WO2016026973A1

WO2016026973A1 - System and method for treating tinnitus

Info

Publication number: WO2016026973A1
Application number: PCT/EP2015/069295
Authority: WO
Inventors: Eimear O'Carroll; Rhona Togher
Original assignee: Restored Hearing Ltd
Priority date: 2014-08-22
Filing date: 2015-08-21
Publication date: 2016-02-25
Also published as: GB201414948D0

Abstract

A system, audio signal and associated apparatus and method, for treating an ear or hearing condition, such as tinnitus, the system comprising a processing system configured to provide a plurality of audio tones and/or an audio signal indicative of a plurality of tones, wherein at least one of the tones may have a different frequency to at least one other of the tones, and the system comprises and/or is connected or connectable or configured to communicate with one or more sound generators for producing sound representative of the plurality of tones.

Description

SYSTEM AND METHOD FOR TREATING TINNITUS

Field of Invention

The present invention relates to a system and method for providing audio signals.

Background

In a world where industrial noise and recreational noisy environments are getting louder the problem of tinnitus, ringing in the ears, is an increasingly prevalent issue. Persistent or permanent tinnitus can lead to people having to opt out of work, having difficulty concentrating or developing depression and anxiety. The problem of tinnitus affects over 300 million people worldwide with between 10% and 15% of the population in the UK affected. The problem is growing with the increasing use of personal music players and exposure to industrial noise globally. While there are many suggested treatments very few of them have been clinically proven and most doctors don't have satisfactory options for their tinnitus patients to try.

Summary of Invention

According to an aspect of the invention is a system for providing audio and/or audio signals, the system comprising a processing system configured to provide a plurality of audio tones and/or an audio signal indicative of a plurality of tones. At least one of the tones may have a different frequency to at least one other of the tones. The system may be, comprise or be comprised in a system for treating an ear or hearing condition, such as tinnitus.

The system may comprise, or the processing system may be configured to access, a memory or data storage. The processing system may be configured to generate the audio signal. The processing system may be configured to provide or generate the audio signal based on data from the memory or data storage. The audio signal may be stored or comprised in the memory or data storage.

The system may comprise a network or interface module. The network or interface module may be connected or connectable to a network connection or data carrier, which may comprise a wired or wireless network connection or data carrier, such as a data cable, powerline data carrier, Wi-Fi, Bluetooth, Zigbee, internet connection or other similar connection. The network interface may comprise a router, modem, gateway and/or the like. The system or processing system may be configured to transmit or otherwise provide the audio signal via the network or interface module, e.g. over the internet, intranet, network or cloud.

The system may comprise and/or be connected or connectable or configured to communicate with one or more sound generators, such as one or more speakers. The one or more sound generators may be configured to be non-implantable or external. The sound generator(s) may be comprised in a set of earphones, headphones or a headset. The sound generator(s) may be comprised in an in-ear device, such as an earbud earphone or a hearing aid or the like. The one or more sound generators may be comprised in over-ear headphones. The system may be adapted such that the audio signals are transmitted from the processing system to the sound generator. The sound generator may be configured to produce sound representative of the audio signal.

The system, or at least the processing system and/or memory or data store, may be or comprise or be comprised in or configured to communicate with at least one server and/or at least one user device such as a computer, desktop computer, portable computing device, tablet, smartphone, PDA, laptop, notebook, audio player, such as a digital audio player, for example configured to play at least one of an mp3 (or MPEG-3), mp4 (or MPEG-4), mp5 (or MPEG 5), wav, aiff, aifc, aac, or similar digital audio file, or the like. The system may be, comprise or be comprised in a hearing aid, e.g. the at least one user device may be, comprise or be comprised in a hearing aid. The system may be a distributed system, e.g. at least part of at least one component of the system, e.g. the processing device, memory or data store and/or at least one of the one or more sound generators, may be physically remote or separated from at least one other component of the system. The system may be configured to operate over a network or internet or intranet or is a cloud based system.

The at least one server and/or the at least one user device may comprise memory or data storage, which may be comprised in the memory or data storage of the system and/or be configured to store the plurality of audio tones and/or audio signal indicative of a plurality of tones. The at least one user device may be configured to run a program or application (e.g. an "app") or web interface or other user interface means. The one or more sound generators may be comprised in, connected or connectable to and/or operable by the at least one user device. The at least one user device may be configured to communicate with the at least one server. The at least one user device may be configured to receive the plurality of audio tones and/or audio signal indicative of a plurality of tones from the at least one server.

