Pressure application device

Abstract

The present invention relates to a method of making an individualized device (10) for improving the health of a subject, comprising scanning the geometry of the concha, generating a 3D model of the individualized device (10), and manufacturing a device (10) specifically adapted to the individual geometry of the subject's concha wherein the device (10) specifically adapts to the individual geometry of the subject's concha; applying pressure to the ear in a manner of changing the position of the auricle; applying pressure to a plurality of pressing point positions around the outer ear; and wherein the device (10) is flexible.

Description

Technical Field

[0001] The present invention relates to the field of improving personal health through pressing devices. Background Art

[0002] Bioelectronic medicine has gradually received attention as a non - pharmaceutical option for treating various diseases. Specifically, electrical stimulation of the auricular vagus nerve is an emerging technology applied in the field of bioelectronic medicine for treatment. Many physiological processes and body states are related to the information transmission between the brain and the body. These include the effects of alleviating diseases and sustainable therapeutic applications, from chronic pain diseases, neurodegenerative diseases, and metabolic diseases to inflammation and cardiovascular diseases.

[0003] Tinnitus is a condition where phantom sounds are perceived in the ear or head, which can be caused by a variety of different medical conditions. This condition is very common, with a prevalence of 10% to 15%. Until recent years, there was still little evidence indicating that tinnitus treatment was effective. Patent WO2019158674 and Patent WO2021250104 first disclosed a device proven to successfully treat patients with tinnitus. The device applies gentle pressure at various points on the ear. The device is configured as a bracket, equipped with a silicone plug, and located in the retroauricular muscle area. The bracket is made of metal and is therefore very hard and not suitable for wearing during sleep.

[0004] Means for 3D scanning the ear and printing an ear impression are commonly used to manufacture in - ear monitors, which are specifically for musicians, hearing - impaired people, and tinnitus patients who need thin earplugs during sleep.

[0005] Patent US2013 / 0301845A1 discloses an earplug system including an earplug device and an electronic control unit. The shape of the earplug device is selected to fit most adults' ears comfortably to provide good sealing to isolate external noise.

[0006] To improve the treatment of tinnitus and / or the health condition of a subject, it is desirable to have a flexible device that can also be worn during sleep.

[0007] Therefore, there is still a need for a flexible device for treating tinnitus and / or improving the health condition of an individual, which is particularly suitable for use during sleep. Summary of the Invention

[0008] The object of the present invention is to provide a flexible device for treating tinnitus and / or improving the health condition of a subject. This object is solved by the subject matter of the present invention.

[0009] According to the present invention, there is provided a flexible and soft device 10 that precisely fits the outer ear of an individual subject.

[0010] One embodiment of the present invention relates to a method of fabricating an individualized device 10 for improving the health condition of a subject, comprising:

[0011] scanning the geometry of the outer ear,

[0012] generating a 3D model of the individualized device 10, and

[0013] fabricating the device 10 specifically adapted to the individual geometry of the subject's outer ear.

[0014] Specifically, a method of fabricating an individualized device 10 for improving the health condition of a subject comprises:

[0015] scanning the geometry of the outer ear;

[0016] generating a 3D model of the individualized device 10; and

[0017] fabricating the device 10;

[0018] wherein the device 10 is specifically adapted to

[0019] the individual geometry of the subject's outer ear;

[0020] applying pressure to the outer ear in a manner that changes the position of the auricle;

[0021] applying pressure to a plurality of pressure points around the outer ear; and

[0022] wherein the device 10 is flexible.

[0023] Alternatively, a forming material is applied to the back of the auricle by an application device so as to form the area between the auricle and the skull.

[0024] Suitable forming materials are, for example, selected from the group consisting of: single-phase impression materials, two-phase impression materials, two-component hybrid materials or alginates.

[0025] A kit is also provided, which comprises a forming material, an application device and an optional processing device or stamping device for forming the impression material after it has cured.

[0026] The kit may also contain a fixing device for fixing the plastic impression behind the ear during wearing. This is advantageous because the device is specifically designed to be worn during sleep, thus preventing it from slipping during sleep.

