic experience of music, an objective assessment of music appreciation ability can be achieved by calculating the music appreciation ability assessment value based on the percentage changes in the time-frequency energy of Beta waves and Gamma waves.

[0281] Specifically, in the digital signal test of the music stimulus paradigm, the target music stimulus is instrumental music without lyrics (keyboard instruments, strings, wind instruments, etc.). When the signal source 110 picks up external sound signals, the signal processing module 120 determines whether the current scene is a music scene through scene recognition. One paradigm lasts approximately 10 minutes. The user needs to remain still and does not need to react to the sound, but must maintain attention to the music stimulus.

[0282] Furthermore, the acquisition method of EEG signals under music signal or music stimulus paradigm test digital signal stimulation is the same as the acquisition method of EEG signals under speech stimulus paradigm test digital signal, speech signal in quiet environment or speech signal in noisy environment stimulation. For details, please refer to the relevant description above, and will not be repeated here.

[0283] Furthermore, by applying a bandpass filter (13Hz-30Hz) to the EEG signals acquired before music stimulation, followed by artifact removal, baseline correction, and reference electrode correction, baseline Beta wave data can be extracted. Similarly, by applying a bandpass filter (30Hz-49Hz) to the EEG signals acquired before music stimulation, followed by artifact removal, baseline correction, and reference electrode correction, baseline Gamma wave data can be extracted. Likewise, by applying a bandpass filter (13Hz-30Hz) to the EEG signals acquired during music stimulation, followed by artifact removal, baseline correction, and reference electrode correction, music-phase Beta wave data can be extracted; and by applying a bandpass filter (30Hz-49Hz) to the EEG signals acquired during music stimulation, followed by artifact removal, baseline correction, and reference electrode correction, music-phase Gamma wave data can be extracted.

[0284] By performing ZAM (Zhao-Atlas-Marks) time-frequency analysis on the extracted baseline Beta wave data, the baseline Gamma wave time-frequency data can be obtained; similarly, by performing ZAM (Zhao-Atlas-Marks) time-frequency analysis on the extracted baseline Gamma wave data, the music-period Beta wave time-frequency data can be obtained; and by performing ZAM (Zhao-Atlas-Marks) time-frequency analysis on the extracted music-period Gamma wave data, the music-period Gamma wave time-frequency data can be obtained. It should be noted that the specific details of ZAM time-frequency analysis can be found in relevant materials known to those skilled in the art, and will not be elaborated upon here.

[0285] In some exemplary embodiments, the calculation of the music appreciation ability assessment value based on the percentage change in Beta wave time-frequency energy and the percentage change in Gamma wave time-frequency energy includes: calculating the music appreciation ability assessment value using the following formula (18):

[0286] (18)

[0287] In the formula, P out P is the assessment value for music appreciation ability. Beta P represents the percentage change in time-frequency energy of the Beta wave. Gamma The percentage change in time-frequency energy of the Gamma wave. For Beta wave weights, and .

[0288] Therefore, by using the above formula (18) to calculate the music appreciation ability assessment value, the music appreciation ability can be accurately quantified, which can provide an objective basis for optimizing the stimulus strategy coding parameters of music scenes.

[0289] It should be noted that musical stimuli targeting the same instrument within the same time period have a greater P-value. out The stimulus strategy encoding parameters are better in this music listening environment. It should also be noted that the present invention... The specific value is not limited. The value can be, but is not limited to, 0.5.

[0290] Please continue to refer to this. Figure 5 This is a schematic diagram of the rectangular structure of a fully implantable cochlear implant. Figure 5 As shown, the fully implantable cochlear implant includes an implantable sound processor 210, a stimulator 220, a pickup unit 230, an external cochlear electrode array 240, and an internal cochlear electrode array 250. The implantable sound processor 210 includes a signal source 110, which can pick up external sound signals subcutaneously via a microphone and / or receive digital audio signals transmitted via Bluetooth from a mobile application 260. The implantable sound processor 210 also includes a signal processing module 120, which can analyze and identify external sound signals, encode them into electrical signals, and perform closed-loop tuning. The signal processing module 120 stores multiple program numbers (stimulation strategy encoding parameters), which are usually set by an audiologist during offline setup. Patients can select one of these program numbers to run during daily use. Parameters in a program number include speech strategy, stimulation mode, reference electrode, stimulation rate, pulse width, T-value, and C-value. The signal processing module 120 encodes the external sound signal according to the currently running program number.

