Neurostimulation device and system for transcutaneous auricular vagus nerve stimulation

Abstract

The present invention relates to a neurostimulation device (1) worn by a user for stimulating the auricular branch vagus nerve (ABVN) in the user's ear. The device (1) is wireless and includes: at least one electrode (2) designed to be positioned at the sympathetic nerve for stimulation of the lamas auricularis nervi vagi (RANV) when a voltage difference is applied; and an infinity-shaped ("figure-eight") holding portion (3) designed to hold the device in the user's ear. The present invention also relates to a neurostimulation system including a wireless device (1) and a controller unit (8), the neurostimulation system having at least one detection means configured to detect one or more parameter values, and transmitting feedback data to a dedicated cloud platform, the system being able to set parameters of the neurostimulation provided by the device (1) based on the feedback parameter values.

Description

[Technical Field]

[0001] The present invention relates to an auricular nerve stimulation device. The present invention further relates to an auricular nerve stimulation system that can be tailored and personalized to a user's needs and can be applied synchronously with multiple nerve stimulation devices (electrode assemblies), resulting in improved efficiency and stability for providing stimulation. The present invention also relates to methods for operating and delivering such a nerve stimulation system. [Background technology]

[0002] The vagus nerve (VN), the 10th cranial nerve, is the longest cranial nerve, connecting the brainstem to the central nervous system, the medulla oblongata to the large intestine, and primarily innervating the thoracic and abdominal organs. This nerve plays a vital role in helping the brain regulate and monitor vital bodily functions and homeostasis. The VN is a key component of the parasympathetic regulation of the autonomic nervous system (ANS), forming neural circuits that regulate important physiological functions, including heart rate, gastrointestinal motility, pancreatic secretion, and glucose production.

[0003] The VN comprises a bidirectional neural structure extending from the brainstem to the neck, abdomen, and major organs, playing a key role in both motor and sensory function. The VN contains approximately 80–90% of sensory nerves. These sensory pathways are responsible for transmitting sensory information about the internal state of major organs to the central nervous system (CNS). This sensory feedback is essential for the function of the neuroendocrine-immune axis, which actively contributes to maintaining homeostasis. These sensory pathways are also connected to key components of physiological regulation, such as the hypothalamic-pituitary-adrenal axis (HPA axis) and the autonomic nervous system (ANS).

[0004] The VN has extensive interconnections that integrate and respond to feedback signals, connecting it to vital systems such as the cardiovascular, respiratory, gastrointestinal, autonomic nervous, immune, and endocrine systems. The VN is primarily composed of cholinergic fibers, but also mediates cholinergic and nonadrenergic transmitters. The VN enters the central nervous system (CNS) through afferent projections to the nucleus tractus solitarius (NTS). From the NTS, further afferent projections extend to the ventral lateral nucleus (PB), which connects with the locus coeruleus (LC) and raphe nuclei, from which ascending projections reach higher brain regions and regulate important brain processes.

[0005] The vagus nerve (VN) has important effects on various physiological systems related to homeostasis and is therefore attracting attention as a target for regulating organ function for therapeutic applications. Invasive cervical vagus nerve stimulation (VNS) was approved by the US FDA in 1997 for the treatment of treatment-resistant epilepsy and in 2005 for the treatment of drug-resistant depression. VNS is performed using a device implanted under the skin, typically on the left cervical vagus nerve, using a spiral electrode surgically attached to deliver electrical impulses directly to the vagus nerve.

[0006] The VNS medical device was first developed by Cyberonics Inc (now Livanova Inc). Since then, other implantable medical devices for VNS have been developed, including: MicroTransponder's Vivistim (for stroke) SetPoint Medical (for rheumatoid arthritis and inflammatory diseases) BioControl Medical's CardioFit (for congestive heart failure) Beijing Pins Medical's G112 (for pediatric drug-resistant epilepsy)

[0007] Despite the clinical adoption of prominent VNS devices, limitations to wider adoption exist, including surgical risks and associated side effects. Implanted VNS is an irreversible procedure and carries the risk of infection (approximately 3% incidence) and nerve damage. Voice changes (e.g., hoarseness) and cough reflex pressure during stimulation are risks (approximately 5% incidence) due to effects on the laryngeal recurrent nerve. Other side effects of VNS treatment include dyspnea, localized pain, and abnormal muscle contractions, which are caused by bidirectional stimulation of vagus nerve fibers.

[0008] To address the challenges associated with invasive VNS devices, non-invasive approaches such as transcutaneous vagus nerve stimulation (tVNS) have emerged. This method delivers electrical stimulation to the skin overlying the vagus nerve, providing neuromodulation without surgical intervention. tVNS typically uses a portable device applied to the neck or ear. The device's electrical impulses activate nerve fibers under the skin, thereby stimulating the vagus nerve and transmitting signals to the brainstem and higher brain regions. tVNS offers a low-risk, effective alternative therapy with significant potential for a variety of clinical applications.

[0009] tVNS, first described by Ventureyra et al. (2000), is achieved by activation of the auricular branch of the vagus nerve (ABVN). The ABVN nerve extends to the pinna of the ear and can be electrically depolarized minimally invasively. tVNS at the cymbal conchae activates the spinal trigeminal nucleus and the nucleus tractus solitarius (NTS), the primary termination sites of the main vagal sensory pathway (Frangos et al., 2015). This nerve stimulation activates brainstem nuclei, such as the locus coeruleus (LC) and parapontine nucleus, as well as midbrain regions such as the periaqueductal gray, dorsal raphe nucleus, substantia nigra, and red nucleus (Frangos et al., 2015; Badran et al., 2017).

[0010] tVNS has been used for a variety of clinical indications, including depression, anxiety, schizophrenia, autism, epilepsy (Rong, 2014; Stefan et al., 2012; Bauer et al., 2016), migraine (Straube et al., 2015), prediabetes (Huang et al., 2014), and post-ischemic stroke rehabilitation recovery (Baig et al., 2019; Redgrave et al., 2018). It has also been used to improve memory function (Jacob et al., 2015) and is a potential therapeutic tool for neurodegenerative diseases such as Alzheimer's disease (Kaczmarczyk et al., 2017; Cai et al., 2019) and Parkinson's disease (Ko, 2021).

[0011] tVNS medical devices offer portability and provide users with the benefits of autonomy, customizable dosing, and drug compatibility with no drug interactions, thus eliminating systemic side effects and the development of treatment resistance.State-of-the-art devices for tVNS stimulation include Nemos® from Cerbomed, Nurosym from Parasym Ltd, Nervana® from Nervana LLC, and Net1000® from Auri-Stim Medical.

[0012] However, prior art tVNS medical devices typically target areas not limited to the area supplied by the ABVN (e.g., the external auditory canal or the earlobe cavity) (e.g., Nurosym by Parasym Ltd). As shown in the study by Peuker and Filler (2002), the symbaconca is the only anatomical location exclusively dominated by the ABVN.

[0013] Cerbomed's Nemos® neurostimulator stimulates the sympathetic nervous system (EP 3100764 (A1) and DE 102015007215 (B3)). However, due to differences in the shape of the device's electrodes and the size of the user's ear, electrode contact with the sympathetic nervous system is less than optimal, resulting in insufficient stimulation of the ABVN, which reduces the device's effectiveness. Furthermore, these devices are wired and require a physical connection, making them inconvenient to use due to their size and limiting the amount of time they can be worn for treatment, making them unsuitable for continuous use.

