DEVICE FOR THE TREATMENT OF TINNITUS

Description

Technical area

[0001] The invention relates to a device for treating tinnitus. State of the art

[0002] Tinnitus is an auditory sensation that occurs in one or both ears in addition to the sound entering them. This sensation is based on a hearing impairment. The apparent sounds vary greatly in nature: The auditory impressions can be described as a humming or whistling sound, hissing, rushing, crackling, or knocking.

[0003] Tinnitus impairs quality of life. Current treatment methods (including various forms of acoustic stimulation, behavioral therapy approaches, combined therapy approaches that incorporate acoustic stimulation and behavioral therapy elements (e.g., tinnitus retraining therapy), drug therapy, physiotherapy, and magnetic and electrical brain stimulation) are not always effective, or not sufficiently effective. For most of the available therapies, there is no evidence of effectiveness from sufficiently large placebo-controlled studies.

[0004] For example, the prior art describes an ear device designed to compensate for rapid pressure changes due to rapid changes in altitude in aircraft to prevent ear pain. GB2450931, for example, describes ear defenders in which the pressure can be regulated using an air pump.

[0005] Hearing protectors worn for noise protection tend to build up heat after prolonged use, which can lead to excessive perspiration. To allow for air exchange, a ventilation opening is provided on the ear cup. This allows for air exchange by changing the volume of the ear cup's interior (DE2910315).

[0006] CN205598091 (U) describes a device comprising glasses, a Bluetooth headset, and headphones. This device can, for example, use software to play ambient sounds, tones, or music for the treatment of tinnitus.

[0007] WO2015164889 describes a headphone that can be placed inside or near a user's ear canal during use, and an earloop for securing the earphone to the user's ear. The earloop includes an inflatable bladder to better secure the earphone to the user's ear during use. US20170303031 describes a headphone comprising an inflatable mounting system to better secure the housing of the headphone to the human ear. CN206743497 describes a headphone with an inflatable corpus cavernosum, but which is mounted in the inner ear.

[0008] JP H09 56774 A discloses a device for treating tinnitus, comprising a bracket that exerts pressure on the acupuncture points in front of the ear. JP H03 142414 describes glasses that have magnetic bodies to improve blood circulation, for example. JP3164048U describes a hearing aid that changes the position of the auricle to improve hearing. AT 8 023 U1 describes an ear clip for stabilizing the position of glasses on the head and for correcting protruding ears. The ear clip is used to attach the glasses to the wearer's head, and the protruding ear edge is pressed toward the head.

[0009] Tinnitus can certainly be cured. Especially in acute cases, the prospects for recovery are good. However, there are no exact figures on how many tinnitus sufferers are cured and in what form. A tinnitus patient can consider themselves cured when the ringing in their ears disappears. Therefore, there is still a need for targeted, long-lasting, and successful treatment of tinnitus. The object of the present invention is therefore to provide a device and its use that do not have the disadvantages and deficiencies of the prior art. In particular, the object of the present invention is to provide a method for treating tinnitus. Brief summary of the invention

[0010] This problem is solved by the independent claims. The present invention thus comprises a novel device for treating tinnitus, which device changes the position of the auricle and thus alters the angle of sound entry. This change in the outer ear alleviates and / or completely cures the tinnitus condition.

[0011] The invention is described in the appended set of claims.

[0012] In particular, the present invention relates to a device for treating a tinnitus condition comprising a pressure point body, the device being dimensioned such that it can be attached to the auricle (outer ear), characterized in that the pressure point body has at least one attachment element and one pressure element, whereby the position of the auricle (outer ear) is changed.

[0013] One embodiment comprises the device as described herein, wherein the pressure point body has a fixed size or is variably fillable.

[0014] One embodiment comprises the device as described herein, wherein the pressure point body is a gel pad.

[0015] One embodiment comprises the device as described herein, wherein the variably filled pressure point body is an air cushion cushion.

[0016] One embodiment comprises the device as described herein, wherein the pleasure cushion is individually fillable.

[0017] One embodiment comprises the device as described herein, wherein the device further comprises a device for individually adjusting the pressure point body.

[0018] One embodiment includes the device as described herein, wherein said device is an air pump, a compressor, or a syringe.

[0019] An embodiment comprises the device as described herein, wherein the device further comprises a control unit with memory.

[0020] One embodiment comprises the device for treating a tinnitus condition, consisting of the device which is dimensioned such that it can be attached to the auricle and has at least one pressure point body, and optionally a device for individually adapting the variable pressure point body to its wearer, as well as an electronic control unit with memory.