[0291] The stimulator 220 includes a control module 130, which is connected to the implanted sound processor 210 via a cable and receives stimulation signals and closed-loop adjustment commands transmitted by the implanted sound processor 210. Both the intracochlear electrode array 250 and the extracochlear electrode array 240 contain multiple electrodes. The intracochlear electrode array 250 is implanted within the cochlear duct (typically in the scala tympani); the extracochlear electrodes can be in array form and / or located on the surface of the stimulator 220, implanted subcutaneously in the temporal scalp or on the surface of the temporal bone. The stimulation electrodes in the stimulation module 140 consist of intracochlear electrodes, and the grounding electrode can consist of one or more intracochlear or extracochlear electrodes (depending on the stimulation mode). The stimulator 220 transmits encoded external stimulation signals or test stimulation signals (dedicated test signals) to the stimulation electrodes, forming a stimulation circuit with the grounding electrode.

[0292] When the signal acquisition module 150 needs to operate, it activates different acquisition arrays according to the type of signal to be acquired; the stimulation module 140 also outputs a dedicated test stimulation signal (dedicated test signal) according to the type of signal to be acquired. The electrical signals acquired by the acquisition array are returned to the implantable sound processor 210 for decoding, analysis, and storage via the acquisition unit 230 (which is the same module as the stimulator 220). The signal decoding, analysis, and storage functions can also be transferred to the mobile software 260 for execution. The implantable sound processor 210 and the mobile software 260 communicate wirelessly via Bluetooth (i.e., the mobile software 260 is part of the signal processing module 120). The implantable sound processor 210 or the mobile software 260 adjusts the parameters based on the analysis results and the existing program number. The patient can operate on the mobile software 260 to choose whether to use the current new program number or revert to an outdated historical program number. The implantable sound processor 210 or the mobile software 260 can also compare similar auditory center signals measured under the same program number at different time periods to provide feedback to the user on the auditory rehabilitation progress. The results of auditory center signal analysis are stored in the implanted sound processor 210 or mobile software 260, which can be retrieved and viewed by audiologists when needed.

[0293] Please continue to refer to this. Figure 6 This is a schematic diagram of the rectangular structure of a semi-implanted cochlear implant. Figure 6As shown, the semi-implantable cochlear implant includes an external sound processor 310, a stimulator 220, a collector 230, an external cochlear electrode array 240, an internal cochlear electrode array 250, and a scalp external electrode array 320. The external sound processor 310 includes a signal source 110, which can pick up external sound signals externally via a microphone and / or receive digital signals transmitted via Bluetooth from a mobile application 260. The external sound processor 310 also includes a signal processing module 120, which can analyze and identify external signals, encode them into electrical signals, and perform closed-loop tuning. The signal processing module 120 stores multiple program numbers (stimulation strategy encoding parameters), which are usually set by an audiologist during offline setup. Patients can select one of these program numbers to run during daily use. Parameters in a program number include speech strategy, stimulation mode, reference electrode, stimulation rate, pulse width, T value, C value, etc. The signal processing module 120 encodes the signal according to the currently running program number.

[0294] The stimulator 220 is separated from the external sound processor 310 by the scalp and is coupled and wirelessly transmits signals via a magnet and a radio frequency (RF) coil. It receives stimulation signals and closed-loop adjustment commands transmitted by the external sound processor 310. Both the intracochlear electrode array 250 and the extracochlear electrode array 240 contain multiple electrodes. The intracochlear electrode array 250 is implanted within the cochlear duct (typically in the scala tympani); the extracochlear electrodes can be in array form and / or located on the surface of the stimulator 220, implanted under the temporal scalp or on the surface of the temporal bone. The stimulation electrodes in the stimulation module 140 consist of intracochlear electrodes, and the grounding electrode can consist of one or more intracochlear or extracochlear electrodes (depending on the stimulation mode). The stimulator 220 transmits encoded external stimulation signals or test stimulation signals (dedicated test signals) to the stimulation electrodes, forming a stimulation circuit with the grounding electrode.

