WO2024038263A1

WO2024038263A1 - Ear apparatus

Info

Publication number: WO2024038263A1
Application number: PCT/GB2023/052141
Authority: WO
Inventors: Nicholas GOMPERTZ
Original assignee: Earswitch Ltd
Priority date: 2022-08-14
Filing date: 2023-08-14
Publication date: 2024-02-22

Abstract

An ear apparatus (2), at least part of which is an ear portion locatable in or near an ear-canal and/or pinna of an individual, the apparatus (2) comprises a processor, capable of controlling an output of the apparatus in response to an input and/or control signal. The ear portion comprises one or more means for stimulating (1) nerves of said ear-canal wall and/or pinna of said individual, directly and/or indirectly, and the one or more means for stimulating (1) being controllable by the processor in response to the input and/or control signal to provide localised stimulation (9) of one or more nerves of said ear-canal wall and/or pinna.

Description

EAR APPARATUS

The present invention relates to an ear apparatus and associated method. In particular, it relates to an ear apparatus and method for providing localised stimulation of one or more nerves of an ear-canal wall and/or pinna.

People who have congenital deafness caused by dysfunction of the cochlea may be offered cochlear implants to transmit sound received from microphones external to the ear, to generate electrical signals within electrodes of cochlear implants, which generate electric signals in the cochlear nerve. These signals are perceived by the person as sound.

Cochlear implants are limited by many factors including the risks of surgical implantation, the invasive method, the risk of early and late infection, including meningitis, the detection of extraneous noise by the external microphones, loss of usual peripheral auditory processing from the pinna and ear-canal and subsequent reduced directional hearing discrimination, and the low resolution of hearing. This results in hearing perception of lower quality than normal hearing and without directional perception of hearing.

It is known that the brain is trainable to convert sensation from one modality to an appreciation of a different sensation. For example prior art exists of a wrist band that vibrates in response to sound which provides additional hearing information for people with limited hearing and aids the understanding of the spoken word. These are limited to peripheral audio input and, such a site, is adversely affected by movement and noise itself. Prior art exists for an ear mould with two frequency vibrotactile stimulation in response to sound, giving only limited transmission of sound related information. Prior art is unable to provide complex appreciation of sound to a wearer of a device.

People with hearing augmentation devices (including hearing aids and cochlear implants) have reduced appreciation of directionality of incoming sound. There is no current method of providing information of directionality to the ear or ears of the wearer.

Vagal nerve stimulation has been proposed as a method of affecting individual’s stress levels, and treating depression and intractable epilepsy and many other benefits. Current invasive methods include implanted electrodes around the carotid artery, and external electrical stimulation applied to a similar area on the neck. Electrical stimulation at sites around the pinna (external ear) have also been proposed, because the vagus nerve has cutaneous (skin) branches to the pinna.

These methods of stimulation are limited by requiring implantation or external application of electrical current (felt as electric shocks and/or muscle contraction of the neck or ear). The vagus nerve is a complex nerve with multiple functions and current described methods and devices deliver non-specific and simple stimulation to one area. There is no current method of applying vagal stimulation in a graded fashion to different areas of vagal innervation or different branches of the vagus nerve.

There is benefit for people to receive cues to the direction and/or proximity of actual or virtual objects, sounds, concepts or other real or imaginary stimuli, for example the proximity and direction of a person behind them, or an imaginary or virtual object within a virtual reality visual experience. Prior art exists for the conversion of optical information from spectacles worn by a user who has reduced vision to tactile or audible stimuli. There is no in-ear device that provides this benefit. Such a device would be beneficial for people who have reduced visual function, or for people in occupations or environments when appreciation of the proximity of an object or another person may alert to a hazard.

People who suffer with Parkinson’s disease may benefit from improved mobility by listening to or receiving rhythmic sound, music and/or vibration or tactile stimulation. These are currently provided by sound including from audio headphones, or devices that cause vibration and/or tactile sensation worn on body sites. There is no current in-ear device that provides complex output to alleviate disordered movement for people with Parkinson’s disease.

The current invention is aimed at a method and apparatus of providing stimulation at different sites of the pinna and/or ear-canal, and of different characteristics related to defined stimuli. The invention is aimed at providing external sensory data, such as sound or light, as information conveyed by complex stimulation of the ear structures in the pinna and/or ear-canal. In addition, or as an alternative, the invention may be aimed at providing stimulation of multiple branches of the vagal nerve within the pinna and/or ear-canal, or other localised stimulation of one or more nerves of said ear-canal wall and/or pinna other .

According to a first aspect, the present invention provides an ear apparatus, at least part of which is an ear portion locatable in or near an ear-canal and/or pinna of an individual, the apparatus comprises a processor, capable of controlling an output of the apparatus in response to an input and/or control signal; wherein, the ear portion comprises one or more means for stimulating nerves of said ear-canal wall and/or pinna of said individual, directly and/or indirectly, the one or more means for stimulating being controllable by the processor in response to the input and/or control signal to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

Preferably, the one or more means for stimulating are controllable by the processor in response to the input and/or control signal to provide localised stimulation of one or more cutaneous nerves of said ear-canal wall and/or pinna.

Preferably, the one or more means for stimulating are individually controllable to stimulate one or more regions of said ear-canal wall and/or pinna in one or more predetermined sequences and/or patterns of stimulation.

Preferably, the one or more means for stimulating are individually controllable to stimulate a plurality of different regions of said ear-canal wall and/or pinna either individually or in combination(s).

Preferably the one or more means for stimulating are individually controllable to independently stimulate nerves in one or more regions of said of said ear-canal wall and/or pinna.

Preferably, the one or more means for stimulating are individually controllable to independently stimulate cutaneous nerves in one or more regions of said of said ear-canal wall and/or pinna.

Preferably, stimulation is capable without interference with nerves in one or more adjoining regions.

Preferably, stimulation is capable without interference with cutaneous nerves in one or more adjoining regions.

Preferably, the one or more means for stimulating are individually controllable to simultaneously stimulate one or more regions of said ear-canal wall and/or pinna at the same time. Preferably, the one or more means for stimulating are individually controllable to simultaneously stimulate two or more regions of said ear-canal wall and/or pinna at the same time.