The system, e.g. the at least one user device, which may be running the program or application, may be configured to receive and/or determine input or data, e.g. from the user. The program or application (e.g. "app") or web interface or other user interface means may be configured to provide selection by the user of, and/or may provide, the plurality of audio tones and/or audio signal indicative of a plurality of tones.

The system, e.g. the at least one user device, which may be running the program or application, may be configured to retrieve, provide and/or suggest the plurality of audio tones and/or audio signal indicative of a plurality of tones. The retrieved, suggested or provided plurality of audio tones and/or audio signal indicative of a plurality of tones may be a specific plurality of audio tones and/or audio signal indicative of a plurality of tones from amongst a set comprising more than one plurality of audio tones and/or audio signal indicative of a plurality of tones, which may be retrieved, suggested or provided responsive to the input or data.

The input or data may comprise health related information, lifestyle information, and/or physical or physiological parameters or the like, which may be associated with or relate to the user. For example, the input or data may comprise information or data regarding at least one of: medication taken, alcohol consumed, nicotine containing products used, caffeine containing products used or consumed, health or medical condition(s) of the user, e.g. tinnitus, such as a perceived, determined or measured (e.g. using a technique such as Tinnitus Functional Index (TFI) or Tinnitus Handicap Inventory (THI)) or otherwise evaluated severity of the condition(s), information regarding sleep of the user, such as an amount and/or quality of sleep, information regarding stress that the user is under, such as a perceived amount of stress, and/or the like.

The system may be configured to record or log the input or data. The system may be configured to build a profile, such as a user specific profile, which may be based on the input or data, e.g. over time. The system may be configured to retrieve, provide and/or suggest the plurality of audio tones and/or audio signal indicative of a plurality of tones at least partially based on the user profile and/or the input or data and/or specifically for the user. The system may be configured to display the input or data and/or a record of use of the system or provision of the plurality of tones over time, which may comprise a calendar or timeline view or the like. The at least one user device and the at least one server may be configured to communicate the input or data therebetween.

The system may be or comprise or be comprised in an in-ear and/or on-ear device that is at least partially or wholly provided in or on the ear in use, such as a hearing aid or similarly styled, shaped, dimensioned and/or formed device.

The system may comprise a display or screen and/or one or more user input devices, such as keyboards, touch screens, one or more buttons, sliders, track pads, trackballs, joysticks, and/or the like. The system may be configured to provide a user interface, e.g. via the display or screen and/or user input devices.

The system may be configured to play music and/or video and/or to receive and/or play radio signals.

The system may be configured to store, access, play and/or provide instructions, guides or other data, such as operating instructions, reminders to use the system, e.g. at appropriate times, meditation guides or instructions, and/or the like. The system may be configured to store, access and/or provide questionnaire interfaces, feedback interfaces and/or other means for assessing a severity or status or other property of the user's condition, e.g. tinnitus. The system may be adapted to determine, store, track, display and/or transmit over a network a current and/or historical severity or status or other property of the user's condition or changes in the user's condition. For example, the severity or status or other property may be transmitted or otherwise provided to remote users or systems, such as the user's physician, a service provider or advisor and/or the like.

The audio signal may comprise control or operating data for controlling or operating the one or more sound generators, i.e. for causing or operating the one or more sound generators to produce the plurality of tones. The audio signals may be digital audio signals, e.g. comprising digital audio data and/or other digital data. The audio signals may be analogue audio signals, e.g. comprising analogue audio data and/or other analogue data.

At least one or each of the tones may be or comprise pure tones and/or tones having substantially a single frequency. The audio signal may be indicative of a series of tones. At least part of the series of tones, such as a first part, may comprise two or more tones, such as consecutive tones, that respectively increase or are higher in frequency relative to a preceding tone. At least part of the series of tones, such as a second part, may comprise at least one tone that consecutively decreases or is lower in frequency relative to a preceding tone. The series of tones may comprise the series of tones of respectively increasing frequency or higher in frequency relative to a preceding tone before the series of tones of respectively decreasing frequency or lower in frequency relative to a preceding tone, or vice versa (e.g. decreasing frequency then increasing frequency). The plurality or series of tones may comprise 20 or less tones. Alternatively, the plurality or series of tones may comprise 30 or more tones.