[0295] When the signal acquisition module 150 needs to operate, it activates different electrode combinations according to the type of signal to be acquired; the stimulation module 140 also outputs a dedicated test stimulation signal according to the type of signal to be acquired. The electrical signals acquired by the in vivo electrode array (including the intracochlear electrode array 250 and the extracochlear electrode array 240) are returned to the external sound processor 310 for decoding, analysis, and storage via the acquisition unit 230 (which is the same module as the stimulator 220). Furthermore, the external sound processor 310 may include an extrascalp electrode array 320 on the scalp side as part of the signal acquisition module 150. The signal decoding, analysis, and storage functions can also be transferred to the mobile software 260 for execution, and the external sound processor 310 and the mobile software 260 communicate wirelessly via Bluetooth (i.e., the mobile software 260 is part of the signal processing module 120). The external sound processor 310 or the mobile software 260 adjusts the parameters based on the analysis results and the existing program number. It should be noted that during signal acquisition, the external sound processor 310 must cease RF (radio frequency) communication with the stimulator 220 to avoid interfering with the acquired waveforms. The external sound processor 310 or the mobile software 260 compares similar auditory center signals measured under different program numbers within the same time period and recommends program numbers with optimal hearing effects in different acoustic scenarios. The user can choose whether to apply the results to the external sound processor 310, which can automatically switch to the optimal program number based on the acoustic environment. The external sound processor 310 or the mobile software 260 can also compare similar auditory center signals measured under the same program number within different time periods and provide feedback to the user on the auditory rehabilitation progress. All auditory center signal analysis results are stored in the external sound processor 310 or the mobile software 260, which audiologists can access and view when needed.

[0296] Please continue to refer to this. Figure 7 This is a schematic diagram of the block structure of an auditory brainstem implantation device. Figure 7 As shown, the auditory brainstem implantation device includes an external sound processor 310, a stimulator 220, a collector 230, a brainstem external electrode array 330, a cochlear nucleus electrode array 340, and a scalp external electrode array 320. The cochlear nucleus electrode array 340 is implanted on the ventral and dorsal surfaces of the cochlear nucleus in the brainstem. The brainstem external electrodes can be in array form and / or located on the surface of the stimulator 220, implanted under the scalp in the temporal region or on the surface of the temporal bone. The stimulation electrodes in the stimulation module 140 consist of cochlear nucleus electrodes, and the grounding electrodes can consist of one or more electrodes from the cochlear nucleus or outside the brainstem (depending on the stimulation mode).

[0297] It should be noted that the auditory brainstem implant device is similar in composition to the semi-implantable cochlear implant, the difference being that the internal electrode array consists of a cochlear nuclear electrode array 340 and a brainstem external electrode array 330. The stimulation function of the intracochlear electrodes and their function in the signal acquisition module 150 of the semi-implantable cochlear implant are replaced by the cochlear nuclear electrodes in the auditory brainstem implant device. Similarly, the functions of the extracochlear electrodes in the stimulation module 140 and signal acquisition module 150 of the semi-implantable cochlear implant are replaced by the brainstem external electrodes in the auditory brainstem implant device.

[0298] In summary, compared with existing technologies, the artificial hearing device provided by this invention has the following beneficial effects: The artificial hearing device provided by this invention allows users to automatically collect auditory-related electrophysiological signals (target auditory electrical signals) imperceptibly during daily use without the need for additional implantation or wearing of external accessories. Based on the collected target auditory electrical signals, it autonomously adjusts parameters to generate stimulation strategy encoding parameters most suitable for the current state of the auditory nerve and / or auditory cortex, thereby effectively improving the user's hearing experience. Simultaneously, this invention can monitor the user's auditory-related electroencephalogram (EEG) signals daily without the need for additional implantation or wearing of external accessories, objectively evaluating the auditory effect of the adjusted stimulation strategy encoding parameters. Furthermore, the artificial hearing device provided by this invention supports real-time operation and can autonomously identify the current acoustic environment, thereby automatically inducing and collecting target auditory electrical signals without affecting the user's normal listening experience. In addition, by performing closed-loop tuning and evaluation of stimulation strategy coding parameters in a quiet environment, this invention can effectively improve the signal-to-noise ratio of the acquired auditory-related electrophysiological signals, thus laying a good foundation for subsequent tuning of stimulation strategy coding parameters based on target auditory electrical signals.

Claims

1. An artificial hearing device, characterized in that, The artificial hearing device includes a signal source, a signal processing module, a control module, a stimulation module, and a signal acquisition module. The signal source, the control module, and the signal acquisition module are all communicatively connected to the signal processing module, and the stimulation module and the signal acquisition module are all communicatively connected to the control module. The signal source is configured to acquire external signals and transmit them to the signal processing module, wherein the external signals include at least one of external sound signals and external digital audio signals; The signal processing module is configured to output a closed-loop debugging command to the control module when the user's acoustic environment is quiet. The control module is configured to output at least one dedicated test signal to the stimulation module based on the closed-loop debugging command, and to output a corresponding auditory electrical signal acquisition command to the signal acquisition module. The stimulation module is configured to output a dedicated electrical pulse based on the dedicated test signal to stimulate the target nerve. The signal acquisition module is configured to acquire the target auditory electrical signal based on the auditory electrical signal acquisition command, and transmit the acquired target auditory electrical signal to the signal processing module; The signal processing module is further configured to automatically update the stimulation strategy coding parameters of the artificial hearing device based on at least one of the target auditory electrical signals, and to evaluate the auditory effect of the updated stimulation strategy coding parameters when it is determined that the external signal collected by the signal source is suitable for auditory central testing and evaluation.