Preferably, the one or more means for stimulating are locatable to stimulate, individually or in combination(s), one or more nerve fibres of an auricular branch of the vagus nerve, an auriculotemporal nerve, a facial nerve sensory branch and/or a greater auricular nerve.

Preferably, the one or more means for stimulating is/are arranged substantially circumferentially and/or radially on or around at least part of an exterior surface of the ear portion.

Preferably, the one or more means for stimulating are arranged substantially longitudinally on or along at least part of an/the exterior surface of the ear portion.

Preferably, at least part of the one or more means for stimulating is/are internally located in the ear portion.

Preferably, the at least part of the one or more means for stimulating is/are directed towards an/the exterior surface of the ear portion.

Preferably, the ear portion comprises a plurality of means for stimulating.

Preferably, the plurality of means for stimulating are arranged to form an array configured to stimulate one or more regions of said ear-canal wall and/or pinna individually or in combination(s).

Preferably, the array comprises: one or more rows of means for stimulating, being arranged along at least part of a length of the ear portion, so as to provide stimulation at various depths of said ear-canal wall; or one or more rows of means for stimulating, being arranged circumferentially and along at least part of a length of the ear portion, so as to provide circumferential stimulation at various depths of said ear-canal wall; and/or the ear portion being configured to stimulate at least part of an outer (cartilaginous) ear-canal wall and/or at least part of an inner two-thirds (bony) earcanal wall. Preferably, the array comprises a plurality of means for stimulating arranged on or around at least part of an/the exterior surface of the ear portion.

Preferably, the array comprises a plurality of means for stimulating arranged circumferentially and longitudinally over substantially all of: an/the exterior surface of the ear portion, or the ear portion itself, if not surface-mounted, or combinations thereto.

Preferably, the array of means for stimulating is configured to stimulate different cutaneous nerve fibres or different combinations of nerve fibres in response to the control and/or input signal. Most preferably, the array of means for stimulating is configured to stimulate different cutaneous nerve fibres or different combinations of nerve fibres in response to the control and/or input signal.

Preferably, the array comprises: one or more rows of means for stimulating, being arranged along at least part of a length of the ear portion, so as to provide stimulation at various depths of said ear-canal wall; or one or more rows of means for stimulating, being arranged circumferentially and along at least part of a length of the ear portion, so as to provide circumferential stimulation at various depths of said ear-canal wall; and/or the ear portion being configured to stimulate at least part of an outer (cartilaginous) ear-canal wall and/or at least part of an inner two-thirds (bony) ear-canal wall. Preferably, the means for stimulating is configured to provide non-electrical stimulation of cutaneous nerves.

Preferably, the means for stimulating is configured to provide light stimulation (in visual or non-visual wavelengths).

Preferably, the means for stimulating is configured to provide non-invasive stimulation of nerves. Most preferably, the means for stimulating is configured to provide non-invasive stimulation of cutaneous nerves.

Preferably, the means for stimulating comprises one or more vibrational, electrical, thermal, tactile, sound and/or electromagnetic output devices.

Preferably, the means for stimulating comprises one or more transducers.

Preferably, the apparatus further comprises one or more input means, control means, detectors or processors, for creating the input and/or control signal for the processor.

Preferably, the input or control means is user-operable. Further preferably, the one or more detectors are configured to detect physiological signals of said individual.

Preferably, the detector comprises a sound sensor, including ultrasound, visible and/or non-visible electromagnetic radiation sensor, motion sensor, orientation sensor and/or positioning sensor, or any other sensor or sensor combination.

Preferably, the processor is capable of analysing the input and/or control signal and reacting to one or more characteristics of that signal to appropriately control the one or more means for stimulating.

Preferably, the processor is capable of controlling the one or more means for stimulating to adjust a relative position, location and/or depth of stimulation output according to those one or more characteristics.

Preferably, the means for stimulating is controllable to provide one or more characteristics of output of the group comprising: relative position, location and/or depth of stimulation with respect to an input signal or control signal; frequency, wavelength and/or amplitude of stimulation; harmonics, phase, interference, and/or audio pressure effects of stimulation; intensity, tactile pressure and/or force of stimulation; vibration, sequence and/or pattern of stimulation; current and/or voltage of stimulation; tissue temperature variations, by site and/or by region of said ear-canal wall and/or pinna; relative position, location and/or depth of stimulation with respect to a detected position, proximity, movement or other detectable characteristic of a nearby object or person in said individual’s surroundings, in real or virtual space; relative position, location and/or depth of stimulation with respect to detected positioning and/or directional information of said individual; relative position, location and/or depth of stimulation with respect to a fixed position, plane or gravitational field, in real or virtual space; and/or predefined rhythmic vibration, sequence and/or pattern of stimulation with respect to a detected adverse movement and/or orientation of said individual.

Preferably, the apparatus comprises first and second ear portions which are operatively connected, the first ear portion is locatable in an ear-canal of said individual and a second ear portion is locatable in the region of a pinna of said individual.

Preferably, the first ear portion and/or second ear portion comprise one or more means for stimulating.

Preferably, at least part of the apparatus is configured to be hand-held.

Preferably, the ear portion comprises a member, preferably a helical member, locatable within said ear-canal so as to bring into contact or proximity the one or more means for stimulating and said ear-canal wall of said individual. Preferably, the member is self-expandable such that, after initial insertion, it expands to bring into contact or proximity the one or more means for stimulating and said ear-canal wall of said individual.

Preferably, the apparatus further comprising: a dispensing tube, being configured to be received within said ear-canal and housing the (preferably helical) member prior to deployment of the (preferably helical) member; and/or an imaging device capable of being inserted through a middle of the (preferably helical member), providing imaging of said ear-canal wall and/or an ear-drum.

Preferably, the (preferably helical) member is: resilient, being expandable; or of fixed size; and flexible or elastic; or inflexible within the ear-canal or inelastic.

According to a second aspect, the invention provides a method for providing localised stimulation of one or more nerves of said ear-canal wall and/or pinna, the method comprising: locating an ear portion, of an ear apparatus, in or near an ear-canal and/or pinna of an individual; analysing an input and/or a control signal; and controlling an output of the ear apparatus in response to that input and/or control signal; wherein the output comprises stimulating nerves of said ear-canal wall and/or pinna of the individual, directly and/or indirectly, to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

Preferably, the method comprising stimulating nerves of said ear-canal wall and/or pinna of the individual, directly and/or indirectly, to provide localised stimulation of one or more cutaneous nerves of said ear-canal wall and/or pinna.

