Neural stimulation modulation system and cochlear implant

Abstract

The application provides a nerve stimulation regulation system and an artificial hearing device, the regulation system comprising: a signal source configured to acquire an external signal; a signal processing module configured to determine whether a current acoustic environment is a quiet environment based on the external signal, and if so, output a closed-loop debugging command to a control module; the control module is configured to output a special test signal to a stimulation module and an acquisition command to a signal acquisition module based on the closed-loop debugging command; the stimulation module is configured to output a test special electric pulse based on the special test signal; the signal acquisition module is configured to acquire a target auditory electric signal based on the acquisition command; the signal processing module is further configured to automatically update stimulation strategy coding parameters according to the target auditory electric signal. The application can automatically induce and acquire a target auditory electric signal for closed-loop parameter adjustment without affecting the normal listening experience of a user.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a neural stimulation modulation system and 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, as the cochlear microenvironment stabilizes and the swelling caused by implantation subsides, 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 adjustments are typically performed only once every six months or less. Therefore, the parameters set by audiologists during adjustments (especially the initial adjustment) cannot adapt to the patient's long-term, rapidly changing auditory nerve electrophysiological condition. Higher-frequency in-person or online adjustments significantly increase the time cost for audiologists and the expense for patients, hindering widespread adoption. Therefore, there is a need to design a neurostimulation modulation system integrated into artificial hearing devices. Summary of the Invention

[0010] The purpose of this invention is to provide a neural stimulation modulation system and an artificial hearing device that allows users to automatically collect auditory-related electrophysiological signals in daily use without the need for additional implantation or wearing of accessories outside the artificial hearing device, and to perform autonomous parameter tuning to generate stimulation strategy coding parameters most suitable for the current state of the auditory nerve and / or auditory cortex.

[0011] To achieve the above objectives, the present invention provides a neural stimulation modulation system integrated with an artificial hearing device. The neural stimulation modulation system 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. The external signals include at least one of external sound signals and external digital audio signals. The signal processing module is configured to determine the current acoustic environment based on the external signals. If the environment is quiet, a closed-loop debugging command is output to the control module. The control module is configured to output at least one dedicated test signal to the stimulation module and an acquisition command to the signal acquisition module based on the closed-loop debugging command. 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 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.

[0012] 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.

[0013] 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.

[0014] 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 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.

[0015] 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.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] 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.

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] Optionally, the signal processing module is further configured to, when determining that the current acoustic environment is a non-quiet environment, encode the external signal into a corresponding electrical stimulation signal according to the currently selected stimulation strategy encoding parameters, and transmit the electrical stimulation signal to the control module; the control module is configured to transmit the electrical stimulation signal to the stimulation module; the stimulation module is configured to output electrical pulses through the selected working electrode for hearing reconstruction.

[0028] Optionally, when the artificial hearing device is a fully implanted cochlear implant or a partially implanted cochlear implant, the control module is configured to output the electrically evoked auditory nerve compound action potential test signal, the electrically evoked auditory brainstem response test signal, and the electrically evoked cortical auditory potential test signal to the stimulation module in a time-division manner based on the closed-loop debugging command. The signal processing module is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module according to the electrically evoked auditory nerve compound action potential signal, the electrically evoked auditory brainstem response signal, and the 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 original comfort value and the adjusted minimum threshold of the stimulation electrode. The difference between the previous minimum threshold; when the artificial hearing device is an auditory brainstem implantation device, the control module is configured to output the local evoked potential test signal, the electrically evoked auditory brainstem response test signal and the electrically evoked cortical auditory potential test signal to the stimulation module in a time-division manner based on the closed-loop debugging command, and the signal processing module is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module according to the local evoked potential signal, the electrically evoked auditory brainstem response signal and the electrically evoked cortical auditory potential signal evoked by the stimulation electrode, and 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.

[0029] To achieve the above objectives, the present invention also provides an artificial hearing device, including the neural stimulation modulation system described above.

