Patent Publication Number: US-2021168545-A1

Title: Electromechanical stimulation system for treating tinnitus

Description:
FIELD OF THE INVENTION 
     The present invention relates to the medical field, and, more in detail, it relates to an electromechanical stimulation system for treating a subject suffering from tinnitus, or phantom noise. 
     More in particular, the invention relates to a device for non-invasively delivering such a treatment. 
     DESCRIPTION OF THE PRIOR ART 
     The phantom noise, or tinnitus, is a hearing disease that can disturb the correct perception of the sounds and, in particular, of the language. In fact, tinnitus is the perception of noises having various frequencies and intensities, which do not relates to any acoustic signal coming from the environment. These noises can be heard in one ear, in both ears or, more in general, as noises coming from within the head. 
     In particular, tinnitus can be heard as a single-frequency noise, for example a whistle, a clinking or the like, in which case it is called a tonal tinnitus, or it can be heard as a broadband noise, such as a swish, a buzzing, a whisper and the like, in which case it is called a non-tonal tinnitus. Tinnitus is extremely frequent, can have various intensities, and can even disturb the patient&#39;s daily activities and his/her sleep, and even cause serious cognitive and behavioural diseases, which can severely affect the subject&#39;s quality of life. 
     Tinnitus is commonly treated by audio devices that are configured to provide the user with tone-based therapies, whose effect is to mask the specific tinnitus frequency. 
     An example of this kind of device is disclosed in U.S. Pat. No. 5,325,872, and comprises a control unit to provide an audio signal at a transmission frequency that can be suitably adjusted within a predetermined range, until an optimum value is found which mitigates or masks the disease at best. 
     Surgically implantable devices are also known, as described in U.S. Pat. No. 6,077,215, in which the most inner ear part are stimulated by an electromechanical transducer implanted within the mastoid process. These devices are invasive, cause side effects and, in any case, have never turned out to be effective (Dobie R A.  “A review of randomized clinical trials in tinnitus” . Laryngoscope 1999, 109, 1202.1211). 
     U.S. Pat. No. 5,788,656 describes a further example of stimulation system comprising an electromagnetically operated electromechanical device to be positioned near the cochlea, in the inner ear. This electromechanical device can stimulate the cochlea in the tinnitus frequency range. In this case, a couple of oscillators working at a low and at a high frequency, respectively, within a range set between 400 Hz and 1000 Hz, provides a stimulation pilot signal. By this system, the user can customize the therapy to his/her own needs, by adjusting the vibration frequency of the actuation device. 
     Also this therapeutic system is invasive, and does not allow a stimulation therapy that is effective in mitigating or suppressing the disease in a middle-long term. 
     US 2008/0064993 A1 describes the use of a device comprising an electromechanical transducer that, if mounted to a mouth bone, such as a teeth or a palate bone, provides mechanical vibrations at a frequency and at an amplitude that can be adjusted. In particular, this device exploits the bone sound conduction, and can provide an acoustic signal that masks the tinnitus perception by superimposing mechanical vibrations to it, which cancels the effects of tinnitus, or by adding pleasant mechanical vibrations that divert the user&#39;s attention away from the tinnitus. However, US 2008/0064993 A1 does not indicate how to identify the frequencies that are suitable for cancelling the tinnitus, but only uses tables of values obtained by investigations made on a sample of patients, or carries out specific audiology tests for each user. 
     U.S. Pat. No. 6,210,321 B1 describes a further example of system for mitigating tinnitus, comprising a semi-rigid membrane, to be placed outside of the ear on the mastoid bone, close to the cochlea. The membrane is configured to be excited by an electric stimulation, and to transmit mechanical vibrations to the cochlea. In this case, the user can obtain a customized therapy by adjusting the frequency and intensity parameters of the stimulation. However, this adjustment is difficult and uncomfortable for the user. 
     Other devices for treating tinnitus are described in US 2015/164381 A1, US 2013/163797 A1, EP 3184046 A1, US 2016/250440 A1. 
     SUMMARY OF THE INVENTION 
     It is therefore a feature of the present invention to provide an electromechanical stimulation system for treating tinnitus, which provides a non-invasive, easily customizable therapy that is centred about the user&#39;s perceptions. 
     It is also a feature of the present invention to provide an electromechanical stimulation system for treating tinnitus that can be easily adjusted by therapist and by the user as well, so that a therapist&#39;s help is less required for a normal use of the system at home. 
     It is also a feature of the present invention to provide an electromechanical stimulation system for treating tinnitus that can be applied without surgical operation. 
     It is still a feature of the present invention to provide such a system that can adjusted by devices commonly available to the user. 
     These and other objects are achieved by an electromechanical stimulation system for treating tinnitus, comprising:
         a proximal unit configured to be placed proximate to a user&#39;s ear, the proximal unit comprising:
           an electromechanical device, configured to transmit mechanical vibrations to tissues near the user&#39;s ear or in any case to the user&#39;s skull, the mechanical vibrations having predetermined frequency, intensity and waveform;   an application device, configured to maintain the electromechanical device in contact with tissues corresponding to bone processes of the head selected among the temporal bone, in particular the mastoid process; the occipital bone; the frontal bone;   a control unit, configured to actuate the electromechanical device in such a way that the frequency, the intensity and the waveform of the mechanical vibrations can be modified;   a transceiver element configured to receive control signals for the control unit;   
           an input interface configured to be operated by the user, comprising:
           a transmitter element configured to transmit control signals to the transceiver element of the proximal unit;   a microcontroller configured to emit said control signals towards said control unit for generating mechanical vibrations of said electromechanical device at a first frequency set within a range between 20 Hz and 20 kHz and at an intensity lower than a predetermined intensity limit value, and for causing a repetition of said mechanical vibrations for a plurality of frequencies within this range;   
           an input element configured to:
           receiving from the user an instruction to start generating mechanical vibrations by said electromechanical device at a plurality of different frequencies,   stand by while said mechanical vibrations at said different frequencies are generated;   receiving from said user a frequency scanning stop-instruction to stop modifying the frequency of the mechanical vibrations at a stationary frequency corresponding to the current frequency of the mechanical vibration being generated, so that the user can notify to the microcontroller a frequency value at which he/she perceives a decrease of the tinnitus symptoms;   continue generating mechanical vibrations at said stationary frequency.   
               

