RU2782510C2 - Electromechanical stimulation system for treatment of tinnitus symptoms - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: claimed invention relates to medical equipment; it is intended for the treatment of tinnitus symptoms. An electromechanical stimulation system contains a proximal unit made with the possibility of being placed near the ear of a user, and an input interface made with the possibility of operation under control of the user. The proximal unit contains an electromechanical device made with the possibility of transmission of mechanical oscillations with a preset frequency, intensity, and waveshape to tissues located near the ear of the user; a control unit made with the possibility of actuation of the electromechanical device in such a way that the frequency, intensity, and waveshape of mechanical oscillations can be changed; a transceiving element intended for reception of control signals for the control unit. The input interface contains a transmitting element and a microcontroller made with the possibility of emission of control signals for generation of mechanical oscillations of the electromechanical device at the first frequency from 20 Hz to 20 kHz and inducement of repetition of oscillations for the entire set of frequencies in this range.

EFFECT: simplification of system setting in the absence of invasive intervention.

13 cl, 15 dwg

Description

FIELD OF TECHNOLOGY

[0001] The present invention relates to the field of medicine and, more specifically, it relates to an electromechanical stimulation system for treating a patient suffering from symptoms of tinnitus or phantom noise.

[0002] More specifically, the invention relates to a device for providing such treatment in a non-invasive manner.

BACKGROUND OF THE INVENTION

[0003] Phantom noise, or tinnitus, is a hearing impairment that can interfere with the correct perception of sounds and, in particular, spoken language. In fact, tinnitus is the sensation of noises having different frequencies and intensities that are not associated with any acoustic signal coming from the environment. These noises can be heard in one ear, in both ears, or more generally as noises from inside the head.

[0004] In particular, tinnitus can be heard as a single frequency noise such as whistling, ringing or the like, in which case it is called tonal tinnitus, or it can be heard as a broadband noise such as whistling, buzzing, whispering and the like, in this case it is called non-tonal tinnitus. The symptoms of tinnitus are quite frequent, can vary in intensity and can even interfere with the patient's daily activities and his/her sleep, and even cause serious cognitive and behavioral illnesses that can seriously affect the patient's quality of life.

[0005] Tinnitus is typically treated with audio devices that are configured to provide the user with tone-based therapeutic therapies, the effect of which is to mask a certain frequency of tinnitus symptoms.

[0006] An example of this type of device is disclosed in US Pat.

[0007] A surgically implantable device is also known, as described in US Pat. No. 6,077,215, in which the innermost part of the ear is stimulated by an electromechanical transducer implanted in the mastoid process. These devices are invasive, cause side effects and, in any case, have never been effective (Dobie RA. "A review of randomized clinical trials in tinnitus." Laryngoscopy 1999, 109, 1202.1211).

[0008] US Pat. No. 5,788,656 describes yet another example of a stimulation system comprising an electromagnetically controlled electromechanical device to be positioned adjacent to the cochlea in the inner ear. This electromechanical device can stimulate the cochlea in the tinnitus frequency range. In this case, several generators operating at low and high frequency, respectively, within a set range of 400 Hz to 1000 Hz provide a stimulating control signal. Through this system, the user can customize the therapeutic treatment according to his/her own needs by adjusting the vibration frequency of the operating device.

[0009] This therapeutic system is also invasive and does not allow for stimulation therapy that is effective in reducing or suppressing symptoms in the medium term.

[0010] US 2008/0064993 A1 describes the use of a device containing an electromechanical transducer that, when placed in oral bone such as dentary or palatal bone, provides mechanical vibrations with a frequency and amplitude that can be adjusted. Specifically, this device utilizes the sound conduction of bone and can generate an acoustic signal that masks the perception of tinnitus symptoms by superimposing mechanical vibrations that suppress tinnitus symptoms, or by adding pleasant mechanical vibrations that divert the user's attention from the tinnitus symptoms. However, US Pat. No. 2008/0064993 A1 does not teach how to determine frequencies suitable for suppressing tinnitus symptoms, but uses only tables of values obtained from studies conducted on a sample of patients or performed specific audiological tests for each user.

[0011] US Pat. No. 6,210,321 B1 describes yet another example of a system for reducing the symptoms of tinnitus, comprising a semi-rigid membrane to be placed outside the ear on the mastoid, in close proximity to the cochlea. The membrane is made with the possibility of excitation by means of electrical stimulation and transmission of mechanical vibrations to the cochlea. In this case, the user can receive individual therapy by adjusting the parameters of the frequency and intensity of stimulation. However, this setup is complicated and inconvenient for the user.

[0012] Other devices for the treatment of tinnitus are described in US 2015/164381 A1, US 2013/163797 A1, EP 3184046 A1, US 2016/250440 A1.

SUMMARY OF THE INVENTION

[0013] Thus, it is a hallmark of the present invention to provide an electromechanical stimulation system for treating tinnitus symptoms that provides a non-invasive, highly customizable therapeutic treatment that focuses on the user's experience.

[0014] It is also a feature of the present invention to provide an electromechanical stimulation system for the treatment of tinnitus symptoms that can be easily adjusted by both the therapist and the user, thus requiring little or no assistance from the therapist during normal use of the system at home.

[0015] It is also a feature of the present invention to provide an electromechanical stimulation system for treating tinnitus symptoms that can be used without surgery.

[0016] Another feature of the present invention is to provide such a system that can be configured using devices normally available to the user.