[0027] Another aspect of the present invention relates to a method of fabricating an individualized device for treating a tinnitus condition and / or improving other health conditions, comprising the steps of:

[0028] (a) Apply an impression material to the area between the auricle and the skull,

[0029] (b) Cure the impression material,

[0030] (c) Remove the cured material; and optionally

[0031] (d) Treat the surface of the impression of the ear geometry.

[0032] To obtain a smooth impression surface, it may be necessary to manually process the impression surface by milling, polishing, sanding, etc. Specifically, after curing, the surface of the impression of the ear geometry is smoothed. This surface treatment can be carried out, for example, by a processing device suitable for this purpose, such as a stamping device.

[0033] Another embodiment relates to a method as described herein, wherein a silicone impression material is applied to the area between the auricle and the skull using a manual impression gun. According to an embodiment of the present invention, a soft vinyl polysiloxane material can be selected due to its low viscosity. The soft and easily moldable material flows into the area after application and cures into the shape of the area between the auricle and the head. Before removing the mold from the area, the mold can be gently touched with a fingernail to ensure that it has cured. Figure 2 A typical mold sample from a subject is depicted.

[0034] Another embodiment relates to a method as described herein, wherein the device 10 includes a curved portion 30 and an approximately straight portion 20 having a circular portion 21, and wherein the device is configured to surround the outer ear.

[0035] Another embodiment relates to a method as described herein, wherein the curved portion 30 has a smaller diameter at the starting points 40, 50 and thickens towards the middle.

[0036] Another embodiment relates to a method as described herein, wherein the device 10 is manufactured as a one-piece unit.

[0037] Specifically, the device 10 includes a straight portion 20 adapted to be disposed in front of the ear, a curved portion 30 adapted to be disposed behind the ear, and a circular portion 21 located in the middle of the straight portion 20.

[0038] An embodiment of the present invention relates to an individualized device 10 manufactured by a method as described herein, wherein the device precisely fits the outer ear of an individual subject.

[0039] Specifically, an individualized device 10 manufactured by a method as described herein, the device 10 is designed to precisely fit the outer ear of an individual subject; and wherein the device 10 is specifically adapted to

[0040] The individual geometry of the outer ear of a subject;

[0041] Applying pressure to the outer ear in a manner that changes the position of the auricle;

[0042] Applying pressure to a plurality of pressing points around the outer ear; and

[0043] Wherein the device 10 is flexible.

[0044] One embodiment of the present invention relates to an individualized device 10 as described herein, wherein an approximately straight portion 20 of the device is disposed in front of the ear, and a curved portion 30 is disposed behind the ear.

[0045] Another embodiment relates to a method as described herein, wherein the curved portion 30 stimulates various pressing points behind the ear.

[0046] Another embodiment relates to a method as described herein, wherein the circular portion 21 stimulates a plurality of pressing points in front of the ear.

[0047] Another embodiment relates to a method as described herein, wherein the curved portion 30 applies stimulation to the auricular vagus nerve.

[0048] One embodiment of the present invention relates to the use of an individualized device 10 as described herein to improve the health condition of a subject.

[0049] Another embodiment relates to a use as described herein, wherein the curved portion 30 of the device changes the position of the auricle and stimulates various ear pressing points.

[0050] Another embodiment relates to a device 10 as described herein for treating tinnitus.

[0051] Another embodiment relates to the use of an individualized device 10 as described herein, wherein the stimulation of the vagus nerve affects multiple physiological functions.

[0052] Another embodiment relates to the use of an individualized device 10 as described herein, wherein the multiple physiological functions are selected from the group consisting of: neurological disorders, psychometric function, metabolic syndrome, cardiovascular disorders, and pain. Brief Description of the Drawings

[0053] Figure 1 Depicted is a device 10, which includes an approximately straight portion 20 and a curved portion 30. The straight portion 20 of the device 10 includes an approximately circular portion 21 located in the middle of the straight portion.

[0054] Figure 2 Depicted is a device 1, which includes an upper portion 2 and a lower portion 3 worn behind the ear. Detailed implementation mode

[0055] The present invention provides a flexible device specifically for wearing during sleep to treat tinnitus and / or improve the health condition of an individual.

[0056] According to an embodiment of the present invention, the device is made into a flexible and soft device that surrounds the outer ear. The device includes an approximately straight portion and a curved portion. The straight portion of the device includes a circular portion located in the middle of the straight portion. The thickness of the straight portion can be uniform.