Preferably, the method comprising individually stimulating one or more regions of said ear-canal wall and/or pinna in one or more predetermined sequences and/or patterns of stimulation.

Preferably, the method comprising individually stimulating a plurality of different regions of said ear-canal wall and/or pinna, either individually or in combination(s).

Preferably, the method comprising independently stimulating nerves in one or more regions of said of said ear-canal wall and/or pinna.

Preferably, the method comprising stimulating without interference with cutaneous nerves in one or more adjoining regions. Most preferably, the method comprising stimulating without interference with cutaneous nerves in one or more adjoining regions. Preferably, the method comprising individually controlling stimulation to simultaneously stimulate one or more regions of said ear-canal wall and/or pinna at the same time.

Preferably, the method comprises individually controlling stimulation to simultaneously stimulate two or more regions of said ear-canal wall and/or pinna at the same time.

Preferably, stimulating, individually or in combination(s), one or more nerve fibres of an auricular branch of the vagus nerve, an auriculotemporal nerve, a facial nerve sensory branch and/or a greater auricular nerve.

Preferably, the method comprising providing non-electrical stimulation of cutaneous nerves. Further preferably, the method comprising non-invasive stimulation of nerves. Most preferably, the method comprising non-invasive stimulation of cutaneous nerves.

Preferably, controlling the output in response to a user-generated input and/or control signal. Preferably, controlling the output in response to one or more detected physiological signals of the individual.

Preferably, the method comprising: analysing the input and/or control signal; reacting to one or more characteristics of that signal: and controlling the output dependent upon the one or more characteristics of that signal.

Preferably, the method comprising controlling the output to adjust a relative position, location and/or depth of stimulation output according to those one or more characteristics.

Preferably, the method comprising controlling the output to provide one or more characteristics of output of the group comprising: relative position, location and/or depth of stimulation with respect to an input signal or control signal; frequency, wavelength and/or amplitude of stimulation; harmonics, phase, interference, and/or audio pressure effects of stimulation; intensity, tactile pressure and/or force of stimulation; vibration, sequence and/or pattern of stimulation; current and/or voltage of stimulation; relative position, location and/or depth of stimulation with respect to a detected position, proximity, movement or other detectable characteristic of a nearby object or person in said individual’s surroundings, in real or virtual space; tissue temperature variations, by site and/or by region of the ear-canal wall and/or pinna; relative position, location and/or depth of stimulation with respect to detected positioning and/or directional information of said individual; relative position, location and/or depth of stimulation with respect to a fixed position, plane or gravitational field, in real or virtual space; and/or predefined rhythmic vibration, sequence and/or pattern of stimulation with respect to a detected adverse movement and/or orientation of said individual. Preferably, the method comprising utilising a contact medium between the ear portion, and ear-canal and/or pinna of the individual, the contact medium being responsive to the output to generate electrical signals in the tissue of the ear-canal and/or pinna. Preferably, the method comprising utilising interference of ultrasound or other sound emissions and /or beamforming, to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

Preferably, the method comprises a non-therapeutic method for providing localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

Preferably, the method comprising inserting a helical member ear portion into the ear of the individual, and bringing into contact or proximity one or more means for stimulating the ear-canal wall of the individual.

Preferably, a method in which the helical member is housed in a dispensing tube, the method comprising inserting the dispensing tube into the ear of the individual, and pushing the helical member along an inside of the dispensing tube into the ear-canal of the individual.

Preferably, inserting an imaging device or other sensor through a middle of the helical member, so as to capture data from the ear-canal of the individual.

The current invention is the method and apparatus to stimulate sites of the ear-canal and/ or pinna (external ear) at any combination of frequency, intensity, direction, variation and/or side of ear or ears, and of any stimulus or combination of stimuli, for example vibration, pressure, sound, ultrasound, thermal, electrical, light or other stimulus type.

This stimulation may be elicited by electrical, vibratory, pressure, sound, ultrasound, thermal, light (in visual or non-visual wavelengths) or any other modality of transducer that stimulates nerves or cutaneous (skin) sensors at these sites, either directly or indirectly.

The transducers of this invention are incorporated in devices configured to be applied close to and/or in contact with, the wall of the ear-canal and/or pinna.

In one embodiment the device incorporating the transducers is worn by the user within the pinna and/or ear-canal, in a similar manner to an in-ear earphone or hearing aid, and such a device will be referred as an ear-phone.

In another embodiment the device incorporating the transducers is a handheld device which is applied to the pinna and/or ear-canal.

The transducers may be configured to stimulate the skin and/or underlying tissues or covering of the ear-structures by contact with the tissues, or non- contact means.

Non-contact stimulation includes stimulation through interference of combinations of wavelengths, amplitudes and/or phases of emissions (for example sound, ultrasound - such as ultrasound interference patterns - or light), and/or stimulation through the effect of the transducers on other materials, substances or structures. These material or substances or structures may include those that generate electrical stimulation and/or tactile (movement) stimulation of the ear-canal and/or pinna, in response to light and/or sound and/or ultrasound and/or pressure emitted from the transducers. These material or substances or structures may include liquid, semi-liquid or other form of permanent or temporary coating of the earcanal and/or pinna, that generates stimuli to the underlying ear-canal and/or pinna, in response to output from the transducers. For example a substance may be a liquid, which may be aerosolised, sprayed onto the ear-canal wall, with optoelectrical properties that generate electrical current in the underlying tissue in response to laser or other light, or radiation emitted from transducer of the device.

In embodiments the transducers may be located to stimulate any aspect of any part of the ear-canal. These embodiments enable different aspects of the ear- canal to be stimulated in different embodiments, or several aspects to be stimulated independently by the same device. An array, therefore, provides more far-reaching stimulation, being both more advanced forms of stimulation and more complex, providing far more sensory input and information to an/the individual than a lone means for stimulating or basic arrangement of a few transducers.