One or more or each of the tones may have a frequency below 30kHz, e.g. below 20kHz, such as below 200Hz, e.g. below 150Hz. One or more or each of the tones may have a frequency above 10 Hz, e.g. above 20Hz, such as above 50HZ. One or more or each of the tones may have a frequency between 20 and 200Hz, e.g. between 50 and 120Hz. The inventors have found that low frequency tones may be particularly effective in alleviating hearing disorders including, for example tinnitus.

At least two or more or each of the tones of the series of tones may differ and/or be separated in frequency, e.g. the two or more or each of the tones may be tones from different frequency bands, such as five or ten Hz wide frequency bands. For example, two or more or each tone from the series of tones, such as one or more or each of the increasing frequency tones or one or more or each of the decreasing frequency tones, may be separated by at least 5 Hz, e.g. 10Hz or more.

For example, the series of tones may comprise tones, which may be consecutive or sequential tones, in at least two or more or each of the following frequency bands, 50 to 60Hz, 60 to 70Hz, 65 to 75Hz, 70 to 80Hz, 80 to 90Hz, 95 to 100 Hz, 100 to 1 10Hz, 1 10 to 120 Hz.

The series of tones may comprise two or more tones, such as consecutive or sequential tones, in respective bands of respectively increasing or higher frequency relative to a preceding or previous tone or band. The series of tones may comprise two or more tones, such as consecutive or sequential tones, in respective bands of respectively decreasing or lower frequency relative to a preceding or previous tone or band. The series of tones may comprise one or more tones, such as consecutive or sequential tones, in respective bands of respectively increasing frequency or higher frequency relative to a preceding tone or band, followed by one or more tones, such as consecutive or sequential tones, in respective bands of respectively decreasing or lower frequency relative to a preceding or previous tone or band, or vice versa (e.g. decreasing frequency then increasing frequency), or vice versa.

The duration of one or more or each tone may last any suitable or required length of time to achieve a therapeutic effect. For example, the duration of one or more or each tone may be in a range from 1 to 60 seconds (or longer if required), e.g. from 2 to 30 seconds such as from 5 to 10 seconds or from 5 to 7 seconds.

The total duration of the audio signal, e.g. of the series of tones, may be up to 30 minutes, e.g. less than 15 minutes, such as 7 or 5 minutes or less. The duration of the audio signal, e.g. of the series of tones, may be at least 2 minutes, e.g. at least 3 minutes, such as 5 minutes or more. For example, the total duration of the audio signal may be between 2 and 15 minutes, such as between 3 and 7 minutes, e.g. substantially 5 minutes.

The tones may transition gradually, e.g. by fading or sweeping in frequency or amplitude, or directly. At least two of each of the tones may be spaced apart, e.g. with intervening portions where no sound is provided or may transition instantly into each other. The tones may be provided at a constant frequency.

The system may be configured to require or accept input of a user identification or user input. The system may be configured to provide an audio file or signal associated with, or appropriate for, the user responsive to the user identification or input. The system may comprise or provide a customization module for allowing alteration or customization of the audio file or signal. The system may provide a user interface for guiding the alteration or customization, e.g. within certain parameters such as frequency range, time, repetition rate and/or the like.

The system may comprise or be configured to implement a timer, e.g. for monitoring and/or notifying a user when a treatment session has finished or when it is time to receive another treatment session (i.e. to listen to the audio file or signal). The notification may comprise a visual notification, e.g. provided using the display or screen or other visual indicator such as an LED or other light source, and/or an audible notification, e.g. using the sound generator(s), or another suitable notification such as a vibrating notification, an e-mail or SMS message e.g. transmitted over the network, and/or the like.

According to a second aspect of the present invention is an audio signal, such as an audio signal provided generated, transmitted, stored or otherwise used by the system of the first aspect.

The tones may be or comprise pure tones and/or tones having substantially a single frequency. The audio signal may be indicative of a series of tones. At least part of the series of tones, such as a first part, may comprise two or more tones, such as consecutive tones, that respectively increase or are higher in frequency relative to a preceding tone. At least part of the series of tones, such as a second part, may comprise at least one tone that consecutively decreases or is lower in frequency relative to a preceding tone. The series of tones may comprise the series of tones respectively increasing or higher in frequency relative to a preceding tone preceding or before the series of tones respectively decreasing or lower in frequency relative to a preceding tone, or vice versa (e.g. decreasing frequency then increasing frequency).