[0021] Furthermore, the use of the device according to the invention for the treatment of tinnitus is described.

[0022] The device according to the invention is suitable for the treatment of tinnitus, whereby the position of the auricle (outer ear) is changed by the device, in particular by the pressure point body.

[0023] The device according to the invention is suitable for the treatment of tinnitus, since the device, in particular the pressure element, changes the angle of entry of the sound at the outer ear.

[0024] The device according to the invention is suitable for treating tinnitus because the device, particularly the pressure point body, exerts pressure on the auricle (outer ear). This pressure can deform the middle ear and refract sound differently.

[0025] Furthermore, a method for treating a tinnitus condition is described, comprising a device which is placed behind the auricle, said device being designed in such a way that it changes the position of the auricle of the outer ear.

[0026] Furthermore, a method for treating a tinnitus condition is provided herein, wherein pressure is exerted on the auricle and / or on the middle ear by this device, in particular by the pressure point body.

[0027] Furthermore, a method for treating a tinnitus condition is described herein, wherein a device, in particular a pressure point body, is placed behind each of the two auricles, wherein pressure is exerted on the auricles in particular by the pressure point body.

[0028] Furthermore, a method for treating a tinnitus condition is described, wherein at least one device as described herein is placed behind one or both auricles. Short description of the drawings

[0029] Figure 1 shows a schematic representation of the ear. Figure 2 shows a schematic representation of the ear with sound entry. Figure 3 shows a schematic representation of the ear with altered sound entry. Figure 4 shows a schematic diagram of glasses. Figure 5 shows a schematic diagram of a spectacle arch with air chambers and control hardware. Figure 6 shows a schematic pressure point body. Figure 7 shows a schematic representation of a bracket with a pressure point body that can be individually fixed on the bracket. Figure 8 shows a schematic representation of a bracket with air chambers and control hardware. Figure 9A and 9B show the trend in the study participants' subjective perception during the study period. Study participants were asked to rate their individual assessment of their tinnitus symptoms over the study period, with their subjective perception being recorded on a scale from 0 = not bothersome / inaudible to 10 = very bothersome / very loud. The trend lines were calculated logarithmically in Excel based on the individual data for each participant. Figure 10 shows a questionnaire. Detailed description of the invention

[0030] The embodiment according to the invention is shown in Figure 7 shown. The Figure 4 , 5 , and 8 The embodiments shown do not fall under the subject matter of the claim.

[0031] The ear consists of the outer, middle and inner ear (see Figure 1 ).

[0032] The outer ear comprises the ear cartilage, the pinna, the earlobe, the external auditory canal, and the outer eardrum. Its function is not only to capture sound, but also to encode a specific direction of sound arrival through spectral minima and maxima (see localization). The numerous elevations and depressions of the pinna form acoustic resonators, each of which is excited when sound arrives from a specific direction. This creates direction-dependent minima and maxima in the frequency spectrum of the ear signal, which the ear uses to determine the direction of arrival: above, below, front, or back (directional bands).

[0033] The middle ear includes the eardrum and the auditory ossicles (hammer, anvil, and stapes). The round window connects the tympanic scala of the inner ear with the middle ear. The Eustachian tube, also called the auditory tube, connects the middle ear and the nasopharynx. A mechanical impedance conversion takes place in the middle ear, enabling optimal signal transmission from the outer ear to the inner ear. Since the acoustic impedance of water is approximately 3,000 times greater than that of air, without the lever system formed by the auditory ossicles, only a small portion of the sound energy reaching the eardrum would be transmitted to the inner ear.

[0034] The inner ear lies in a small system of cavities (bony labyrinth) within the petrous bone, a part of the temporal bone. Within this bony labyrinth lies the membranous labyrinth, consisting of the cochlea, where sound is converted into nerve impulses, and the vestibular system. The vestibular system consists of the semicircular canals and two vesicle-like parts, the utricle and the saccule. It serves to detect changes in movement and the direction of gravity. The cochlea and vestibular system are similarly constructed: Both are filled with two common parallel fluid systems (perilymph and endolymph) and contain hair cells. The hair cells are cylindrical and get their name from the approximately 30 to 150 hair-like projections at the top of the cell (stereocilia). Movements in the fluid bend the hairs, thereby triggering nerve impulses.At the lower end is a synapse with a sensory neuron. This neuron releases neurotransmitters even at rest. If the hair extensions are deflected by sound vibrations or changes in head movement, the amount of neurotransmitters changes. In the vestibular system, the hair extensions are coated with a gelatinous layer, on which small calcium carbonate crystals are deposited, amplifying the effect of movement. From the cochlea, the auditory nerve, along with the nerve bundles of the vestibular system, runs toward the brain as the vestibulocochlear nerve.

