Device for treating inner ear disorders such as tinnitus or hearing loss

Abstract

The present invention relates to a device (1) for treating inner ear disorders such as tinnitus or hearing loss in a patient (100), comprising at least one electrode (5a, 5b) adapted to transmit an electrical stimulation signal (3) to the patient (100). The at least one electrode (5a, 5b) is mounted on a support (6) configured such that when the at least one electrode (5a, 5b) is placed on the patient (100), it is arranged on the anterosuperior part of the mastoid process (101) of the patient (100) such that the electrical stimulation signal (3) transmitted from the at least one electrode (5a, 5b) reaches the anterosuperior part of the mastoid process (101) of the patient (100).

Description

[0001]

[0002] “Device for the treatment of inner ear pathologies such as acatenous or hearing loss”

[0003] Technical sector of the invention

[0004] The device for the treatment of inner ear pathologies of the present invention is one that allows generating electrical stimuli suitable for treating auditory pathologies such as acatenous (tinnitus) or hearing loss.

[0005] Background of the invention

[0006] Hearing loss is classified as conductive or sensorineural. Conductive hearing loss tends to be mechanical in origin, as sound is not efficiently conducted from the outer ear to the middle ear. Discrimination is minimally affected, and most cases can be resolved with surgery or appropriate prescription amplification.

[0007] Sensorineural hearing loss, as a hearing disorder, tends to occur when there is damage to the inner ear, or to the nerve pathway that runs from the inner ear to the brain. This is the most common type of hearing loss and cannot be corrected medically or surgically. Most cases can be resolved with appropriate prescription amplification.

[0008] A patient's level of hearing loss can be measured in a known way using an audiogram. An audiogram is a graph that shows the results of pure-tone audiometry, automated audiometry, or computerized audiometry tests, usually at a standardized set of frequencies. It illustrates the type, degree, and configuration of the hearing loss.

[0009] Another sensorineural hearing disorder is tinnitus, which presents as a continuous tone perceived by a patient in one or both ears. To determine the frequency of tinnitus, a familiar method is to introduce a broadband noise and ask the patient to determine the moment at which their tinnitus becomes inaudible. Additional tinnitus tests include residual inhibition, which records the amount of time the noise in an individual's ears decreases or disappears after a period of masking.

[0010] There are well-known devices for treating sensorineural hearing disorders such as tinnitus using an electrical stimulation signal. However, in known devices, the electrical stimulation signal is aimed at generating an electric current that stimulates neurons and maintains a neuronal firing rate. It is necessary to maintain a frequency that allows neurons to recover from the stimulation. This means using low frequencies to maintain the neuronal firing rate.

[0011] It is also important where the electrical stimulation signal is applied to a patient, being necessary to apply said electrical stimulation signal at points adjacent to nerves, being the placement of the devices that apply the electrical stimulation signal important to achieve satisfactory results.

[0012] There are known devices in which the electrical stimulation signal is applied to the tongue. These devices are equipped with a peripheral device that the patient must insert into the mouth so that it comes into contact with the tongue to achieve a therapeutic effect. Patent document EP2842530 presents one such device. However, using these devices is uncomfortable for the patient.

[0013] It is therefore an objective of the present invention to provide a device for the treatment of hearing pathologies that is simple, easy for the patient to use and effective.

[0014] Explanation of the invention

[0015] The device of the present invention for the treatment of inner ear pathologies such as neurosensory pathologies of the inner ear such as tinnitus or hearing loss in a patient is one that comprises at least one electrode adapted to transmit an electrical stimulation signal to the patient.

[0016] Essentially, the device is characterized in that the at least one electrode is mounted on a support configured so that when placed on the patient, the at least one electrode is arranged on the anterosuperior part of the patient's mastoid process, behind the insertion line of the auricle, on the skin, such that the electrical stimulation signal transmitted from the at least one electrode reaches the anterosuperior part of the patient's mastoid process. Naturally, contact with the hair should be minimized, such that the electrode(s) are arranged on the skin in the continuation of the imaginary horizontal line that passes through the external auditory canal.Since this part of the mastoid process on which the electrode(s) will be placed is located behind the auricle, it is important that the device allows the electrode(s) to be placed on the skin behind the auricle and on the anterior end of the mastoid process, which is located next to the external auditory canal. The electrode(s) will thus be positioned away from the muscular insertion of the sternocleidomastoid muscle. The device is expected to have two electrodes to conduct the electrical stimulation signal between them, although only one of the electrodes needs to be placed on the anterosuperior part of the mastoid process; the other electrode can be placed at another point on the head.However, when the two electrodes are mounted on the support and positioned over the anterior-superior aspect of the mastoid process, the energy of the electrical stimulation signal is concentrated on the anterior-superior aspect of the mastoid process, achieving a better effect. Naturally, the electrical stimulation signal, which will be alternating and without a continuous component, will be conducted through the patient's skin between the electrodes, diffusing the electrical stimulation signal through the skin to the indicated part of the mastoid process.

