WO2019220331A1

WO2019220331A1 - Vibro-tactile device for the treatment of hearing disorders

Info

Publication number: WO2019220331A1
Application number: PCT/IB2019/053973
Authority: WO
Inventors: Claudio PAGANELLI
Original assignee: Horentek S.R.L.
Priority date: 2018-05-15
Filing date: 2019-05-14
Publication date: 2019-11-21

Abstract

The present invention relates to a wearable device configured for the treatment of hearing disorders through the tactile stimulation associated to the detection of an acoustic signal.

Description

VIBRO-TACTILE DEVICE FOR THE TREATMENT OF HEARING

DISORDERS

DESCRIPTION

Field of application

The present invention relates to the field of the medical devices for the treatment of the disorders linked to the dysfunctions of the hearing apparatus.

Background

The coming of cochlear implants has revolutionized the rehabilitation strategy of the disabling paediatric deafness.

The experiences confirming the absolute effectiveness of the surgical treatment are several, which in any case has to be associated to a serious post implant rehabilitation treatment and to a correct technology management in order to be successful.

The spreading of the neonatal screenings has confirmed that it is possible to establish the presence, or not, of deafness as from the first months of life. In this sense scientific studies suggest to start the rehabilitation treatments already in the above-mentioned period, so as to exploit to the maximum the capability of neurological plasticity proper to the neonatal or paediatric age.

Moreover, most part of the treatment protocols provide a test period of few months with the acoustic prostheses before deciding the eligibility, or not, of the partially hearing subject to the cochlear implant which, however, is recommended when the physical features of the child are so as to allow the operation with minimum surgical risks. The acoustic prosthetization then remains an essential operation until the child has developed the physical requirements necessary to be subjected to the cochlear implant operation without serious risks.

Up to now, however, there are no effective solutions in paediatric field supporting the therapeutic approach of hearing disorders, in the period preceding the operation for inserting the cochlear implant.

Said pre-surgical treatments, to say the truth, should be fundamental as they would allow to exploit and develop best the innate brain plasticity of the child, in an age range of vital importance for his/her cognitive growth.

A child, profoundly deaf as from birth, in fact has to be helped to obtain more consciousness and perception of the outer world, the so-called awareness, and the stimulation through other sensors can be of help in this sense. An example is certainly the sense of touch: stimuli of mechanical type such as for example vibrations on the body, connected to acoustic stimuli, allow a response of the child, who in this way succeeds in realizing that around him/her something is occurring and then he/she has to pay attention. This allow his/her a development of cognitive as well as muscle type.

Obviously, devices have known for some time apt to transform sound stimuli into stimuli of vibro-tactile type.

US5784478 for example describes a device for reconstructing the sounds existing in the surrounding environment, comprising one or more microphones and a bone transducer or loudspeaker, for converting audio electric signals into vibrations which are transmitted to the body of a subject, preferably through the stern. The device then allows the profoundly deaf subject to perceive audible sounds, including the sounds of his/own voice and the voices of the others, through his/her sense of touch, wherein the transducer is assembled against the body of the subject, preferably against the sternum. However, the field of the pre-surgical treatment of paediatric subjects, who are profoundly deaf as from birth, intended for surgical operations of cochlear implant, remains still wholly unexplored.

Brief description of the invention

The object of the present invention is then to solve the above-mentioned problems by providing a wearable vibro-tactile device for the treatment of hearing disorders, in particular in paediatric field, as defined in claim 1 . Secondary features of the device according to the present invention are further defined in the depending claims.

The present invention thanks to the joint use of the above-mentioned device in combination with hearing aids of known type, allows a rehabilitation of the partially hearing subjects by allowing to obtain results even in terms of brain and muscle stimulation, by activating more fibres concerning the brain stem and thus providing a neurosensorial stimulation additional to that of the hearing aids.

According to an additional aspect of the present invention, a kit is then provided comprising a vibro-tactile device according to claim 1 provided in a joint use with a hearing aid, preferably of digital type.

Said kit is particularly suitable in the rehabilitation treatment of paediatric subjects, profoundly deaf as from birth, in the period preceding the surgical intervention for inserting the cochlear implant.

Therefore, it is clear that said kit relates to the presentation of a method for the rehabilitation treatment of profoundly deaf paediatric subjects comprising the use of the kit according to claim 9 in the period of pre-surgical operation for the insertion of a cochlear implant. The present invention relates to a device wearable configured for the treatment of hearing disorders comprising a wearable element at the thorax of a user and means for detecting an input acoustic signal operatively connected to the wearable element.