[0014] ABVN electrical stimulation is gaining attention as a new therapeutic approach that offers diverse control over key physiological mechanisms between the brain and body, and therefore holds great potential for new technologies that offer user optimization, efficiency, personalization, and comfort during use.

[0015] The objective of the present invention is to provide a wireless, wearable neurostimulator for tVNS stimulation of the sympathetic nerve branches for ABVN nerve stimulation, which increases efficiency, comfort and provides personalization through feedback analysis from user data, allowing it to adapt to the needs of each user. Summary of the Invention [Problem to be solved by the invention]

[0016] In view of the above-mentioned prior art, a first aspect of the present invention relates to a wearable auricular nerve stimulator. The nerve stimulator (electrode assembly) is wireless and intended to be worn by a user to stimulate the auricular vagus nerve (ABVN) of the user's ear. The nerve stimulator (electrode assembly) has at least one electrode positioned in the sympathetic nervous system, such that when a voltage difference is applied, the electrode effectively utilizes the entire sympathetic nervous system to stimulate the ABVN.

[0017] The present invention relates to a user-wearable nerve stimulator (1) configured to stimulate the auricular vagus nerve (ABVN) in the user's ear. The invention also relates to a nerve stimulation system including the nerve stimulator (electrode assembly) (1) and a control unit (8). The nerve stimulator (electrode assembly) (1) is wireless and designed to place at least one electrode (2) in the sympathetic nervous system, which stimulates a branch of the auricular vagus nerve (Ramus Auricularis Nervi Vagi, RANV) when a voltage difference is applied. The nerve stimulator (electrode assembly) (1) includes at least one electrode (2) that generates stimulation pulses. The nerve stimulation system includes at least one detection means configured to detect one or more parameter values, and the system includes a control unit (8) suitable for setting one or more parameters of the stimulation pulses provided by the nerve stimulator (electrode assembly) (1) based on the detected parameter values. The neurostimulator (electrode assembly) (1) includes at least one electrode (2) and an indefinite-shaped ("figure-eight") holding portion (3) designed to be worn on the user's ear.

[0018] The present invention further relates to a neurostimulation system for auricular vagus nerve (ABVN) stimulation, comprising at least one electrode (2) for generating stimulation pulses, the neurostimulation system including at least one input device for inputting feedback data by a device user, a memory for storing the feedback data or for transmitting the feedback data to a dedicated platform in the cloud, and a control unit (8) suitable for setting one or more parameters of the stimulation pulses wirelessly provided by the neurostimulator (electrode assembly) (1) or providing the parameters of the stimulation pulses provided by the neurostimulator (electrode assembly) (1) for user selection. Furthermore, the success of the treatment provided by the neurostimulator (electrode assembly) (1) can be personalized, or parameters affecting the stimulation can determine stimulation that enhances the success of the treatment over an unalterable stimulation pattern (e.g., stimulation protocol).

[0019] The present invention further relates to a neurostimulation system for auricular vagus nerve (ABVN) stimulation, in which two wireless neurostimulators (electrode assemblies) (1) can be applied simultaneously, each generating a stimulation pulse, and a control unit (8) of the neurostimulation system adjusts the synchronous or asynchronous stimulation of the pulse parameters by the electrode assemblies.

[0020] Preferably, the electrodes are made of biocompatible materials (non-toxic metals such as titanium, nickel-titanium, platinum, platinum-iridium, and gold) and biocompatible polymers, and are used to ergonomically adapt to the user's ear, providing a comfortable and secure fit and accurate positioning and contact to the stimulation site. Furthermore, the placement of the nerve stimulator (electrode assembly) does not block the user's ear canal, meaning that auditory perception during ABVN stimulation is not impaired.

[0021] The neurostimulator (electrode assembly) of the present invention is an inventive electrode assembly for neurostimulation, particularly for ABVN stimulation, and includes at least one electrode and an infinity-shaped ("figure-eight") holding portion designed to hold the electrode assembly in the user's ear.

[0022] Since nerve stimulation activity depends heavily on good contact between the electrode and the tissue to be stimulated, it has proven advantageous in practice for the connection part where the electrode is connected to the holding part to be inclined relative to the connection part.

[0023] The nerve stimulator (electrode assembly) of the present invention includes a conduction sensor that indicates proper skin contact between the sympathetic nerve and the electrode, thus ensuring good fit integrity.

[0024] Preferably, the auricular nerve stimulation device (electrode assembly) of the present invention is used in combination with two wireless stimulation electrodes in each of the user's ears, allowing stimulation of each of the user's ABVNs to be performed synchronously or asynchronously.

[0025] The auricular nerve stimulator (electrode assembly) of the present invention implements a waveform-based stimulation protocol based on a square wave, bidirectional, symmetric pulse shape.

[0026] In one preferred embodiment, the auricular nerve stimulator (electrode assembly) of the present invention is configured to coordinate stimulation pulses with the user's neurophysiological processes, particularly with periodically occurring physiological processes.

[0027] Generally, the present invention includes a smartphone application that allows a user to interact with a neurostimulator device.

[0028] According to a second object, the present invention relates to an auricular nerve stimulation system including a wireless nerve stimulator (electrode assembly) and a control unit, wherein the control unit can charge the built-in battery of the nerve stimulator (electrode assembly) when nerve stimulation is not being performed. When performing stimulation on the user's ear, the control unit can be used by the user to control the stimulation intensity of the nerve stimulator (electrode assembly). Stimulation data performed by the nerve stimulator (electrode assembly) can be collected by the control unit and transmitted to a dedicated platform in the cloud. Connection between the control unit and an application in a smartphone enables data transfer to an external cloud.

[0029] The control unit communicates with the wireless neurostimulator (electrode assembly) to perform ABVN stimulation. The control unit allows the user to increase the stimulation intensity of the wireless neurostimulator (electrode assembly) to perform ABVN stimulation. The control unit has a control panel with an illuminated display for reference, showing accumulated usage time, stimulation intensity, and quality of skin contact to the ear.

[0030] Preferably, the neurostimulation device includes optical pulse generation (PPG) or biosensors or at least one external input mechanism for inputting feedback data from the user into the control unit of the neurostimulation system, thereby estimating the hemoglobin and oxygenated hemoglobin levels in the user's circulatory system and using these data to calculate heart rate (HR), heart rate variability (HRV), respiratory rate and phase, or parameters related to the autonomic nervous system (e.g., sympatho-vagal balance), or parameters related to the user's motor activity or muscle response (i.e., electromyogram (EMG)), or a combination of the aforementioned parameters.

[0031] PPG or biosensors, or external input mechanisms for data feedback, are configured for detection of physiological markers such as slow heart rate (bradycardia) and hypopnea.

[0032] A neurostimulation system for performing ABVN stimulation therapy comprises at least one wireless neurostimulator (electrode assembly) for generating stimulation pulses, the neurostimulation system being configured with detection means for detecting one or more parameter values, and the neurostimulation system being equipped with a controller unit suitable for setting one or more parameters of the stimulation pulses transmitted by the neurostimulator (electrode assembly) based on the detected parameter values.