[0017] In an embodiment variant, the electrical stimulation signal has a main frequency component greater than 200 kHz and less than 600 kHz, preferably greater than 300 kHz, the main frequency of the electrical stimulation signal being within the intermediate frequency band according to the ITLI-R V.431-8 recommendation of August 2015, for example within the lower 10% of this intermediate frequency band, between 300 and 600 kHz. Advantageously, by means of the device object of the present invention, the electrical stimulation signal is applied by means of the electrodes, carrying out stimulation on the anterosuperior part of the patient's mastoid process, target, which has a spongy constitution with multiple cavities and is adjacent to the external auditory canal, producing a localized diathermic effect that achieves the therapeutic effect of improving inner ear pathologies.A main frequency component may be a frequency peak or lobe that includes that main frequency, with a certain bandwidth, or a frequency band that includes the main frequency. This main frequency component may also be the fundamental frequency of a periodic signal, such as, for example, a square, triangular or sinusoidal signal. It is envisaged that a main frequency component is preferably greater than one of the following frequencies: 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 310, 320, 330, 340, 350, 360, 370, 380, 390, 400, 410, 420, 430, 440 or 450 kHz; and is preferably less than one of the following frequencies: 600, 590, 580, 570, 560, 550 or 540 kHz.Naturally, other electrical stimulation signals having sufficient power within this frequency band, for example, greater than 5 W, or greater than 6 W, or greater than 7 W, such as 7.5 W, may be considered to have a main frequency component in this band and can be used for the therapeutic effect, for example, when applied by the device of the present invention. Naturally, it is advisable that the power of the electrical stimulation signal be concentrated within the frequency bands that produce the therapeutic effect, in order to optimize the concentration and use of the signal power.

[0018] In one embodiment, the electrical stimulation signal has a main frequency component between 450 and 540 kHz, within the intermediate frequency band. Specifically, the electrical stimulation signal may have a main frequency component of 495 kHz, which, although ideally it will have the narrowest possible bandwidth, is contemplated to have a bandwidth of up to 90 kHz, thus covering the frequencies between 450 and 540 kHz, where an optimal diathermic effect is achieved to improve inner ear pathologies. Thus, a main frequency component will preferably be greater than 450, 460, 470, 480 or 490 kHz, and will preferably be less than 540, 530, 520, 510 or 500 kHz. The electrical stimulation signal is expected to have a voltage of 5 V and a current of 1.5 A, and may even be generated by a portable battery that could be incorporated into the device.

[0019] In one embodiment, in the direction of shortest distance between the first electrode and the second electrode, the distance between the first electrode and the second electrode is shorter than the distance between the ends of the first electrode and the distance between the ends of the second electrode, thus ensuring that when applied to the patient's skin, the resistance presented by the skin between the first electrode and the second electrode is low and allows the passage of the electrical stimulation signal and its propagation towards the anterosuperior part of the mastoid process. Specifically, the separation distance is expected to be between 3 and 7 millimeters, typically 5 millimeters, with the distance between the ends of each electrode being between 10 and 15 millimeters, typically 14 millimeters, with the electrodes having a width of approximately 10 millimeters, these dimensions being suitable for the electrodes to be arranged on the anterosuperior part of the mastoid process.Naturally, if the holder only has one electrode, with the other electrode in the pair of electrodes placed on a different area of ​​the head, the distance between the electrodes could be up to 35 millimeters. However, it is planned to use different pairs of electrodes to treat each patient's inner ear.

[0020] In one embodiment, the first electrode and the second electrode are equal, avoiding imbalances and one electrode becoming hotter or worn out more than the other.