     This way, the application device, which is configured to maintain the electromechanical device in contact with tissues corresponding to bone processes of the head selected among the temporal bone, in particular the mastoid process, the occipital bone, the frontal bone, has the technical effect of causing the mechanical vibrations to be transmitted in the form of:
         auditory stimulation by bone conduction;   vestibular stimulation by bone conduction;   tactile stimulation of the skin;   vibratory proprioceptive stimulation,
 
thus obtaining a multisensorial stimulation. In fact, besides reaching the vestibular zone by bone conduction and mitigating tinnitus, a vibration delivered to the skin in a suitable way also provides, in a broader sense, a proprioceptive localization of the vibratory stimulation transmission zone.
       

     Moreover, the system: tries the possible frequencies of such a multisensorial stimulation, accordingly generates the mechanical vibrations at all the frequencies set between 20 Hz and 20 kHz, in particular set between 125 Hz and 8000 Hz, said frequencies differing from each other for instance by 1 Hz, awaits the frequency scanning stop-instruction for the mechanical vibrations, which occurs when the user perceives a decrease or disappearance of the tinnitus symptoms, and maintains the frequency of the subsequent mechanical vibrations at the stationary frequency value. This solution allows to find each personally different stationary-frequency value at which, for each user, tinnitus disappears or decreases in intensity. 
     In comparison with US 2015/164381 A1, US 2013/163797 A1, EP 3184046 A1, US 2016/250440 A1, the present invention has the differences and the advantages described hereinafter. 
     In the invention, the multisensorial stimulations are used to mitigate/suppress tinnitus, by delivering mechanical vibrations to skin regions close to the temporal bone, and/or the occipital bone, and/or the frontal bone, at an intensity below a predetermined intensity threshold, which can be the patient&#39;s auditory threshold, or at an intensity slightly higher than the audibility threshold, as described hereinafter, in order to avoid any distortion or increase of the auditory perception and to promote a 24 hour application of the device, which would be uncomfortable and discouraging at a higher intensity. The multisensorial stimulations comprise the auditory stimulation by bone conduction, the vestibular stimulation by bone conduction, the tactile stimulation of the skin and the vibratory proprioceptive stimulation. 
     The vibrations of the electromechanical device, such as a voice coil actuator, have an intensity that is normally lower or slightly higher than the audibility threshold. However, the vibrations are not generated at an intensity lower than the tactile perception threshold, and provide therefore the user with a tactile sensation that triggers the proprioception, i.e., it makes the user aware of the region of the body where the electromechanical device is applied, and where the same delivers the vibrations to the skin. On the contrary, the vibrations of the prior art systems have an intensity far higher than the audibility threshold, since they are intended for causing the user to hear a sound that is in opposition of phase to the tinnitus symptoms, or that must cover the tinnitus symptoms. For this reason, in such prior art systems, the proprioception is shadowed by the emitted sound. 
     In the case of the invention, the patient substantially does not hear any sound coming from the electromechanical device, therefore the proprioception plays a most important role. In other words, the patient has a tactile perception of a slight vibration on his/her skin, localizes it (proprioception) and, at the same time, the vibration is transmitted to the head bones close the skin region where the vibration is delivered, i.e. it propagates by bone conduction, and finally reaches the auditory apparatus (vestibular stimulation). It is believed that the combination of the multisensorial stimulation with a specific optimum tinnitus-mitigating frequency, which is identified by the user, i.e. the combination of the two main characteristics of the invention distinguishing it from the prior art, makes it possible to obtain the therapeutic effect of suppressing the tinnitus symptoms. 
     Moreover, due to the frequency scanning performed during the stimulation by bone conduction, with the invention it is not necessary to determine or to know the features of the tinnitus symptoms, unlike the prior art treatments. In fact, it is the patient him/herself who directly selects the stimulation that is suitable for suppressing the tinnitus symptoms, even if the origin or the parameters characterizing the tinnitus symptoms are not known. 
     Above all, the advantage of the device consists in that it has been observed that if the patient, after a first vibration application time of a few hours, during which he/she receives mechanical vibrations at the stationary frequency which mitigates at best the tinnitus symptoms, stops the vibrations, the tinnitus symptoms are further mitigated during a first tinnitus silence time, and therefore can set the vibrations off for a vibration stand-by time. When the tinnitus symptoms begin again, the user has just to start a second vibration application step at the stationary frequency, therefore the vibration stand-by time is preferably selected equal to the tinnitus silence time, the second vibration application step is maintained for a second vibration time and is discontinued and maintained off until the tinnitus symptoms begins once again, after a second tinnitus silence time longer than the first tinnitus silence time, and so on. In fact, it has been observed that if the vibration time and the stand-by time are repeated with the device according to the invention, the tinnitus silence time always increases, which shows the therapeutic efficacy of the device. 
     Moreover, the system is particularly customizable and easy to use because the electromechanical device can transmit mechanical vibrations at different frequencies to tissues proximate to the user&#39;s ear, and the user can adjust these mechanical vibrations by an input interface. 
     In fact, the user can easily carry out therapeutic sessions according to his/her own needs by means of a personal mobile communication device provided with a touchscreen graphic display interface such as a smartphone, in which a mobile app is installed. Therefore, the user doesn&#39;t need any therapist&#39;s help. 
     As an alternative, the input element can be a PC, a smartwatch, a smart-TV or a tablet. In this case, the user can provide start and stop-instructions by a keyboard, by a remote control device, or even by a touch screen device. 
     Advantageously, the application device comprises a support configured to be mounted close to a bone of the user&#39;s skull, in particular selected among the temporal bone, the occipital bone and the frontal bone, where the skin layer is thinner, and outside of the ear, the support having a housing for receiving, in particular for removably receiving the electromechanical device. This way, the support allows a contact of the electromechanical device with the skin, so as to enable the above-mentioned four types of stimulation. 
     In particular, the application device includes an adhesive support, comprising:
         an adhesive portion configured to be applied close to said bone of the skull;   a support portion comprising said housing for receiving the electromechanical device.       