[0057] The curved portion of the device has the same diameter as the straight portion at its starting point, that is, at the starting points of the upper end and the lower end, so as to connect the curved portion and the straight portion. The curved portion thickens towards the middle portion.

[0058] The outer ear, that is, the pinna, is the visible part of the ear and is also called the auricle. The function of the outer ear is to collect sound by acting as a funnel, amplify the sound and direct it to the ear canal. The entire outer ear is the auricle. It is divided into different parts. The auricle of each person produces a unique imprint on the sound waves entering the ear canal. The numerous ridges and depressions of the auricle form a sound wave resonator, which is excited whenever sound from a certain direction hits. This produces direction-related minima and maxima in the spectrum of the human ear signal, and the human ear uses them to determine the incident direction, such as above, below, in front or behind.

[0059] The middle ear includes the tympanic membrane and the ossicles (malleus, incus and stapes). The round window connects the scala tympani of the inner ear to the middle ear. The eustachian tube, also called the ear trumpet, connects the middle ear and the nasopharynx. A mechanical impedance conversion occurs in the middle ear, enabling the signal to be optimally conducted from the outer ear to the inner ear. Since the acoustic impedance of water is approximately 3000 times that of air, without the lever system formed by multiple ossicles, only a small part of the acoustic energy reaching the tympanic membrane can be transmitted to the inner ear.

[0060] The inner ear is located in the bony labyrinth, a system of small cavities within the petrous bone (a part of the temporal bone). The membranous labyrinth lies within the bony labyrinth and consists of the cochlea, which converts sound into nerve impulses, and the balance organs. The balance organs are composed of the semicircular canals and two sac-like parts (the utricle and the saccule). The balance organs are used to detect changes in the direction of gravity and movement. The cochlea and the balance organs have a similar structure: both are filled with two common parallel fluid systems, perilymph and endolymph, and have hair cells. The hair cells are cylindrical and are named for the approximately 30 to 150 hair-like protrusions - stereocilia - at their tips. Movements of the fluid cause these hairs to bend, triggering nerve impulses. The base of the hair cell forms a synapse with a sensory neuron. This synapse releases neurotransmitters even at rest. If sound waves vibrate or changes in head movement cause the protrusions to deflect, the amount of neurotransmitter changes. In the balance organs, the protrusions are covered by a gel layer on which tiny calcium carbonate crystals are deposited, which enhances the effect of movement. Starting from the cochlea, the auditory nerve and the nerve bundles of the balance organs together form the vestibulocochlear nerve and extend towards the brain.

[0061] The effects of tinnitus depend to a large extent on the subjective perception and evaluation of the ringing in the ears. The ringing in the ears can occur on one or both sides.

[0062] Tinnitus means "ringing in the ears". Medically, tinnitus is defined as an auditory perception that occurs without a corresponding sound stimulus from outside the body and has no information content.

[0063] In principle, it is divided into two forms. In objective tinnitus, there is a source of sound within the body itself, either in or near the ear, and the sound emitted by this source can be perceived. That is to say, the sounds that often come from blood vessels or muscle tissue do exist, and thus can also be heard by others, even if in most cases they can only be heard using a stethoscope or other medical devices.

[0064] However, much more common is subjective tinnitus. In this case, the patient perceives tones and noises that cannot be traced back to a physical sound source and thus cannot be heard by others. However, this does not mean that the patient is just imagining the buzzing, beeping, whistling, ringing, hissing or knocking sounds. On the contrary, subjective tinnitus is due to abnormalities in the auditory system during information formation or information processing, which extends from the ear via the auditory nerve to the auditory centers in the brain.

[0065] However, for many patients, it is not possible to exactly determine what causes the ringing in the ears. This is called idiopathic tinnitus.

[0066] Surprisingly, it has now been found that by changing the position of the outer ear relative to the rest of the ear, the sound is altered, that is, refracted compared to "normal entry". This results in a change in the point of impact on the eardrum. Thereby, the handle of the first ossicle moves in a different way and sends the altered pressure signal to the next ossicle or then further to the cochlea. In the cochlea, the sensory cilia stored in the fluid are set in motion in an altered way. This results in a change in the converted electrical signals entering the brain and leads to a change in the synapses in terms of learning technology - previous sounds are no longer heard and are thus "forgotten" in the long term.