One or more or each of the tones may have a frequency below 30kHz, e.g. below 20kHz, such as below 200Hz, e.g. below 150Hz. One or more or each of the tones may have a frequency above 10 Hz, e.g. above 20Hz, such as above 50HZ. One or more or each of the tones may have a frequency between 20 and 200Hz, e.g. between 50 and 120Hz.

For example, the series of tones may comprise tones, which may be consecutive or sequential tones, in at least two or more or each of the following frequency bands, 50 to 60Hz, 60 to 70Hz, 65 to 75Hz, 70 to 80Hz, 80 to 90Hz, 95 to 100 Hz, 100 to 1 10Hz, 1 10 to 120 Hz. The series of tones may comprise two or more tones, such as consecutive or sequential tones, in respective bands of respectively increasing or higher frequency relative to a preceding or previous tone or band. The series of tones may comprise two or more tones, such as consecutive or sequential tones, in respective bands of respectively decreasing or lower frequency relative to a preceding or previous tone or band. The series of tones may comprise one or more tones, such as consecutive or sequential tones, in respective bands of respectively increasing frequency or higher frequency relative to a preceding tone or band, followed by one or more tones, such as consecutive or sequential tones, in respective bands of respectively decreasing or lower frequency relative to a preceding or previous tone or band, or vice versa (e.g. decreasing frequency then increasing frequency), or vice versa.

As stated, the duration of one or more of each tone may be any suitable or required length to achieve a therapeutic outcome. For example the duration of one or more or each tone may be in a range from 1 to 60 seconds (or longer if required), e.g. from 2 to 30 seconds such as from 5 to 10 seconds or from 5 to 7 seconds.

The total duration of the audio signal, e.g. of the series of tones, may be up to 30 minutes, e.g. less than 15 minutes, such 7 or 5 minutes or less. The duration of the audio signal, e.g. of the series of tones, may be at least 2 minutes, e.g. at least 3 minutes, such as 5 minutes or more. For example, the total duration of the audio signal may be between 2 and 15 minutes, such as between 3 and 7 minutes, e.g. substantially 5 minutes.

The tones may transition gradually, e.g. by fading or sweeping in frequency or amplitude, or directly. At least two or each of the tones may be spaced apart, e.g. with intervening portions where no sound is provided or may transition instantly into each other. The tones may be provided at a constant frequency.

According to a third aspect of the present invention is a processing system for use in the system of the first aspect and/or for use in treating a hearing or ear condition such as tinnitus. The processing system may be configured to provide a plurality of audio tones and/or an audio signal indicative of a plurality of tones and/or an audio signal according to the second aspect.

The processing system of the third aspect of this invention may also find application in a method of treating a hearing condition such as tinnitus, wherein the system is used to deliver (or administer) to a subject in need thereof, a plurality of audio tones and/or an audio signal indicative of a plurality of tones and/or an audio signal according to the second aspect of the invention.

According to a fourth aspect of the present invention is a carrier medium comprising, storing or encoding an audio signal as described above in the relation to the second aspect and/or configured for use in or with the system of the first aspect and/or the processing system of the third aspect.

According to a fifth aspect of the present invention is a memory or data store comprising, storing or encoding an audio signal as described above in the relation to the second aspect and/or configured for use in or with the system of the first aspect and/or the processing system of the third aspect.

According to a sixth aspect of the present invention is a network comprising or configured for use with the system of the first aspect and/or the processing system of the third aspect and/or the memory or data store according to the fourth aspect and/or comprising or carrying or transmitting or using or being configured to carry, transmit or use an audio signal as described above in the relation to the second aspect.

According to seventh aspect of the present invention is a method of transmitting an audio signal as described above in the relation to the second aspect, the method comprising providing the audio signal on a carrier medium and/or transmitting the audio signal over a network, such as a wireless or cabled network or internet, intranet or the like, e.g. from a system according to the first aspect, optionally to a user device. The method may comprise transmitting or providing the audio signal in the form of an audio file from the system according to the first aspect to a user device and may comprise converting the audio signal into sounds representing the plurality of tones at the user device.