In the present context, under “acoustic signal” a simple or complex combination of sound waves or one sound, of any duration or nature, is meant.

In a preferred embodiment, the device according to the present invention comprises two wearable elements operatively connected therebetween, one thereof is provided with means for detecting an acoustic signal and for its processing aimed at the correct driving of the second wearable element, applied to the thorax of the user, and responsible for the transmission of the mechanical vibration.

In the specific case, the first wearable element comprises a programmable control unit, applicable for example through comfortable grip in the point most congenial to the patient along the trunk and configured to process the input acoustic signal detected by the detection means and to provide an electric signal which, reaching the transducer, is then converted thereby into mechanical vibration released on the patient’s sternum with an intensity adjustable by the control unit.

Such solution improves the perception threshold and allows a more effective activation of the awareness, of the attention and detection, which constitute the fundamental audible pre-requirements for activating the linguistic cognitive processes leading to the verbal comprehension, even if in absence of a useful prosthetized hearing.

Advantageously, the suitable adjustment and use in combination of the device according to the present invention with a hearing aid, that is the use of the kit according to claim 9, allows the partially hearing subjects in neonatal or paediatric age, even those with the most important losses, to activate in each case the arousal, that is the attention and audible detection which represent the bases allowing the experienced speech therapist to perform his/her own rehabilitation strategy even thanks to the learning of the lip-reading which the effects of the combined sound-vibratory action ease.

Additionally, the above-mentioned device allows to improve the hypotonia of the neck’s muscles produced by the sensory activation leading the user to look for the origin of the sound which has generated the stimulation, by increasing the attention and, consequently, by increasing all base capabilities therefrom especially the cognitive processes linked to communication will take advantage.

Still, thanks to the rehabilitation activity provided by the device according to the present invention in joint use with the hearing aid, that is thanks to the use of the kit of the invention, the subject eligible for the cochlear implant could arrive at the time of the surgical operation ready to develop his/her hearing capabilities, as the cognitive ones were set in the pre-surgical period and, consequently, even the subsequent recovery time is subjected to a positive considerable reduction.

The speech learning and coding subsequent to the cochlear implant, thanks to the use of the kit of the invention, then is considerably better.

Advantageously, the vibro-tactile device of the invention can continue to be used in combination with the cochlear implants, in the post-surgical operation period, with the purpose of improving and speeding-up the rehabilitation course in particular with reference to the recovery of the verbal skills.

In an alternative embodiment of the invention the above-mentioned device could be used even alone, that is without the use in association to hearing aid devices or cochlear implants, as alternative to other vibro-tactile devices currently available on the market.

Other advantages, together with the features and use modes of the present invention, will result evident from the following detailed description of preferred embodiments thereof, shown by way of example and not for limitative purposes.

Brief description of the figures

The drawings shown in the enclosed figures will be referred to, wherein:

Figure 1 shows an overall view of a wearable device configured for the treatment of hearing disorders according to a preferred embodiment according to the present invention;

Figure 2 shows a photograph of an enlarged detail of the operative connection of the transduction means and of the band according to a preferred embodiment of the device of Figure 1 ;

Figures 3, 4 and 5, respectively, show an overall view, a side view and a view from the bottom of the control unit of the device of Figure 1 ;

Detailed description of embodiments of the invention

The present invention will be described hereinafter by making reference to the above-mentioned figures.

By firstly referring to Figure 1 a device 1 is illustrated configured for the treatment of hearing disorders, according to a preferred embodiment thereof. The device 1 is wearable, that is portable, and it finds preferred intended use for subjects affected by hypoacusis, or deafness, of various nature and gravity in neo-natal or paediatric age.

More in details, the device comprises a wearable element, designated with the reference 2, at the thorax of the subject. In the preferred embodiment, the element 2 is a band, for example made of washable fabric and with elastic properties, which is worn to surround the thorax at or near the sternum. In use, preferably the band is never in contact with the skin of the subject.

In another embodiment said device could be inserted in wearable clothing, like rompers, crawlers, vest or the like.

Advantageously the band 2 can be adjusted by (not illustrated) adjusting means, such as for example Velcro®.

With additional reference to Figures 3, 4 and 5, the device 1 further comprises a programmable control unit 4, configured to process an acoustic signal entering the device. To this purpose means 3 is provided for detecting said input acoustic signal operatively connected to said wearable element 2 and associated, preferably incorporated, to the control unit 4.