[0067] Tinnitus has many causes, from medications and painkillers to neck or jaw problems, lack of sleep and stress, anxiety and depression. Research has shown that tinnitus may be related to synchronous hyperactivity in the auditory cortex. If someone has neck tension or jaw problems, these neurons run along the auditory nerve. When they are hyperactive or excited, energy flows to the auditory nerve, triggering these neurons to fire. This leads to the perception of sound in the auditory cortex. Approximately two-thirds of people with tinnitus can change the loudness and pitch of their tinnitus through somatic movements, such as clenching their teeth or tightening their neck muscles.

[0068] In addition to changing the position of the outer ear relative to the rest of the ear, the device also massages multiple pressure points around the ear. The device is specifically configured to stimulate the muscles behind the ear, such as the superior auricular muscle and the posterior auricular muscle.

[0069] The superior auricular muscle is the muscle above the concha of the outer ear. It originates from the galea aponeurotica and inserts into the upper part of the medial surface of the auricle. It raises the concha upward. The superior auricular muscle can be stimulated by the upper part 40 of the device, which is located at the upper part of the ear.

[0070] The posterior auricular muscle is the muscle behind the concha of the outer ear. It originates from the mastoid part of the temporal bone and inserts into the lower part of the craniofacial surface of the concha of the outer ear. It usually pulls the concha slightly backward. The posterior auricular muscle can be stimulated by the part 30b of the curved part 30 of the device, which is located behind the concha.

[0071] In addition, there is a complex bidirectional interaction between tinnitus and stress. Tinnitus patients generally consider their tinnitus to be stressful, disturbing, and annoying, and a significant proportion of them experience insomnia, attention problems, and psychological problems such as anxiety or depression due to the persistent tinnitus sensation. The interaction is bidirectional because stress also exacerbates the tinnitus sensation. Many patients report that there were stressful events prior to the onset of their tinnitus. Stress levels and emotional states modulate the relationship between tinnitus loudness and the perceived tinnitus distress of an individual. In addition, over time, the dynamic changes in emotions are associated with the evolution of tinnitus, which increases the complex interaction between tinnitus distress, tinnitus loudness, stress, and emotional perception. This complex interaction was also observed during the first wave of the COVID-19 pandemic.

[0072] The curved portion 30 of the device can have different thicknesses, depending on the condition to be treated. The same portions 30a, 30b of the curved portion 30 of the device can have individually customized thicknesses in order to massage the vagus nerve. The outer ear is an ideal site for non-invasive stimulation of the vagus nerve. In fact, the auricular branch of the vagus nerve presents as the auricular afferent vagus nerve and thus forms a cutaneous receptive field in the auricle of the ear. This receptive field can be stimulated by the device according to the present invention.

[0073] Through the change in the sound entry angle, the "disturbing" noise (tinnitus) felt in the ear is no longer perceived because the sound hits other impact points on the eardrum.

[0074] The sound changes frequency due to the refractive change in the path length. The frequency is changed by varying the distance between the observer (eardrum) and the sound source (Doppler effect). In the ear, the sound path between the outer ear and the eardrum changes. Therefore, the "old" frequencies that were previously felt as disturbing are no longer perceived because they have changed in terms of "frequency" and are no longer perceived in the brain. This will mainly occur at high frequencies.

[0075] By means of the device according to the present invention, the sound entry angle is changed so that the patient can no longer hear the previously learned disturbing tones. Therefore, the device according to the present invention includes a thicker portion in the curved part, and the size of this thicker portion is designed to be located behind the auricular concha. Thus, due to the thicker portion of the device, the position of the auricular concha is changed. By changing the position of the outer ear, the sound entry angle into the ear is changed.

[0076] Specifically, it is advantageous to apply pressure to the outer ear by means of this device. Such pressure can cause the position of the outer ear to be changed, such that the angle of sound entry is also changed, so that the disturbing tinnitus tone is no longer heard. By means of the device according to the invention, the perception of noise caused by sound signals that do not originate from the outside world is reduced or completely cut off.