     This way, as the electromechanical device is configured to be arranged at a bone region and out of the user&#39;s ear, no surgery operation is required to use the system. This makes it possible to eliminate the risks and the side effects inherent to surgical interventions. Moreover, as the electromechanical device is removable, it is not necessary to wear the support all the time. The support can be mounted to the patient, for instance, by an adhesive that stays attached to the skin for a few days, in particular, as long as required to perform the therapy, or in any case for a number of days so short to require few replacements of the adhesive support during the whole treatment, besides allowing not to wear the electromechanical device in the time between one therapy session and the subsequent session. 
     In particular, the electromechanical device is a voice coil type actuator, of small dimensions, comprising an output shaft that is free of moving axially, in which the mechanical force generated by the shaft is proportional to the current circulating in its own electric coil, and is therefore proportional to the intensity of the electric actuation signal produced by the control unit in the time unit. 
     This way, the frequency, the intensity and the waveform of the mechanical vibrations that are transmitted to the tissues proximate to the user&#39;s ear through the output shaft, can be modified, which enables the user to customize the therapy according to his/her own needs. 
     The system according to the invention, and, in particular, the voice coil actuator located on a temporal or occipital or front bone, makes it possible to deliver a multisensorial stimulation, in which the vibration is transmitted to the bone through the skin along two propagation paths, i.e. a first path through the bone tissue surrounding the area where the actuator is applied, and a second path through the fluids and the soft tissues of the vestibular region. Accordingly, due to the pulses applied to the skin, a tactile sensation triggers the patient&#39;s proprioceptive system that makes it possible to identify the area where the skin is stimulated. It is believed that the association of the multisensorial stimulation with the frequency scanning in order to find out the tinnitus-mitigating value, and the delivering of vibrations at that frequency, is the reason why the system according to the invention can more effectively cure the tinnitus disease. 
     As an alternative, the electromechanical device can be a voice coil type actuator comprising such a body as a membrane, which can vibrate due to the excitations caused by the current that circulates in a coil surrounding this body. 
     In a further exemplary embodiment, the electromechanical device can be a piezoelectric type actuator. 
     Advantageously, the microcontroller is configured to carry out a step of fine tuning the frequency of the mechanical vibrations, upon receiving a frequency scanning stop-instruction from the user. 
     In particular, after perceiving a tinnitus decrease for a given frequency, the user can interact with the input element by providing a frequency scanning stop-instruction at the frequency at which he/she has perceived a tinnitus decrease, i.e. at the above-mentioned stationary frequency, and then by finely scanning the frequencies in a neighbourhood of the stationary frequency, thus adjusting the frequency more finely than what was made by the stationary frequency, in order to further reduce or suppress the noise, without any external assistance and according to his/her own perceptions. 
     Advantageously, the microcontroller is configured to carry out an intensity adjustment of the mechanical vibrations upon receiving the frequency scanning stop-instruction at said stationary frequency. 
     This way, the signal intensity adjustment can improve the therapy by using an intensity value that is most suitable for treating tinnitus. 
     Advantageously, the microcontroller is configured to carry out an intensity adjustment of the mechanical vibrations at the end of the step of fine tuning the frequency. 
     This way, the user, after causing a first train of mechanical vibrations to be delivered at frequencies within a first range and then a second train of mechanical vibrations at frequencies within a second range, narrower than the first range, can perform a third adjustment of the signal intensity, so as to generate mechanical vibrations of the electromechanical device that can further reduce the perceived tinnitus symptoms. 
     As an alternative, the microcontroller can perform a step of fine tuning the intensity of the mechanical vibrations after receiving the scan stop-instruction and after the intensity adjustment of the mechanical vibrations. 
     An advantage of this solution is to provide an a stimulation even more targeted to the subject&#39;s needs. For instance, a user who has obtained a satisfactory tinnitus symptoms reduction by the frequency adjustment or by the frequency fine tuning, can perform an intensity fine tuning step after the scan stop-instruction, which makes the stimulation system even more targeted to his/her needs. 
     Advantageously, the microcontroller is configured to modify the intensity of the mechanical vibrations when the user has not perceived any tinnitus decrease at the end of the step of adjusting the frequency of the mechanical vibrations, i.e. after scanning all the frequencies within the predetermined scanning/adjusting range. In particular, the stimulation used is weaker than the user&#39;s auditory threshold or has an intensity level that cannot disturb the subject&#39;s hearing during his/her ordinary activities. 