Under acoustic signal, as previously mentioned, a simple or complex combination of sound waves or one sound, of any duration or nature, such as for example voices, music, environmental noises or noises in general.

In the illustrated embodiment, the detection means 3 comprises a microphone positioned on a perimetral edge of the control unit 4, preferably in the same region 40 which comprises even input doors for auxiliary components which will be described more in details hereinafter in the present description. The region 40 preferably is a recess of the casing of the control unit 4 positioned at one end of a longitudinal symmetry axis of the casing itself.

The control unit 4 comprises means for detecting an acoustic signal, preferably a microphone (designated with the reference 3 in Figure 4), which allows to detect the acoustic signal and subsequently sends an electric signal to the sternal transducer which then converts it into mechanical vibration signal, which can be heard by the end user through said wearable element 2. Preferably, the control unit 4 is configured to convert the input acoustic signal into a mechanical vibration signal starting from a predetermined function of the input acoustic signal.

Such function can be parametrized on the features of the input acoustic signal, such as for example frequencies, intensity, duration of the latter.

The mechanical vibration signal, in reality, is a vibration which, through suitable components illustrated hereinafter, is transferred to the body of the subject.

It will be appreciated that the programmability of the control unit 4 allows to obtain great flexibility and use effectiveness of the device 1 . In fact, before using the latter, the operator (for example the hearing aid technician or the medical specialist) can arrange for programming the control unit 4 according to the medical prescriptions, for example by taking into consideration the patient’s age, health state and/or residual hearing, so as to adjust the tactile sensation provided by the wearable element according to the specific needs of the subject.

To this purpose the control unit 4 is preferably provided with a microprocessor and a memory area configured to store one or more profiles containing sets of parameters related to the operating modes of operation of the device 1 .

Connection means suitable to establish an operating connection with auxiliary devices for programming (for example servers or terminals) the device 1 , is preferably provided in the region 40 of the control unit 4, illustrated with the reference 44 in figure 4.

In the region 40 of the control unit 4 means 43 for adjusting the intensity of the signal of mechanical vibration is preferably further provided. In this way, it is possible to obtain a better customization of the use conditions of the device 1 as it is possible to adjust the tactile sensation perceived by the subject relatively to the same detected signal. The adjusting means 43 can include an adjusting trimmer, which can be rotated in the clockwise/counterclockwise direction to increase/decrease the intensity of the signal of mechanical vibration.

In preferred embodiments an ad hoc implementation of dedicated programming on the several memories of the device can be performed, such as for example:

- the possibility of performing different tests on different memories to monitor the different patient response modes;

- the possibility of emphasizing or removing determined frequencies in customized way (for example, should the child live near a known noise source which one would like to eliminate, or, on the contrary, should one want to emphasize some sounds particularly dear to the child, such as for example mum’s steps, and so on);

- the possibility of performing a programming of the device which follows that of the hearing aid combined thereto, so as to optimize to the maximum the joint use of the two tools;

- the possibility of a gradual programming covering both the pre-implant period, with greater attention to the development of the awareness and to the preservation of the residual hearing, and the post-implant period, with a programming more correlated to the development of the verbal skills.

The control unit 4 too is wearable thanks to removable anchoring means 42, illustrated in Figure 5 in form of clip or applicable to a piece of clothing.

The removable anchoring means 42 is configured to allow an orientation of the control unit 4 so that the detection means 3, in particular the microphone therewith it is provided, is directed to a direction, or way, for detecting the acoustic signal which is not directed to the position of transduction means 3 of the device 1 . As it can be seen in Figure 2, the wearable element 2 in fact provides a housing 21 apt to include means 5 for transducing the input acoustic signal, said transduction means 5 being operatively connected to said control unit 4 and/or to the detection means 3.

In other embodiments two or more transducers, as well as two or more microphones, can be provided, so as to be able to provide to the patient a greater sense of spatiality in relation to the origin and derivation of sounds.

The operative connection is meant to show that the wearable element 2 vibrates in response to a detection of the input acoustic signal detected by the detection means 3. In this sense and in the illustrated embodiment, the operative connection is obtained through a connecting cable 6 the ends thereof insert respectively into the transduction means 5 and in the control unit 4, preferably in the region 40a opposed to the region 40 of the casing of the control unit 4. In the illustrated example, the casing of the control unit 4 further provides relief means 49 to show the correct direction for inserting the end of the connecting cable 6.