[0017] These and other goals are achieved using [1] an electromechanical stimulation system for the treatment of tinnitus symptoms, comprising:

- a proximal block configured to be positioned near the user's ear, the proximal block comprising:

- an electromechanical device configured to transmit mechanical vibrations to the tissues near the user's ear or, in any case, to the user's skull, the mechanical vibrations having a predetermined frequency, intensity and waveform;

- an application device configured to keep the electromechanical device in contact with tissues corresponding to bony processes of the head selected from the temporal bone, in particular the mastoid process; occipital bone; frontal bone;

- a control unit configured to actuate the electromechanical device in such a way that the frequency, intensity and waveform of mechanical vibrations can be changed;

- a transceiver element configured to receive control signals for the control unit;

- an input interface configured to operate under user control, comprising:

- a transmitting element configured to transmit control signals to the transceiver element of the proximal unit;

- a microcontroller configured to emit the above control signals towards the above control unit to generate mechanical vibrations of the above electromechanical device in the first frequency range, set in the range from 20 Hz to 20 kHz, and with an intensity less than a predetermined intensity limit value, and cause repetition of the above mechanical vibrations for a plurality of frequencies in this range;

- an input device configured to:

- receiving from the user a command to start generating mechanical vibrations by means of the above electromechanical device at a plurality of different frequencies,

- waiting while mechanical vibrations are generated at the above different frequencies;

- receiving from the above user a frequency scan stop command to stop changing the mechanical vibration frequency at a stationary frequency corresponding to the current frequency of the generated mechanical vibration, so that the user can notify the microcontroller of the frequency value at which he/she feels a reduction in tinnitus symptoms;

- continuation of the generation of mechanical vibrations at the above stationary frequency.

[0018] Thus, the application device, which is configured to keep the electromechanical device in contact with the tissues corresponding to the bony processes of the head selected from the temporal bone, in particular the mastoid process, the occipital bone, the frontal bone, has the technical effect of causing the transmission of mechanical fluctuations in the form:

- auditory stimulation through bone conduction;

- vestibular stimulation through bone conduction;

- tactile skin stimulation;

- vibratory proprioceptive stimulation,

thus achieving multisensory stimulation. In fact, in addition to reaching the vestibular zone through bone conduction and reducing the symptoms of tinnitus, vibrations delivered to the skin in a suitable way also provide, in a broader sense, proprioceptive localization of the vibrostimulation transmission zone.

[0019] In addition, the system: tries to determine the possible frequencies of such multisensory stimulation, respectively, generates mechanical vibrations at all frequencies in the specified range from 20 Hz to 20 kHz, in particular, in the range from 125 Hz to 8000 Hz, and the above frequencies differ from each other, for example 1 Hz, waits for the command to stop scanning the frequency for mechanical vibrations, which occurs when the user feels a decrease or disappearance of tinnitus symptoms, and maintains the frequency of subsequent mechanical vibrations at a stationary frequency value. This solution makes it possible to individually find for each user different values of the stationary frequency, at which each user's symptoms of tinnitus disappear or decrease in intensity.

[0020] Compared with US Pat.

[0021] In the present invention, multisensory stimulations are used to alleviate/suppress the symptoms of tinnitus by delivering mechanical vibrations to areas of the skin located near the temporal bone and/or occipital bone and/or frontal bone at an intensity below a predetermined intensity threshold, which can be the patient's hearing threshold, or at an intensity slightly above the hearing threshold, as described below, to avoid distortion or amplification of hearing and to facilitate 24-hour use of the device, which would be inconvenient and difficult at higher intensities. Multisensory stimulations include auditory bone conduction stimulation, vestibular bone conduction stimulation, skin tactile stimulation, and vibratory proprioceptive stimulation.

[0022] The vibrations of an electromechanical device, such as a voice coil mechanism, have an intensity that is typically below or slightly above the threshold of hearing. However, vibrations are not generated at an intensity below the tactile threshold and therefore provide the user with a tactile sensation that induces proprioception, i.e. it informs the user about the area of the body where the electromechanical device is applied and where the vibrations are also transmitted to the skin. Conversely, the vibrations of prior art systems have an intensity well above the threshold of hearing because they are designed to cause the user to hear a sound that is opposite in phase to the symptoms of tinnitus, or that should cover the symptoms of tinnitus. For this reason, in such prior art systems, proprioception is shielded by emitted sound.

[0023] With respect to the present invention, the patient does not actually hear any sound coming from the electromechanical device, so proprioception plays the most important role. In other words, the patient tactilely perceives a slight vibration on his skin, localizes it (proprioception), and at the same time the vibrations are transmitted to the bones of the head, in close proximity to the area of the skin where the vibrations are transmitted, that is, propagated through bone conduction, and finally reaches the auditory apparatus (vestibular stimulation). It is believed that the combination of multisensory stimulation with a certain optimal frequency of tinnitus suppression, which is determined by the user, that is, the combination of the two main characteristics of the invention that distinguish it from the prior art, allows you to get a therapeutic effect of suppressing tinnitus symptoms.

[0024] In addition, due to the frequency of scanning performed during stimulation by bone conduction, in accordance with the present invention, it is not necessary to determine or know the characteristic features of tinnitus symptoms, in contrast to known methods of treatment. In fact, it is the patient who directly selects the stimulation suitable for suppressing the symptoms of tinnitus, even if the origin or parameters characterizing the symptoms of tinnitus are unknown.

[0025] First of all, the advantage of the device is that it has been noticed if the patient stops the vibrations after the first application of the vibrations for several hours, during which he/she receives mechanical vibrations at a constant frequency, which best alleviates the symptoms of tinnitus, symptoms tinnitus is further reduced during the first period of time without tinnitus murmurs, and therefore may turn off the fluctuations for the waiting time. When tinnitus symptoms reappear, the user should simply start the second waveform application at the stationary frequency, thus the waveform waiting time is preferably chosen to be the tinnitus noise-free time, with the second waveform application being maintained for the second waveform time period and terminated and turned off. until the tinnitus symptoms reappear, after a second tinnitus noise-free time longer than the first tinnitus-noise-free time, and so on. In fact, it has been observed that if the oscillation time and the waiting time with the device according to the present invention are cyclic, the tinnitus noise-free time always increases, which shows the therapeutic efficacy of the device.

[0026] In addition, the system is customizable and easy to use, because the electromechanical device can transmit mechanical vibrations at different frequencies to tissues near the user's ear, and the user can adjust these mechanical vibrations using the input interface.