2. The artificial hearing device according to claim 1, characterized in that, The types of dedicated test signals include electrically evoked auditory nerve compound action potential test signals, electrically evoked auditory brainstem response test signals, electrically evoked cortical auditory potential test signals, and local evoked potential test signals. The types of target auditory electrical signals include electrically evoked auditory nerve compound action potential signals evoked by the stimulation electrodes of the stimulation module, electrically evoked auditory brainstem response signals evoked by the stimulation electrodes of the stimulation module, electrically evoked cortical auditory potential signals evoked by the stimulation electrodes of the stimulation module, and local evoked potential signals evoked by the stimulation electrodes of the stimulation module.

3. The artificial hearing device according to claim 2, characterized in that, The types of dedicated test signals also include impedance test signals, and the types of target auditory electrical signals also include the current or voltage values ​​between the stimulation electrodes and the ground electrode of the stimulation module. The control module is configured to output the impedance test signal and at least one of the following to the stimulation module in a time-sharing manner based on the closed-loop debugging command: the electrically evoked auditory nerve compound action potential test signal, the electrically evoked auditory brainstem response test signal, the electrically evoked cortical auditory potential test signal, and the local evoked potential test signal.

4. The artificial hearing device according to claim 3, characterized in that, When the control module outputs an impedance test signal to the stimulation module, the signal acquisition module is configured to acquire the current or voltage value between the stimulation electrode and the ground electrode based on the auditory electrical signal acquisition command. The signal processing module is configured as follows: Based on the current or voltage value between the stimulating electrode and the grounding electrode, calculate the inter-electrode impedance value corresponding to the stimulating electrode; Based on the impedance value between the electrode pairs corresponding to the stimulation electrode, determine whether the stimulation electrode is an electrode with abnormal impedance; If the stimulating electrode is an impedance-abnormal electrode and is the selected working electrode, then the stimulating electrode is deactivated and the impedance-normal electrode adjacent to the stimulating electrode is used as the new working electrode.

5. The artificial hearing device according to claim 4, characterized in that, The signal processing module is also configured to: If the number of impedance normal operating electrodes is less than the preset number, the center frequency of the impedance normal operating electrodes is redistributed so that the frequency range of the impedance normal operating electrodes can completely cover the preset sound stimulation frequency range.

6. The artificial hearing device according to claim 4, characterized in that, The signal processing module is also configured to: Based on the impedance value between the electrode pairs corresponding to the stimulation electrode, calculate the maximum output current value or the maximum output voltage value of the stimulation electrode; If the maximum output current value of the stimulation electrode is less than the maximum set current value corresponding to the stimulation electrode, or the maximum output voltage value of the stimulation electrode is less than the maximum set voltage value corresponding to the stimulation electrode, the comfort value of the stimulation electrode will be automatically lowered until the stimulation electrode passes the current or voltage compliance detection.

7. The artificial hearing device according to claim 6, characterized in that, The signal processing module is also configured to: If the maximum output current value of the stimulation electrode is greater than or equal to the maximum set current value, and the comfort value of the stimulation electrode was automatically reduced due to the maximum output current value being less than the maximum set current value, or if the maximum output voltage value of the stimulation electrode is greater than or equal to the maximum set voltage value, and the comfort value of the stimulation electrode was automatically reduced due to the maximum output voltage value being less than the maximum set voltage value, then the comfort value of the stimulation electrode is automatically increased so that the difference between the increased comfort value of the stimulation electrode and the minimum threshold value is close to the original difference value.

8. The artificial hearing device according to claim 4, characterized in that, The signal processing module is also configured to: if the inter-electrode impedance value of a previously disabled stimulation electrode due to abnormal inter-electrode impedance value returns to normal, then the stimulation electrode is reactivated and the working electrode and center frequency are automatically redistributed.