[0077] The final appearance of device 10 depends on the individual subject who requires such a device and the intended function of the device. For the treatment of tinnitus, the thickness of the middle part of the curved portion of the device can be increased in order to apply a gentle pressure at various points behind the ear and to change the position of the auricle. For the improvement of other health conditions, the thickness of the middle part of the curved portion of the device can be increased to a lesser extent in order to apply only a gentle pressure at various points behind the auricle without significantly changing the position of the auricle.

[0078] For the treatment of tinnitus or other health conditions during sleep, a customized device is required that can be easily worn during sleep without disturbing sleep.

[0079] The ear is the organ closest to the brain and is also the most sensitive organ because it can transmit stimuli quickly. For centuries, the treatment of various diseases through the ear has been known. For example, pressing at certain points on the auricle can relieve headaches, toothaches, backaches, insomnia and other diseases.

[0080] Ear acupressure therapy has been successfully used in patients with insomnia (published by Cha N.H et al. in the Journal of Holistic Nursing Practice, pages 102 - 109 in 2017). Patients with tinnitus are also often troubled by insomnia. The curved portion of the individualized device is arranged behind the ear, and this portion can stimulate the corresponding points. Due to this stimulation, an improvement in the sleep of the wearers of the device according to the invention can be observed.

[0081] Stress can be defined as any type of change that causes physical, emotional or mental tension. Stress is your body's reaction to anything that requires attention or action. Everyone experiences some level of stress. However, the way you cope with stress can have a great impact on your overall health. Stress affects the brain and the body. A small amount of stress is good for people to perform and protect themselves, but too much stress can overwhelm them, leading to fighting, obsessive thoughts or catatonic reactions. Therefore, learning how to cope with stress is very important for our physical and mental health.

[0082] Stress is a feeling of emotional or physical tension. It can come from any event or thought that makes you feel frustrated, angry, or nervous. Stress affects the physical state in the same way it affects the mind. It can lead to illnesses ranging from mild to severe, such as forgetfulness and concentration problems, sleep disorders, limited performance and creativity, restlessness, and so on.

[0083] The autonomic nervous system consists of two parts that are active simultaneously. One part, the so-called sympathetic nervous system, provides tension, and the other part, the parasympathetic nervous system, provides relaxation. Stress causes tension, and if the tension persists, the autonomic nervous system enters a mode of overactivation of the sympathetic nervous system, while the parasympathetic nervous system is responsible for reducing stress in the human body.

[0084] The curved part of the individualized device is set behind the ear and can stimulate various points of the autonomic nervous system, more precisely the parasympathetic nervous system. Due to this stimulation, it can be observed that the stress of the wearer of the device according to the present invention is relieved.

[0085] In addition, studies have shown that the incidence of sexual problems is higher in tinnitus patients, and in particular, the association between tinnitus and erectile dysfunction (ED) has been confirmed. This association was empirically tested in a study in Taiwan, China (published by Cheng Y-F et al. on page 6982 of Volume 111 of the journal *Scientific Reports* in 2021). Therefore, successful treatment of tinnitus can have a positive impact on erectile dysfunction.

[0086] To improve other health conditions, the device also includes a generally (more or less) circular part 21 at the approximate straight part 20. This generally circular part 21 exerts a gentle pressure on the tragus.

[0087] The vagus nerve is the 10th cranial nerve. It originates from the brainstem, has two branches on both sides, and is widely coiled and meandering in the neck, chest, and abdomen. The vagus nerve establishes interconnections between the brain and major body structures such as the pharynx, larynx, trachea, heart, aorta, lungs, and the entire gastrointestinal tract including the esophagus, stomach, liver, pancreas, and spleen. The level of activity of the vagus nerve is proportionally related to health, well-being, relaxation, and even emotions such as empathy. Therefore, the vagus nerve plays a crucial role in determining brain-body interactions (published by Kaniusas E. et al. on pages 1 - 23 of Volume 13 of the journal *Frontiers in Neuroscience* (Front. Neurosci) in 2019).