According to an eighth aspect of the present invention is a method of generating an audio signal as described above in the relation to the second aspect, the method comprising providing an audio file comprising, encoding or defining the audio signal. The method may comprise converting the audio signal into a plurality of tones having differing frequencies

According to a ninth aspect of the present invention is a method of forming a sound from, or applying, the audio signal of the second aspect. The method may comprise stimulating a user's ear or ears or hearing. The method may comprise a method of alleviating or treating a hearing or ear related condition, such as tinnitus.

The method may comprise providing an audio signal or a series of tones, e.g. to the user's ear or ears. The method may comprise applying the audio signal using the system of the first aspect, e.g. using headphones, earbuds, speakers and/or an in-ear device. The audio signal may be or comprise an audio signal according to the second aspect.

The method may comprise applying the audio signal for up to 30 minutes, e.g. less than 15 minutes, such 7 or 5 minutes or less, e.g. at least once a day. The method may comprise applying the audio signal for at least 2 minutes, e.g. at least 3 minutes, such as 5 minutes or more, e.g. at least once a day. For example, The method may comprise applying the audio signal for between 2 and 15 minutes, such as between 3 and 7 minutes, e.g. substantially 5 minutes, e.g. at least once a day. The method may comprise applying the audio signal daily, e.g. at least once a day. The method may comprise applying the method for at least two weeks, e.g. at least three weeks, advantageously for four weeks or more.

In a tenth aspect, the invention provides a method of treating a hearing condition, said method comprising administering a subject in need thereof a plurality of audio tones and/or an audio signal indicative of a plurality of tones as described herein. For example, the method of the tenth aspect of this invention may exploit the systems and/or audio signals of the first and second aspects of this invention.

The invention further provides a plurality of audio tones and/or an audio signal indicative of a plurality of tones for use in (or for use in a method of) treating a hearing condition. For example, the invention may provide the systems and/or audio signals of the first and second aspects of this invention for use in treating a hearing condition.

Sound therapy may be useful in the treatment of hearing disorders (including, for example tinnitus). Sound therapy may be regarded as a type of sensory training aimed at modifying the brain signals associated with, for example, tinnitus. Depending on the type of sound therapy, it may require the use of residual inhibition, post-masking suppression of tinnitus and/or lateral inhibition. The term "masking" relates to a process in which sound therapy exploits sounds that are louder than the tinnitus so as to drown it out. The term "lateral inhibition" relates to the capacity of an excited neuron to reduce the activity of its neighbours - if a sound therapy can increase the activity of certain neurons in the auditory cortex it may be able to suppress the activity of others (preferably those causing tinnitus.) The term "residual inhibition" describes the introduction of sounds to the ear/brain which cause the tinnitus to abate for a period of time.

Sound relief works by residual/lateral inhibition. Working off the framework in the Textbook of Tinnitus it is a passive, off-frequency sound therapy as it's not focused around the tinnitus frequencies. As stated, sound therapy aims to modify the brain signals associated with tinnitus. While all sound therapy works on similar principles there are varying levels of listening time, listening type, types of sounds, and effectiveness. Sound Relief has been shown to give an average of 15% reduction in tinnitus by using the therapy for 5 minutes a day for 30 days. Further, residual inhibition arguably gives more relief than masking and sound relief works faster than comparable online therapies.

The methods and uses of this invention may be exploited in the treatment of tinnitus and other similar or related hearing disorders and it should be understood that the term tinnitus includes all forms of tinnitus including, for example permanent tinnitus, subjective tinnitus, pulsatile tinnitus as well as related conditions and/or conditions caused or contributed to by tinnitus such as, for example, hyperacusis. The methods and uses of this invention may exploit any of the audio tones or signals described herein - including those generated by the systems of the first aspect of this invention and characteristic of the signals of the second aspect of this invention. For example, the methods of treating a hearing condition and/or the audio tones for use, may exploit or comprise one or more pure audio tones and/or tones having substantially a single frequency. The methods and uses may exploit one or more pure audio tones, in the range 50 to 120 Hz.

A method of treating a hearing condition according to this invention may comprise, for example, administering a subject in need thereof a variety of tones which modulate between about 50 and 120 Hz. For example, a subject may be administered a first pure tone in the range 50-60 Hz, for example 50-55Hz. The tone may be administered for a predetermined period of time and then replaced with a second, higher frequency tone. The second tone may be at least about 2-5 Hz higher in frequency and may be administered for the same (or a different) length of time as the first tone. The subject may be exposed to third and further tones. Each subsequent tone may be progressively higher in frequency than a preceding tone. The subject may be exposed to progressively higher frequency tones up to a maximum of 120 Hz. The subject may then be exposed to series of progressively lower tones with the lowest tone being one selected from the band 50-60 Hz.