9. The artificial hearing device according to claim 2, characterized in that, When the control module outputs an electrically evoked auditory nerve compound action potential test signal to the stimulation module, the signal acquisition module is configured to use the electrode adjacent to the stimulation electrode of the stimulation module as the acquisition electrode to acquire the electrically evoked auditory nerve compound action potential signal induced by the stimulation electrode. The signal processing module is configured as follows: Based on the electrically evoked auditory nerve compound action potential signal induced by the stimulation electrode, the test electrically evoked auditory nerve compound action potential threshold corresponding to the stimulation electrode is obtained. Based on the comparison between the test electrical evoked auditory nerve compound action potential threshold corresponding to the stimulation electrode and the historical electrical evoked auditory nerve compound action potential threshold of the stimulation electrode, the amplitude of the change in the electrical evoked auditory nerve compound action potential threshold corresponding to the stimulation electrode is obtained. Based on the amplitude of the threshold change of the electrically evoked auditory nerve compound action potential corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the original comfort value and the original minimum threshold of the stimulation electrode.

10. The artificial hearing device according to claim 2, characterized in that, When the control module outputs an electrically evoked auditory brainstem response test signal to the stimulation module, the signal acquisition module is configured to use an extracochlear electrode, an extrascalp electrode, or an extrabrain electrode as acquisition electrodes to acquire the electrically evoked auditory brainstem response signal induced by the stimulation electrodes of the stimulation module. The signal processing module is configured as follows: Based on the electrically evoked auditory brainstem response signals induced by the stimulation electrodes under different currents, the test electrically evoked auditory brainstem response threshold corresponding to the stimulation electrodes is obtained. Based on the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the original comfort value and the original minimum threshold of the stimulation electrode.

11. The artificial hearing device according to claim 10, characterized in that, The adjustment of the minimum threshold and comfort value of the stimulation electrode based on the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode includes: Based on the comparison between the test electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode and the historical electrical evoked auditory brainstem response threshold of the stimulation electrode, the amplitude of the change in the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode is obtained. Based on the amplitude of the change in the threshold of the electrically evoked auditory brainstem response corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly.

12. The artificial hearing device according to claim 2, characterized in that, The signal processing module is also configured to: Based on the electrically evoked auditory brainstem response signals induced by the left stimulation electrode of the stimulation module under different currents, the latency of the electrically evoked auditory brainstem response corresponding to the left stimulation electrode is obtained. Based on the electrically evoked auditory brainstem response signals induced by the right stimulation electrode of the stimulation module under different currents, the latency of the electrically evoked auditory brainstem response corresponding to the right stimulation electrode is obtained. Based on the difference in the latency of the electrically evoked auditory brainstem response corresponding to the left and right stimulation electrodes, the electrical signals of the left and right stimulation electrodes are processed synchronously.

13. The artificial hearing device according to claim 2, characterized in that, When the control module outputs an electrically evoked cortical auditory potential test signal to the stimulation module, the signal acquisition module is configured to use an external cochlear electrode, an external scalp electrode, or an external brainstem electrode as the acquisition electrode to acquire the electrically evoked cortical auditory potential signal induced by the stimulation electrode of the stimulation module. The signal processing module is configured as follows: Based on the amplitude difference between the P200 and N100 waveforms in the electrically evoked cortical auditory potential signals induced by the stimulation electrode under different currents, the test electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode is obtained. Based on the test electroevoked cortical auditory potential threshold corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the original comfort value and the original minimum threshold of the stimulation electrode.

14. The artificial hearing device according to claim 13, characterized in that, The adjustment of the minimum threshold and comfort value of the stimulation electrode based on the test electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode includes: Based on the comparison between the test electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode and the historical electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode, the amplitude of the change in the electro-evoked cortical auditory potential threshold corresponding to the stimulation electrode is obtained. Based on the amplitude of the change in the threshold of the electrically evoked cortical auditory potential corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the original comfort value and the original minimum threshold of the stimulation electrode.

15. The artificial hearing device according to claim 2, characterized in that, The signal processing module is also configured to: Based on the electro-evoked cortical auditory potential signals induced by the left stimulation electrode of the stimulation module under different currents, the latency of the electro-evoked cortical response corresponding to the left stimulation electrode is obtained. Based on the electroevoked cortical auditory potential signals induced by the right stimulation electrode of the stimulation module under different currents, the electroevoked cortical response latency corresponding to the right stimulation electrode is obtained. Based on the difference in the latency of the electrically evoked cortical response corresponding to the left and right stimulation electrodes, the electrical signals of the left and right stimulation electrodes are processed synchronously.