[0030] Compared with existing technologies, the neural stimulation modulation system and artificial hearing device provided by this invention have the following beneficial effects: The neural stimulation modulation system provided by this invention, integrated into the artificial hearing device, 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, it autonomously adjusts parameters to generate stimulation strategy coding parameters most suitable for the current state of the auditory nerve and / or auditory cortex, thereby effectively improving the user's hearing experience. Furthermore, the neural stimulation modulation system provided by this invention supports real-time operation and can autonomously identify the current acoustic environment, thus automatically inducing and collecting target auditory electrical signals without affecting the user's normal listening experience. Additionally, by performing closed-loop tuning of the stimulation strategy coding parameters in a quiet environment, this invention can effectively improve the signal-to-noise ratio of the collected auditory-related electrophysiological signals, thereby laying a solid foundation for subsequent tuning of stimulation strategy coding parameters based on the target auditory electrical signals.

[0031] Since the artificial hearing device provided by this invention and the neural stimulation modulation system provided by this invention belong to the same inventive concept, the artificial hearing device provided by this invention has at least all the beneficial effects of the neural stimulation modulation system provided by this invention. For details, please refer to the relevant description above. Therefore, the beneficial effects of the artificial hearing device provided by this invention will not be elaborated here. Attached Figure Description

[0032] Figure 1 This is a block diagram of a neural stimulation modulation system provided in one embodiment of the present invention.

[0033] Figure 2 This is a dedicated test + closed-loop control link diagram for a neural stimulation modulation system provided in one embodiment of the present invention.

[0034] Figure 3 An external signal stimulation link diagram of a neural stimulation modulation system provided in one embodiment of the present invention.

[0035] Figure 4 This is a schematic diagram of the rectangular structure of a fully implanted cochlear implant.

[0036] Figure 5 This is a schematic diagram of the box structure of a semi-implanted cochlear implant.

[0037] Figure 6 A schematic diagram of the block structure of an auditory brainstem implantation device.

[0038] 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

[0039] The neural stimulation modulation system and artificial hearing device proposed in this invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0040] To facilitate understanding, a brief explanation of the research background of this invention will be given first.

[0041] 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:

[0042] 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.

[0043] 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.

[0044] 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.).

[0045] 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.

[0046] 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.

[0047] Based on this, the core idea of ​​the present invention is to provide a neural stimulation modulation system and an artificial hearing device, which allows users to automatically collect and decode auditory-related electrophysiological signals in real time without the need for additional implantation or wearing of accessories outside the artificial hearing device, and to perform autonomous parameter tuning to generate stimulation strategy coding parameters most suitable for the current state of the auditory nerve and / or auditory cortex.

[0048] To achieve the above-mentioned goals, this invention provides a neural stimulation modulation system, which is integrated with an artificial hearing device. Please refer to... Figure 1 This is a block diagram of a neural stimulation modulation system provided in one embodiment of the present invention. Figure 1As shown, the neural stimulation modulation system 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, the control module 130, and the signal acquisition module 150 are all communicatively connected to the signal processing module 120, and the stimulation module 140 and the signal acquisition module 150 are all communicatively connected to the control module 130. The signal source 110 is configured to pick up 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 determine, based on the external signals, whether the current acoustic environment is suitable for... In a quiet environment, if so, a closed-loop debugging command is output to the control module 130; the control module 130 is configured to output at least one dedicated test signal to the stimulation module 140 based on the closed-loop debugging command, and to output a collection 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 collection command, and transmit the acquired target auditory electrical signal to the signal processing module 120; the signal processing module 120 is further configured to automatically update the stimulation strategy encoding parameters according to at least one of the target auditory electrical signals.

[0049] The neural stimulation modulation system provided by this invention, integrated into an artificial hearing device, 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 system 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. Furthermore, the neural stimulation modulation system supports real-time operation and can autonomously identify 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 of the 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.

[0050] It should be noted that, as those skilled in the art will understand, if the energy of the external signal acquired or received 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 data points of the target auditory electrical signal 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.

[0051] 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.

[0052] The signal acquisition module 150 is responsible for acquiring 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. Acquiring neural electrical signals 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.

[0053] 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.

[0054] Please continue to refer to this. Figure 2 This is a dedicated test + closed-loop regulation link diagram of the neural stimulation regulation system provided in 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.