[0021] In one embodiment, the first and second electrodes are placed in a holder that allows for quick and easy placement of the electrodes on the patient's mastoid process, which can even be performed by the patient themselves without the assistance of a healthcare professional. The holder is expected to have different shapes suitable for the electrode(s) to be properly positioned when placed on the patient's head. Naturally, the holder is expected to have different shapes that easily allow for correct placement of the electrode(s) on the patient.These shapes may include, but are not limited to, a headphone shape, a hearing aid shape, a headphone, a hook-type headset, a glasses or glasses-arm shape, or a helmet or cap shape, so that when the support is placed on the patient, the electrode(s) that will transmit the electrical stimulation signal are correctly positioned on the upper anterior part of the mastoid process of the ear to be treated.

[0022] In one embodiment, the first electrode and the second electrode are arranged symmetrically in the support, thus achieving a homogeneous flow of the electrical stimulation signal.

[0023] In one embodiment, the first and second electrodes are curved, allowing them to adapt to the shape of the patient's head and even allowing them to sink slightly into the skin of the patient's head. Thus, it is also envisioned that the support is adapted to exert a certain force in the direction normal to the electrodes, improving their contact with the skin, for example when the support is shaped like a headphone. Naturally, it is envisioned that only one electrode can be curved and the other can be placed on other parts of the patient, although it is preferably contemplated that both be curved and located close together, on the anterosuperior part of the mastoid process.

[0024] In one embodiment, the first electrode and the second electrode are parallel to each other, thus ensuring that the electrical stimulation signal flows homogeneously.

[0025] In one embodiment, the support is adapted to be placed on the patient's head, the support being configured such that when the support is placed on the patient's head, the patient's mastoid process is disposed adjacent to the first electrode and the second electrode.

[0026] In one embodiment, the support comprises an earmuff adapted to be placed over the patient's auricle. Naturally, it is envisaged that the support may have two earmuffs, each earmuff being provided with a first electrode and a second electrode, each pair of electrodes being adapted to be arranged adjacent, respectively, to each of the two mastoid processes on each side of the patient's head. It may even be possible to use the same generation means and the same electrical stimulation signal, which may be part of the same device or be arranged remotely, for example on a console connected to the device, for example by a cable.

[0027] In an embodiment variant, the first electrode and the second electrode are arranged on the periphery of the earmuff, thus facilitating the first electrode and the second electrode to be properly arranged when putting on the earmuff and the patient being able to clearly see the first electrode and the second electrode.

[0028] In one embodiment, the support comprises an earmuff whose section, for example its horizontal section, determines a projecting arc, i.e., it is C-shaped, forming an arc greater than 180 degrees that defines an interior enclosure in which to accommodate, and trap, the auricle. Therefore, the earmuff is adapted to be placed covering and rolling the auricle of the patient, with at least one electrode arranged at one end of the earmuff, such that the electrode is arranged behind the patient's auricle, on the anterosuperior part of the mastoid process when the patient puts on the earmuff, which may be mounted on headphones.

[0029] In one embodiment, the support is also provided with sound-emitting means, such as a speaker, which complement the therapeutic effect of the electrical stimulation signal on the mastoid process. In one embodiment, the sound-emitting means are adapted to emit sound with a frequency band eliminated, the eliminated frequency band being the frequency band of the patient's tinnitus.

[0030] In one embodiment, the device comprises processing means adapted to remove a frequency band from an audio signal, such that the removal of the frequency band can be programmed, for example in a processor, by means of signal processing techniques.

[0031] In one embodiment, the support is a headset that allows the electrode(s) to be properly positioned on the target part of the patient's mastoid process.

[0032] Thus, a therapeutic method for treating inner ear pathologies, for example neurosensory inner ear pathologies such as tinnitus or hearing loss, can be carried out by using, for example, a device of the present invention. Thus, ear pathologies can be treated by applying an electrical stimulation signal to the anterior-superior part of the mastoid process, by means of electrodes, for example a stimulation signal as described above, for example with a main frequency component greater than 200 and less than 600 kHz, more specifically an intermediate frequency in this range, more specifically an electrical stimulation signal with a main frequency component between 450 and 540 kHz and more specifically an electrical stimulation signal with a main frequency component of 495 kHz.

[0033] Brief description of the drawings

[0034] To complement the description being made and in order to facilitate the understanding of the characteristics of the invention, a set of drawings is attached to this specification in which, for illustrative and non-limiting purposes, the following has been represented:

[0035] Fig. 1 shows a diagram of a device of the present invention; Figs. 2 shows an example of an electrical stimulation signal for a device of the present invention; Fig. 3 shows, in a patient's skull, the arrangement of the anterosuperior part of the mastoid process, the target for a device of the present invention. Fig. 4 shows an operating diagram of a device of the present invention in a patient. Fig. 5 shows a first electrode and a second electrode for a device of the present invention in a correlative fitting position. Figs. 6a and 6b show a first embodiment of a device according to the present invention placed on a patient's head; Figs. 7a and 7b show the device of Figs. 6a and 6b; Fig. 7c shows a detail of the section of the device of Figs. 7a and 7b; Figs.8a and 8b show a second embodiment of a device according to the present invention placed on a patient's head; and Fig. 9 shows a third embodiment of a device according to the present invention placed on a patient's head.