[0035] The effects of tinnitus depend largely on the subjective perception and assessment of the noises in the ear. These can occur unilaterally or bilaterally.

[0036] Tinnitus aurium means "ringing in the ears." Medically, tinnitus is defined as an acoustic perception that occurs without a corresponding acoustic stimulus from outside the body and has no informational content.

[0037] In principle, two forms are distinguished. In objective tinnitus, there is a body-specific sound source in or near the ear whose sound emissions are perceived. This means that the sounds, often emanating from blood vessels or muscles, actually exist and are therefore audible to others, albeit usually only with a stethoscope or other medical devices.

[0038] However, subjective tinnitus is much more common. Here, those affected perceive sounds and noises that cannot be attributed to a physical source and are therefore inaudible to other people. This does not mean, however, that the patients are merely imagining the humming, buzzing, whistling, ringing, hissing, or knocking. Rather, subjective tinnitus is due to faulty information formation or processing in the auditory system, which extends from the ear via the auditory nerve to the auditory centers in the brain.

[0039] However, for many sufferers, the cause of the ringing in the ears cannot be definitively determined. This is referred to as idiopathic tinnitus.

[0040] Surprisingly, it has now been discovered that changing the position of the outer ear relative to the rest of the ear alters the sound, meaning the sound is refracted compared to the "normal" entry point. This leads to a different point of entry on the eardrum. As a result, the hammer (handle) of the first auditory bone moves differently, sending different pressure signals to the next auditory bones and then on to the cochlea. In the cochlea, the sensory hairs, which are immersed in fluid, move in a different way. This leads to a different conversion of the electrical signals to the brain and to a learning change in the synapses – the previous sounds are no longer heard and are thus "forgotten" in the long term.

[0041] By changing the angle of entry of the sound, the noises in the ears (tinnitus) that are perceived as "disturbing" are no longer perceived, since the sound hits the eardrum at different points of incidence.

[0042] Sound changes frequency due to different refraction (change in path length). Frequency changes due to a change in distance between the observer (eardrum) and the sound source (Doppler effect). The sound path in the ear between the outer ear and the eardrum changes. Therefore, the previously perceived "old" frequencies are no longer perceived, as their frequency has changed and is no longer perceived by the brain. This occurs primarily at high frequencies.

[0043] The device according to the invention changes the angle of sound entry so that the affected person no longer hears the previously learned disturbing sounds. The device according to the invention therefore comprises a pressure point body, which is dimensioned so that it can be attached to the auricle and has at least one pressure element, whereby the pressure point body changes the position of the auricle. By changing the position of the outer ear through this pressure point body, the angle of sound entry into the ear is therefore changed.

[0044] In particular, it is advantageous to apply pressure to the outer ear through the pressure point body. This pressure can change the position of the outer ear in such a way that the angle of entry of the sound is also changed, thus eliminating annoying tinnitus sounds. The perception of noises that are not caused by acoustic signals from the environment is reduced or completely eliminated with the device according to the invention.

[0045] The punctual pressure point body can be attached to any conventional device that can be attached to the auricle. Depending on the design of the device, one or more punctual pressure point bodies can be attached.

[0046] Conventional devices include eyeglass frames or simple ear hooks, such as those used in headphones or hearing aids. The embodiment according to the invention is a simple ear hook or ear hook-like holder that can be attached to the outer ear.

[0047] The term "point-to-point" as used herein refers to a single location on the device where a pressure-point body is attached. In particular, earphones may already have a cavernous body, which is, for example, ring-shaped and thus covers the entire ear. One or more pressure-point bodies can also be attached point-to-point, allowing the position of the auricle to be individually adjusted.

[0048] The pressure point body can be made of various materials. In principle, any material suitable for changing the normal position of the auricle can be used. For example, the pressure point body can be made of plastic, fabric, felt, foam, gel, rubber, elastic adhesive strips, or similar materials. The pressure point body can be made of a foamed material, an elastic, deformable material, or a plastic material, such as polypropylene.