[0055] In some exemplary embodiments, the signal processing module 120 is further configured to, when determining that the current acoustic environment is a non-quiet environment, encode the external signal into a corresponding electrical stimulation signal according to the currently selected stimulation strategy encoding parameters, 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 selected working electrodes for hearing reconstruction.

[0056] 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.

[0057] 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.

[0058] Please continue to refer to this. Figure 3 This is an external signal stimulation link diagram of a neural stimulation modulation system 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).

[0059] In some exemplary embodiments, the signal processing module 120 is further configured to store multiple sets of stimulus strategy encoding parameters for users 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 users' personalized listening needs in different acoustic environments and effectively improving users' auditory comfort.

[0060] In some exemplary embodiments, 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 evoked by the stimulating electrodes of the stimulation module, electrically evoked auditory brainstem response signals evoked by the stimulating electrodes of the stimulation module, electrically evoked cortical auditory potential signals evoked by the stimulating electrodes of the stimulation module, and local evoked potential signals evoked by the stimulating electrodes of the stimulation module.

[0061] 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.

[0062] 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 of the stimulation module 140 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.

[0063] 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.

[0064] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (1):

[0065] (1)

[0066] 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 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 .

[0067] It should be noted that the present invention relates to the first regulatory factor. The specific value of the first regulatory factor is not limited. 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.

[0068] Furthermore, for each stimulation electrode, the comfort value of that stimulation electrode can be adjusted using the following formula (2):

[0069] (2)

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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).

[0074] 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.

[0075] 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.

[0076] 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.

[0077] In some exemplary embodiments, when the control module 130 outputs an electrically evoked auditory brainstem response (EBR) 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 acquisition electrodes to acquire the EBR signals evoked by the stimulation electrodes of the stimulation module 140; the signal processing module 120 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.

[0078] Therefore, by adjusting the minimum threshold and comfort value accordingly based on the threshold of the electrically evoked auditory brainstem response, it can be ensured that the stimulation strategy parameters always match the user's actual physiological conditions. Furthermore, 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.

[0079] 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.

[0080] 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).

[0081] 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.

[0082] 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.

[0083] 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.

[0084] Furthermore, 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.

[0085] In some exemplary embodiments, 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 in the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode based on a 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; and adjusting the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of change in the electrical evoked auditory brainstem response threshold corresponding to the stimulation electrode.

[0086] 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.

[0087] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (3):

[0088] (3)

[0089] 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 .

[0090] It should be noted that the present invention relates to the second regulatory factor. The specific value of the second regulatory factor is not limited. 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.

[0091] 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. .

[0092] In some other exemplary embodiments, for each stimulating electrode, the minimum threshold of that stimulating electrode is adjusted using the following formula (4):

[0093] (4)

[0094] in, It is the third regulatory factor, and C1 is the first preset constant.

[0095] It should be noted that the present invention relates to the third regulatory factor. The specific value of the third regulatory factor is not limited. 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.

[0096] 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. .

[0097] In some exemplary embodiments, the signal processing module 120 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 140 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 140 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.

[0098] 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.

[0099] Specifically, the electrical signals of the left and right stimulation electrodes can be synchronized according to the following formula (5):

[0100] (5)

[0101] 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. The latency of the evoked auditory brainstem response (EABR) corresponding to the left stimulation electrode is given. The latency of the evoked auditory brainstem response (EABR) corresponding to the right-side stimulation electrode is given. The difference (delay time difference) is the difference between the evoked auditory brainstem response latency (EABR latency) corresponding to the left and right stimulation 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.

[0102] 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.

[0103] 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, 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.

[0104] 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.

[0105] 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).

[0106] 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.

[0107] 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.

[0108] 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.

[0109] Furthermore, 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.

[0110] In some exemplary embodiments, adjusting 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: obtaining the amplitude of the change in the electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode based on a comparison between the test electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode and the historical electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode; and adjusting the minimum threshold and comfort value of the stimulation electrode accordingly based on the amplitude of the change in the electrically evoked cortical auditory potential threshold corresponding to the stimulation electrode.