[0033] Therefore, stimulation provided by a wireless neurostimulator (electrode assembly) offers the important advantage that the treatment can be determined in terms of a stimulation pattern (stimulation protocol) where the treatment is either user-specific (individualized) or the parameters that may affect the stimulation cannot be altered.

[0034] The neurostimulation system also includes a cloud platform that can integrate data obtained from devices and sensors, such as watches, bracelets, and rings, to continuously monitor heart rate activity, sleep cycle patterns, etc. Analysis of this data can, for example, determine the user's physiological state and define personalized stimulation therapy to improve negative conditions.

[0035] According to a third aspect, the present invention relates to a method of operating an auricular nerve stimulation system, comprising the steps performed in the following order: a. Setup Phase: The user enters personal information to create a profile (e.g., weight, age, medical history including symptom frequency and severity) and / or baseline physiological data from the user is collected at rest using external sensors. This data includes heart rate, HRV (heart rate variability), respiratory rate, and measures of autonomic nervous activity related to sympathetic and parasympathetic balance. b. Stimulation Protocol: Unilateral, bilateral, synchronous or asynchronous neurostimulation may be specified for the user, and these may be tailored to trigger active neurostimulation via physiological, motor or muscle responses (e.g., electromyogram). c. Stimulation Start: Stimulation begins when the device is placed in the user's ear. d. Data Collection: During stimulation, biosensors or external input devices collect physiological data from the user, which is then transmitted to the controller unit. e. Stimulation Session Completion and Data Storage: Once stimulation for a session is complete, the controller unit stores the data for the treatment session. f. Data Transmission to Cloud: The Controller Unit transmits the therapy session data to a cloud platform to facilitate subsequent analysis. g. Cloud Data Repository: The cloud-based platform stores the received therapy session data. h. Algorithmic Analysis: An algorithm analyzes all collected data and optimizes stimulation parameters specific to each individual user. These optimized parameters are presented to the user for selection if preferred. [Brief explanation of the drawings]

[0036] The features, advantages and objects of the present invention will become apparent to those skilled in the art from the following detailed description of the preferred embodiments of the invention, when read in conjunction with the accompanying drawings. [Figure 1] Diagram of the anatomical structures of the outer ear that can be targeted with auricular nerve stimulation in humans. [Figure 2] Schematic diagram showing the effects of vagus nerve stimulation (VNS). Stimulation of the vagus nerve (VN) via the auricular branch of the vagus nerve (ABVN) activates ascending neural pathways, resulting in modulation of neural activity. The diagram shows that the VN projects to the nucleus tractus solitarius (NTS) and dorsal motor nucleus (DMN), as well as to higher brain regions such as the locus coeruleus, hypothalamus, thalamus, basal ganglia, and forebrain cholinergic centers. [Figure 3] 1 is a schematic diagram of the components of a connected auricular nerve stimulation system of the present invention. [Figure 4]A diagram of the nerve stimulation device (electrode assembly) of the present invention showing that the connection portion is inclined with respect to the vertical center line (y-axis) of the infinitely shaped holding portion. [Figure 5] An example of a nerve stimulation device (electrode assembly) of the present invention in which the holding portion and the connecting portion are made of materials with similar hardness. [Figure 6] An example of the nerve stimulation device (electrode assembly) of the present invention, in which a pad containing an electrical component for generating electrical pulses to perform nerve stimulation is attached. [Figure 7] FIG. 1 is a side view of a nerve stimulation device (electrode assembly) of the present invention. [Figure 8] 1 is a diagram of a controller unit of the neurostimulation system of the present invention. [Figure 9] A diagram of the neurostimulator (electrode assembly) housed in the controller case. The holding part is housed inside the case and connected to the controller unit via copper pogo pins, allowing the neurostimulator (electrode assembly) to be charged. [Figure 10A] Diagram of the neurostimulator (electrode assembly) for binaural neurostimulation, showing ABVN neurostimulation in a synchronous stimulation configuration. [Figure 10B] Diagram of the neurostimulator (electrode assembly) for binaural nerve stimulation, showing nerve stimulation of the ABVN in an asynchronous stimulation configuration. [Figure 11] Diagram showing user flow for user account setup, device setup, data analysis, and feedback. DETAILED DESCRIPTION OF THE INVENTION

[0037] The object of the present invention is a user-wearable auricular nerve stimulator (electrode assembly) (1) for optimizing stimulation of the ABVN at the concha, as shown in Figure 1.

[0038] The neuroanatomy of ABVN stimulation is shown in Figure 2. Neurostimulation of the ABVN via the pedunculoturbinalis mediates stimulation of the auricular branch of the vagus nerve (RANV), activating vagal pathways to the nucleus tractus solitarius (NTS) and dorsal motor nucleus (DMN), which subsequently activates projections to higher brain regions including the locus coeruleus, hypothalamus, thalamus, basal ganglia, and forebrain.

[0039] The auricular nerve stimulation device (electrode assembly) (1) of the present invention is designed to be worn on a user's ear, as shown in Figure 4, and is composed of the following components: At least one electrode placed on the concha: The device has at least one electrode (2) placed on the concha (the only ear site where 100% ABVN exists) and configured as the active electrode. A second electrode placed on the concha: A second electrode is placed on the concha. In a preferred embodiment, both electrodes are configured as working electrodes and a potential is applied to optimize activation of the ABVN. Biocompatible electrode assembly configuration: Electrodes are typically manufactured from biocompatible materials (non-toxic metals such as titanium, nickel-titanium, platinum, platinum-iridium, and gold) and biocompatible polymers to adapt to the user's ear. They are designed to fit snugly to provide comfort and precise positioning and contact to the stimulation site. Furthermore, the electrodes do not block the ear canal and do not interfere with auditory perception during ABVN stimulation.

[0040] The auricular nerve stimulator (electrode assembly) (1) integrates electronic circuits that achieve the following functions: Wireless ABVN nerve stimulation Synchronous or asynchronous bilateral wireless ABVN nerve stimulation (Figure 10) Stimulation pattern generation (including variables such as duration, intensity, burst and pulse frequency, number of pulses per burst, pulse width, pulse delay, etc.) Generating stimulation patterns synchronized with parameters related to the autonomic nervous system (e.g., sympathetic and vagal balance) and the user's motor activity and muscle responses (e.g., electromyography (EMG)). Wireless data transfer with controller units (Figure 3) -Detection of adequate skin contact to ensure adequate nerve conduction The ergonomic design of the neurostimulator (electrode assembly) (1) is designed to allow for easy and convenient stable placement in the user's ear or controller unit (12) while protecting the electronic circuitry.

[0041] The auricular nerve stimulator (electrode assembly) (1) implements various stimulation protocols. In a preferred embodiment, the stimulation protocol is based on a rectangular, biphasic, symmetric waveform, synchronized for bilateral ABVN nerve stimulation (Figure 10A). This configuration aims to elicit highly efficient activation of the nerve endings of the ABVN fibers.

[0042] Additionally, the stimulation protocol includes burst stimulation to enhance the intrinsic response of ABVN nerve terminals. Burst stimulation interrupts intrinsic neural activity in the range of 1–20 bursts per second, resulting in an enhanced response.