In other embodiments such operative connection can be equally obtained with other modes, for example through connections of wireless type.

Preferably such wireless connection will be between the control unit 4 and the transduction means 5.

The housing 21 wherein the transduction means 5 is inserted removably, develops in length at least for a central tract of the wearable element 2, and it is for example in the form of a slot shaped so as to keep indeed removably inside thereof at least partially the connecting cable 6 and indeed the transduction means 5. The housing 21 is implemented so that, under the condition of worn device 1 , it results to be positioned at the sternum of the subject.

The device 1 is powered by a rechargeable battery, preferably by a 3.7-V (Polymer Li-ion)-Lithium battery housed in a compartment obtained in the control unit 4. A complete charging cycle is provided preferably in a period of time of at least three hours, preferably from four to five hours.

A preferably magnetic connector 45 is provided on the bottom of the control unit 4 for the connection to a recharge cable of the device 1 , as well as a control switch 46 for switching-on and switching-off the latter.

In other embodiments the connector can be even of NFC type.

The control unit 4 further provides indicating means 47, 48 associated to the charge level of the power supply and to the operation condition. Preferably the indicating means 48 is indicator lights which, during the battery charge light up with blue and red colours, and they are placed at the region 40 of the casing of the control unit. Once reached the charge of the device 1 , the same indicator lights could assume a combination of different colours (green and red for example).

The indicator light 47 is a led - preferably having red colour - which switches on and it is visible on the casing under discharged battery conditions.

The mentioned indicator lights can perform even the function of indicator for possible faults of the device or not correct recharge modes, being able to assume different colours depending upon the nature of the found problem.

For example, the light indicators 48 can assume one single colour (for example red) which can show the presence, or not, of malfunctions of the battery or the fact that the device has been put in recharge not correctly.

In each case, when the device 1 is wholly charged, the indicator light 48 changes its colour, going for example from the blue-red colour to the green-red colour.

In other embodiments the recharge can take place thanks to a connection of wireless type.

The present invention has been sofar described according to preferred embodiments, shown by way of example and not for limitative purposes. It is to be meant that there may be other embodiments, even obtainable with different combinations with respect to the described ones, all to be considered within the protective scope of the same, as defined by the enclosed claims.

Claims

1. A wearable device (1 ) configured for the treatment of hearing disorders, which device (1 ) comprises:

- a wearable element (2) at the thorax of a user;

- means (3) for detecting an input acoustic signal operatively connected to said wearable element (2);

- a programmable control unit (4) configured to process the input acoustic signal detected by said detection means (3) and to provide an output signal to said wearable element (2),

wherein said output signal is an electric signal, converted by a transducer into mechanical vibration signal obtained by a predetermined function of the input acoustic signal.

2. The device (1 ) according to claim 1 , wherein said wearable element is in the form of an adjustable band configured to wrap the thorax of the user at the sternum.

3. The device (1 ) according to claim 1 or 2, wherein said control unit (4) comprises means (5) for transducing the processed signal, said transduction means (5) being housed in a housing (21 ) obtained in said wearable element (2).

4. The device (1 ) according to claim 3, wherein said housing (2) is positioned, under the condition of worn device (1 ), near the sternum and it is configured to receive removably said transduction means (5).

5. The device (1 ) according to anyone of the previous claims, wherein said control unit (4) comprises means (43) for adjusting the intensity of the signal of mechanical vibration.

6. The device (1 ) according to anyone of the previous claims comprising means of rechargeable self-power supply.

7. The device (1 ) according to anyone of the previous claims, wherein said control unit (4) comprises means (47, 48) for indicating the power supply charging level.

8. The device (1 ) according to anyone of the previous claims, wherein said control unit (4) comprises means (42) for removably anchoring to a piece of clothing.

9. A kit for use in the treatment of hearing disorders, preferably intended to subjects of paediatric age, comprising a device (1 ) according to anyone of the previous claims and an auxiliary acoustic device.

10. The kit according to the preceding claim wherein said auxiliary device comprises a hearing aid preferably of digital type.

11. The kit according to claim 9 or 10 for use during a pre-operative condition of acoustic prosthetization of a subject.

12. The kit according to claim 9 wherein said auxiliary device comprises a cochlear implant.

13. The kit according to claim 9 or 12 for use during the post-operative condition of acoustic prosthetization of a subject.