[0027] In fact, the user can easily conduct therapy sessions in accordance with his/her needs using a personal mobile communication device equipped with a touch screen graphic display, for example, using a smartphone in which a mobile application is installed. Therefore, the user does not need any assistance from the therapist.

[0028] Alternatively, the input element may be a PC, smart watch, smart TV, or tablet. In this case, the user can follow the start and stop instructions via a keyboard, via a remote control device, or even via a touch screen device.

[0029] [13] Preferably, the application device comprises a support configured to be placed adjacent to the user's skull bone, in particular selected from the temporal bone, occipital bone, and frontal bone, where the skin layer is thinner, and outside of the ear, wherein the support has a housing for accommodating, in particular for accommodating a removable electromechanical device. Thus, the support provides contact of the electromechanical device with the skin, which allows the use of the above four types of stimulation.

[0030] [14] Specifically, the applicator comprises an adhesive backing comprising:

- adhesive area, made with the possibility of imposition next to the mentioned skull bone;

- a support part containing said housing for accommodating the electromechanical device.

[0031] Thus, since the electromechanical device is configured to be located in the bone region and outside the user's ear, the system does not require surgery to use. This eliminates the risks and side effects inherent in surgical interventions. In addition, since the electromechanical device is detachable, it is not necessary to wear the support all the time. The support can be attached to the patient, for example, with an adhesive that remains attached to the skin for several days, in particular for as long as required for therapy, or in any case for several days, sufficient for several replacements of the adhesive substrate. during the entire treatment, in addition, allowing not to wear the electromechanical device in the period of time between one therapy session and the next session.

[0031] [11] In particular, the electromechanical device is a small-sized voice coil actuator comprising an output shaft that freely moves in the axial direction, in which the mechanical force generated on the shaft is proportional to the strength of the current circulating in its own electrical coil, and, therefore, proportional to the intensity of the electrical influencing signal received by the control unit, per unit of time.

[0033] In this way, the frequency, intensity, and waveform of the mechanical vibrations that are transmitted to the tissues in the immediate vicinity of the user's ear via the output shaft can be changed, allowing the user to customize the therapy according to his/her needs.

[0034] The system in accordance with the present invention, and in particular the voice coil drive located on the temporal or occipital or anterior bone, allows for multisensory stimulation, in which vibrations are transmitted to the bone through the skin along two propagation trajectories, that is, the first path through the bone tissue surrounding the area where the drive is applied, and the second way through the fluids and soft tissues of the vestibular region. Accordingly, due to the impulses applied to the skin, the tactile sensation triggers the patient's proprioceptive system, which makes it possible to identify the area where the skin is being stimulated. It is believed that the association of multisensory stimulation with frequency scanning to determine the tinnitus symptom reduction value and transmission of vibrations at that frequency is the reason why the system of the present invention can treat tinnitus symptoms more effectively.

[0035] Alternatively, the electromechanical device may be a voice coil actuator comprising a membrane housing that can vibrate due to excitations caused by the strength of the current that circulates in the coil surrounding the housing.

[0036] [11] In yet another exemplary embodiment of the present invention, the electromechanical device may be a piezoelectric type actuator.

[0037] [2] Advantageously, the microcontroller is configured to perform the step of fine-tuning the mechanical vibration frequency upon receiving an instruction from the user to stop the frequency scan.

[0038] In particular, after experiencing a reduction in tinnitus symptoms at a given frequency, the user can interact with the input device by executing a command to stop scanning the frequency at the frequency at which he/she experienced a reduction in tinnitus symptoms, that is, at the above stationary frequency, and then, by accurately scanning frequencies in the region closest to the stationary frequency, thus adjusting the frequency more precisely than the stationary frequency, to further reduce or suppress noise without any external assistance and according to his/her own perception.

[0039] [3] Preferably, the microcontroller is configured to adjust the mechanical vibration intensity upon receiving an instruction to stop the frequency scan at the above stationary frequency.

[0040] Thus, adjusting the intensity of the signal can improve therapy by using the intensity value most appropriate for treating the symptoms of tinnitus.

[0041] [4] Preferably, the microcontroller is configured to adjust the mechanical vibration intensity at the end of the frequency fine tuning step.

[0042] Thus, after the first series of mechanical vibrations is delivered at frequencies within the first range, and then the second series of mechanical vibrations at frequencies in the second range, narrower than the first range, the user can perform a third signal intensity adjustment to generate mechanical vibrations of the electromechanical device, which can further reduce the perceived symptoms of tinnitus.

[0043] [5] Alternatively, the microcontroller may perform a mechanical vibration intensity fine tuning step after receiving the scan stop command and after adjusting the mechanical vibration intensity.

[0044] The advantage of this solution is to provide stimulation that is more focused on the needs of the patient. For example, a user who has obtained a satisfactory reduction in tinnitus symptoms with frequency adjustment or frequency fine tuning can perform the intensity fine tuning step after the scan stop command, making the stimulation system even more tailored to his/her needs.

[0045] [6] Advantageously, the microcontroller is configured to change the intensity of the mechanical vibrations when the user has not experienced any reduction in tinnitus symptoms at the end of the mechanical frequency adjustment step, i.e., after scanning all frequencies within a predetermined scanning/adjustment range. In particular, the stimulation used is weaker than the user's hearing threshold, or at an intensity level that cannot disturb the patient's hearing during his/her normal activities.

[0046] Thus, the user, having performed the frequency adjustment step, can decide to change the intensity of the stimulation signal and perform a new frequency adjustment step, causing the generation of mechanical vibrations with a new intensity.

[0047] [8] In particular, the microcontroller is configured to cause mechanical vibrations emitted by the electromechanical device with an intensity in the range of -20 dB HL (threshold) to 200 dB HL.