[0088] The outer ear is the only place on the human body where the vagus nerve sends out its only peripheral branch. The auricular branch of the vagus nerve serves as the afferent branch of the auricular vagus nerve and thus forms cutaneous receptive fields in the auricle of the ear. In terms of peripheral nerve stimulation, this receptive field is vulnerable to external stimuli. In particular, the auricular vagus nerve allows easy access from the outside through electrical stimulation and then conducts the applied stimulus directly and smoothly to the brainstem (Kaniusas, 2019).

[0089] Therefore, auricular vagus nerve stimulation is a peripheral, non-pharmacological, and minimally invasive neuromodulation technique that can alter the signal processing of the central nervous system, activate reflex circuits, and utilize brain plasticity to achieve different therapeutic purposes, thereby having a profound impact on different regions of the brain (Kaniusas, 2019).

[0090] Reported clinical applications of human auricular vagus nerve stimulation involve neurological diseases, psychometric functions, metabolic syndrome, cardiovascular disorders, and pain. Auricular vagus nerve stimulation is also anticipated to have a positive impact on epilepsy, depression, stroke, Alzheimer's disease, and many other diseases.

[0091] To date, electrical stimulation has been mainly used for the auricular vagus nerve. Surprisingly, the device according to the present invention has also been found to be able to stimulate the auricular vagus nerve through a substantially circular portion of an approximately straight section. When wearing the device, the circular portion is positioned in the concha of the ear, thereby stimulating the auricular vagus nerve.

[0092] The device according to the present invention is specifically adapted to stimulate the auricular vagus nerve. According to one embodiment of the present invention, the device is configured to be worn during sleep. This is particularly advantageous because individual subjects do not need to waste time traveling to various sites for bioelectronic medical treatment by electrical stimulation. The device is used to treat tinnitus and / or stimulate the auricular vagus nerve during sleep. However, if necessary, the device can also be worn while awake.

[0093] The device can be made as a single piece or can consist of several components that are connected together to form a single piece. If the device is produced as a single piece, it must have a certain flexibility to be placed around the outer ear. For some embodiments, it may be advantageous to provide a device having two or more components that are connected together to form a single piece when placed around the outer ear. This will allow the device to be placed around the outer ear in a convenient manner under the same circumstances. Connect two or more components to obtain a single piece and ensure a proper fit.

[0094] Two or more components can be connected by a plug-in connector, a connection assembly, or by a hook-and-loop fastener.

[0095] The device can be made of synthetic materials, such as plastic materials. Preferably, the device is made by a 3D printing device. Typical materials for 3D printing are silicone, polyurethane, and hydrogel. According to the present invention, the individualized device consists of an elastomer, preferably composed of one or more crosslinks of silicone and / or polyurethane and / or hydrogel, also known as an emulsion with a crosslinking agent, such as ink or 3D printing ink.

[0096] The device can be produced by additive manufacturing techniques. Additive manufacturing techniques are processes that start from 3D modeling data (usually computer-aided design files) and manufacture 3D products by stacking or combining materials, usually layer by layer.

[0097] To precisely fit the outer ear of an individual subject, ear scanning is an important step in manufacturing the device. To obtain a perfect model of the individual ear geometry, the detailed geometry of the subject's ear needs to be obtained. Therefore, according to the present invention, the geometry of the individual ear includes the outer ear, which includes the helix, antihelix, tragus, and lobule, and these are obtained by scanning the outer ear. After the outer ear is scanned, it is converted into a model of the device, such as a computer-aided design (CAD) model or other digital representations that are directly converted into a model of the physical device. Then, the model of the device can be manufactured, preferably by additive manufacturing techniques, such as 3D printing.

[0098] Additive manufacturing systems manufacture three-dimensional (3D) objects by curing multiple layers of build materials. Additive manufacturing systems manufacture objects based on data in a 3D model of an object generated, for example, by a computer-aided design (CAD) computer program product. The model data is processed into multiple slices, and each slice defines a portion of a layer of build material to be cured.

[0099] The 3D printing method can be a method step of batch manufacturing the device at one time by additive manufacturing using a layer-by-layer technique and a 3D printing device.

[0100] According to the present invention, a composition of a silicone 3D printing ink is provided as an additive manufacturing ink. This ink contains no solvents, is biocompatible with the human body, and is non-toxic, and is used to manufacture the device in ( Figure 1 ) this kind.