In some embodiments the transducers may be single or multiple (subsequently termed arrays), a single type or combination of transducer types, which may include electrode, vibratory, pressure, temperature, sound, light or ultrasound transducer, or any other transducer capable of stimulating nerves of the ear-canal or pinna, either directly or indirectly.

The transducers may be in contact with the ear-canal wall or pinna, or not in contact with the ear-canal wall or pinna for example in an embodiment wherein the transducer may be an ultrasound (including CMLIT transducer) or sound transducer. Ultrasound or audible sound transducers of the current invention may emit ultrasound and/or other frequency sound, of single or multiple frequencies, amplitudes, phase and/ or harmonics, of single or multiple amplitudes, and from single or multiple transducers , providing simple or complex outputs, which may include air or tissue pressure effects resulting from interference of ultrasound or other sound emissions and /or beamforming.

In the current invention a processor is located within an earphone or in-ear structure, or structure connected directly or through wire, or wirelessly to the ear- related structure in which the transducers are mounted.

In embodiments the transducers of the device are located within earphone devices that may have any other additional functionality, to include, but not limited to audio (including communications, music and/ or audio playback , and/or any other audio function), hearing assistive function, leisure or industrial function, control function and/or health, fitness and/or medical monitoring function.

The processor, and/or algorithm of the processor of the invention effects an output from the transducers in response to an input to the processor.

The input to the processor may be from a further directly connected, wirelessly connected or remote processor or from any other control signal.

The processor or processors provide output to the transducers which result in the transducers outputting an output to affect the ear-canal wall and/or pinna and/or ear structures.

The output from the processor or processors provide output to the transducers at sites along the ear-canal and/or pinna dependent upon the input to the processor.

The output from the processor or processors provide output to the transducers at amplitudes and or frequency at transducers at different sites along the ear-canal and/or pinna dependent upon the input to the processor.

The input to the processor or processors that affect the output of the transducers may be related to input from a receiver or sensor, and/or input from another processor.

In embodiments the receiver or sensor that provides input to processor/s may be audio, including microphone or microphones, visual including cameras or other optical sensors, LIDAR, optical interferometry, optical spectroscopy (of visible or non-visibility light wavelength, or any combination), distance including proximity sensors, ultrasound, positional including gyroscopic, accelerometers and inertial measurement units (IMU) or any other sensor. In particular, positional sensors such as gyroscopes, accelerometers and/or IMUs may be used to detect gravity - for example to assist astronauts, divers, pilots, etc. or for those suffering from unsteadiness - and, thereby, assist with orientation of the user.

In embodiments the sensors or receivers providing the input to the processor/s may include sensors located with the earphone device, a hand-held device, or any other remote device connected by wire or wirelessly, and may include multiple sensor or receivers at different sites.

In embodiments two- or three-dimensional data from the sensors or receivers, or input from other processors, result in patterns of output to transducers of the invention at sites, and at frequencies and at amplitudes configured by algorithm of the processor/ s related to the input data from the sensors or receivers.

In embodiments the current inventions include assistive hearing devices or hearing aids, visual augmentation devices, proximity sensing devices (of proximity for real or virtual or imaginary objects), proximity indication device, orientation and navigation devices, mobility aid devices and I or vagal nerve stimulation devices and/or device to generate sensation in the ear-canal related to any control and/or signal. In a yet further embodiment, the device may provide feedback from a touch, grip, or level of grip input sensation, for those with prosthesis, Such as a prosthetic hand.

In embodiments the transducers of the device I embodiment are ultrasound transducers, such as CMLIT, PMLIT and/or piezoelectric and/or other ultrasound transducer.

The invention will now be disclosed, by way of example only, with reference to the following drawings, in which:

Figure 1 is a graphical representation of an embodiment in which transducer arrays are located within ear-phone device and orientated to stimulate the ear-canal wall and/or pinna, with function as a hearing assistive and/or vagal nerve stimulation device;

Figure 2 is a graphical representation of an embodiment in which transducer arrays if the device are located in a hand-held device with function as a vagus nerve stimulation device;

Figure 3 is a flow chart of embodiments in which the embodiments provide navigational, proximity and/or directional information to the user;

Figure 4 is a flow chart of embodiments in which the embodiments provide pressure information, or temperature information, to a user of a remote device;

Figure 5 is a flow chart of embodiments in which the embodiments provide movement stimulus to a user with impaired mobility; and

Figures 6 a to 6c and 6d are schematic views of first and second helical ear inserts.

Figure 1 shows an embodiment wherein the transducer, or array of transducers 1 , are positioned in the outer surface of a device 2, worn as an earphone partially within the ear-canal 3. The transducers 1 are arranged circumferentially around the in-ear aspect of the device 2 and located at multiple distances along the length of the in-ear aspect of the device. In an embodiment the transducers 1 are in contact with the ear-canal wall 3. In one embodiment the transducers 1 are vibration or haptic transducers and activation of the transducers is felt by the wearer as a vibration of the adjacent ear-canal wall 3. In this embodiment sensor or receivers are microphones 4 within external aspect of one ear-phone device 2, or each of an earphone device 2 worn within each ear 5, with or without wireless communication between the two devices. In this embodiment the processor in each earphone device 2 receives audio signal 6 from the microphone 4, incorporating data from microphone and outputs vibration stimulation 7 to the earcanal 3 by the transducers 1 of the device 2.

In a preferred variant, the device 2 provides a hearing device, which provides hearing augmentation or hearing replacement. In effect, the invention aims to use the ear-canal like a cochlear by vibrating (or otherwise stimulating) along a length of the ear-canal, at various distances according to a frequency of a sound input - for example a microphone.

In addition, or in an alternative, the hearing device may include an ability to add directional hearing, for example by stimulating a front I back I roof I floor of the ear-canal dependent upon a relative direction of an input sound source, the algorithm of the processor of the device/s 2 analyses the input time for audio signal 6 from the sensor 4 in each ear, and/or other differences in audio signal 6, the difference of which give information on the direction of incidence of a sound signal 8. The transducers 1 of the device 2 positioned towards the area of the ear-canal 3 in the substantial direction of the sound 8 will stimulate the ear-canal 3 in the direction of the incident sound 8, at an amplitude to reflect the amplitude of the sound 8 and at a depth position along the ear-canal 3 to reflect the sound frequency 8.