[0036] Detailed description of the drawings

[0037] Using the device 1 according to the invention, a pilot clinical study has been carried out to evaluate the effect of applying high frequencies on the mastoid process 101 of adult patients with tinnitus, and also sensorineural hearing loss.

[0038] The device 1 used comprises, in addition to means of generating 2 an electrical stimulation signal 3 and electrodes 5a, 5b to apply the electrical stimulation signal 3 to the patient 100. To facilitate the correct placement of the electrodes 5a, 5b on the mastoid process 101 of the patient 100, the target area, the electrodes 5a, 5b are configured so that, when arranged on the head 102 of the patient 100, they are correctly positioned to be able to apply the electrical stimulation signal 3 to the anterosuperior part of the mastoid process 101 of the patient 100.

[0039] In one embodiment, the electrical stimulation signal 3 is high frequency, with a main frequency component greater than 200 kHz and less than 600 kHz. This frequency range is not recommended in the state of the art for the treatment of hearing disorders, as it is higher than the neuronal activation rate. Known devices act directly on the nerves, stimulating them to treat hearing disorders such as tinnitus.

[0040] However, applying a frequency higher than 200 kHz and lower than 600 kHz to the mastoid process 101 , applying an electrical stimulation signal 3 of 5 V and 1 .5 A, has been seen to have a surprisingly localized diathermic effect that has allowed, after the study, not only to obtain an improvement in the tinnitus previously diagnosed in patients, but also an improvement in neurosensory hearing loss. Naturally, it is expected that other similar voltages and amperages will have the same effect.

[0041] The study inclusion criteria were patients aged 18–70 years, without chronic disabling diseases, without pharmacological treatment, with indifferent hearing loss, without dizziness or instability. With tinnitus of more than 6 months' duration, non-pulsating, gradual onset, not associated with traumatic events, with a tinnitus loudness scale (1–100) between 40 and 60, with a tinnitus handiwork inventory (THI) between 25 and 65. An experimental group was established, experimental treatment, and a placebo group, randomly assigned to one or the other group.

[0042] During the study, a screening phase was initially conducted, with a maximum duration of three months required for recruitment of study participants. Patients who have already been treated at USD Audiology and have undergone audiological and audiometric examinations within the last six months are expected to be enrolled.

[0043] The treatment provided in the study lasted a total of 6 consecutive weeks, with two weekly sessions lasting approximately 40 minutes each, using device 1 for approximately 15-20 minutes per ear, with sessions spaced at least two days apart and at most four days apart. Treatment ended at the end of the sixth week. Subsequently, two follow-up evaluations were planned, one at 12 weeks and one at six months after the start of the study.

[0044] The study results showed a significant improvement in both THI (>10 points) and minimal masking level (>5 dB) at the end of treatment in the experimental group compared to the placebo group. Furthermore, although the study was initially designed to specifically investigate tinnitus, the study found a large number of patients who showed an improvement in PTA of more than 10 dB HL in the treated ear at the end of treatment and at three months following treatment.

[0045] According to the study, these results may be related to a localized diathermy effect on inner ear metabolism and homeostasis, so they are expected to be applicable to other inner ear pathologies, for example, for the treatment of patients with Ménière's disease.

[0046] This study was conducted using a device 1 according to the present invention, some embodiments of which are described below. Naturally, it is anticipated that other embodiments of device 1, the embodiments of which are not described, would also achieve the desired therapeutic effect.

[0047] Fig. 1 shows a diagram of a device 1 for treating neurosensory pathologies of the inner ear such as tinnitus or hearing loss in a patient 100. As can be seen, the device 1 shown comprises means 2 for generating an electrical stimulation signal 3 and electrodes 5a, 5b of the electrical stimulation signal 3 to the patient 100, specifically, the electrodes 5a, 5b are configured to apply the electrical stimulation signal 3 to the anterosuperior part of the mastoid process 101 of the patient 100. The device 1 comprises a first electrode 5a and a second electrode 5b. The placement of the at least one electrode 5a, 5b on the patient 100 is important for the invention, as will be detailed later.Naturally, the generation means 2 can be arranged outside the device 1, for example in a console, peripheral or control, and transfer the electrical stimulation signal 3 for example by means of a cable directly to the electrodes 5a, 5b of the device 1.