16. The artificial hearing device according to claim 2, characterized in that, When the control module outputs a local evoked potential test signal to the stimulation module, the signal acquisition module is configured to use the electrode adjacent to the stimulation electrode of the stimulation module as the acquisition electrode to acquire the local evoked potential signal induced by the stimulation electrode. The signal processing module is configured as follows: Based on the local evoked potential signal induced by the stimulation electrode, the test local evoked potential threshold corresponding to the stimulation electrode is obtained. Based on the comparison between the test local evoked potential threshold corresponding to the stimulation electrode and the historical local evoked potential threshold of the stimulation electrode, the change amplitude of the local evoked potential threshold corresponding to the stimulation electrode is obtained. Based on the amplitude of the change in the local evoked potential threshold corresponding to the stimulation electrode, the minimum threshold and comfort value of the stimulation electrode are adjusted accordingly. The difference between the adjusted comfort value and the adjusted minimum threshold of the stimulation electrode is equal to the difference between the original comfort value and the original minimum threshold of the stimulation electrode.

17. The artificial hearing device according to claim 1, characterized in that, The signal processing module is configured to encode external signals suitable for auditory central nervous system testing and evaluation into corresponding electrical stimulation signals using updated stimulation strategy encoding parameters, and transmit them to the control module, and send an auditory central nervous system signal acquisition command to the control module. The control module is also configured to control the stimulation module to output corresponding auditory center evaluation electrical pulses based on the electrical stimulation signal, and to control the signal acquisition module to acquire target auditory center signals based on the auditory center signal acquisition command; The signal processing module is also configured to evaluate the auditory effect of the updated stimulus strategy coding parameters based on the target auditory center signal.

18. The artificial hearing device according to claim 17, characterized in that, The signal processing module is configured as follows: If the external signal is an external sound signal and the external sound signal meets the preset sound conditions, then the external signal is determined to be suitable for auditory center testing and evaluation. The preset sound conditions include the external sound signal being a speech signal in a quiet environment, a speech signal in a noisy environment, or a music signal. If the external signal is an external digital audio signal, and the external digital audio signal is an auditory event-related potential paradigm test digital signal or an auditory brainwave paradigm test digital signal, then the external signal is determined to be suitable for auditory central nervous system testing and evaluation. The auditory event-related potential paradigm test digital signal includes at least one of the following: a passive trolley paradigm test digital signal for inducing mismatch negative waves, an active trolley paradigm test digital signal for inducing P300 waves, and an auditory semantic misalignment paradigm test digital signal for inducing N400 waves; the auditory brainwave paradigm test digital signal includes at least one of the following: a speech stimulation paradigm test digital signal and a music stimulation paradigm test digital signal. When the external signal is a digital signal of the auditory event-related potential paradigm test, the signal of the target auditory center acquired by the signal acquisition module is an event-related potential signal; When the external signal is a speech signal in a quiet environment, a speech signal in a noisy environment, a music signal, or a digital signal from an auditory EEG paradigm test, the target auditory center signal acquired by the signal acquisition module is an EEG signal.

19. The artificial hearing device according to claim 18, characterized in that, When the external signal is a passive spherical paradigm test digital signal used to induce mismatch negative waves, the signal acquisition module is configured to mark the time point of stimulus occurrence when acquiring event-related potential signals; the signal processing module is configured to determine the amplitude and latency of the mismatch negative waves based on the event-related potential signals acquired by the signal acquisition module, and calculate the first speech discrimination ability score based on the amplitude and latency of the mismatch negative waves.

20. The artificial hearing device according to claim 19, characterized in that, The calculation of the first speech discrimination ability score based on the mismatch negative wave amplitude and the mismatch negative wave latency includes: The first speech discrimination score is calculated using the following formula: In the formula, Score_MMN is the first speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_MMN A represents the amplitude of the mismatched negative wave obtained from the current measurement. baseline_MMN A is the amplitude of the mismatch negative waveform recorded during the user's initial device setup. target_MMN For the target mismatch negative wave amplitude, L current_MMN L represents the currently measured latency of the mismatched negative wave. baseline_MMN L is the latency period of the mismatch negative wave recorded during the user's first implantation and tuning. target_MMN For the target mismatch negative wave latency, w A_MMN For the mismatched negative wave amplitude weight, w L_MMN For mismatched negative wave latent options, 0 < w A_MMN <1, 0 <w L_MMN <1, and w A_MMN +w L_MMN =1.

21. The artificial hearing device according to claim 18, characterized in that, When the external signal is an active spherical paradigm test digital signal used to induce the P300 wave, the signal acquisition module is configured to mark the time point of stimulus occurrence when acquiring event-related potential signals; the signal processing module is configured to determine the P300 wave amplitude and P300 wave latency based on the event-related potential signals acquired by the signal acquisition module, and calculate the second speech discrimination ability score based on the P300 wave amplitude, the P300 wave latency, and the user's behavioral response accuracy.