     This way, the user, after performing the frequency adjustment step, can decide to modify the intensity of the stimulation signal, and carry out a new frequency adjustment step by causing mechanical vibrations at a new intensity to be generated. 
     In particular the microcontroller is configured to cause the mechanical vibrations emitted by the electromechanical device within an intensity range between −20 dB HL and 200 dB HL. 
     In particular, the intensity limit value below which the microcontroller is configured to modify the intensity of the mechanical vibrations is equal to the user&#39;s auditory threshold, in other words, the microcontroller is configured to cause the mechanical vibrations to be emitted by the electromechanical device at an intensity lower than or equal to the audibility threshold. 
     In particular, the intensity limit value below which the microcontroller is configured to modify the intensity of the mechanical vibrations can be equal to the user&#39;s auditory threshold increased by 10% in dB HL. More in detail, the microcontroller is configured to cause the electromechanical device to emit the mechanical vibrations at an intensity at most 10% higher than an audibility threshold, during an acclimation time after the instruction to start generating the mechanical vibrations, in order to enable the user to feel the generated vibrations as acoustic vibrations, and is also configured to reduce the intensity to a value lower than the audibility threshold, once the acclimation time has elapsed. 
     Advantageously, the electromechanical device is programmed for automatically transmitting mechanical vibrations at predetermined time intervals. 
     This way, customized stimulation therapeutic programs can be obtained in which, for instance, a mechanical vibrations delivery is provided at predetermined frequencies for predetermined periods of time. For example, if after a time during which the device is off the user realizes that the tinnitus symptoms has disappeared, the stand-by time of the device can be extended, or shortened if, on the contrary, tinnitus occurs again before the stand-by time has elapsed. 
     Advantageously, the microcontroller is configured to carry out a step of adjusting the waveform of the mechanical vibrations. This adjustment can be provided when the user has not experienced any relief during the frequency scanning with a given vibration waveform, and can therefore repeat the scanning for a different waveform. 
     This way, by the stimulation system according to the invention, the user can provide mechanical stimulations widely differentiated, in order to obtain a decrease of the tinnitus symptoms. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further characteristic and/or advantages of the present invention will be made clearer with the following description of an exemplary embodiment thereof, and its exemplary embodiments, exemplifying but not limitative, with reference to the attached drawings in which: 
         FIG. 1  diagrammatically shows an example of an electromechanical stimulation system for treating tinnitus, according to the invention, comprising a proximal unit and an input interface that are in communication with each other, for delivering mechanical vibrations to tissues proximate to a user&#39;s ear; 
         FIG. 2  shows a flow diagram, according to the invention, of virtual devices for controlling the interface of the microcontroller of the input interface and installed in an input element; 
         FIGS. 2A, 2B, 2C  show examples of interface screens of the microcontroller, according to the invention, which are available in an input element; 
         FIG. 3  shows an exemplary flow diagram of the microcontroller, according to the invention, to generate mechanical vibrations at frequencies variable in a predetermined range; 
         FIG. 4  shows an exemplary flow diagram of the microcontroller, according to the invention, similar to that of  FIG. 3 , including a step of fine tuning the frequency of the mechanical vibrations; 
         FIG. 5  shows an exemplary flow diagram of the microcontroller, according to the invention, similar to that of  FIG. 4 , including a step of adjusting the intensity of the mechanical vibrations; 
         FIG. 6  shows an exemplary flow diagram of the microcontroller, according to the invention, similar to that of  FIG. 5 , including a step of fine tuning the intensity; 
         FIG. 7  shows an exemplary flow diagram of the microcontroller, according to the invention, including a step of adjusting the waveform of the mechanical vibrations; 
         FIG. 8  shows an exemplary flow diagram of the microcontroller, according to the invention, including a step of changing the intensity of the mechanical vibrations if, at the end of the step of adjusting the frequency, the user has not perceived any decrease of the tinnitus symptoms; 
         FIG. 9  shows a time operation diagram of an electromechanical device in manual operation mode; 
         FIG. 9A  shows an exemplary flow diagram to actuate the diagram of  FIG. 9 ; 
         FIG. 10  shows a time operation diagram of an electromechanical device in automatic operation mode; 
         FIG. 10A  shows an exemplary flow diagram to actuate the diagram of  FIG. 10 . 
     