An embodiment is of one or more hearing assistive structures, or hearing aids 2, that detects sound 8 and provides stimulus 7 of the ear-canal 3 at positions, depths according to direction and frequency of the detected sound 8, and at amplitude of the sound frequencies. Sensors of skin stimulated by the transducers effects 7 cause electrical nerve impulses 9 along nerves including nerves fibres 10 that join to form nerves 11 including the trigeminal nerve 11 . Alternatively, or in addition, electrical nerve impulses may be formed in one or more nerve fibres of an auricular branch of the vagus nerve, an auriculotemporal nerve, a facial nerve sensory branch and/or a greater auricular nerve. This embodiment provides the advantage of a hearing aid 2 that provides response to multiple frequencies and/or amplitudes of sound 8, with directional information to the wearer 12 without requiring functional cochlea or cochlear nerve, and worn as a user acceptable device (an earphone) without need for invasive surgery.

One of such embodiments will be a hearing assistive device 2 for wearers 12 with reduced hearing capacity, and additionally such embodiment will provide the users with stimulus related to sound 8 which is perceived as the brain as sound of frequency, amplitude and direction, directly related to the sound 8 detected by the microphone 4. It is envisaged that these embodiments, particularly if worn by children 13 from young age, may allow adjustment of the processes of the auditory areas of the brain to interpret the stimulation of the ear-canal wall 3 and/or pinna 5 as sound. This embodiment will provide complex appreciation of sound by people without normally functioning eardrum 14 and/or cochlea and/or cochlear nerve, providing the same function as a cochlear implant, in a non-invasive device 2 worn as an earphone. The device of this embodiment may be termed a “cochlear prosthesis”.

In an embodiment or embodiments the transducers 1 of an earphone device 2 provide output that stimulates the vagus nerve 11 fibres 10 within the ear-canal wall 3 and/or pinna 5. Stimulation of the earphone of either side, the site or sites, frequency or frequencies, amplitude or amplitudes or any other characteristic or modality of transducer or transducer arrays 1 (which may be any combination of vibration, pressure, thermal , electrical, optical, sound, ultrasound or any other transducer) is determined by algorithm and/or input from a processor of the device 2. The input may be configured in response to measurements of physiological parameters of the wearer 12, which may include heart rate, heart rate variability and/or electrodermal activity (galvanic skin response), and/or any other measure which may indicate autonomic nervous system status, or other status of the wearer 12. The processor of the device 2 may alter any output characteristics 7 of the transducers of the device 1 in relation to the wearers 12 physiological response to a preceding output of the device 2, and/or to any predefined, and/or user generated, and/or adjustable control or algorithm; which may be generated by and/or altered by machine learning techniques.

An embodiment of this device 2 includes earphones which stimulate 9 vagal nerve 11 fibres 10 to reduce physiological stress response of an individual, for example to improve sleep and/or psychological stress symptoms, or to reduce heart rate and affect other physiological characteristics, which may include reducing inflammation within the body of the wearer 12.

In further embodiment the processor of the ear-phone device 2 is configured to simulate 7 different aspects of ear-canal 3 and/or pinna 5 with the effect of stimulating 9 different nerve fibres 10 of the vagus nerve 11 . The effect of the differential stimulation 9 of different combinations of different vagal nerve fibres 10 will effect different physiological effects on the body of the user 12.

Embodiments including those detailed above include those wherein a temporary coating is applied to the ear-canal wall 3, that may have properties that respond to light or any other physical stimulus from the transducers 1 of the device 2. An embodiment includes the temporary coating administered to the ear-canal 3 and/or pinna 5, via fluid drops and/or spray. Transducers 1 of the device 2 may be laser or other light emitters and may stimulate the coating of the ear-canal 3 to stimulate the underlying tissue and adjacent nerve fibres 10 in response to the transducer emitted signal 7. The stimulation of the coating by the transducer 1 may stimulate electrical current, charge or electrons, temperature, movement or vibration, or any combination thereof, to affect the adjacent tissues and/or nerves to generate nerve impulses 9 in the nerve fibres 10 and nerves 11 .

Vagal stimulation may be provided: in response to feedback from, e.g. biometric sensing; or voluntarily, as triggered by a user to obtain an effect.

The present invention may provide complex vagal stimulation along the earcanal, owing to the array of transducers, or arrangement of individual transducers. This is considered different to superficial stimulation of the pinna and any basic electrical stimulation of an ear-canal.

Vagal stimulation may be provided following an input signal from a biometrics apparatus, such as an ear biometrics apparatus and/or non-ear biometrics apparatus, which biometrics apparatus may be alternatively or additionally used to measure a response to vagal stimulation of one of both ears.

The invention may combine both of the above aspects, so as to alter a site of ear-canal stimulation to generate an optimum response, e.g. in reducing heart rate or heart rate variability in a user, and for repositioning the device upon each insertion I re-insertion, as the position may be subtly different each time.

The invention may also provide differential stimulation, for example: to determine which nerve and/or nerves to stimulate; to stimulate the nerves differently, either at the same time or different times; and provide different effects, such as providing proximity sensation at same time as vagal stimulation. Figure 2 shows a further embodiment wherein the device 2 of the current invention is a handheld device 14 that, may in one embodiment have a handle 15, and has a component 2 that is applied to the ear-canal 3 and/or pinna 5 and provides stimulation 7 in the method of the current invention to stimulate 9 nerve fibres 10 of the vagus nerve 11 . This device will be used to affect physiological characteristics and processes of the user to whom which it is applied, in similar methods to those outlined above in connection with Figure 1 , ear-phone embodiments.

Figure 3 is a flow chart showing the use of further embodiments wherein the characteristics of output 7 of transducers or transducer arrays 1 of an ear phone device 2 are affected by the input from sensors indicating the presence and proximity of objects in front of the eyes of the user 12, which may be detected by any proximity, optical or other sensors worn by the wearer 12 of the device and transmitted via the processor of any device to the device 2 of the current invention.

In an embodiment the earphone device 2 is an assistance device for people with visual impairment to receive information relating to proximity and presence of physical objects, which may be used for the user to help navigate around, between and towards objects.