[0043] The stimulation protocol also offers variations in pulse shape, pulse width, and pulse frequency for user comfort and optimized stimulation. Stimulation intensity is adjustable from 0 to 3 mA. Pulse width determines the engagement of specific A-beta, A-delta, and C-type ABVN fibers. Short pulses of 10 to 300 microseconds stimulate thick A-beta fibers and avoid eliciting A-delta and C-type fibers, which transmit pain signals. The desired recruitment of thick fibers is dependent on the frequency of 1 to 100 Hz, and this frequency range is used.

[0044] Usability, Stability, and Comfort: Conventional auricular nerve stimulators typically utilize a bulky generator connected to an accessory via a cable to deliver voltage to different ear regions. The size and weight of these devices limit their portability and practicality for users. In contrast, the auricular nerve stimulator (electrode assembly) (1) of the present invention offers a compact and lightweight form factor, ensuring wearer comfort. The wireless auricular nerve stimulator (electrode assembly) (1) configuration and ergonomic ear design prevent ear canal blockage and disruption of auditory perception. The auricular nerve stimulator (electrode assembly) design also allows for familiar product associations that promote user adoption, and wireless data transfer further enhances user convenience (Figure 3). Furthermore, the ergonomic design of the auricular nerve stimulator (electrode assembly) (1) ensures stable placement in the user's ear and high-quality contact between the electrode (2) and the ABVN stimulation region.

[0045] The nerve stimulator (electrode assembly) (1) is an inventive electrode assembly for nerve stimulation, particularly suitable for ABVN stimulation, and includes at least one electrode (2) and an infinity-shaped ('figure-eight') holding portion (3) designed to hold the electrode assembly in the user's ear.

[0046] Since the effectiveness of nerve stimulation depends heavily on good contact between the electrode and the tissue to be stimulated, a configuration in which the connection part where the electrode is connected to the holding part is inclined with respect to the vertical center line (y-axis) of the holding part (3) has proven to be advantageous in practice.

[0047] At least one electrode (2) is connected to an infinitely shaped ('figure eight') holding portion (3) via a connecting portion (4) which is inclined relative to the vertical centerline (y-axis) of the infinitely shaped holding portion, preferably at an angle of about 10 to 40 degrees, particularly preferably about 30 degrees (Figure 4).

[0048] The angle of the connection and the infinity-shaped ('figure-eight') retaining portion (3) are positioned to allow access to the user's ear canal (5), ensuring safe contact and sufficient contact pressure between the electrodes (2) and the user's skin even when the user is moving, for example while sleeping or exercising.

[0049] In practice, it has proven advantageous for the retaining part (3) and the connecting part (4) to be made of materials of similar hardness, in particular materials with a Shore hardness ranging from about 60 Shore A to about 90 Shore A, and especially from about 70 Shore A to about 90 Shore A.

[0050] The hardness of the materials used also ensures good structural stability and rigidity of the electrode assembly.

[0051] The retaining portion (3) is primarily made of a relatively soft material, and the connecting portion (4) and sections of the retaining portion adjacent to the connecting portion can also be made of materials of different hardness. Preferably, the portion made of the relatively hard material is inserted, embedded, or submerged into the portion made of the relatively soft material. The combination of hard and soft materials has the advantage of maintaining the structural stability of the neurostimulation device (electrode assembly) (1) while improving wearing comfort with the relatively soft material.

[0052] Preferably, a portion made of a relatively hard material is inserted or embedded into a portion made of a relatively soft material, or vice versa, which creates a smooth surface and improves the wearing comfort of the nerve stimulation device (electrode assembly) (1), as well as providing hygienic benefits.

[0053] It is also contemplated that only a framework made of a relatively hard material may be provided that is integrated or embedded into a portion made entirely or partially of a soft material. For example, the retention portion may include a soft material that encases the framework.

[0054] Furthermore, it has proven advantageous in practice for the cable associated with at least one electrode (2) to run inside the infinitely shaped ('figure eight') holding portion (3).

[0055] Furthermore, it has proven advantageous for the nerve stimulation device (electrode assembly) (1) to include two electrode contacts (2), preferably made of coated titanium.

[0056] Another advantage of the nerve stimulation device (electrode assembly) (1) of the present invention is that it is arranged with at least one electrode (2) and an infinity-shaped ('figure-eight') retaining portion (3), so that even when the nerve stimulation device (electrode assembly) (1) is placed in the user's ear, access to the ear canal is not completely blocked, and hearing is not impaired.

[0057] To achieve this, the lower part of the infinity-shaped ('figure-eight') retaining portion (3) is designed to fit into the user's ear canal. Furthermore, a complete circular ring can be attached to the inside of the lower part (5), providing additional support for firmly securing the neurostimulator (electrode assembly) (1) to the user's ear. In this way, the infinity-shaped retaining portion (3) fits into the ear with sufficient contact pressure, ensuring that the electrode contact portion (2) is in safe contact with the user's skin. The neurostimulator (electrode assembly) (1) supports good contact between the electrode contact portion (2) and the sympathetic nerve (the cartilage at the top of the ear) to maximize the stimulation effect. The advantage of this shape is that the lower part of the infinity-shaped retaining portion fits into the ear canal (5), while not blocking the user's hearing from surrounding sounds or blocking the ear canal, making it suitable for long-term use.

[0058] As shown in Figures 5-7, one embodiment of the nerve stimulation device (electrode assembly) (1) according to the present invention includes two electrodes (2) and an infinity-shaped ('figure-eight') holding portion (3). The two electrodes are connected to the infinity-shaped ('figure-eight') holding portion via a connecting portion (4). The infinity-shaped ('figure-eight') retaining portion (3) can include a full circular ring that can be attached to the inside of the lower portion (5). The hollow portion ensures that it does not interfere with the user's ability to hear ambient sounds within the ear canal. The infinity-shaped ('figure eight') holding section (3) contains a pad (6) with electrical components connected to the holding section that generate electrical pulses to perform ABVN nerve stimulation. Two copper pogo pins (7) allow for recharging of the pad (6) containing the electrical components. The cables associated with the electrodes can be placed within the holding portion (3). The two electrodes (2) are arranged symmetrically with respect to the center line (y-axis) of the infinitely shaped ('figure eight') holding portion (Figure 4). In the embodiment where the majority of the retaining portion is made of a relatively soft material, it may be advantageous to provide the necessary rigidity by inserting a framework or inlay made of a relatively hard material into the retaining portion (4).

[0059] Efficiency and Safety: The auricular nerve stimulation device (1) of the present invention targets only the sympathetic nerve (sympathetic nerve) in the ear, the only area in the ear that is 100% distributed with nerve endings of the auricular branch of the vagus nerve (ABVN). Among existing auricular nerve stimulation devices in the art, only the Cerbomed stimulates the sympathetic nerve in one ear (monaurally). In contrast, the present invention enables binaural simultaneous nerve stimulation of the ABVN with synchronous or asynchronous stimulation (Figure 10). Furthermore, the present invention detects sufficient skin conductance to ensure high-quality contact for efficient nerve stimulation.