[0048] In particular, the value of the limiting intensity, below which the microcontroller is configured to change the intensity of mechanical vibrations, is equal to the user's audibility threshold, in other words, the microcontroller is configured to cause mechanical vibrations generated by the electromechanical device with an intensity lower than or equal to the audibility threshold.

[0049] In particular, the limit value of the intensity, below which the microcontroller is configured to change the intensity of mechanical vibrations, may be equal to the threshold of hearing of the user, increased by 10% in dB FS. In more detail, the microcontroller is configured to cause the electromechanical device to emit mechanical vibrations with an intensity of not more than 10% above the hearing threshold, during the acclimatization time after receiving the instruction to start generating mechanical vibrations, so that the user can perceive the generated vibrations as acoustic vibrations, and is also made with the possibility of reducing the intensity to a value below the threshold of hearing, after the acclimatization time.

[0050] [7] Advantageously, the electromechanical device is programmed to automatically transmit mechanical vibrations at predetermined time intervals.

[0051] Thus, individual stimulation therapy programs can be obtained, in which, for example, mechanical vibrations are delivered at predetermined frequencies for predetermined periods of time. For example, if after the time the device is turned off, the user realizes that the tinnitus symptoms have disappeared, the standby time of the device can be extended or shortened if, on the contrary, the tinnitus symptoms reappear before the standby time has elapsed.

[0052] [12] Advantageously, the microcontroller is configured to perform the mechanical vibration waveform adjustment step. This adjustment may be made when the user has not experienced any improvement during a frequency scan with a given oscillation waveform, and therefore may repeat the scan for a different waveform.

[0053] Thus, using the stimulation system in accordance with the present invention, the user can provide various options for mechanical stimulation in order to achieve a reduction in the symptoms of tinnitus.

BRIEF DESCRIPTION OF GRAPHICS

[0054] Additional characteristics and / or advantages of the present invention will be better understood from the following description, given as an example of a variant of its implementation, as well as examples of variants of its implementation, given by way of example, but not exhaustive, with reference to the accompanying drawings, on which:

- Fig. 1 schematically illustrates an example of an electromechanical stimulation system for treating tinnitus symptoms, in accordance with the present invention, comprising a proximal unit and an input interface that can communicate with each other to deliver mechanical vibrations to tissues in close proximity to the user's ear;

- Fig. 2 illustrates a block diagram, in accordance with the present invention, of virtual devices for controlling an input interface of a microcontroller interface and located in an input device;

- Fig. 2A, 2B, 2C illustrate examples of microcontroller interface screens, in accordance with the present invention, that are available on an input device;

- Fig. 3 illustrates an example block diagram of a microcontroller, in accordance with the present invention, for generating variable frequency mechanical vibrations over a predetermined range;

- Fig. 4 illustrates an exemplary block diagram of a microcontroller in accordance with the present invention, similar to FIG. 3, including the step of fine tuning the frequency of mechanical vibrations;

- Fig. 5 illustrates an exemplary block diagram of a microcontroller in accordance with the present invention, similar to FIG. 4, including the step of adjusting the intensity of mechanical vibrations;

- Fig. 6 illustrates an exemplary block diagram of a microcontroller in accordance with the present invention similar to FIG. 5 including the step of fine tuning the intensity;

- Fig. 7 illustrates an exemplary block diagram of a microcontroller in accordance with the present invention, including the step of adjusting the mechanical vibration waveform;

- Fig. 8 illustrates an exemplary block diagram of a microcontroller in accordance with the present invention, including the step of changing the intensity of mechanical vibrations if, at the end of the frequency adjusting step, the user does not notice any reduction in tinnitus symptoms;

- Fig. 9 illustrates a timing diagram of the operation of an electromechanical device in manual mode;

- Fig. 9A illustrates an exemplary block diagram for driving the circuit in FIG. 9;

- Fig. 10 illustrates a timing diagram of the operation of an electromechanical device in an automatic mode of operation;

- Fig. 10A illustrates an exemplary block diagram for driving the circuit in FIG. ten.

DETAILED DESCRIPTION OF THE INVENTION

[0055] FIG. 1 illustrates an exemplary embodiment of an electromechanical stimulation system for treating symptoms of tinnitus. The system includes a proximal unit 10 configured to be located next to the user's ear 1 and an input interface 50 configured to operate under the user's control for communicating with the proximal unit 10.

[0056] In the illustrated example, the proximal block 10 is located in a zone close to the mastoid process, but it can be located both on the mastoid processes and on the forehead of the user.

[0057] The proximal unit 10 includes an electromechanical device 30, its overlay device 32, a control unit 20, and a transceiver element 40 configured to receive control signals 45 for the control unit 20.

[0058] In particular, the control unit 20 is a hardware component configured to generate an stimulus signal 21 for the electromechanical device 30 responsive to control signals 45 transmitted by the transceiver element 40. The frequency f and intensity A of the stimulus signal 21 can be changed, and The signal can have different waveforms. This allows different parameters of frequency f, intensity A and different waveforms of mechanical vibrations 35 emitted by the electromechanical device 30 to be used for each patient.

[0059] For example, the control unit 20 may be a microcontroller containing a CPU (central processing unit), which may contain resident operating instructions for generating influencing signals 21, 45 to be transmitted to the electromechanical device 30 so that the control unit 20 can autonomously send actuating signals 21 to the electromechanical device 30. Alternatively, the control unit 20 may have a library of actuating signals 21 that differ from each other and can be generated by transmitting control signals 45 from the input interface 50. In particular, the control unit 20 may be implemented by the Arduino platform containing the microprocessor.

[0060] The electromechanical device may be a voice coil actuator 30 comprising an axial movable output shaft 31 in which the mechanical force generated by the shaft 31 is proportional to the strength of the current circulating in its electric coil and thus the intensity of the electrical stimulating signal. 21 provided by the control unit 20 per unit time. In accordance with an exemplary embodiment of the invention, which is not illustrated, the electromechanical device 30 may still be a voice coil actuator, which also contains a membrane, in addition to the shaft 31, while the specified membrane is free to vibrate in response to excitation caused by a current circulating in the actuator coil. In a further exemplary embodiment of the present invention that is not illustrated, the electromechanical device 30 may be a piezoelectric actuator.