    
    
     DESCRIPTION OF SOME PREFERRED EXEMPLARY EMBODIMENTS 
       FIG. 1  shows a possible exemplary embodiment of an electromechanical stimulation system for treating tinnitus. The system comprises a proximal unit  10 , configured to be positioned near a user&#39;s ear  1 , and an input interface  50  configured to be operated by the user, in order to communicate with proximal unit  10 . 
     In the shown example, proximal unit  10  is located in a zone close to a mastoid process, but it can be located on both mastoid processes or on the user&#39;s forehead. 
     Proximal unit  10  comprises an electromechanical device  30 , an application device  32  thereof, a control unit  20  and a transceiver element  40  configured to receive control signals  45  for control unit  20 . 
     In particular, control unit  20  is a hardware component configured to generate an actuation signal  21  for electromechanical device  30 , responsive to control signals  45  transmitted by transceiver element  40 . The frequency f and the intensity A of actuation signal  21  can be modified, and the signal can have various waveforms. This makes it possible to use different parameters of frequency f, intensity A, and different waveforms of mechanical vibrations  35  emitted by electromechanical device  30  for each patient. Control unit  20  also allows combining particular values of such parameters of actuation signal  21 , for which the user perceives a stop or a decrease of tinnitus. 
     For instance, control unit  20  can be a microcontroller including a CPU, in which operating instructions can be resident to generate actuation signals  21 , 45  to be transferred to electromechanical device  30 , so that control unit  20  can autonomously send actuation signals  21  to electromechanical device  30 . As an alternative, control unit  20  can have a library of actuation signals  21  that are different from each other and can be generated by transmitting control signals  45  from input interface  50 . In particular, control unit  20  can be implemented by an Arduino platform including a microprocessor. 
     Electromechanical device can be a voice coil-type actuator  30  including an axially movable output shaft  31 , in which the mechanical force generated by shaft  31  is proportional to the current circulating in an electric coil thereof, and so to the intensity of electric actuation signal  21  provided by control unit  20  in the time unit. According to an exemplary embodiment, not shown, electromechanical device  30  can still be a voice coil-type actuator that also includes a membrane, besides shaft  31 , said membrane free to vibrate responsive to the excitation caused by the current circulating in the actuator coil. In a further exemplary embodiment, not shown, electromechanical device  30  can be a piezoelectric actuator. 
     Electromechanical device  30  is configured to deliver mechanical vibrations  35  to tissues near user&#39;s ear  1 , through a movable element, for example shaft  31  or the membrane of the voice coil actuator, which delivers mechanical vibrations  35  to tissues  2  close to user&#39;s ear  1 . Frequency f, intensity A and the waveform of mechanical vibrations  35  can be adjusted, so that the user can customize the therapy according to his/her own needs. 
     Application device  32  is configured to maintain electromechanical device  30 , in particular also the whole proximal unit  10 , in contact with external tissues like skin  2  at a protruding bone  3  of the head, for example the temporal bone, in particular the mastoid process or mastoid apophysis  3 , the occipital bone or even the frontal bone, the last not shown. In particular, application device  32  comprises a support configured to be mounted at above-indicated protruding bone  3 , and has a housing for receiving electromechanical device  30 , preferably in a removable way. The support can have an adhesive portion to be attached to skin  2  and a support portion, which can be removable from the adhesive portion comprising the housing for receiving electromechanical device  30 . This application device is configured in such a way that the force required for removing electromechanical device  30  from the support portion and/or the support portion from the adhesive portion is weaker than the force required for detaching the adhesive portion from patient&#39;s skin  2 . No detailed description is given of this device, since it can be easily implemented by a skilled person. 
     Input interface  50  comprises a transmitter element  60 , a microcontroller  70  and an input element  80 . 
     Microcontroller  70  configured to actuate the generation of mechanical vibrations  35  having a plurality of frequencies f set in a predetermined range, by emitting actuation signal  45 . More in detail, actuation signal  21 , 45  is configured to cause the actuation of electromechanical device  30  by control unit  20  at a predetermined frequency f set between 20 Hz and 20 kHz, in particular in such a narrower range as 125 Hz÷8000 Hz. Microcontroller  70  can also cause the plurality of frequencies of this range to be repeated as actuation frequencies 
     Input element  80  is configured to receive instructions from the user, in particular an instruction to start a step  200  ( FIGS. 3-8 ) of delivering mechanical vibrations, said instruction also triggering a step  121  of modifying or adjusting frequency f of mechanical vibrations  35 , which consists in modifying this parameter starting from a predetermined value. Input element  80  is also configured to stand by and receive from the user a frequency scanning stop-instruction  300  of frequency adjustment step  121 , when the user perceives a significant decrease or a stop of tinnitus symptoms, and is also configured to continue generating vibrations  35  for a predetermined time while keeping unchanged the frequency at the value used when the frequency scanning stop-instruction has been inputted, when the step of adjusting frequency f of mechanical vibrations  35  is discontinued. 