[0060] In accordance with the second objective, the present invention relates to an auricular nerve stimulation system for ABVN stimulation, including a wireless auricular nerve stimulator (electrode assembly) (1) and a controller unit (8). The controller unit can charge the internal battery (12) of the auricular nerve stimulator (electrode assembly) (1) when nerve stimulation is not being performed. When stimulating the user's ear, the controller unit (8) can be used to control the stimulation intensity (9) of the nerve stimulator (electrode assembly) (1). Stimulation data performed by the nerve stimulator (electrode assembly) (1) can be collected by the controller unit (8) and transmitted to a dedicated cloud platform. The controller unit can connect to an internal smartphone application, allowing the data to be transferred to the external cloud (Figure 3).

[0061] Preferably, the neurostimulator comprises a photointerferometer (PPG) or biosensor, or at least one external input mechanism for the user to input feedback data into the controller unit (8) to estimate the hemoglobin and oxygenated hemoglobin levels in the user's circulatory system, which are used to calculate the user's heart rate (HR), HRV (heart rate variability), respiratory rate and phase, or parameters related to the autonomic nervous system such as sympathetic-vagal balance, or parameters such as motor activity and muscle response (electromyogram: EMG), or a combination of the aforementioned parameters.

[0062] The PPG or biosensor, or external input mechanism for data feedback, is configured to detect physiological markers such as slow heart rate (bradycardia) or hypopnea, in which case stimulation will automatically stop to avoid health risks.

[0063] Based on measurements and input data obtained by the sensors, it is possible to provide stimulation protocols tailored to achieve optimal vagus nerve stimulation for the device user, enabling personalized stimulation therapy that results in significantly more effective VAG nerve stimulation than other existing devices.

[0064] Furthermore, PPG or biosensors, or external input mechanisms for data feedback, can detect parameters related to the autonomic nervous system, such as sympathetic-vagal balance, motor activity, and muscle responses (electromyogram: EMG). These inputs can be used to automatically synchronize the neurostimulator (1) and improve the efficiency of vagal activation.

[0065] Furthermore, the wireless connection of the controller unit is connected to a mobile application through a smartphone device, and a connection to an external cloud is made, thereby establishing a complete neurostimulation system of the present invention (Figure 3).

[0066] The auricular nerve stimulator (electrode assembly) (1) is housed in a controller unit (8), which holds and charges the nerve stimulator (electrode assembly) (1) via pogo pins (7) (11) (Figure 9). The controller unit (8) acquires data from the nerve stimulator (electrode assembly) (1) and transmits it to a dedicated platform in the external cloud.

[0067] The neurostimulation system includes a smartphone application that allows users to interface with the auricular neurostimulator (electrode assembly) (1) and controller unit (8) to set and adjust specific stimulation parameters. This mobile app interacts with a dedicated platform in the cloud and receives data captured by PPG, biosensors, or external input mechanisms for data feedback during stimulation sessions.

[0068] The controller unit (8) of the neurostimulation system of the present invention is configured to detect parameters related to the user's autonomic nervous system, such as heart rate, HRV (heart rate variability), respiratory rate and respiratory phase, or sympathetic-vagal balance, or parameters such as motor activity and muscle response (electromyogram: EMG), or a combination of the aforementioned parameters. The adopted stimulation protocol is offered to the user as a choice based on the user profile and feedback data, which can improve the efficiency of the user's vagus nerve activation.

[0069] The auricular nerve stimulator (electrode assembly) (1) of the present invention offers significant advantages over existing nerve stimulators in terms of ease of use, stability, comfort, efficiency, safety, and customization.

[0070] The PPG or biosensor, or external input mechanism for data feedback, is configured to continuously monitor cardiac activity patterns via an external wearable such as a watch, bracelet, or ring to detect physiological markers such as slow heart rate (bradycardia) and hypopnea.

[0071] Customization: The neurostimulation system of the present invention features therapy customization, allowing users to select personalized stimulation protocols based on the user profile and received feedback data, which can be synchronized with parameters such as sympathetic-vagal balance, motor activity, and muscle response (electromyography: EMG). These customizations allow users to improve the efficiency of vagal activation.

[0072] A neurostimulation system for performing ABVN stimulation therapy comprises at least one electrode (2) for generating stimulation pulses, which are transmitted wirelessly, the neurostimulation system comprising at least one detection means configured to detect one or more parameter values, and a controller unit (8) adapted to set one or more parameters of the stimulation pulses transmitted from the electrode (2) based on the detected parameter values.

[0073] Unlike fixed stimulators known in the prior art, the stimulation protocol implemented by the neurostimulation system can be modified / personalized for the user, relying on one or more parameter values ​​measured by external sensors, such as pulse duration and intensity.

[0074] Therefore, a key advantage is that stimulation is delivered from a wireless auricular nerve stimulator (electrode assembly) (1), allowing for personalized treatment success and enabling parameters affecting stimulation to determine stimulation that enhances treatment success based on an unalterable stimulation pattern (i.e., stimulation protocol).

[0075] The detection means preferably consist of one or more sensors.

[0076] The detection means is configured to measure parameter values, such as the user's heart rate, in real time, and the controller unit (8) of the neurostimulation system is configured to set stimulation pulses based on the parameter values ​​measured in real time.

[0077] The detecting means is connected to a memory, and parameter values ​​measured by the detecting means are stored in the memory, such that the controller unit (8) of the neurostimulation system is configured to set stimulation pulses based on the parameter values ​​stored in the memory. For example, physiological recording data such as heart rate and sleep cycle patterns can be determined and stored over a long period of time, and the stimulation pulses provided by the neurostimulator (electrode assembly) (1) can then be based on the stored values.

[0078] By way of example, the user parameter or parameters may be physiological signals such as heart rate, breathing or sleep cycle patterns, which may be determined using external sensors, or parameters related to breathing, or parameters related to the autonomic nervous system such as sympathetic-vagal balance, or parameters such as motor activity or muscle response (electromyogram: EMG), or a combination of the aforementioned parameters.

[0079] For example, it is conceivable that the controller unit (8) of the nerve stimulation system is configured to control the wireless auricular nerve stimulation device (electrode assembly) (1) to adjust the parameter value detected by the detection means to a predetermined value (9) or a predetermined range of values.

[0080] Furthermore, the neurostimulation system may be configured such that VAG stimulation affects the autonomic nervous system, i.e., sympathovagal balance. When vagal tone is detected directly through an external sensor or by other means, the controller unit (8) of the neurostimulation system may be configured to specifically affect stimulation of the neurostimulator (electrode assembly) (1) to adapt vagal tone to a predetermined value or a predetermined range of values.

[0081] The controller unit (8) of the neurostimulation system is configured to periodically synchronize the stimulation pulse or pulses with the physiological processes, in particular neurophysiological processes, of the user.

[0082] According to a method of the neurostimulation system for performing ABVN stimulation therapy, stimulation pulses are generated by at least one wireless neurostimulator (electrode assembly) (1), one or more parameter values ​​are detected in advance, and one or more parameters of the stimulation pulses transmitted from the wireless neurostimulator (electrode assembly) (1) are set by a controller unit (8) of the neurostimulation system based on the detected parameter values.

[0083] Unlike previously known devices for performing ABVN stimulation, the neurostimulation system according to the present invention provides adaptive neurostimulation, i.e., stimulation protocols that are not fixed or uniform, but are based on one or more parameters specific to the user.

[0084] Thus, the present invention encompasses applications that evolve from conventional ABVN neurostimulators, with a variety of sensors serving as inputs for control and variation of stimulation parameters.