22. The artificial hearing device according to claim 21, characterized in that, The calculation of the second speech discrimination ability score based on the P300 wave amplitude, the P300 wave latency, and the user's behavioral response accuracy includes: The second speech discrimination score is calculated using the following formula: In the formula, Score_P300 is the second speech discrimination ability score, max indicates taking the maximum value, min indicates taking the minimum value, and A current_P300 For the currently measured P300 wave amplitude, A baseline_P300 The P300 waveform amplitude recorded during the user's initial device setup, A target_P300 For the target P300 wave amplitude, L current_P300 L represents the currently measured latency of the P300 wave. baseline_P300 The latency of the P300 wave recorded during the user's initial device setup, L target_P300 For the target P300 wave latency period, w A_P300 For the P300 wave amplitude weight, w L_P300 For P300 wave latent options, P be For the accuracy of user behavior response, w B_P300 For behavioral response weights, 0 < w A_P300 <1, 0 <w L_P300 <1, 0 <w B_P300 <1, and w A_P300 +w L_P300 +w B_P300 =1.

23. The artificial hearing device according to claim 18, characterized in that, When the external signal is a digital signal used to induce the N400 wave in an auditory semantic misalignment paradigm test, the signal acquisition module is configured to mark the occurrence time of key ending words in each trial when acquiring event-related potential signals; the signal processing module is configured to determine the N400 wave latency under the conditions of N400 difference wave amplitude and semantic inconsistency based on the event-related potential signals acquired by the signal acquisition module, and to evaluate semantic understanding ability based on the N400 difference wave amplitude and the N400 wave latency.

24. The artificial hearing device according to claim 18, characterized in that, When the external signal is a digital signal from a speech stimulus paradigm test, a speech signal in a quiet environment, or a speech signal in a noisy environment, the signal processing module is configured as follows: Based on the speech stimulus paradigm, test digital signals, speech signals in quiet environments, or speech signals in noisy environments, extract the Delta wave actual speech envelope and the Theta wave actual speech envelope. Based on the EEG signals acquired by the signal acquisition module, Delta wave data and Theta wave data are extracted. Based on the extracted Delta wave data and Theta wave data, the Delta wave reconstructed speech envelope and the Theta wave reconstructed speech envelope are reconstructed. The third speech discrimination ability score is calculated based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope.

25. The artificial hearing device according to claim 24, characterized in that, The calculation of the third speech discrimination ability score based on the correlation coefficient between the Delta wave reconstructed speech envelope and the Delta wave actual speech envelope, and the correlation coefficient between the Theta wave reconstructed speech envelope and the Theta wave actual speech envelope, includes: The third speech discrimination ability score is calculated using the following formula: In the formula, Score_EEG is the third speech discrimination ability score, and C Delta C is the correlation coefficient between the reconstructed speech envelope of the Delta wave and the actual speech envelope of the Delta wave. Theta The correlation coefficient between the reconstructed speech envelope of the Theta wave and the actual speech envelope of the Theta wave. For Theta wave weights, and .

26. The artificial hearing device according to claim 18, characterized in that, When the external signal is a music signal or a digital signal from a music stimulus paradigm test, the signal processing module is configured as follows: Based on the EEG signals acquired by the signal acquisition module before music stimulation, baseline Beta wave data and baseline Gamma wave data are extracted. Time-frequency analysis was performed on the baseline period Beta wave data and the baseline period Gamma wave data respectively to obtain the corresponding baseline period Beta wave time-frequency data and baseline period Gamma wave time-frequency data; Based on the baseline period Beta wave time-frequency data, the baseline period Beta wave time-frequency energy is obtained; based on the baseline period Gamma wave time-frequency data, the baseline period Gamma wave time-frequency energy is obtained. Based on the EEG signals acquired by the signal acquisition module during music stimulation, Beta wave data and Gamma wave data during music stimulation are extracted. Time-frequency analysis was performed on the music period Beta wave data and the music period Gamma wave data respectively to obtain the corresponding music period Beta wave time-frequency data and music period Gamma wave time-frequency data; Based on the music period Beta wave time-frequency data, obtain the music period Beta wave time-frequency energy; based on the music period Gamma wave time-frequency data, obtain the music period Gamma wave time-frequency energy. Based on the Beta wave time-frequency energy during the music period and the Beta wave time-frequency energy during the baseline period, the percentage change in Beta wave time-frequency energy is obtained; based on the Gamma wave time-frequency energy during the music period and the Gamma wave time-frequency energy during the baseline period, the percentage change in Gamma wave time-frequency energy is obtained. The music appreciation ability assessment value is calculated based on the percentage change in time-frequency energy of the Beta wave and the percentage change in time-frequency energy of the Gamma wave.