[0048] In the diagram presented, the device 1 is also provided with sound emission means 9 adapted to emit sound with a frequency band eliminated, presenting processing means 11 adapted to eliminate a frequency band from an audio signal 12. These sound emission means 9 are optional and their incorporation has been seen to further improve the therapeutic effect of the applied electrical stimulation signal 3. Naturally, the processing means 11 can also be arranged outside the device 1 , for example in a console, peripheral or control, and transfer the audio signal 12 for example by means of a cable directly to the sound emission means 9 of the device 1.It is envisaged that a single cable can be used for one or more of powering the device 1, transferring the electrical stimulation signal 3 and transferring the audio signal 12, optionally already processed, and sending other data, such as start or stop commands or transferring records of the status of the device 1.

[0049] Fig. 2 shows an electrical stimulation signal 3 suitable for use in the device 1 of the present invention and used in the study. It is observed that Fig. 2 shows the frequency spectrum of an electrical stimulation signal 3 suitable for use in a device 1 of the present invention, specifically its power spectrum or power spectral density, where it is observed that the electrical stimulation signal 3 has a main frequency component greater than 200 and less than 600 kHz, specifically the main frequency is between 450 kHz and 540 kHz with its peak around 495 kHz. It is possible that the signal additionally has other main frequency components, for example, frequency peaks in other ranges. It is observed that in the electrical stimulation signal 3 represented.It is observed in the electrical stimulation signal 3 represented that outside this main frequency bandwidth, the other frequency components of the signal will be sufficiently attenuated, being considered noise. Thus, it is expected that the electrical stimulation signal 3 could be an essentially sinusoidal signal with a fundamental frequency around 495 kHz, although other forms of electrical stimulation signal 3 whose main or fundamental frequency is the same are also contemplated, for example a square or sawtooth signal, which will have other frequency components, but will maintain the fundamental frequency within the range indicated above. It is observed that the electrical stimulation signal 3 is represented in dBm, so the scale is logarithmic, the power of the peak at 495 kHz being much greater, which would be slightly below 40 dBm, while the power of the remaining frequencies would be much lower.It is observed that since in this case the electrical stimulation signal 3 is a 5 V and 1.5 A signal, its power would be 7.5 W, corresponding to 38.75 dBm which would be approximately the peak value at 495 kHz, so mainly all the signal power would be found around this frequency, specifically the power would be concentrated at that peak frequency and possibly within a bandwidth of up to about 90 kHz, between 450kHz and 540kHz, where the power drops by 30 dBm. Outside of this bandwidth, in signal 3 represented, the signal power is very low, comparable to noise.It is not ruled out that another type of electrical stimulation signal 3 could be used, with other frequencies, to obtain the therapeutic effect when applied to the anterosuperior part of the mastoid process 101, specifically other signals with main frequencies within the intermediate band, or frequencies close to this band, such as between 200 kHz and 600 kHz, not ruling out that effects could even be produced with lower frequencies and that, for example, are higher than 100 kHz.

[0050] Fig. 3 shows the anterosuperior part of the mastoid process 101 of a patient 100 on which the at least one electrode 5a, 5b of a device 1 of the present invention must be placed, this anterosuperior part will be the target part on which the electrical stimulation signal 3 must fall when circulating between the two electrodes 5a, 5b, so that the electrical stimulation signal 3 transmitted from the at least one electrode 5a, 5b reaches the anterosuperior part of the mastoid process 101 of the patient 100. That the electrical stimulation signal 3 transmitted from the at least one electrode 5a, 5b reaches the anterosuperior part of the mastoid process 101 of the patient 100 is achieved when at least one electrode 5a, 5b is arranged on the anterosuperior part of the mastoid process 101.Figure 3 shows the auricle 103 of patient 100, noting that the anterosuperior part of the mastoid process 101 is covered by the auricle 103, so the device 1 must be configured to access the posterior part of the auricle 103 to arrange the electrode(s) 5a, 5b on the anterosuperior part of the target mastoid process 101, so that the passage of the electrical stimulation signal 3 stimulates this target area. This target area is the middle part of the mastoid behind the line of insertion of the auricle 103 on the skin, which can be considered the anterior upper quadrant of the mastoid process 101, in the area adjacent to the external auditory canal 105, typically in the continuation of the imaginary horizontal line 104 that passes through the external auditory canal.Thus, when at least one electrode 5a, 5b is placed on the patient 100, it is arranged on the anterosuperior part of the mastoid process 101 of the patient.