[0085] A closed-loop application is envisaged, where a parameter is adjusted to a predetermined value or range of values.

[0086] The auricular nerve stimulator (electrode assembly) (1) is wirelessly controlled by the controller unit (8) of the nerve stimulation system. The controller unit can wirelessly connect (e.g., Bluetooth) to external devices via a smartphone application, which then connects to software in the cloud (Figure 3). Stimulation session data from the nerve stimulator (electrode assembly) (1) is transferred through this connection.

[0087] The auricular nerve stimulation device (electrode assembly) (1) is controlled by a controller unit (8) of the nerve stimulation system, which is the size of a smartphone, for user convenience and ease of use.

[0088] The controller unit (8) of the neurostimulation system communicates with the wireless neurostimulator (electrode assembly) (1) to perform ABVN stimulation. The controller unit (8) of the neurostimulation system allows the user to increase the stimulation intensity of the wireless neurostimulator (electrode assembly) (1) to perform ABVN stimulation. The controller unit of the neurostimulation system is equipped with a controller panel (9) with an illuminated display that allows the user to refer to the usage time, stimulation intensity, and quality of skin contact with the ear.

[0089] When not stimulating, the neurostimulator (electrode assembly) is placed in a predetermined location (10) on the neurostimulation system controller unit (8) for charging (12), which is configured to hold the neurostimulator (electrode assembly) (10) in an infinity ("figure eight") shape.

[0090] When at least one neurostimulator (electrode assembly) (1) is placed in the controller unit (8), the battery of the neurostimulator (electrode assembly) is charged. Two copper connector pogo pins (11) are allocated for placement and connection for charging.

[0091] As shown in Figure 8, the neurostimulation system controller unit (8) of the present invention includes a user panel (9) that allows the user to adjust stimulation. When stimulation is not being performed, the neurostimulator (electrode assembly) is placed in place and the neurostimulator (electrode assembly) (12) is held in place. The connection between the neurostimulation system controller unit (8) and the neurostimulator (electrode assembly) (1) is made via two copper pogo pins, which initiate charging (11) when the neurostimulator (electrode assembly) is placed in the neurostimulation system controller unit (12) (see Figure 9).

[0092] The neurostimulation system controller unit (8) for ABVN stimulation includes at least one wireless neurostimulator (electrode assembly) (1) that generates stimulation pulses, the neurostimulation system has at least one input device for inputting feedback data by a device user, the neurostimulation system has a memory in which the feedback data is stored, and the neurostimulation system can adjust to set one or more parameters of the stimulation pulses transmitted from the wireless neurostimulator (electrode assembly) (1) depending on the user feedback, or can suggest to the device user to select parameters of the stimulation pulses transmitted from the neurostimulator (electrode assembly) (1).

[0093] The electrical components of the neurostimulation system controller unit (8) consist of electrical circuits that perform the following functions: Wireless control of ABVN neurostimulation Synchronous or asynchronous bilateral wireless ABVN nerve stimulation (Figure 10) Generation of stimulation patterns (including duration, intensity, burst and pulse frequency, number of pulses per burst, pulse width, pulse delay, and other factors) Generation of stimulation patterns synchronized with parameters such as the autonomic nervous system (e.g., sympathetic-parasympathetic balance), the user's motor activity, and muscle responses (e.g., electromyogram (EMG)). Wireless data transfer with external devices (Figure 3) Charging the battery of the neurostimulator (electrode assembly) -Detection of adequate skin contact for adequate nerve conduction

[0094] In accordance with the present invention, the effectiveness of the neurostimulation system is optimized by taking into account defined parameters and feedback from the user.

[0095] The neurostimulation system controller unit (8) for ABVN stimulation recognizes the defined parameters of the stimulation sent from the wireless neurostimulator (electrode assembly) (1) and learns from the user or from feedback from the user. Based on the feedback, the neurostimulation system controller unit (8) can modify the stimulation pulses of the wireless neurostimulator (electrode assembly) (1) in the next treatment to improve the condition, and performs optimization based on the feedback data.

[0096] The technical settings of the neurostimulation system controller unit (8) (e.g., pulse duration, intensity, duration of use, etc.) are set based on the device user or user feedback, allowing the user to decide whether to enable the suggested settings.

[0097] The feedback data stored in the neurostimulation system may be user-specific, meaning that stimulation can be optimized for each individual user.

[0098] It is also within the scope of the present invention that the feedback data is not user specific, but rather relates to all device users for a particular disease or related condition.

[0099] The memory in which the feedback data is stored may be integrated as part of the neurostimulation system or may be located as a component of an external device, as applies to all other components of the system.

[0100] A "neurostimulation system" may be understood to be a system in which all components are not necessarily co-located, and thus the memory may be formed as a data pool by, for example, a server that is spatially separated from the user-operated portion of the device.

[0101] The neurostimulation system may include one or more external sensors capable of detecting user parameters or external parameters, and the neurostimulation system controller unit (8) is configured to set one or more parameters of the stimulation pulses transmitted by the wireless neurostimulator (electrode assembly) (1) based on the user parameters or the external parameters, or may suggest to the user to select parameters of the stimulation pulses transmitted by the wireless neurostimulator (electrode assembly) (1).

[0102] In this case, parameters such as heart rate parameters, sleep cycles, stress, physical activity, exercise, muscle response, etc., would be included in the parameter values ​​of the stimulation pulses.

[0103] In this manner, the method of the neurostimulation system for providing ABVN stimulation therapy can store feedback data stored by the device user via the input device in memory and set one or more parameters of the stimulation pulses transmitted by the wireless neurostimulator (electrode assembly) (1) based on the feedback data or suggested for selection by the user.

[0104] The collected data and feedback data will form a data pool that will be analyzed, particularly for positive or negative correlations between variables, with regard to their impact on changes in perceived health and negative conditions.

[0105] Possible applications of the method of the nerve stimulation system according to the present invention include the following: Tinnitus Addiction Headache disorders Brain fog Confusion Loss of concentration Obesity Cognitive impairment Neuro-psychiatric behavioral disorders Learning disabilities ·Dementia Stress Physical performance Inflammatory disorders ·Autoimmune disorders ·Persisting symptoms from COVID-19 infection Immune system disorders Eating disorders Parkinson's disease Alzheimer's disease High blood pressure ·Diabetes Stroke

[0106] A method of operating a nerve stimulation system according to the present invention includes the following steps, proceeding in the following order (FIG. 11):

[0107] A. Setup Phase: 1. The user downloads the mobile application onto their smartphone and creates an account in the system. During registration, the user is asked to enter accurate personal information (e.g., weight, age, medical history including symptom frequency and severity). Optionally, there is also a step to measure baseline physiology (metrics such as heart rate, HRV, respiratory rate, and autonomic nervous system activity related to sympathetic-parasympathetic balance) using commonly worn external wearable sensors (e.g., watches, bracelets, rings, etc.) or other external sensors. 2. Based on the user's profile, appropriate stimulation protocols are assigned based on data groups and statistical studies. Once an auricular nerve stimulator is employed, these stimulation protocols are customized through analysis of data captured by PPG or biosensors, or external input mechanisms for data feedback. 3. Once account registration is complete, the user logs into the application and establishes a connection with the auricular nerve stimulator. Through the mobile application, the user is prompted to scan the unique QR code on the auricular nerve stimulator. This connection assigns the device's serial number to the user account.