[0061] The electromechanical device 30 is configured to deliver mechanical vibrations 35 to tissues near the user's ear 1 via a movable element, such as a shaft 31 or a voice coil actuator diaphragm, which delivers mechanical vibrations 35 to tissues 2 near the user's ear 1. The frequency f, the intensity A, and the waveform of the mechanical vibrations 35 can be adjusted so that the user can customize the therapy according to his/her needs.

[0062] The application device 32 is configured to keep the electromechanical device 30, in particular also the entire proximal block 10, in contact with external tissues, such as the skin 2 on the protruding bone 3 of the head, for example the temporal bone, in particular the mastoid process or mastoid process of apophysis 3, the occipital bone, or even the frontal bone, the latter not illustrated. In particular, the applicator 32 comprises a support adapted to the aforementioned protruding bone 3 and has a housing to accommodate the electromechanical device 30, preferably in a removable manner. The support may have an adhesive part for attaching to the skin 2 and a support part that can be removable with respect to the adhesive part containing the housing for receiving the electromechanical device 30. This application device is configured so that the force required to remove the electromechanical device 30 from the support area and/or the support part from the adhesive part is weaker than the force required to separate the adhesive part from the skin of the patient 2. This device will not be described in detail since it can be easily implemented by a person skilled in the art.

[0063] The input interface 50 includes a transmitter element 60, a microcontroller 70, and an input device 80.

The microcontroller 70 is configured to actuate the generation of mechanical vibrations 35 having a plurality of frequencies f set in a predetermined range by emitting an actuating signal 45. In more detail, the actuating signal 21, 45 is configured to cause the electromechanical device 30 to be actuated by the control unit 20 at a predetermined frequency f set in the range from 20 Hz to 20 kHz, in particular in such a narrower range, for example 125 Hz ÷ 8000 Hz. The microcontroller 70 may also cause a plurality of frequencies in this range to repeat as stimulus frequencies.

[0065] The input device 80 is configured to receive instructions from the user, in particular an instruction to start a mechanical vibration delivery step 200 (FIGS. 3-8), said instruction also triggering a step 121 of changing or adjusting the mechanical vibration frequency f 35, which is in changing this parameter starting from the preset value. The input device 80 is also configured to wait and receive from the user an instruction 300 to stop the frequency scan in the frequency adjustment step 121 when the user perceives a significant reduction or cessation of the tinnitus symptoms, and is also configured to continue generating oscillations 35 for a predetermined time while maintaining the same frequency at the value used when the frequency scan stop command is input when the mechanical vibration frequency f adjustment step 35 is terminated.

[0066] Other start/stop commands may be transmitted by input device 80, as will be explained in describing some exemplary system implementations with reference to FIG. 3-8.

[0067] The microcontroller 70 may be integrated with the input device 80 in one device. For example, input device 80 may be a smartphone, tablet, PC, smart TV, or smart watch. In these cases, the microcontroller 70 determines a "mobile application" that can be run on the input device 80 on which it is installed. Alternatively, input device 80 may be a PC. In this case, the microcontroller 70 determines the software installed on the PC.

[0068] A transmitter element 60, which is configured to transmit control signals 45 generated by the microcontroller 70, to a transceiver element 40, which is a Bluetooth antenna, which is located inside or outside the input device 80.

[0069] Alternatively, in other exemplary embodiments of the present invention that are not illustrated, the transmission of control signals 45 from the interface/input devices 50, 80 to the proximal unit may occur in another manner, such as through cable transmission.

[0070] In FIG. 2 illustrates a possible flowchart in which virtual devices 71, 72, 73 are configured to control input interface 50 of microcontroller 70 and installed in input device 80. In particular, in the example illustrated in FIG. 2, the input device 80 is a personal mobile communication device, for example, selected from the above types, in which the graphical interface is controlled by three main virtual units, i.e., a request generator 73, a button generator 72, and a touch screen virtual device 71. In this case, the transmitting element 60 for transmitting control signals is a Bluetooth antenna, also integrated in the input device 80.

[0071] In FIG. 2A illustrates an example microcontroller interface screen 70 that defines a "mobile application" installed on input device 80, typically if the latter is a personal mobile communications device.

[0072] After installing the application on the input device 80, the user can select the waveform 90, intensity 91, and frequency range 92 parameters with which/within which the mechanical vibrations 35 are to be generated. The operation confirmation step 93 allows the user to view the following screen illustrated in FIG. 2B and enter instructions for starting the generation and transmission of mechanical vibrations 35 and adjusting at least the frequency of these mechanical vibrations with the start button 100. As expected, and as will be better described hereinafter, the user can stop the rate adjustment step 121 with the on-screen stop button 101, in particular if he/she experiences a reduction in tinnitus symptoms.

[0073] In FIG. 2C illustrates an exemplary microcontroller 70 interface screen following the screen in FIG. 2B in the exemplary system implementation described below. After the frequency scan stop command 101, this screen allows the operator to enter the command 110 to start the fine tuning step f of the frequency of the influencing signal 45 and the stop step 111 of the fine tuning step.

[0074] FIG. 3 illustrates a block diagram of the operation of the microcontroller 70 for generating mechanical vibrations 35. The user instruction calls the step 200 of generating mechanical vibrations 35 and, at the same time, the step 121 of adjusting the frequency f to start.

[0075] The step of adjusting the frequency f of mechanical vibrations 35 performs the step of changing the frequency of vibrations 35, which are delivered when scanning a predetermined frequency range f, at predetermined time intervals that can be selected by the user.