[0051] 100 so that the electrical stimulation signal 3 transmitted from the at least one electrode 5a, 5b reaches the anterosuperior part of the mastoid process

[0052] 101 of patient 100, stimulating it to obtain a therapeutic effect.

[0053] Fig. 4 shows a diagram of the electrodes 5a, 5b for transmitting the electrical stimulation signal 3 of the device 1 when they are applied to a patient 100. It can be seen that the electrodes 5a, 5b comprise a first electrode 5a and a second electrode 5b that are arranged on the head.

[0054] 102 of the patient 100. The electrodes 5a, 5b are mounted on a support 6 that facilitates the application of the electrodes 5a, 5b on the anterosuperior part of the mastoid process 101 which is where the electrical stimulation signal 3 is to be applied. As can be seen, the electrical stimulation signal 3 is conducted through the patient 100 between the electrodes 5a, 5b, the electrical stimulation signal 3 propagating, covering the mastoid process 101 of the patient 100. It is anticipated that, depending on the resistivity that the patient 100 presents between the electrodes 5a, 5b, the electrical stimulation signal 3 may also be radiated, for example in part, since the connection between the electrodes 5a, 5b through the patient 100 can be modeled as a resistor and a capacitor in parallel. Fig. 5 presents an example of electrodes 5a, 5b for a device 1 of the present invention.It is observed that the electrodes 5a, 5b are arched, to facilitate contact with the skin of the patient 100. It is also observed that in the direction of shortest distance between the first electrode 5a and the second electrode 5b, the separation distance d1 between the first electrode 5a and the second electrode 5b is less than the distance between ends d2 of the first electrode 5a and the distance between ends d2 of the second electrode 5b. In this case the distance between ends d2 of each electrode 5a, 5b is the same because the electrodes 5a, 5b are equal and parallel to each other. It is observed that in this case the electrodes 5a, 5b, which will be metallic, are attached to a dielectric base 15 that will be installed in the support 6 of the device 1, so that the electrodes 5a, 5b are arranged in the support 6.

[0055] Figs. 6a and 6b show a first embodiment of the device 1 according to the invention, comprising a first electrode 5a and a second electrode 5b. It is noted that the first electrode 5a and the second electrode 5b are equal and parallel to each other, and that in the direction of shortest distance between the first electrode 5a and the second electrode 5b, the distance between the first electrode 5a and the second electrode 5b is smaller than the distance between ends of the first electrode 5a and the distance between ends of the second electrode 5b and are arranged in an earmuff 10 provided with a pad 8.

[0056] The first electrode 5a and the second electrode 5b are placed on a support 6 which in this case has the form of headphones 7, also known as headphone or headband headphones, which facilitate the placement of the device 1 on the head 102 of a patient 100, such that the electrodes 5a, 5b are configured arranged to apply the electrical stimulation signal 3 on the anterosuperior part of the mastoid process 101 of the patient 100, that is, they are properly placed on the skin of the head 102 of the patient 100, behind the auricle 103. The electrodes 5a, 5b will apply during the treatment of the inner ear pathology an electrical stimulation signal 3 as previously described, with a main frequency component greater than 200 kHz and less than 600 kHz, preferably a signal with a main frequency within the intermediate frequency band.

[0057] It is envisaged that the device 1 is provided with a timer to limit the time in which the electrical stimulation signal 3 can be applied, preferably allowing use of about 15 or 20 minutes for each ear, and not allowing the electrical stimulation signal 3 to be applied again in an ear until at least 24 hours have passed.

[0058] It is noted that the support 6 comprises an ear flap 10 adapted to be placed over and around the auricle 103 of the patient 100 with a pad 8 for a more comfortable fit. The first electrode 5a and the second electrode 5b are arranged on the periphery of the ear flap 10, which allows the electrodes 5a, 5b to be easily positioned behind the auricle 103, on the anterosuperior part of the mastoid process 101 of the patient 100. Since the device 1 has two ear flaps 10, it is possible to arrange pairs of electrodes 5a, 5b on each of the ear flaps 10. Naturally, treatment of inner ear pathologies will be carried out only on the affected ear, for example, due to tinnitus or hearing loss.This treatment will be carried out by applying the electrical stimulation signal 3 through the electrodes 5a, 5b and optionally for the treatment of tinnitus by emitting sound through the sound emission means 9 with an eliminated frequency band, the eliminated frequency band being the one corresponding to the frequency of the patient's tinnitus 100 in that ear which will have been previously determined by known techniques.