[0108] B. Application of ABVN nerve stimulation: 1. The user selects from the available stimulation protocols according to their needs (unilateral, bilateral, synchronous or asynchronous, and / or physiological, motor or muscle response, e.g., electromyography (EMG) triggered). The mobile app sends the data of the selected protocol to the neurostimulation system controller (8). 2. After the user removes and wears the wireless neurostimulator (electrode assembly) (1) from the neurostimulation system controller (8), the controller automatically detects sufficient skin contact using the sensor built into the wireless neurostimulator (electrode assembly) (1). If the neurostimulator (electrode assembly) (1) is properly worn on the user's ear and the impedance of the electrode contact (2) with the ABVN region is good, the neurostimulation system allows the user to start stimulation using the neurostimulation system controller (8). 3. The neurostimulation system controller (8) monitors the stimulation intensity and duration (9). Stimulation will automatically stop if the maximum stimulation duration is reached, if the electrodes no longer provide sufficient skin contact, or if the user removes and reinserts the neurostimulator (electrode assembly) (1) into the neurostimulation system controller case (12). 4. During stimulation, PPG or biosensor data of the user's physiological indicators, or data collected from external input devices, are transmitted to the neurostimulation system via Bluetooth. 5. After stimulation is completed, the neurostimulation system controller (8) stores the session data (including date, time, stimulation duration, stimulation parameters, and the user's physiological indicators). The battery of the neurostimulator (electrode assembly) (1) is recharged by returning it to the neurostimulation system controller (8). 6. The neurostimulation system controller (8) sends data from each stimulation session to the mobile application, which then sends the data to the cloud for analysis. 7. Cloud-based platforms store session user data. 8. The algorithm systematically processes all user-specific data. If a more suitable stimulation protocol is available based on the user's profile, the platform sends this value to the application, allowing the user to select the optimized stimulation protocol if desired.

[0109] <References> Cai et al., Neurosci Lett 2019; 703:104-110 Baig et al., J Stroke Cerebrovasc Dis 2019; 28(12):104348 Bauer et al., Brain Stim 2016; 9(3): 356-363 Badran et al., Brain Stim 2018; 11(3):492-500 Frangos et al., Brain Stim 2015; 8(3):624-36 Huang et al., BMC Complement Altern Med 2014; 14:203 Jacobs et al., Neurobiol Aging 2015; 36(5):1860-7 Kaczmarczyk et al., J Neurochem 2017; jnc.14284 Ko, Auton Neurosci 2021; 235: 102858 Peuker and Filler, Clin Anat 2002; 15(1): 35-7 Redgrave et al., J Stroke Cerebrovasc Dis 2018; 27(7):1998-2005 Rong et al., Clin Sci (Lond) 2014 Safi et al., Anat Rec 2016; 299(9): 1184-91 Stefan et al., Epilepsia 2012; 53(7): e115-8 Straube et al., J Headache Pain 2015; 16: 543 Ventureyra, Childs Nerv Syst 2000; 16(2): 101-2

[0110] <Patent Documents> [1] EP3100764 (A1); 07-12-2016 [2] DE102015007215 (B3); 25-02-2016

[0111] Although the present invention has been described in terms of preferred embodiments, various modifications and adaptations may be made by those of ordinary skill in the art without departing from the scope of the invention, which is defined by the appended claims.

Claims

1. A wireless auricular neurostimulator (electrode assembly) (1) wearable by a user and configured to simultaneously neurostimulate both sides of the auricular branch vagus nerve (ABVN), comprising: The auricular neurostimulator (electrode assembly) (1) is wireless and has at least one electrode contact (2) that is positioned in the sympathetic nervous system to deliver electrical stimulation exclusively to the nerve branches of the ABVN; The neurostimulator (electrode assembly) (1) is constructed in the shape of a wireless earphone and integrates a compact design (6) that avoids complete blockage of the user's ear canal (5) or suppression of the user's hearing perception; The electrode contacts (2) are placed on the ear impression of the neurostimulator (electrode assembly) (1) and are designed to surround the anatomical region of the ABVN; Conductive sensors designed into ear molds; A compact faceplate design (6) incorporating all electrical components is connected to an infinity-shaped ("figure eight") holding section (3) and is surrounded by a printed circuit board (PCB) that generates the electrical pulses to perform ABVN stimulation. An auricular neurostimulation device (electrode assembly) (1) characterized by:

2. The auricular neurostimulation device (electrode assembly) (1) of claim 1, wherein the electrode (2) is made of biocompatible materials (including non-toxic metals such as titanium, nickel titanium, platinum, platinum-iridium, and gold) and biocompatible polymers, is designed to conform to the user's ear for comfortable and secure wear, and provides accurate positioning and contact with the stimulation area.

3. 1. An auricular neurostimulation device (electrode assembly) (1) for nerve stimulation, particularly ABVN stimulation, according to claim 1, comprising at least one electrode (2) and an infinity-shaped ("figure-eight") holding portion (3), which is designed to be worn on a user's ear.

4. 4. The neurostimulator (electrode assembly) (1) according to claim 3, characterized in that at least one electrode (2) is connected to an infinitely shaped ("figure eight") holding portion (3), and the connection portion (4) is inclined with respect to the vertical center line (y-axis) of the infinitely shaped holding portion (3), the inclination angle being preferably between about 10 and 40 degrees, particularly preferably about 30 degrees.

5. The neurostimulator (electrode assembly) (1) according to claim 3 or 4, characterized in that the holding part (3) and the connecting part (4) are made of materials of similar hardness, in particular materials having a Shore hardness in the range of about 60 Shore A to about 90 Shore A, particularly preferably in the range of about 70 Shore A to about 90 Shore A.

6. The neurostimulator (electrode assembly) (1) according to claim 5, characterized in that the holding portion (3) is mainly made of a relatively soft material, and the connecting portion and a portion of the holding portion adjacent to the connecting portion can be made of a material of a different hardness, preferably such that the portion made of the relatively hard material is inserted, embedded or sunk into the portion made of the relatively soft material.

7. A nerve stimulation device (electrode assembly) (1) according to any one of claims 1 to 6, characterized in that the cable associated with at least one electrode (2) runs along or inside the holding part of the infinite shape ("figure eight") (3).

8. A nerve stimulation device (electrode assembly) (1) according to any one of claims 1 to 7, characterized in that the at least one electrode (2) and the preferably infinitely shaped ("figure eight") holding portion (3) are arranged so as not to completely block access to the user's ear canal and not to interfere with the user's hearing when the nerve stimulation device (electrode assembly) (1) is placed in the ear.

9. A nerve stimulation device (electrode assembly) (1) according to any one of claims 1 to 8, characterized in that at the bottom of the second ring, in particular the infinite-shaped ("figure-eight") holding portion, an additional full-circular ring is attached to the inner part of the lower part (5), thereby enabling the nerve stimulation device (electrode assembly) (1) to be more securely fixed in the user's ear.