The method may comprise administering a tone or tones (for example a series of tones), wherein the tone or tones is/are one or more selected from the group consisting of:

(i) a tone selected from the band 50 to 60 Hz;

(ii) a tone is selected from the band 60-70Hz;

(iii) a tone is selected from the band 65-75Hz;

(iv) a tone from the band 70-80 Hz;

(v) a tone from the band 80-90 Hz;

(vi) a tone from the band 95-100 Hz;

(vii) a tone from the band 100-1 10 Hz; and

(viii) an tone from the band 1 10-120 Hz.

The method may comprise administering one or more pure tones from within each of the bands (i) to (viii) above. The method may comprise administering a repeat cycle of one or more tones selected from (i) to (viii) above. The tones may be administered in order of frequency. The tones may be administered as a series of tones which ascend and/or then descend in frequency. The treatment may comprise a repeating cycle of tones which ascend and/or descend in frequency.

The tones used to treat hearing conditions may be sequentially administered with the transitions between each being independently delayed, gradual, phased or instant. Each tone used may be administered for any suitable length of time so as to achive the necessary therapeutic effect. For example each tone may be administered for anywhere between about 1 to about 60 seconds (or longer if required); for example, any given tone may be administered for about 2 to about 30 seconds such as from about 5 to about 10 seconds or from about 5 to about 7 seconds.

The total treatment time (i.e. the total duration of the audio signal administered to a subject being treated) may last up to about 30 minutes, for example about 15 minutes, such as 7 or 5 minutes or less. For example, a single treatment may last about 5 minutes and may comprise administering a subject a series of tones which ascend in frequency from 50 to 120 Hz and then a series of tones which descend in frequency from 120 Hz to 50Hz.

The treatment as defined herein may be used or administered at least once. Typically, the treatment may be used or administered one or more times daily and for a period of at least one, two, three, four or more weeks.

The step of administering a subject in need thereof may comprise delivering or exposing said subject to, the relevant audio tones or signal. For example, the audio tones or signal may be delivered to the ear or ears of a subject using devices such as, for example, in-ear devices (including earbud earphones and/or hearing aids), speakers, headphones (including earphones), earpieces and the like.

The methods and uses disclosed herein may find application in patients suffering from tinnitus which is not noise or stress/sleep deprivation based. For example, the inventors have discovered that the methods of treatment and uses disclosed herein are particulalry effective when administered to those individuals between about 45 and 54 years of age or older than about 65 with non-noise or stress/sleep deprivation based tinnitus. The methods and uses described herein may be particularly effective in those patients who have been suffering from tinnitus for less than about 5 years. By way of summary, the methods and uses of this invention may, for example, be applied/administered to patients falling into one or more, for example all of the following categories:

(i) suffering from non-noise or stress/sleep deprivation based tinnitus;

(ii) between about 45 and 54 years of age or older than about 65; and/or

(iii) suffering from tinnitus for less than about 5 years.

According to an eleventh aspect of the present invention is a hearing aid. The hearing aid may be configured to treat an ear related or hearing condition, such as tinnitus. The hearing aid may comprise a processing system. The processing system may be configured to provide a plurality of audio tones and/or an audio signal indicative of the plurality of tones. At least one of the tones may have a different frequency to at least one other of the tones. The hearing aid may comprise and/or be connected or connectable or configured to communicate with one or more sound generators for producing sound representative of the plurality of tones. The hearing aid may comprise or be comprised in the system of the first aspect. The hearing aid may comprise a digital signal processor and/or an audio amplifier and/or other audio components. The digital signal processor, audio amplifier, processor and/or other audio components may be configured to produce tones having a frequency below 30kHz, e.g. below 20kHz, such as below 200Hz, e.g. below 150Hz. One or more or each of the tones may have a frequency above 10 Hz, e.g. above 20Hz, such as above 50HZ. One or more or each of the tones may have a frequency between 20 and 200Hz, e.g. between 50 and 120Hz. The duration of one or more or each tone may be in a range from 1 to 60 seconds, e.g. from 2 to 30 seconds such as from 5 to 10 seconds or from 5 to 7 seconds.