[0059] In this case, since the support 6 is a headphone 7, sound emission means 9 incorporated within the earmuffs 10 can also be used to emit sound to complement the treatment of inner ear pathologies as described above. Naturally, it is envisaged that the headphones 7 are provided with an adjustable headband 13 that joins the two earmuffs 10 above the head 102 of the patient 100, so that the patient 100 can adjust the device 1 so that it is correctly positioned surrounding and embracing the auricles 103, with the electrodes 5a, 5b thus automatically being properly positioned on each of the mastoid processes 101, exerting a certain pressure on the head 102 to ensure contact of the electrodes 5a, 5b.Naturally, the earmuffs 10 may be devoid of a headband 13, for example by fitting into the patient's earlobe 03, or provided with other fastening means that allow for their correct positioning.

[0060] Figs. 7a and 7b show more detailed views of this first embodiment of the device 1 in the form of a head headset 7 in which the support 6 comprises an earmuff 10 adapted to be placed over the auricle 103 of the patient 100, the first electrode 5a and the second electrode 5b being arranged symmetrically, arcuately around the periphery of the earmuff 10, and parallel to each other. It is further noted that in order for the device 1 to be self-supporting, the power supply means, such as batteries, are arranged inside the earmuffs 10, the earmuffs 10 being provided with a charging port 14, for example a USB port suitable for connecting a power cable and sending data. It is also envisaged that the device 1 can be directly connected to a power supply, in this case being provided with a power cable.When the device 1 is self-supporting, it allows greater freedom of movement for the patient 100 during use, but it is also envisaged that it may be connected to a power source, for example by means of a cable. It is envisaged that the cable may directly connect the electrodes 5a, 5b to means 2 for generating the electrical stimulation signal 3 arranged separately, for example arranged in a control console connected to the headphones 7. In this case, the device 1 would be formed by the headphones and the control console. This same console may also provide the duly processed sound directly to the sound emission means 9.It is also envisaged that when the device 1 is self-supporting and the sound emission means 9 are used, it is provided with means for receiving a wireless radio signal that allows receiving from remote transmitters a wireless radio signal that will be converted into the audio signal 12 to be transmitted by the sound emission means 9. These means for receiving a wireless radio signal may be a Bluetooth sound receiver or even a frequency modulated radio receiver. In this case, it is envisaged that the audio signal 12 may be sent already processed, for example with the frequency band eliminated, or it may be processed after its reception. It is also envisaged that when the device 1 is self-supporting and contained, the means for processing 11 of the audio signal 12 generate a predetermined audio signal 12, for example a white noise signal with a frequency band eliminated.Device 1 is expected to have control means that allow the frequency to be eliminated to be indicated.

[0061] Fig. 7c shows the section C that can be seen in Fig. 7b to illustrate that the support 6 comprises an earmuff 10 with a section C that determines an exceeded arch, that is, it is C-shaped, forming an arc greater than 180 degrees to thus form an interior enclosure 16, for example 5 cm by 7 cm, with a rim of at least 1 cm of overhang, where to house, trapping, the auricle 103. Therefore, the earmuff 10 is adapted to be placed covering and rolling the auricle 103, with, in this case, the first electrode 5a arranged at one end of the earmuff 10, so that the first electrode 5a, which is mounted on the base 15 is arranged behind the auricle 103 of the patient 100, on the anterosuperior part of the mastoid process 101. At the end of the earmuff 10 there is also includes a flexible pad 8 to facilitate housing the auricle 103 in the inner enclosure 16.Thus, when the patient puts on the earmuff 10, which may be mounted on headphones 7, the electrodes 5a, 5b will be properly positioned for treatment without the need for medical personnel to intervene, so that the patient 100 can perform the treatment themselves, for example at home. Naturally, the earmuff 10 could have a single electrode 5a, 5b, with the other electrode placed on another area of ​​the patient's body 100, although for a more effective treatment, it is recommended that both electrodes 5a, 5b be placed on the anterosuperior part of the mastoid process 101, minimizing contact with the hair. It is also noted that the earmuff 10 also has sound emission means 9, a speaker, which can be used to complement the treatment.