The following steps are undertaken: a) the user inserts the ear-phone of the device 2; b) optical, camera or proximity sensors, which may include those embedded in spectacles of the user, transmits output data signal via a processor, via wired or wirelessly connection, to the ear-phone device 2 of this embodiment; c) the algorithm of the processor of the device 2 generates output 7 from the transducers, or transducer arrays 1 related to the proximity of any detected object, size, movement, and/ or any other quality, to the ear-canal 3 and/or pinna 5 of the user 12; and d) the user and/or wearer 12, of the device 2 is enabled to perceive the proximity of objects from stimulus 7 of the ear-canal wall 3, and/or pinna 5, which may help the wearer 12 navigate in the absence of sight of the surrounding objects.

In this example the embodiment may be an assistance device for a user 12 with visual impairment, and/or may be a navigation or proximity detection aid for a user when visual cues are sub-optimal, for example in dark environments and when vision is obscured. Further, the invention may receive directional inputs, for example from a satnav or the like, and provide navigational prompts to the user 12 through the device 2.

In a related embodiment, visual sensors or LIDAR may be used to help navigate in low-light conditions or for when a user suffers from visual impairment.

In a further embodiment the earphone device 2 transducer 1 outputs 7 are affected by input from sensors receiving proximity information from sensors around the body of the user that are located outside the visual field of the wearer. An embodiment is an earphone device 2 worn by law enforcement workers, or other users, to provide hazard alerts for the user about possible assailants approaching the user from outside of their visual field, or about other potential hazards. In this embodiment the earphone 2 may incorporate other functions which may include those for audio communication, for example an audio speaker.

Other embodiments include earphone devices 2 generating stimuli 7 to the ear-canal 3 and/or pinna 5 to reflect the position and/or proximity and/or any other characteristic of a virtual representation, including visual representation of an object or image projected to the users eyes from a virtual or augmented reality head worn device. In one such embodiment the earphone worn device 2 provides immersive subjective experience for the wearer 12 of a virtual reality headset.

Other embodiments include earphone device 2 generating stimuli to the earcanal 3 and/or pinna 5 to reflect directional information. Embodiments include the directional information reflecting navigational information, to include to provide information to the user 12 to direct the user, or user’s hand or other aspect, to a place or position. This may include embodiments wherein the user 12 is directed across terrain or other location or space, either below or above water, to a geographical position, depth or position in space. In an embodiment the stimuli to the ear-canals 3 and/or pinna 5 direct the user along roads, and turns in roads, to a location, which may be controlled by an input from a satellite navigation system or other device or system.

In embodiments three dimensional directional information is communicated to the user 12 according to the position on the ear-canal wall 3 and/or pinna 5 that is stimulated by the transducer 1 of the device 2, for example, a direction indicating upwards, and/or away from a perceived or actual gravitational force, may be indicated by stimulation of an aspect of an ear-canal wall 3. Similar embodiments include those wherein the user 12 is exposed to directional stimuli 7 associated with movement, or simulated movement, for example within a mechanical (such as a flight) simulator, or from a virtual reality visual display. Over time the association between the stimulus 7 of the ear-canal wall 3 and/or pinna 5 may be associated by the wearer 12 as three dimensional movement, or direction of gravitational force, wherein the user experience of movement within virtual reality and other environments may be enhanced. One embodiment of the device 2 provides an astronaut 12 with a signal and/or stimulus 7 to the ear-canal wall 3 and/or pinna 5 to orientate against a fixed constant position within an environment. Such an embodiment may enable the astronaut, or other user 12, to orientate themselves in absence of stable position or gravitational field, for example in space, under water, or on moving objects such as boats. Similar embodiments include directional stimulus 7 from the device 2 during balance training and/or in alleviation of dizziness and/or vertigo symptoms.

Figure 4 shows use of further embodiments wherein earphone device 2 generates stimuli 7 to the ear-canal 3 and/or pinna 5 which reflects pressure or other physical effect on a device sensor, including but not limited to pressure and temperature, which may include remote sensors which may include those located on robotic devices and/or prostheses. In embodiments the remote sensors may be on the hands and/or fingers of robotic prosthetic hand, and the device 2 of the current invention stimulates 7 sites and quality of stimulation of the ear-canal 3 and/or pinna 5, dependent on the site and quality of the physical stimulus detected by the remote sensor. In further embodiments the device 2 of the current invention provides information to the user 12, through stimulation 7 of skin of the ear-canal 3, reflecting the tactile pressure exerted by robotic prosthetic fingers on an object. The following steps are undertaken: a) the user 12 inserts the ear-phone device 2; b) the user 12 wears a robotic prosthetic hand on which tactile sensors are located which detect the degree of pressure exerted by the fingers of the robotic hand when objects are touched or grasped by the robotic hand. The output data from the sensors of the robotic hand are communicated through wires or wirelessly to the processor of the ear-phone device 2 worn by the user 12; c) the algorithm of the processor of the device 2 generates output 7 from the transducers, or transducer arrays 1 related to the degree of pressure detected from the sensors of the robotic hand, and the fingers of the robotic hand on which the pressures are detected, to the ear-canal 3 and/or pinna 5 of the user 12; d) the user and/or wearer 12, of the device 2 is enabled to perceive the degree of pressure the robotic hand is exerting on an object, from stimulus 7 of the ear-canal wall 3, and/or pinna 5, providing tactile feedback which may enable the wearer 12 to manipulate objects with the robotic prosthetic hand. In this example the embodiment may be a sensory feedback device 2 enabling a wearer 12 who has suffered an amputation to manipulate objects with more precision, using robotic upper limb prosthesis.

Figure 5 shows use of other embodiments wherein the earphone device 2 transducer output 7 is configured to provide a rhythmic output, or any other characteristic of output to the user 12, which may be of any characteristic of transducer emitter types, including audible sound, ultrasound, vibration, optical and/or electrical. This rhythmic, or other, output 7 may be configured or affected by a wired or wirelessly connected processor, which may be: controlled by the user 12; and/or controlled by a processor and/or feedback from other sensors, which may include IMU which may detect user movement. In an embodiment the device 2 output provides a stimulus 7 that aids the user to improve their mobility at a time when their mobility is determined to be impaired, as related to the altered movement detected by a movement sensor, for example an IMU. Such an embodiment includes a device 2, which is an assistive aid to improve mobility for user 12 suffering from Parkinson’s disease, or other movement impairment, or dysfunction.