     Other start/stop-instructions can be transmitted by input element  80 , as it will be explained when describing some exemplary embodiments of the system, with reference to  FIGS. 3-8 . 
     Microcontroller  70  can be integrated with input element  80  in a same device. For instance, input element  80  can be a smartphone, a tablet, a PC, a smart-TV, or a smartwatch. In these cases, microcontroller  70  defines a “mobile app” that can be run in input element  80  where it is installed. As an alternative, input element  80  can be a PC. In this case, microcontroller  70  defines a software program installed in the PC. 
     Transmitter element  60 , which is arranged to transmit control signals  45  generated by microcontroller  70  to transceiver element  40 , can be a Bluetooth antenna that is present inside or outside of input element  80 . 
     As an alternative, in other exemplary embodiments, not shown, the transmission of control signals  45  from interface/inlet element  50 , 80  to the proximal unit can occur in a different way, for example it can be a cable transmission. 
       FIG. 2  shows a possible flow diagram in which virtual devices  71 ,  72 ,  73  are configured to control the interface of microcontroller  70  of input interface  50  and are installed in input element  80 . In particular, in the example of  FIG. 2 , input element  80  is a personal mobile communication device, for example one selected among the above-indicated types, in which the graphic interface is controlled by three main virtual units, i.e. a prompt generator  73 , a button generator  72 , and a virtual touchscreen device  71 . In this case, transmitter element  60  for transmitting the control signals is a Bluetooth antenna also incorporated in input element  80 . 
       FIG. 2A  shows an example of interface screen of microcontroller  70 , which defines a “mobile app” installed in input element  80 , typically if the latter is a personal mobile communication device. 
     After installing the application in input element  80 , the user can select the parameters of waveform  90 , intensity  91  and frequency range  92  with which/within which mechanical vibrations  35  must be generated. An operation confirmation step  93  allows the user to view a subsequent screen,  FIG. 2B , and to provide instructions of starting generating and delivering mechanical vibrations  35 , and of adjusting at least the frequency of these mechanical vibrations through a start button  100 . As anticipated, and as it will be better described hereinafter, the user can stop step  121  of adjusting the frequency through a stop button  101  of the screen, in particular, if he/she perceives a decrease of tinnitus symptoms. 
       FIG. 2C  shows an exemplary interface screen of microcontroller  70 , which follows that of  FIG. 2B , in an exemplary embodiment of the system described hereinafter. After frequency scanning stop-instruction  101 , this screen enables the operator to input a command  110  of starting a step of fine tuning frequency f of actuation signal  45  and a step  111  of stopping the fine tuning step. 
       FIG. 3  shows a flow diagram of the operation of microcontroller  70  for generating mechanical vibrations  35 . A user&#39;s instruction causes a step  200  of generating mechanical vibrations  35  and, at the same time, a step  121  of adjusting frequency f to start. 
     The step of adjusting frequency f of mechanical vibrations  35  provides a step of modifying the frequency of vibrations  35  that are being delivered while scanning a predetermined frequency f range, at predetermined time intervals, which can be selected by the user. 
     If a decrease  122  of tinnitus is perceived by the user, he/she can input a frequency scanning stop-instruction through input element  80 . This event causes an interruption  300  of frequency scanning  121  at a frequency value at which mechanical vibrations  35  were being delivered when the stop-instruction has been inputted, and the stimulation, i.e. the delivering of vibrations  35 , continues at a fixed frequency value equal to the tinnitus-mitigating frequency, which is identified as described above. 
     On the contrary, if the user does not perceive any significant decrease  122  of tinnitus, in the absence of the frequency scanning stop-instruction, the delivering of mechanical vibrations  35  continues with a step  123  of changing of the frequency range to be scanned, and with a new step  121  of adjusting the frequency, where frequency f is modified within a frequency range different from the range scanned before. The step proceeds this way, with different steps  121  of adjusting the frequency, as long as the user does not perceive any significant decrease  122  of tinnitus. 
       FIG. 4  shows a flow diagram of the operation of microcontroller  70 , similar to that of  FIG. 3 , of an exemplary embodiment of the system in which a step  124  is further provided of fine tuning frequency f of actuation signal  45  and, therefore, of mechanical vibrations  35  being delivered. 
     In this case, in the absence of a frequency scanning stop-instruction for step  121  of adjusting the frequency, microcontroller  70  proceeds in the same way as in  FIG. 3  by a step  123  of changing the frequency range to be scanned, and with a new generation of mechanical vibrations  35 , along with step  121  of adjusting frequency f by scanning a different frequency range. 
     On the contrary, if the user, while mechanical vibrations  35  are being delivered at frequency f set in a given range, perceives a significant decrease  122  of tinnitus, he/she can notify this event to microcontroller  70 , which performs a step  124  of fine tuning frequency f. In other words, microcontroller  70  narrows the frequency range to be scanned while delivering the subsequent mechanical vibrations  35 , i.e. it selects a new frequency f range that is a neighbourhood of the frequency value at which the tinnitus decrease has been perceived and notified, and proceeds with a new step of adjusting, this time a step of fine tuning, frequency f, causing the latter to scan this neighbourhood.
 