[0076] If the user experiences a decrease in tinnitus symptoms 122, he/she can enter a frequency scan stop instruction via the input device 80. This event causes an interrupt 300 of the frequency scan 121 at the frequency value at which the mechanical vibrations 35 were delivered when the stop command was entered, and stimulation, ie delivery of vibrations 35, continues at a fixed rate equal to the rate of reduction in tinnitus symptoms, which is determined as described above.

[0077] On the contrary, if the user does not experience any significant reduction in tinnitus symptoms 122 in the absence of a frequency scan stop command, the supply of mechanical vibrations 35 continues from the step 123 of changing the scanned frequency range, and from a new step 121 of adjusting the frequency, where the frequency f is changed to a frequency range that is different from the range previously scanned. The step is performed in this manner with various frequency adjustment steps 121, provided that the user does not experience any significant reduction 122 in tinnitus symptoms.

[0078] In FIG. 4 illustrates a block diagram of the operation of the microcontroller 70 similar to that illustrated in FIG. 3 of an exemplary system embodiment, further comprising a step 124 of fine tuning the frequency f of the driving signal 45 and hence delivering the mechanical vibrations 35.

[0079] In this case, in the absence of a frequency scan stop command in the frequency adjustment step 121, the microcontroller 70 operates in the same manner as in FIG. 3 through the step 123 of changing the scanned frequency range, and with the new generation of mechanical vibrations 35 together with the step 121 of adjusting the frequency f by scanning another frequency range.

On the contrary, if the user, while the mechanical vibrations 35 are delivered at a frequency f set in a predetermined range, perceives a significant reduction 122 of tinnitus symptoms, he/she can notify the microcontroller 70 of this event, which performs the frequency fine tuning step 124 f. In other words, microcontroller 70 narrows down the frequency range to scan when delivering subsequent mechanical vibrations 35, i.e., it selects a new frequency range f that is in the nearest frequency range at which a reduction in tinnitus symptoms was perceived and recorded, and proceeds with a new tuning step, this time, the step of fine-tuning the frequency f, prompting the latter to scan this immediate area.

If the user experiences a further reduction in the symptoms of tinnitus 125, the latter may provide a frequency scan stop command for the fine tuning step to cause frequency fine tuning 124 to stop 300 at the value at which the mechanical vibrations 35 were delivered when this scan stop command was entered and pacing, that is, the delivery of vibrations 35 continues at a fixed frequency value equal to the additional frequency of tinnitus symptom reduction, which is identified as described above.

In contrast, if the user sees no further significant reduction in tinnitus symptoms 125 in the absence of a frequency scan stop instruction for the fine tune step, delivery of mechanical vibrations 35 continues from step 126 to change the scanned nearest frequency region as the new closest region for the value that caused the previous decrease, and from step 124 fine tune the frequency f by scanning this new closest area. The step continues in this manner with new frequency fine tuning steps 124 until the user finds any significant reduction 125 in tinnitus symptoms.

[0080] In this way, the user can more accurately determine the frequency at which further reduction of 125 tinnitus symptoms occurs, i.e., he/she can check the frequency or frequencies closest to the frequency of phantom noise, thus improving the reduction process.

[0081] In FIG. 5 illustrates a block diagram of the operation of the microcontroller 70 similar to that illustrated in FIG. 4, in an exemplary implementation of the system, in which a step 127 is additionally provided for adjusting the intensity of the acting signal 45 and, therefore, performing the delivery of mechanical vibrations 35.

In the absence of a frequency scan stop command, microcontroller 70 operates in the same manner as in FIG. four.

On the contrary, if while the mechanical vibrations 35 are delivered at a frequency f set in a predetermined nearest area of the tinnitus symptom-reducing value, the user perceives a further reduction, he/she can notify the microcontroller 70 of this event, which performs the step 127 of adjusting the intensity of the tinnitus. signal 45 and hence the delivery of mechanical vibrations 35.

This step 127 of adjusting the intensity A of the mechanical vibrations 35 provides a step of changing the intensity A of the vibrations 35 delivered by scanning a predetermined range of intensity A in accordance with predetermined levels of increase and decrease that can be selected by the user.

If the user experiences a further reduction in the symptoms of tinnitus 128, he can provide an intensity scan stop command to cause intensity adjustment 127 A to stop 301 at the value at which the mechanical vibrations 35 were delivered when this scan stop instruction was entered, and stimulation, i.e. delivery of the vibrations 35 continues at a fixed intensity value equal to the tinnitus symptom reduction intensity, which is identified as described above.

On the contrary, if the user does not see a further significant reduction in tinnitus symptoms 128 in the absence of an intensity scan stop command, the delivery of mechanical vibrations 35 continues from the step 129 of changing the intensity range to be scanned, and with a new step 127 of adjusting the intensity, in which the intensity A changes within the range intensity that is different from the previously scanned range. The step is carried out in this manner with steps 127 of adjusting the intensity until the user experiences any further significant reduction 128 in the symptoms of tinnitus.

[0082] In FIG. 6 shows a block diagram of the operation of the microcontroller 70 similar to that of FIG. 5 in an exemplary implementation of the system, which additionally provides a step 130 to fine-tune the intensity of the acting signal 45 and, therefore, the delivered mechanical vibrations 35.

[0083] In this case, in the absence of an intensity scan stop command for the intensity adjustment step 127 A, the microcontroller 70 operates in the same manner as in FIG. 5.

In contrast, if while the mechanical vibrations 35 are being delivered at an intensity A set within a predetermined range, the user perceives a significant reduction in the symptoms of tinnitus 128, he/she can notify the event to the microcontroller 70, which performs step 130 to fine-tune the intensity A. In other words , the microcontroller 70 narrows down the intensity range to be scanned when delivering subsequent mechanical vibrations 35, that is, it selects the intensity range that is the closest area of intensity value A at which a reduction in tinnitus symptoms is perceived and recorded, and proceeds to the setting step, this time to the step of fine-tuning the intensity A, causing the latter to scan this nearest area.