[0101] 3D printing of silicone completely omits the model and mold steps and directly prints the final part. The silicone material used for 3D printing must provide specific material properties, for example, excellent thermal stability, having different hardness grades, water resistance and suitability as a sealing material, ultraviolet resistance, antioxidant properties, compressive and shear resistance, flame retardancy, electrical insulation, biocompatibility, and optionally suitability for disinfection, color, and translucency options. The silicone material can be mixed with additives such as curing agents or other polymers. An example of a suitable material is, for example, that of Wacker Chemie AG Silicone

[0102] Example

[0103] The following examples are provided to assist in understanding the present invention, but are not intended and should not be construed as limiting the scope of the present invention in any way.

[0104] Case study

[0105] A longitudinal observational study is investigating the course of tinnitus over time and related symptoms during combined treatment. The combined treatment includes wearing a device around the ears during sleep and a smartphone application that provides self-help prompts to the participants. The participants provide self-reports on tinnitus loudness, tinnitus stress, mood, stress level, mandibular and neck muscle tension, as outlined in Table 1. In addition to these questions, the participants are asked whether they are using the device and to enter an evaluation in a free text field.

[0106] Table 1 Questions regarding ecological momentary assessment

[0107]

[0108] Both the treatment and the application evaluation are conducted under natural conditions, with data collection minimized, and tinnitus and the development of other health conditions are evaluated in a way that has high ecological validity and low interference with daily life. The participants only need to answer short questions in the application.

Claims

1. A method of manufacturing an individualized device (10) for improving the health condition of a subject, comprising: Scanning the geometry of the outer ear; Generating a 3D model of the individualized device (10); And Manufacturing the device (10); Wherein the device (10) is specifically adapted to The individual geometry of the outer ear of the subject; Applying pressure to the outer ear in a manner that changes the position of the auricle; Applying pressure to a plurality of pressing points around the outer ear; and Wherein the device (10) is flexible.

2. The method according to claim 1, wherein, The device (10) includes a curved portion (30) and an approximately straight portion (20) having a circular portion (21), and wherein the device (10) is configured to surround the outer ear of the subject.

3. The method according to claim 2, wherein, The curved portion (30) has a smaller diameter at the start and thickens towards the middle.

4. The method according to any one of claims 1 to 3, wherein, The straight portion (20) is adapted to be disposed in front of the ear, the curved portion (30) is adapted to be disposed behind the ear, and the circular portion (21) is located in the middle of the straight portion (20).

5. The method according to any one of claims 1 to 4, wherein The device (10) is manufactured as an integral piece.

6. An individualized device (10) produced by the method according to any one of claims 1 to 5, wherein, The device fits precisely to the outer ear of an individual subject; and wherein the device (10) is specifically adapted to The individual geometry of the outer ear of the subject; Applying pressure to the outer ear in a manner that changes the position of the auricle; Applying pressure to a plurality of pressing points around the outer ear; and Wherein the device (10) is flexible.

7. The individualized device (10) according to claim 6, wherein, The approximately straight portion (20) of the device is disposed in front of the ear, while the curved portion (30) is disposed behind the ear.

8. The individualized device according to claim 6 or 7, wherein The curved portion (30) is adapted to stimulate a plurality of different pressing points behind the ear.

9. The individualized device (10) according to any one of claims 6 to 8, wherein, The circular portion (21) is adapted to stimulate a plurality of pressing points in front of the ear.

10. The individualized device (10) according to any one of claims 6 to 8, wherein, The circular portion (21) is adapted to stimulate the auricular vagus nerve.

11. A use of the individualized device (10) according to any one of claims 6 to 10 for improving the health condition of a subject.

12. Use of the individualized device (10) according to claim 11, wherein, The curved portion (30) of the device changes the position of the auricle and / or stimulates a plurality of different ear pressing points.

13. Use of the individualized device (10) according to claim 12 for treating tinnitus.

14. Use of the individualized device (10) according to claim 11, wherein, Stimulation of the vagus nerve affects a variety of physiological functions.

15. Use of the individualized device (10) according to claim 14, wherein, The variety of physiological functions is selected from the group consisting of: neurological diseases, psychometric functions, metabolic syndrome, cardiovascular disorders, and pain.

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