[0062] Figs. 8a and 8b show a second embodiment of the device 1 according to the invention, in which the electrodes 5a, 5b are mounted on a support 6 in the form of a spectacle frame, the electrode(s) 5a, 5b being mounted on the curved terminal of the temple, so that they are arranged behind the auricle 103 and on the anterosuperior part of the mastoid process 101.

[0063] Fig. 9 shows a third embodiment of the device 1 according to the invention, in which the electrodes 5a, 5b are mounted on a support 6 in the form of a helmet or cap, the helmet or cap being adapted to be arranged behind the auricle 103, the part of the helmet or cap being adapted to be arranged behind the auricle 103 provided with one or more electrodes 5a, 5b, so that they are arranged behind the auricle 103 and on the anterosuperior part of the mastoid process 101.

Claims

23 MODIFIED CLAIMS received by the International Bureau on 22 January 2025 (22.01.2025) 1. Device (1) for the treatment of inner ear pathologies such as tinnitus or hearing loss in a patient (100) comprising at least one electrode (5a, 5b) adapted to transmit an electrical stimulation signal (3) to the patient (100), wherein the at least one electrode (5a, 5b) is mounted on a support (6) configured so that when placed on the patient (100) the at least one electrode (5a, 5b) is arranged on the anterosuperior part of the mastoid process (101) of the patient (100) so that the electrical stimulation signal (3) transmitted from the at least one electrode (5a, 5b) reaches the anterosuperior part of the mastoid process (101) of the patient (100), characterized in that the electrical stimulation signal (3) has a main frequency component greater than 200 kHz and less than 600 kHz.

2. Device (1) according to the preceding claim, characterized in that the electrical stimulation signal (3) has a main frequency component between 450 kHz and 540 kHz.

3. Device (1) according to the preceding claim, characterized in that the electrical stimulation signal (3) has a main frequency component of 495 kHz.

4. Device (1) according to any one of the preceding claims, characterized in that it comprises a first electrode (5a) and a second electrode (5b) mounted on the support (6) configured so that when placed on the patient (100) the electrodes (5a, 5b) are arranged on the anterosuperior part of the mastoid process (101) of the patient (100).

5. Device (1) according to the preceding claim, characterized in that, in the direction of shortest distance between the first electrode (5a) and the second electrode (5b), the separation distance (d1) between the first electrode (5a) and the second electrode (5b) is smaller than the distance between ends (d2) of the first electrode (5a) and the distance between ends (d2) of the second electrode (5b). MODIFIED SHEET (ARTICLE 19) 6. Device (1) according to any one of claims 4 to 5, characterized in that the first electrode (5a) and the second electrode (5b) are equal.

7. Device (1) according to any one of claims 4 to 6, characterized in that the first electrode (5a) and the second electrode (5b) are arranged symmetrically in the support (6).

8. Device (1) according to any one of claims 4 to 7, characterized in that the first electrode (5a) and the second electrode (5b) are arcuate.

9. Device (1) according to any one of claims 4 to 8, characterized in that the first electrode (5a) and the second electrode (5b) are parallel to each other.

10. Device (1) according to any one of the preceding claims, characterized in that the support (6) comprises an earmuff (10) whose section (C) determines an exceeded arc, the earmuff (10) being adapted to be placed covering and rolling the auricle (103) of the patient (100), the at least one electrode (5a, 5b) being arranged at one end of the earmuff (10).

11. Device (1) according to any one of the preceding claims, characterized in that it is also provided with sound emission means (9).

12. Device (1) according to the preceding claim, characterized in that the sound emission means (9) are adapted to emit sound with an eliminated frequency band.

13. Device (1) according to the preceding claim, characterized in that it comprises processing means (11) adapted to eliminate a frequency band from an audio signal (12). MODIFIED SHEET (ARTICLE 19) 14. Device (1) according to any one of the preceding claims, characterized in that the support (6) is a headset (7). MODIFIED SHEET (ARTICLE 19) In the International Search Report of the present PCT7 patent application ES2024 / 070459, documents US 2017 / 353807 (D1) and US 2020 / 038658 (D2) are considered particularly relevant to the originally filed claims 1 and 5-15 with category (X) and / or (Y). Claim 2 is considered to be new and inventive in view of documents D1 and D2. For this reason, the wording of original claim 1 is modified by incorporating the technical characteristics of original claim 2, whereby the modified claim 1 is considered new and inventive in view of documents D1 and D2, as well as their dependent claims. DECLARATION ACCORDING TO ARTICLE 19 (1)

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