If the user experiences a further reduction in the symptoms of tinnitus 131, the latter may provide an intensity scan stop command for the fine-tuning step to cause intensity fine-tuning 130 to stop 301 at the value at which mechanical vibrations 35 were delivered when this scan stop command was entered, and pacing, that is, the delivery of oscillation 35 continues at a fixed intensity value equal to the additional tinnitus symptom-reducing intensity, which is identified as described above.

Conversely, if the user does not see a further significant reduction in tinnitus symptoms 131 in the absence of a scan stop instruction for the intensity fine tuning step, mechanical vibration generation 35 continues with the intensity range change step 132 A, which will be scanned as the new nearest area of the value that caused the previous decrease, and in steps of 130 fine tune the intensity A by scanning this new closest area. The step is performed in this manner with new intensity fine tuning steps 130, provided that the user does not experience any significant reduction in tinnitus symptoms 131 .

[0084] In an exemplary embodiment of the system, which is not illustrated in the diagrams described above, but which can be easily derived from them, an intensity adjustment or scanning step A can be provided, and preferably also a fine tuning step, i.e. fine tuning intensity A without performing the step of fine tuning or fine adjustment of the frequency of the influencing signal 45 and, consequently, mechanical vibrations 35.

[0085] In FIG. 7 illustrates a flowchart of the operation of the microcontroller 70 in an exemplary implementation of the system, including the step 140 of adjusting the waveform of the stimulus signal 45 and, therefore, the mechanical vibrations 35. In this case, the user instruction starts the step 200 of generating mechanical vibrations 35, which begins concurrently with the step of adjusting the frequency and includes the step of scanning a predetermined frequency range f, which can be selected by the user. Before this frequency setting or at each frequency scan step, the microcontroller 70 may perform a waveform adjustment step 140 by selecting a waveform from a predetermined library located in the input interface 50 to generate mechanical vibrations. In more detail, in the first case, if the user does not experience any significant reduction in tinnitus symptoms 141, a step 142 of changing the waveform type is provided until the desired effect of reducing tinnitus symptoms 141 is obtained. The user can then notify the microcontroller 70 of this event by providing a scan stop command to adjust the waveform to cause the waveform type scanning step 140 to stop 302 at the type with which mechanical vibrations 35 were delivered when this stop instruction was entered, and stimulation, i.e. delivery of vibrations 35, continues with that waveform type.

[0086] The diagram in FIG. 8 refers to a modification of the system, in which it is possible to change the intensity of the acting signal 45 and therefore the mechanical vibrations 35, if after generating the mechanical vibrations 35 and after changing their frequency by means of a full scan of the predetermined frequency range, the user does not notice any significant reduction tinnitus symptoms. In this case, if no reduction in tinnitus symptoms 122 is obtained after providing an instruction to start the step 200 of generating mechanical vibrations 35 and the simultaneous step 121 of adjusting their frequency, the user can start changing the intensity of the signal 152 and ensure that the generation of 200 mechanical vibrations 35 continues by starting a new step 121 frequency adjustment using the new intensity value, and then he/she can stop this mechanical frequency adjustment 35 by entering the frequency scan stop command when tinnitus symptoms are significantly reduced 122 . If after the first step 121 of adjusting the frequency of the mechanical vibration 35, the user does not experience any significant reduction in the symptoms of tinnitus, and if the verification step 150 detects that the frequency band has not been completely scanned, a step 151 of changing the frequency f of the mechanical vibration band 35 is provided.

[0087] In particular, microcontroller 70 is configured to deliver vibrations 35 at an intensity lower than the patient's hearing threshold. In an exemplary embodiment of the invention, which is not illustrated, the acclimatization step is provided at the beginning of the mechanical vibration delivery step 200, that is, immediately after receiving the command to start it, and the microcontroller 70 is configured to deliver vibrations 35 whose intensity is no more than 10% higher than an absolute value in dB PS of the patient's hearing threshold to help the patient identify the mechanical vibrations 35 generated by the electromechanical device 30.

[0088] FIG. 9 is a diagram illustrating an ON delivery period and an OFF waiting period of the electromechanical device 30 in manual operation. In more detail, delivery time intervals 160 (ΔT _ON ), 160', as well as standby time intervals 162 (ΔT _{OFF MANUAL} ) of the electromechanical device 30 are defined, which the user can select according to his needs by providing instructions through the input device 80.

[0089] FIG. 9A is an example of a block diagram of the operation of the electromechanical device 30 in the manual mode of operation according to FIG. 9. In this mode, the user provides on instructions 160 and off instructions 162 based on their perception of tinnitus symptoms 163, and in accordance with delivery times 160 based on their own perception.

[0090] In contrast, FIG. 10 is a diagram illustrating ON delivery values and OFF waiting period values of the electromechanical device 30 in automatic operation. In particular, the electromechanical device 30 can be programmed to automatically transmit mechanical vibrations 35 at predetermined time intervals, providing both time intervals 160 or ΔT _ON during which the electromechanical device 30 operates and delivers stimulations at a frequency f, with an intensity A, and with a predetermined predetermined waveform, as well as time intervals 162 in standby mode, during which the electromechanical device 30 does not work, i. standby time intervals (ΔT _{OFF AUTOMATIC} ) can be defined.

[0091] In particular, in automatic mode of operation, individual therapeutic stimulation programs can be obtained in which mechanical vibrations 35 are delivered at frequencies f, intensities A and with predetermined vibration waveforms for predetermined periods of time, which alternate with stages of the waiting period . In particular, if the user experiences a significant reduction or cessation of tinnitus symptoms after a predetermined period of time during which the device is inactive, the device timeout may be increased or may be reduced if, conversely, tinnitus symptoms reappear during one of these periods. expectations.