[0111] 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.

[0112] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (6):

[0113] (6)

[0114] 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 cortical auditory potential threshold (the currently tested eCAEP threshold) 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 .

[0115] 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.

[0116] 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. .

[0117] In some other exemplary embodiments, for each stimulating electrode, the minimum threshold of that stimulating electrode is adjusted using the following formula (7):

[0118] (7)

[0119] in, It is the fifth regulatory factor, and C2 is the second preset constant.

[0120] It should be noted that the present invention relates to the fifth regulatory factor. The specific value of the fifth regulatory factor is not limited. 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.

[0121] 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. .

[0122] 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 electrical evoked cortical auditory potential signals evoked 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 electrical evoked cortical auditory potential signals evoked by the right stimulation electrode of the stimulation module 140 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.

[0123] 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.

[0124] 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.

[0125] 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 an electrode adjacent to the stimulation electrode of the stimulation module 140 as an 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 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.

[0126] 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, 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.

[0127] Specifically, for each stimulation electrode, the minimum threshold of that stimulation electrode can be adjusted using the following formula (8):

[0128] (8)

[0129] 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 .

[0130] It should be noted that the present invention relates to the sixth regulatory factor. The specific value of the sixth regulatory factor is not limited. 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.

[0131] 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. .

[0132] 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.

[0133] 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.

[0134] 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 the electrically evoked auditory nerve compound action potential test signal, the electrically evoked auditory brainstem response test signal, and the electrically evoked cortical auditory potential test signal to the stimulation module 140 in a time-division manner based on the closed-loop debugging command. 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, the electrically evoked auditory brainstem response signal, and the 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.

[0135] 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.

[0136] 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):

[0137] (9)

[0138] 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.

[0139] It should be noted that the present invention relates to the first weight. The second weight and the third weight The specific value is not limited, the first weight The second weight and the 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. .

[0140] In some exemplary embodiments, when the artificial hearing device is an auditory brainstem implant, the control module 130 is configured to output the local evoked potential test signal, the electrically evoked auditory brainstem response test signal, and the electrically evoked cortical auditory potential test signal to the stimulation module 140 in a time-division manner based on the closed-loop debugging command. 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, the electrically evoked auditory brainstem response signal, and the 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.

[0141] 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.

[0142] 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):

[0143] (10)

[0144] 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.

[0145] 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 (10). Then, the adjusted comfort value of the stimulation electrode can be calculated using formula (2) above. .

[0146] In some exemplary embodiments, the type of the dedicated test signal further includes an impedance test signal, and the type of the target auditory electrical signal further includes the current value or voltage value between the stimulation electrode and the ground electrode of the stimulation module 140; the control module 130 is configured to output the impedance test signal and at least one of the following to the stimulation module 140 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.

[0147] 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.

[0148] 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 the 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] In some exemplary embodiments, the signal processing module 120 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.

[0156] 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 of the stimulation electrode and the maximum operating voltage of the stimulation driving chip in the stimulation module 140, and 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 reduced, which can ensure 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 of the stimulation electrode 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).

[0157] 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 can be detected by impedance testing.

[0158] In some exemplary embodiments, the signal processing module 120 is further configured to: automatically increase the comfort value of the 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 if 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; such that the difference between the increased comfort value of the stimulation electrode and the minimum threshold value is close to the original difference value.

[0159] 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.

[0160] In some exemplary embodiments, the signal processing module 120 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.

[0161] 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.

[0162] Based on the same inventive concept, the present invention also provides an artificial hearing device, including the neural stimulation modulation system described above. Since the artificial hearing device provided by the present invention and the neural stimulation modulation system provided by the present invention belong to the same inventive concept, the artificial hearing device provided by the present invention possesses at least all the beneficial effects of the neural stimulation modulation system provided by the present invention. For details, please refer to the relevant descriptions above; therefore, the beneficial effects of the artificial hearing device provided by the present invention will not be elaborated upon here.

[0163] Furthermore, the artificial hearing device can be a fully implanted cochlear implant, a partially implanted cochlear implant, or an auditory brainstem implant.