27. The artificial hearing device according to claim 26, characterized in that, The calculation of the music appreciation ability assessment value based on the percentage change in time-frequency energy of the Beta wave and the percentage change in time-frequency energy of the Gamma wave includes: The following formula is used to calculate the assessment score for music appreciation ability: In the formula, P out P is the assessment value for music appreciation ability. Beta P represents the percentage change in time-frequency energy of the Beta wave. Gamma The percentage change in time-frequency energy of the Gamma wave. For Beta wave weights, and .

28. The artificial hearing device according to claim 18, characterized in that, The signal processing module is also configured to evaluate the speech discrimination ability under digital signal and / or external sound signal stimulation based on speech stimulation paradigms of speech scenarios with different levels of signal-to-noise ratio, and to comprehensively evaluate the listening effect of the updated stimulation strategy encoding parameters. The different levels of signal-to-noise ratio speech scenarios include quiet speech scenarios, slightly noisy speech scenarios, moderately noisy speech scenarios, and highly noisy speech scenarios.

29. The artificial hearing device according to claim 28, characterized in that, The evaluation results of speech discrimination ability under digital signal and / or external sound signal stimulation based on speech stimulus paradigms in speech scenarios with different signal-to-noise ratios are used to comprehensively evaluate the listening effect of the updated stimulus strategy encoding parameters, including: The following formula is used to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters: In the formula, Score_EEG_synthetic represents the comprehensive speech discrimination ability score based on EEG signals; Score_EEG_silent represents the speech discrimination ability score in quiet speech scenarios; Score_EEG_mild represents the speech discrimination ability score in mildly noisy speech scenarios; Score_EEG_medium represents the speech discrimination ability score in moderately noisy speech scenarios; and Score_EEG_intense represents the speech discrimination ability score in highly noisy speech scenarios. silent For quiet speech scenarios, w mild For weighting in mildly noisy speech scenarios, w medium For moderately noisy speech scenarios, w intense For weights in highly noisy speech scenarios, 0 < w silent <1, 0 <w mild <1, 0 <w medium <1, 0 <w intense <1, and w silent +w mild +w medium +w intense =1.

30. The artificial hearing device according to claim 18, characterized in that, The signal processing module is also configured to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters based on the speech discrimination ability assessment results under the stimulation of the passive monster ball paradigm test digital signal used to induce mismatch negative waves and the active monster ball paradigm test digital signal used to induce P300 waves.

31. The artificial hearing device according to claim 30, characterized in that, The assessment of speech discrimination ability based on the results of the passive monster ball paradigm test digital signal used to induce mismatch negative waves and the active monster ball paradigm test digital signal used to induce P300 waves comprehensively evaluates the auditory effect of the updated stimulus strategy encoding parameters, including: The following formula is used to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters: In the formula, Score_ERP is the comprehensive speech discrimination ability score based on event-related potential signals, Score_MMN is the speech discrimination ability assessment result under digital signal stimulation of the passive spherical paradigm test used to induce mismatch negative waves, and Score_P300 is the speech discrimination ability assessment result under digital signal stimulation of the active spherical paradigm test used to induce P300 waves. MMN For the mismatched negative wave weights, w P300 For P300 wave weights, 0 < w MMN <1, 0 <w P300 <1, and w MMN +w P300 =1.

32. The artificial hearing device according to claim 18, characterized in that, The signal processing module is also configured to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters based on the evaluation results of speech discrimination ability stimulated by digital signals from the auditory event-related potential paradigm test and the auditory brainwave paradigm test.

33. The artificial hearing device according to claim 32, characterized in that, The assessment results of speech discrimination ability under stimulation by digital signals from the auditory event-related potential paradigm test and the auditory electroencephalogram paradigm test are used to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters, including: The following formula is used to comprehensively evaluate the auditory effect of the updated stimulus strategy encoding parameters: In the formula, Score_ is the comprehensive speech discrimination ability score that integrates event-related potential signals and EEG signals; Score_ERP is the comprehensive speech discrimination ability score based on event-related potential signals; Score_EEG_ is the comprehensive speech discrimination ability score based on EEG signals; and w ERP For event-related potential weights, w EEG For brainwave weights, 0 < w ERP <1, 0 <w EEG <1, and w ERP +w EEG =1.