The following steps are undertaken: a) the user 12 who suffers from Parkinson’s disease inserts the ear-phone device 2; b) when the user 12 determines that their movement is adversely affected by Parkinson’s disease they trigger a switch, which is wired or wirelessly connected to the ear-phone device 2, to change the output 7 of the device 2; c) the algorithm of the processor of the device 2 generates output 7 from the transducers, or transducer arrays 1 in a predefined rhythmic pattern, to the ear-canal 3 and/or pinna 5 of the user 12, which aids the user to move their limbs with less restriction; d) the user and/or wearer 12, of the device 2 is enabled to improve its/their mobility by altering the output from the device 2.

In this example of an embodiment, the device 2 may be a mobility aid enabling a wearer 12 who has Parkinson’s disease to improve its mobility. In particular, improving one’s mobility may have both therapeutic and non-therapeutic attributes.

Figures 6 a to 6c show a first helical ear insert, indicated generally by reference 60. The ear insert 60 includes a helical member 61 , a dispensing tube 62, a dispensing rod 63, and electrical connections 64 capable of conducting data and/or stimulation signals.

The helical member 61 is resilient and comprises a plurality of transducers 65, which may be either regularly spaced or irregularly spaced, as exemplified in Figures 6b and 6c, respectively, which are provided so as to contact different regions of the ear-canal, once in situ. The helical member 61 is capable of being pushed out of the confines on the dispensing tube 62, following which it is expandable though its own resilience - in a similar way to a stent - to contact the ear-canal wall of the user.

As described above, the plurality of transducers may provide a multitude of different types of stimulation, at different depths and locations within the ear-canal, and for a multitude of different purposes.

In use, the dispensing tube 62 - within which is the confined the helical member 61 - is located in an ear of a user and, once appropriately located, the dispensing rod 63 is used to push the helical member in to the ear-canal of a user, as shown in Figure 6b. The helical member 61 expands once removed from the constraints of the dispensing tube 62, so as to bring one of more of the plurality of transducers 65 into contact - or at least proximity - with the ear-canal wall of the user, ready for subsequent stimulation.

In a variant based upon Figures 6a to 6c, Figure 6d shows a second insert 60’ - accordingly, only the differences will be described. Insert 60’ includes a camera 66, although this could be a different sensor or be part of an ear biometrics apparatus, which is located towards a tip of dispensing rod 63’, which is sized so as to be insertable through the helical member 61 , and capture ear data once the helical member 61 is in situ, and/or facilitate appropriate positioning of the helical member. Rod 63’ may be flexible and/or curved, so as to aid insertion through the helical member 61 .

Those skilled in the art will know that innervation of the ear-canal wall and pinna is complex, with their being a plethora of cutaneous, and deeper, nerve fibres in different regions feeding into a number of different nerves, providing feedback to the brain via a multitude of pathways.

Methods according to the present are, preferably, non-therapeutic methods, and not considered to be excluded from patentability as such. Accordingly, if any method of the invention covers both therapeutic and non-therapeutic uses, the Applicant reserves the right to restrict the claimed invention to just 'non-therapeutic' use.

Claims

Claims:

1 .) An ear apparatus, at least part of which is an ear portion locatable in or near an ear-canal and/or pinna of an individual, the apparatus comprises a processor, capable of controlling an output of the apparatus in response to an input and/or control signal; wherein, the ear portion comprises one or more means for stimulating nerves of said ear-canal wall and/or pinna of said individual, directly and/or indirectly, the one or more means for stimulating being controllable by the processor in response to the input and/or control signal to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

2.) An ear apparatus as claimed in claim 1 , wherein, the one or more means for stimulating are: a) individually controllable to stimulate one or more regions of said ear-canal wall and/or pinna in one or more predetermined sequences and/or patterns of stimulation; b) individually controllable to stimulate a plurality of different regions of said ear-canal wall and/or pinna either individually or in combination(s); c) individually controllable to independently stimulate nerves in one or more regions of said of said ear-canal wall and/or pinna; and/or d) individually controllable to simultaneously stimulate one or more regions of said ear-canal wall and/or pinna at the same time.

3.) An ear apparatus as claimed in claim 1 or claim 2, wherein the one or more means for stimulating are locatable to stimulate, individually or in combination(s), one or more nerve fibres of an auricular branch of the vagus nerve, an auriculotemporal nerve, a facial nerve sensory branch and/or a greater auricular nerve.

4.) An ear apparatus as claimed in any preceding claim, wherein the one or more means for stimulating is/are arranged circumferentially and/or radially on or around at least part of an exterior surface of the ear portion.

5.) An ear apparatus as claimed in any preceding claim, wherein the one or more means for stimulating are arranged longitudinally on or along at least part of an/the exterior surface of the ear portion.

6.) An ear apparatus as claimed in any preceding claim, wherein at least part of the one or more means for stimulating is/are: internally located in the ear portion; and/or directed towards an/the exterior surface of the ear portion.

7.) An ear apparatus as claimed in any preceding claim, wherein the ear portion comprises a plurality of means for stimulating and the plurality of means for stimulating are arranged to form an array configured to stimulate one or more regions of said ear-canal wall and/or pinna individually or in combination(s).

8.) An ear apparatus as claimed in claim 7, wherein the array comprises: one or more rows of means for stimulating, being arranged along at least part of a length of the ear portion, so as to provide stimulation at various depths of said ear-canal wall; or one or more rows of means for stimulating, being arranged circumferentially and along at least part of a length of the ear portion, so as to provide circumferential stimulation at various depths of said ear-canal wall; and/or the ear portion being configured to stimulate at least part of an outer (cartilaginous) ear-canal wall and/or at least part of an inner two-thirds (bony) ear-canal wall.

9.) An ear apparatus as claimed in any preceding claim, wherein the means for stimulating comprises one or more vibrational, electrical, thermal, tactile, sound and/or electromagnetic output devices.

10.) An ear apparatus as claimed in any preceding claim, wherein the apparatus further comprises one or more input means, control means, detectors or processors, for creating the input and/or control signal for the processor.

11.) An ear apparatus as claimed in any preceding claim, wherein the detector comprises a sound sensor, including ultrasound, visible and/or non-visible electromagnetic radiation sensor, motion sensor, orientation sensor and/or positioning sensor.