10. The electronic circuit is as follows: - Central circuit for generating stimulation patterns - A voltage amplifier that can adjust the potential difference supplied from the battery ・Charging circuit ・Impedance detection circuit ・Rechargeable battery The auricular nerve stimulation device (electrode assembly) (1) according to claim 1, characterized in that it comprises:

11. An auricular nerve stimulation system comprising a bidirectional wireless nerve stimulator (electrode assembly) (1) and a controller unit (8), wherein, when placed in the controller unit (12), the internal battery of the nerve stimulator (electrode assembly) (1) is charged, and stimulation data performed by the nerve stimulator (electrode assembly) (1) is collected by the controller unit (8) and transmitted to a dedicated cloud-based platform.

12. 12. The auricular nerve stimulation system according to claim 11, characterized in that it comprises a PPG or biosensor or at least one external input mechanism for the device user to input feedback data into the controller unit (8), which estimates the levels of hemoglobin and oxygenated hemoglobin in the user's circulatory system, and these data are used to calculate heart rate, HRV (heart rate variability) and respiratory rate, respiratory phase, or parameters related to the autonomic nervous system (e.g. sympathetic-parasympathetic balance) or motor activity or muscle response (e.g. electromyogram (EMG)), or a combination of these parameters.

13. The PCB electronic circuit is characterized in that it is configured to have the following functions: - Implementing wireless control of ABVN neurostimulation Generate synchronous or asynchronous bidirectional wireless ABVN neurostimulation - Generating stimulation patterns with varying duration, intensity, burst and pulse frequency, number of pulses per burst, pulse width, pulse delay, and other factors. - generating stimulation patterns synchronized with parameters related to the autonomic nervous system, e.g., sympathetic-parasympathetic balance, or motor activity or muscle response (e.g., electromyogram (EMG)); - Wireless data transfer with external devices ・Charging the battery of the neurostimulator (electrode assembly) Detecting adequate skin contact for adequate nerve conduction 12. The auricular nerve stimulation controller unit (8) according to claim 11, characterized in that it comprises:

14. 14. The auricular nerve stimulation system according to claim 1, incorporating multiple stimulation protocols suitable for bilateral ABVN nerve stimulation, characterized in that the current intensity, pulse width and pulse frequency are variable and the stimulation protocols are based on rectangular biphasic symmetric waveforms.

15. 15. An auricular nerve stimulation system according to any one of claims 1 to 14, characterized in that the stimulation protocol applied via the nerve stimulation device (electrode assembly) (1) is individualized for each user depending on the treatment requirements.

16. 16. An auricular nerve stimulation system according to any one of claims 1 to 15, characterized in that the voltage difference applied to the electrodes is measured in real time to obtain an indication of the impedance of the electrodes in contact with the skin.

17. 12. The auricular nerve stimulation system according to claim 11, further comprising a smartphone application, wherein a connection between the controller unit (8) and the application in the smartphone allows data to be transferred to an external cloud, and the user can interact with the nerve stimulation device using the smartphone application.

18. 13. The auricular nerve stimulation system according to claim 12, characterized in that it has at least one input device for inputting feedback data by a device user, the neurostimulation system is provided with a memory in which the feedback data is stored, and the neurostimulation system has a controller unit (8) suitable for setting one or more parameters of the stimulation pulses transmitted by the neurostimulator (electrode assembly) (1) based on the feedback data or for proposing parameters of the stimulation (stimulation protocol) transmitted by the neurostimulator (electrode assembly) (1) for selection by the device user.

19. 20. The auricular nerve stimulation system of claim 18, wherein the stored feedback data is individualized to the user.

20. 20. The auricular nerve stimulation system of claim 18, wherein the stored feedback data is not user-specific but corresponds to all users of the neurostimulation system, as opposed to multiple users with a particular or related disorder.

21. 21. An auricular nerve stimulation system according to any one of claims 1 to 20, characterized in that the memory device is an integral component of the nerve stimulation system or is arranged as a component of an external device.

22. 22. An auricular nerve stimulation system according to any one of claims 1 to 21, characterized in that it comprises at least a two-point communication link from the input controller unit (8) to a storage device.

23. 23. An auricular nerve stimulation system according to any one of claims 1 to 22, characterized in that the nerve stimulation device (electrode assembly) (1) is wireless and the controller unit (8) of the nerve stimulation system is portable, preferably the size of a smartphone.

24. 24. The auricular nerve stimulation system according to claim 1, wherein the nerve stimulation system comprises one or more sensors for detecting one or more user parameters and / or external parameters, and wherein the controller unit (8) is configured to set one or more parameters of the stimulation pulses delivered by the wireless nerve stimulation device (electrode assembly) (1) based on the user parameters and / or the external parameters, or to suggest parameters of the stimulation pulses delivered by the electrodes to be selected by the device user.

25. 25. An auricular nerve stimulation system according to any one of claims 1 to 24, characterized in that the nerve stimulation device (electrode assembly) (1) comprises at least one electrode (2) for wirelessly generating stimulation pulses, the nerve stimulation system comprises at least one detection means configured to detect one or more parameter values, and the nerve stimulation system further comprises a controller unit (8) suitable for setting one or more parameters of the stimulation pulses delivered by the wireless nerve stimulation device (electrode assembly) (1) based on the detected parameter values.

26. 26. The neurostimulation system according to any one of claims 1 to 25, characterized in that the detection means are configured to measure the parameter values ​​in real time, and further characterized in that the controller unit (8) of the neurostimulation system is configured to set stimulation pulses based on the parameter values ​​measured in real time.

27. 27. A nerve stimulation system according to any one of claims 1 to 26, characterized in that the parameter measured by the detection means is a user parameter or an external parameter.

28. 27. The neurostimulation system of claim 26, wherein the user parameter is a physiological signal of the user, such as heart rate, which can be determined using an ECG sensor, a parameter related to respiration, or a parameter related to the autonomic nervous system, such as sympathetic-parasympathetic balance, or a parameter related to the user's motor activity or muscle response (e.g., electromyogram (EMG)), or a combination of these parameters.

29. 29. The nerve stimulation system according to any one of the preceding claims, characterized in that the controller unit (8) is configured to wirelessly control the nerve stimulation device (electrode assembly) (1) to adjust the parameter value detected by the detection means to a desired value or range by means of stimulation pulses.

30. 30. A neurostimulation system according to any one of claims 1 to 29, characterized in that the controller unit (8) is configured to regulate the periodically occurring stimulation pulses to physiological processes, in particular neurophysiological processes, of the user.

31. Steps below: a. Before stimulation: - The user enters personal data to create a user account in the system through a smartphone application. • Assign appropriate stimulation protocols based on user profile, data groups and statistical studies. The user logs in to the mobile application and establishes a connection with the auricular nerve stimulator by scanning the device's QR code, which assigns the device's serial number to the user account. b. After stimulation: After stimulation is completed, the neurostimulation system controller unit (8) saves the session data (including date, time, stimulation duration, stimulation parameters, and the user's physiological indicators). The battery of the neurostimulator (electrode assembly) (1) is returned to the neurostimulation system controller unit (12) to be charged. The neurostimulation system controller unit (8) sends the data from each stimulation session to a mobile application, which then sends the data to the cloud for analysis. - The cloud-based platform stores user data sessions. The algorithm systematically processes all user-specific data and, based on the user's profile, provides a more appropriate or adapted stimulation protocol, which the platform then sends to the application, allowing for the selection of an optimized or personalized stimulation protocol.

19. A method for operating the auricular nerve stimulation system according to claim 17 or claim 18, comprising:

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