[0164] Please continue to refer to this. Figure 4 This is a schematic diagram of the rectangular structure of a fully implantable cochlear implant. Figure 4As 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 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 external signals according to the currently running program number.

[0165] 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.

[0166] 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 (dedicated test signal) according to the type of signal to be acquired. The electrical signals acquired by the electrode array are returned to the implantable sound processor 210 for decoding, analysis, and storage via the acquisition unit 230 (which is in 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 procedure number. The patient can operate on the mobile software 260 to choose whether to use the current new procedure number or revert to an outdated historical procedure number.

[0167] Please continue to refer to this. Figure 5 This is a schematic diagram of the rectangular structure of a semi-implanted cochlear implant. Figure 5 As 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.

[0168] 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.

[0169] 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 needs to stop RF (radio frequency) communication with the stimulator 220 to avoid interfering with the acquired waveform.

[0170] Please continue to refer to this. Figure 6 This is a schematic diagram of the block structure of an auditory brainstem implantation device. Figure 6 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).

[0171] 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.

[0172] In summary, compared with existing technologies, the neurostimulation modulation system and artificial hearing device provided by this invention have the following beneficial effects: Based on existing artificial hearing devices, this invention can achieve real-time closed-loop modulation without adding extra components, making optimal parameter matching based on the user's current auditory nerve state and effectively improving hearing performance. Furthermore, the neurostimulation modulation system provided by this invention can effectively reduce the cost of manual device adjustment and improve user rehabilitation efficiency. At the same time, the neurostimulation modulation system provided by this invention is applicable to most commercially available and mature artificial hearing devices, possessing strong scalability.

[0173] It should be noted that the above description is only a description of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A neural stimulation modulation system, comprising: The neural stimulation modulation system is integrated with the artificial hearing device. The neural stimulation modulation system 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. 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 determine whether the current acoustic environment is quiet based on the external signal; if so, it outputs a closed-loop debugging command to the control module. 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 an 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 acquisition command, and transmit the acquired target auditory electrical signal to the signal processing module; The signal processing module is also 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.

2. The neural stimulation regulation system of claim 1, wherein, 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 neural stimulation modulation system 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 neural stimulation modulation system 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 value or voltage value between the stimulation electrode and the ground electrode based on the 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system according to claim 4, characterized in that, 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 the stimulation electrode is reactivated and the working electrode and center frequency are automatically redistributed.

9. The neural stimulation modulation system 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 neural stimulation modulation system 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 electrode under different currents, the test electrically evoked auditory brainstem response threshold corresponding to the stimulation electrode 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system 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 neural stimulation modulation system according to claim 1, characterized in that, The signal processing module is further configured to, when determining that the current acoustic environment is a non-quiet environment, encode the external signal into a corresponding electrical stimulation signal according to the currently selected stimulation strategy encoding parameters, and transmit the electrical stimulation signal to the control module; The control module is configured to transmit the electrical stimulation signal to the stimulation module; The stimulation module is configured to output electrical pulses through selected working electrodes for hearing reconstruction.

18. The neural stimulation modulation system according to claim 2, characterized in that, When the artificial hearing device is a fully implanted cochlear implant or a partially implanted cochlear implant, the control module is configured to output the electrically evoked auditory nerve compound action potential test signal, the electrically evoked auditory brainstem response test signal, and the electrically evoked cortical auditory potential test signal to the stimulation module in a time-division manner based on the closed-loop debugging command. The signal processing module is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module according to the electrically evoked auditory nerve compound action potential signal, the electrically evoked auditory brainstem response signal, and the 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. When the artificial hearing device is an auditory brainstem implantation device, the control module is configured to output the local evoked potential test signal, the electrically evoked auditory brainstem response test signal, and the electrically evoked cortical auditory potential test signal to the stimulation module in a time-division manner based on the closed-loop debugging command. The signal processing module is configured to adjust the minimum threshold and comfort value of each stimulation electrode of the stimulation module according to the local evoked potential signal, the electrically evoked auditory brainstem response signal, and the 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.

19. An artificial hearing device, characterized in that, Includes the neural stimulation modulation system as described in any one of claims 1 to 18.

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