If a further decrease  125  of tinnitus is perceived by the user, the latter can provide a frequency scanning stop-instruction for the step of fine tuning, in order to cause a stop  300  of the frequency fine tuning  124  at the value at which mechanical vibrations  35  were being delivered when this scan stop-instruction has been inputted, and the stimulation, i.e. the delivering of vibrations  35 , continues at a fixed frequency value equal to further tinnitus-mitigating frequency, which is identified as described above.
 
On the contrary, if the user does not perceive any further significant decrease  125  of tinnitus, in the absence of the frequency scanning stop-instruction for the fine tuning step, the delivering of mechanical vibrations  35  continues with a step  126  of changing the frequency neighbourhood to be scanned as a new neighbourhood of the value that has caused the previous decrease, and with a step  124  of fine tuning frequency f by scanning this new neighbourhood. The step proceeds this way, with new steps of frequency fine tuning  124 , as long as the user does not perceive any significant decrease  125  of tinnitus.
 
     This way, the user can more precisely define the frequency at which a further decrease  125  of tinnitus symptoms occurs, i.e. he/she can check the frequency or the frequencies closest to the phantom noise frequency, thus improving the decrease thereof. 
       FIG. 5  shows a flow diagram of the operation of microcontroller  70 , similar to that of  FIG. 4 , in an exemplary embodiment of the system in which a step  127  is further provided of adjusting the intensity of actuation signal  45  and, therefore, of mechanical vibrations  35  being delivered. 
     In the absence of a frequency scanning stop-instruction, microcontroller  70  proceeds in the same way as in  FIG. 4 .
 
On the contrary, if the user, while mechanical vibrations  35  are being delivered at frequency f set in a given neighbourhood of a tinnitus-mitigating value, perceives a further decrease thereof, he/she can notify this event to microcontroller  70 , which performs a step  127  of adjusting the intensity of actuation signal  45  and, therefore, of mechanical vibrations  35  being delivered. This step  127  of adjusting the intensity A of mechanical vibrations  35  provides a step of modifying intensity A of vibrations  35  being delivered by scanning an intensity A predetermined range, according to predetermined increase and decrease amounts, which can be selected by the user.
 
If a further decrease  128  of tinnitus is perceived by the user, the latter can provide an intensity scan stop-instruction in order to cause a stop  301  of the adjustment  127  of intensity A at the value at which mechanical vibrations  35  were being delivered when this scan stop-instruction has been inputted, and the stimulation, i.e. the delivering of vibrations  35 , continues at a fixed intensity value equal to the tinnitus-mitigating intensity, which is identified as described above.
 
On the contrary, if the user does not perceive any further significant decrease  128  of tinnitus, in the absence of the intensity scan stop-instruction, the delivering of mechanical vibrations  35  continues with a step  129  of changing of intensity A range to be scanned, and with a new step  127  of adjusting the intensity, in which intensity A is modified within an intensity range different from the range scanned before. The step proceeds this way, with steps  127  of adjusting the intensity, as long as the user does not perceive any further significant decrease  128  of tinnitus.
 
       FIG. 6  shows a flow-sheet of the operation of microcontroller  70 , similar to that of  FIG. 5 , in an exemplary embodiment of the system in which a step  130  is further provided of fine tuning the intensity of actuation signal  45  and, therefore, of mechanical vibrations  35  being delivered. 
     In this case, in the absence of an intensity scan stop-instruction for step  127  of adjusting intensity A, microcontroller  70  proceeds in the same way as in  FIG. 5 . 
     On the contrary, if the user, while mechanical vibrations  35  are being delivered at intensity A set in a given range, perceives a significant decrease  128  of tinnitus, he/she can notify this event to microcontroller  70 , which performs a step  130  of fine tuning intensity A. In other words, microcontroller  70  narrows the intensity range to be scanned while delivering the subsequent mechanical vibrations  35 , i.e. it selects an intensity range that is a neighbourhood of the intensity value A at which the tinnitus symptoms decrease has been perceived and notified, and proceeds with a step of adjusting, this time a step of fine tuning, intensity A, causing the latter to scan this neighbourhood.
 
If a further decrease  131  of tinnitus is perceived by the user, the latter can provide an intensity scan stop-instruction for the step of fine tuning in order to cause a stop  301  of the intensity fine tuning  130  at the value at which mechanical vibrations  35  were being delivered when this scan stop-instruction has been inputted, and the stimulation, i.e. the delivering of vibrations  35 , continues at a fixed intensity value equal to the further tinnitus-mitigating intensity, which is identified as described above.
 
On the contrary, if the user does not perceive any further significant decrease  131  of tinnitus, in the absence of the intensity scan stop-instruction for the intensity fine tuning step, the generation of mechanical vibrations  35  continues with a step  132  of changing the intensity A range to be scanned as a new neighbourhood of the value that has caused the previous decrease, and with a step  130  of fine tuning intensity A by scanning this new neighbourhood. The step proceeds this way, with new steps of intensity fine tuning  130 , as long as the user does not perceive any significant decrease  131  of tinnitus.
 