[0092] In FIG. 10A shows a block diagram of the operation of the electromechanical device 30 in automatic mode of operation. During the mechanical vibration delivery time interval 160 in which the electromechanical device 30 is turned on, the system counts the time 161 elapsed since the beginning of this interval, and if this time exceeds a predetermined delivery time threshold, the waiting phase 162 of the electromechanical device 30 begins. Otherwise, the electromechanical device 30 continues with the delivery step 160 . The standby step 162 of the electromechanical device 30 continues until the standby OFF time 170 exceeds the programmed duration. Before reactivating the electromechanical device 30 to begin a new delivery step, a query step 171 is provided in which the user is asked if he/she is still hearing tinnitus symptoms. If so, a new delivery step 160 begins, while if the tinnitus symptoms disappear, a wait time extension step 172 is performed.

[0093] The above description of some examples of specific embodiments of the present invention fully discloses the invention from a fundamental point of view in such a way that other specialists, applying current knowledge, will be able to modify and / or adapt certain exemplary embodiments of the present invention for various applications without additional studies and without departing from the invention, and, accordingly, such adaptations and modifications are to be considered equivalent to certain embodiments of the present invention. For this reason, the means and materials for implementing the various functions described herein may be of a different nature without departing from the scope of the present invention. It should be understood that the phraseology or terminology used herein is intended to be descriptive and not limiting.

Claims (31)

1. An electromechanical stimulation system for treating tinnitus symptoms, comprising: - a proximal block (10) configured to be placed near the user's ear (1), said proximal block (10) comprising: - an electromechanical device (30) configured to transmit mechanical vibrations (35) having a given frequency (f), intensity (A) and waveform to the tissues located near the specified ear of the user (1), moreover, the specified electromechanical device (30) is a device selected between the actuator in the form of a voice coil and a piezoelectric actuator; - a device (32) for keeping the electromechanical device (30) in contact with the tissues (2) corresponding to the bone processes (3) of the head selected from the temporal bone, in particular the mastoid process; occipital bone; frontal bone; - a control unit (20) configured to actuate said electromechanical device (30) so that said frequency (f), said intensity (A) and said waveform of said mechanical vibrations (35) can be changed; - a transceiver element (40) configured to receive control signals (45) for the specified control unit (20); - interface (50) input, made with the ability to work under the control of the above user and containing: - a transmitting element (60) configured to transmit control signals (45) to the specified transceiver element (40) of the specified proximal block (10); - a microcontroller (70) configured to emit said control signals (45) in the direction of said control unit (20) to generate mechanical vibrations (35) of said electromechanical device (30) with a first frequency (f) set in the range from 20 Hz up to 20 kHz and with an intensity below a predetermined intensity limit value, and to induce repetition of said mechanical vibrations (35) for a plurality of frequencies in a given range; - an input device (80) configured to: - receive instructions from said user to start generating said mechanical vibrations (35) by means of said electromechanical device at a plurality of different frequencies; - be in standby mode; - receive from the specified user a command to stop scanning the frequency to stop changing the frequency of the specified mechanical oscillations (35) at a stationary frequency corresponding to the current frequency of the generated specified mechanical oscillations, so that the specified user can notify the specified microcontroller (70) of the frequency value at which he / she feels a decrease in the indicated symptoms of tinnitus; - continue to generate mechanical oscillations at a stationary frequency. 2. The stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to perform a fine tuning step of said frequency (f) of said mechanical vibrations (35) after receiving said command to stop frequency scanning, wherein said fine tuning step includes repetition of said mechanical vibrations (35) at frequencies (f) in the frequency region (f) of one of said mechanical vibrations (35) generated upon receipt of said command to stop frequency scanning. 3. Stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to perform intensity adjustment (A) of said mechanical vibrations (35) after receiving said command to stop frequency scanning at said stationary frequency. 4. Stimulation system according to claim 2, characterized in that said microcontroller (70) is configured to adjust the intensity (A) of said mechanical vibrations (35) at the end of said step of fine tuning said frequency (f). 5. The stimulation system according to claim 1 or 3, characterized in that said microcontroller (70) is configured to perform the step of fine tuning the intensity (A) of said mechanical vibrations (35) after receiving said scan stop instruction and after said intensity adjustment (A ) of the indicated mechanical vibrations (35). 6. Stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to change the intensity (A) of said mechanical vibrations (35) so that said user can change said intensity if there is no reduction in said tinnitus symptoms. at the end of the indicated mechanical vibrations (35). 7. Stimulation system according to claim 1, characterized in that said electromechanical device (30) is programmed to automatically transmit mechanical vibrations (35) at predetermined time intervals. 8. The stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to change said mechanical vibrations (35) emitted by said electromechanical device (30) in the intensity range (A) from -20 dB PS (threshold audibility) up to 200 dB PS. 9. Stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to change said mechanical vibrations (35) emitted by said electromechanical device (30) with an intensity less than or equal to the hearing threshold. 10. The stimulation system according to claim 8, characterized in that said microcontroller (70) is configured to: - induce the specified electromechanical device (30) to emit mechanical vibrations (35) with an intensity of not more than 10% above the hearing threshold during the acclimatization time after the specified instruction to start generating mechanical vibrations (35); - reduce the specified intensity to a value lower than the specified hearing threshold after the specified acclimatization time. 11. The stimulation system according to claim 1, characterized in that said microcontroller (70) is configured to perform the step of adjusting the waveform of said mechanical vibrations (35). 12. The stimulation system according to claim 1, characterized in that said device (32) for maintaining the electromechanical device (30) in contact with the tissues (2) corresponding to the bone processes (3) of the head, contains a support configured to be installed next to with the bone (3) of the user's skull, while the specified bone, in particular, is selected among the temporal bone, occipital bone, frontal bone and outside the specified ear of the user, and the specified support has a housing for placement, in particular for removable placement of the specified electromechanical device (30 ). 13. The stimulation system according to claim 12, characterized in that said support is an adhesive support containing: - an adhesive part intended to be applied next to the indicated bone (3) of the skull; - a support section containing said housing for accommodating the electromechanical device (30), in particular in a removable manner.

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