12.) An ear apparatus as claimed in any preceding claim, wherein the processor is capable of analysing the input and/or control signal and reacting to one or more characteristics of that signal to appropriately control the one or more means for stimulating.

13.) An ear apparatus as claimed in claim 12, wherein the processor is capable of controlling the one or more means for stimulating to adjust a relative position, location and/or depth of stimulation output according to those one or more characteristics.

14.) An ear apparatus as claimed in claim 12 or claim 13, wherein the means for stimulating is controllable to provide one or more characteristics of output of the group comprising: relative position, location and/or depth of stimulation with respect to an input signal or control signal; frequency, wavelength and/or amplitude of stimulation; stimulating along a length the ear portion and, thereby, said the ear-canal, at various distances according to a frequency of a sound input; harmonics, phase, interference, and/or audio pressure effects of stimulation; intensity, tactile pressure and/or force of stimulation; vibration, sequence and/or pattern of stimulation; current and/or voltage of stimulation; tissue temperature variations, by site and/or by region of said ear-canal wall and/or pinna; relative position, location and/or depth of stimulation with respect to a detected position, proximity, movement or other detectable characteristic of a nearby object or person in said individual’s surroundings, in real or virtual space; relative position, location and/or depth of stimulation with respect to detected positioning and/or directional information of said individual; relative position, location and/or depth of stimulation with respect to a fixed position, plane or gravitational field, in real or virtual space; and/or predefined rhythmic vibration, sequence and/or pattern of stimulation with respect to a detected adverse movement and/or orientation of said individual.

15.) An ear apparatus as claimed in any preceding claim, wherein the apparatus comprises first and second ear portions which are operatively connected, the first ear portion is locatable in an ear-canal of said individual and a second ear portion is locatable in the region of a pinna of said individual.

16.) An ear apparatus as claimed in any preceding claim, wherein the ear portion comprises a member, locatable within said ear-canal so as to bring into contact or proximity the one or more means for stimulating and said ear-canal wall of said individual.

17. An ear apparatus as claimed in claim 16, further comprising: a dispensing tube, being configured to be received within said ear-canal and housing the member prior to deployment of the member; and/or an imaging device capable of being inserted through a middle of the member, providing imaging of said ear-canal wall and/or an ear-drum.

18.) An ear apparatus as claimed in claim 16 or claim 17, wherein the member is: self-expandable; resilient, being expandable; or of fixed size; and flexible or elastic; or inflexible within the ear-canal or inelastic.

19.) A method for providing localised stimulation of one or more nerves of said ear-canal wall and/or pinna, the method comprising: locating an ear portion, of an ear apparatus, in or near an ear-canal and/or pinna of an individual; analysing an input and/or a control signal; and controlling an output of the ear apparatus in response to that input and/or control signal; wherein the output comprises stimulating nerves of the ear-canal wall and/or pinna of the individual, directly and/or indirectly, to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

20.) A method as claimed in claim 19, the method comprising: a) individually stimulating one or more regions of said ear-canal wall and/or pinna in one or more predetermined sequences and/or patterns of stimulation; b) individually stimulating a plurality of different regions of said ear-canal wall and/or pinna, either individually or in combination(s); c) independently stimulating nerves in one or more regions of said of said earcanal wall and/or pinna; and/or d) individually controlling stimulation to simultaneously stimulate one or more regions of said ear-canal wall and/or pinna at the same time.

21 .) A method as claimed in claim 19 or claim 20, the method comprising stimulating, individually or in combination(s), one or more nerve fibres of an auricular branch of the vagus nerve, an auriculotemporal nerve, a facial nerve sensory branch and/or a greater auricular nerve.

22.) A method as claimed in any one of claims 19 to 21 , the method comprising: analysing the input and/or control signal; reacting to one or more characteristics of that signal: and controlling the output dependent upon the one or more characteristics of that signal.

23.) A method as claimed in claim 22, the method comprising controlling the output to adjust a relative position, location and/or depth of stimulation output according to those one or more characteristics.

24.) A method as claimed in claim 22or claim 23, the method comprising controlling the output to provide one or more characteristics of output of the group comprising: relative position, location and/or depth of stimulation with respect to an input signal or control signal; frequency, wavelength and/or amplitude of stimulation; stimulating along a length the ear portion and, thereby, said the ear-canal, at various distances according to a frequency of a sound input; harmonics, phase, interference, and/or audio pressure effects of stimulation; intensity, tactile pressure and/or force of stimulation; vibration, sequence and/or pattern of stimulation; current and/or voltage of stimulation; relative position, location and/or depth of stimulation with respect to a detected position, proximity, movement or other detectable characteristic of a nearby object or person in said individual’s surroundings, in real or virtual space; tissue temperature variations, by site and/or by region of the ear-canal wall and/or pinna; relative position, location and/or depth of stimulation with respect to detected positioning and/or directional information of said individual; relative position, location and/or depth of stimulation with respect to a fixed position, plane or gravitational field, in real or virtual space; and/or predefined rhythmic vibration, sequence and/or pattern of stimulation with respect to a detected adverse movement and/or orientation of said individual.

25.) A method as claimed in any one of claims 19 to 24, the method comprising utilising a contact medium between the ear portion, and ear-canal and/or pinna of the individual, the contact medium being responsive to the output to generate electrical signals in the tissue of the ear-canal and/or pinna.

26.) A method as claimed in any one of claims 19 to 25, the method comprising utilising interference of ultrasound or other sound emissions and /or beamforming, to provide localised stimulation of one or more nerves of said ear-canal wall and/or pinna.

27.) A method as claimed in any one of claims 19 to 26 comprising inserting a helical member ear portion into the ear of the individual, and bringing into contact or proximity one or more means for stimulating the ear-canal wall of the individual.

28. A method as claimed in claim 27, in which the helical member is housed in a dispensing tube, the method comprising inserting the dispensing tube into the ear of the individual, and pushing the helical member along an inside of the dispensing tube into the ear-canal of the individual.

29. A method as claimed in claim 26 or claim 27 comprising inserting an imaging device or other sensor through a middle of the helical member, so as to capture data from the ear-canal of the individual.