     In an exemplary embodiment of the system, which is not shown in the diagrams described above but can be easily derived therefrom, a step can be provided of adjusting or scanning intensity A, and preferably also the step of fine tuning, i.e. finely adjusting intensity A, without carrying out the step of fine tuning or finely adjusting the frequency of actuation signal  45  and, therefore, of mechanical vibrations  35 . 
       FIG. 7  shows a flow diagram of the operation of microcontroller  70 , in an exemplary embodiment of the system including a step  140  of adjusting the waveform of actuation signal  45  and, therefore, of mechanical vibrations  35 . In this case, a user&#39;s instruction triggers a step  200  of generating mechanical vibrations  35 , which starts at the same time as the frequency-adjusting step and includes a step of scanning a predetermined frequency f range, which can be selected by the user. Before this frequency adjustment, or at each frequency scanning stage, microcontroller  70  can carry out the waveform adjustment step  140  by selecting the waveform from a predetermined library that is resident in input interface  50 , in order to generate the mechanical vibrations. In the former case, more in detail, if the user does not perceive any significant decrease  141  of tinnitus, a step  142  is provided of changing the waveform type, until the desired effect of tinnitus decrease  141  is obtained. Then, the user can notify this event to microcontroller  70  by providing a waveform adjustment scan stop-instruction in order to cause a stop  302  of the step  140  of scanning the waveform types at the type with which mechanical vibrations  35  were being delivered when this stop-instruction has been inputted, and the stimulation, i.e. the delivering of vibrations  35  continues with this waveform type. 
     The diagram of  FIG. 8  relates to a modification of the system in which the possibility is provided of changing the intensity of actuation signal  45  and, therefore, of mechanical vibrations  35 , if, after generating mechanical vibrations  35  and after modifying the frequency thereof by fully scanning a predetermined frequency range, the user has not perceived any significant decrease of the tinnitus symptoms. In this case, if no decrease  122  of the tinnitus symptoms is obtained after providing an instruction to start the step  200  of generating mechanical vibrations  35  and the contemporary step  121  of adjusting their frequency, the user can cause a change  152  the intensity of the signal and allow generation  200  of mechanical vibrations  35  to go on by starting a new frequency adjustment step  121  using the new value of the intensity, and then he/she can stop this frequency adjustment of mechanical vibrations  35  by providing a frequency scanning stop-instruction, upon perceiving a significant decrease  122  of tinnitus. If, after a first step  121  of adjusting the frequency of mechanical vibrations  35 , the user does not perceive any significant decrease of tinnitus and if a check step  150  detects that the frequency range has not been fully scanned, a step  151  is provided of changing the frequency f range of mechanical vibrations  35 . 
     In particular, microcontroller  70  is configured to deliver vibrations  35  at an intensity lower than the patient&#39;s auditory threshold. In an exemplary embodiment, not shown, a step of acclimation is provided at the beginning of the step  200  of delivering mechanical vibrations, i.e. immediately after receiving the start-instruction therefor, and microcontroller  70  is configured to deliver vibrations  35  having an intensity higher by at most 10% than the absolute value in dB HL of patient&#39;s auditory threshold, in order to help the patient to identify mechanical vibrations  35  generated by electromechanical device  30 . 
       FIG. 9  is a diagram showing the delivery times ON and the stand-by times OFF of electromechanical device  30 , in a manual operation mode. More in detail, delivery time intervals  160  (ΔT ON ),  160 ′ are defined, as well as stand-by time intervals  162  (ΔT OFF MANUAL ) of electromechanical device  30 , which the user can select according to his/her own needs by providing instructions through input element  80 . 
       FIG. 9A  is an example of a flow diagram for the operation of electromechanical device  30  in manual operation mode, according to  FIG. 9 . In this mode, the user provides switch-on instructions  160  and switch-off instructions  162  based on his/her perception of tinnitus symptoms  163 , and according to delivery time intervals  160  based on his/her own perceptions. 
     Instead,  FIG. 10  is a diagram showing delivery values ON and stand-by values OFF of electromechanical device  30  in an automatic operation mode. In particular, electromechanical device  30  can be programmed for automatically transmitting mechanical vibrations  35  at predetermined time intervals, providing both time intervals  160  or ΔT ON  during which electromechanical device  30  is working and delivering stimulations at frequency f, intensity A and with a predetermined waveform, as well as stand-by time intervals  162  during which electromechanical device  30  is not working, i.e. stand-by time intervals can be defined (ΔT OFF AUTOMATIC ). 
     In particular, in the automatic operation mode, customized therapeutic stimulation programs can be obtained, in which mechanical vibrations  35  are delivered at frequencies f, intensities A and with predetermined waveforms for predetermined periods of time, which alternate with stand-by steps. In particular, if the user perceives a significant decrease or a stop of tinnitus symptoms after a predetermined time interval in which the device is inactive, the stand-by times of the device can be prolonged, or they can be shortened, if, on the contrary, tinnitus occurs again during one of these stand-by periods. 
       FIG. 10A  shows a flow diagram for the operation of electromechanical device  30  in an automatic operation mode. During a time interval  160  of delivering mechanical vibrations, in which electromechanical device  30  is on, the system counts the time  161  elapsed after the beginning of this interval, and if this time exceeds a prefixed delivery time threshold, a stand-by step  162  of electromechanical device  30  begins. In the opposite case, electromechanical device  30  continues the delivering step  160 . The stand-by step  162  of electromechanical device  30  continues until OFF mode time  170  exceeds a programmed duration. Before activating electromechanical device  30  again, in order to begin a new delivering step, an interrogation step  171  is provided, in which the user is asked whether he/she is still hearing the tinnitus symptoms. If that is the case, a new delivery step  160  step begins, whereas, if tinnitus disappears, a step  172  takes place of prolonging the stand-by times. 
     The foregoing description of some exemplary specific embodiments will so fully reveal the invention according to the conceptual point of view, so that others, by applying current knowledge, will be able to modify and/or adapt in various applications the specific exemplary embodiments without further research and without parting from the invention, and, accordingly, it is meant that such adaptations and modifications will have to be considered as equivalent to the specific embodiments. The means and the materials to realise the different functions described herein could have a different nature without, for this reason, departing from the field of the invention. It is to be understood that the phraseology or terminology that is employed herein is for the purpose of description and not of limitation.