[0049] The pressure point body can have a fixed or variable shape. In one embodiment, the pressure point body consists of a fastening element and a pressure element. In particular, the pressure point body can also consist of a pressure element, wherein the fastening element is designed as the adhesive side of the pressure element. In this embodiment, the pressure point body is attached directly behind the auricle using the adhesive side. For this purpose, the adhesive side can have a surface coating, such as a rubber coating or an adhesive or adhesive coating.

[0050] Preferably, the fastening element is cylindrical with a circular cross-sectional geometry. However, the fastening element can also be oval, triangular, rectangular, square, triangular, polygonal, L-shaped, or similar in cross-section. This means that the fastening element can have any desired geometry in cross-section. This allows the fastening element to be attached to any location on the device and thus adapted to the individual needs of the wearer. In a further embodiment, the fastening element can be fixed to the device by means of a clip mechanism.

[0051] Another embodiment of the pressure point body also includes a pressure element, which can have a fixed or variable volume. For pressure elements with a variable volume, for example, pads that can be filled with air, water, and / or liquids as needed, and thus optimally adapted to the wearer's needs, are particularly suitable.

[0052] Printing elements with a fixed volume and a fixed shape are preferably made of plastic.

[0053] A further embodiment therefore comprises the device according to the invention, which, in addition to the pressure point body and the variably adjustable pressure element, also contains a miniature air pump, a (miniature) syringe, or a miniature compressor for individually filling the pressure element. The miniature compressor can operate by reciprocating motion, by rotating screws, by helical motion, by centrifugation, or other methods. One embodiment also includes a thermal modification of the pressure element, for example, by rubbing, kneading, pressing (i.e., mechanical effects), by adding or removing heat, or by using micropumps with a piezoelectric membrane.

[0054] In order to optimally adjust the setting of the variable pressure element, it may be advantageous if the device has a control unit with which the corpus cavernosum can be individually adjusted to the needs of the wearer.

[0055] The control unit may further comprise a memory in which the status information of the corpus cavernosum is stored. Examples of implementation

[0056] The following embodiments illustrate the present invention without, however, limiting its scope

[0057] Figure 5 shows a temple (1) with three variable pressure points (2) on the inside of the temple. These variable pressure points can be individually filled with the compressor (3).

[0058] A pressure point body (2) is shown schematically in Figure 6 shown. Figure 6 shows a pressure point body (2) consisting of a fastening element (4) and a pressure element (5).

[0059] Figure 7shows the embodiment according to the invention, consisting of a bracket with a pressure point body. This pressure point body (2), consisting of a fastening element (4) and a pressure element (5), can be individually adjusted according to the wearer's needs, with the pressure point body (2) being fixed to the bracket accordingly to ensure optimal and individual pressure application. Case studies

[0060] A first case study has already been conducted under the supervision of the inventor and applicant. Participants had to meet the following requirements for study participation: People who are considered to have already exhausted all medical treatment options for their tinnitus. This means people who no longer respond to any possible treatment; people who wear glasses; and people who agreed to participate in an online survey twice a day.

[0061] A total of seven participants, selected by a general practitioner in a doctor's office, participated in this first case study. A pressure point device was attached to the temples of these study participants' glasses. This device, containing the pressure point devices, was worn by the study participants for the majority of the day.

[0062] In 70% of the patients, a significant improvement in the subjectively perceived tinnitus suffering was observed within the study period of approximately 8 weeks (see Figure 9). For this purpose, the online survey of study participants over this period was evaluated. The study participants were asked about their personal perception of the loudness of their tinnitus. They were asked to rate their personal assessment on a scale from 0 = not audible at all to 10 = very loud. They were also asked to rate the personal distress caused by their tinnitus on this scale from 0 = not bothersome at all to 10 = very bothersome.

[0063] The participants answered the following questionnaire in Figure 10 online, where ForgTir denotes the pressure point body.

Claims

1. Device for treating a tinnitus condition, comprising an ear clip (1) that is not part of a spectacle frame, and a pressure point body (2) comprising a fastening element (4) and a pressure element (5), wherein the pressure point body (2) alters the position of the auricle, characterized in that the pressure point body (2) is adjustably displaceable along the ear clip (1).

2. Device according to claim 1, characterized in that the pressure element (5) has a defined size.

3. Device according to any one of claims 1 to 2, characterized in that the fastening element (4) is an annular retaining element.

4. Device according to any one of claims 1 to 3, characterized in that the pressure point body (2) stimulates individually different points of the auricle and individually alters the position of the auricle.