According to a twelfth aspect of the present invention is a computer program product or computer file configured to at least partially implement the system of the first or third aspects, the audio signal of the second aspect, the carrier medium of the fourth aspect, the memory or data store of the fifth aspect, the network of the sixth aspect, and/or the method of any of the seventh to tenth aspects.

According to a thirteenth aspect is a carrier medium comprising or encoding the computer program product or computer file of the eleventh aspect.

According to a fourteenth aspect is a processing apparatus when programmed with the computer program product of the eleventh aspect.

It should be understood that the individual features and/or combinations of features defined above in accordance with any aspect of the present invention or below in relation to any specific embodiment of the invention may be utilised, either alone or in combination with any other defined feature, in any other aspect or embodiment of the invention. Furthermore, the present invention is intended to cover apparatus configured to perform any feature described herein in relation to a method and/or a method of using or producing or manufacturing any apparatus feature described herein.

Brief Description of the Drawings

These and other aspects of the present invention will now be described, by way of example only, with reference to the accompanying drawings, in which:

Figure 1 is schematic of a system for treating tinnitus;

Figures 2, 3, 4 and 5 are views of a user interface of a user device of the system of Figure 1 generated by an application running on the user device;

Figure 6 is a schematic of an alternative system for treating tinnitus;

Figure 7 is a representation of an audio signal provided by the system of Figure 1 or Figure 5; Figure 8: Plot of per group sample size curve based on effect size estimated from data. The red line indicates a threshold power of 95%. This suggests that a sample size (per group) of between 70 and 150 should be sufficient to establish an effect.

Detailed Description of the Drawings

Figure 1 shows a system 5a for the treatment of hearing conditions, particularly tinnitus. The system comprises a processing system 10a, in this case in the form of a server. The server 10a comprises a processor 15 and a network module 20. It will be appreciated that the server 10a also comprises one or more components such as one or more of the following: at least one display or monitor, one or more user input devices such as keyboards, a mouse, a track pad, touch screen, rollerball and/or the like, on-board memory, data storage in the form of one or more hard disk units, solid state memory units, such as flash memory, DRAM, SRAM and/or the like, which are not shown for brevity and clarity.

The network module 20 is configured to communicate over a network 25, e.g. the internet and/or an intranet, and can comprise a suitable modem, router, Wi-Fi interface, fibre optic and/or data cable connection and/or the like. The server 10a is configured to access a data store 30a, such as one or more hard-disk units, solid state memory units such as flash memory and/or the like. Although in this example, the data store 30a is shown as a separate module to the server 10a and connected via a wired or wireless connection or network, it will be appreciated that the data store 30a may be equally provided within the server 10a. The data store 30a is arranged to store one or more audio files 35 representative of one or more digital audio signals 40 (see Figure 7).

The server 10a is configured to access the audio files 35 from the data store 30a and communicate the audio files 35 using the network module 20 to a user device 45, e.g. over the network 25, internet or intranet. The user device 45 may be any suitable device that is configured to produce sounds embodying the audio signal 40 defined by the audio file 35. The audio file comprises any control codes or commands necessary to have a sound generator such as a speaker 50 of user device 45 emit a sound that represents the tones of audio signal 40. The user device 45 in this example is an internet connected device configured to receive the audio file(s) 35 over the network 25 (e.g. the internet) from the server 10a. Examples of suitable user devices 45 include a personal computer, a tablet, a smartphone, a PDA, a digital music player, a smart TV or smart hi-fi, stereo or music system, a phablet, or a custom or bespoke network connected or connectable audio device, such as an in-ear device and/or the like.

The user device 45 is suitably programmed with a computer program, an application (e.g. an "app") and/or the like. As shown in Figures 2 to 5, the user device 45 running the program or app is configured to provide a user interface, e.g. a touch screen 52, to receive input of user related data and selections from the user, e.g. including data such as medication taken, alcohol consumed, nicotine containing products used, caffeine containing products used or consumed, health or medical condition(s) of the user, e.g. tinnitus, such as a perceived or measured or otherwise evaluated severity of the condition(s), information regarding sleep of the user, such as an amount and/or quality of sleep, information regarding stress that the user is under, such as a perceived amount of stress, and/or the like. This data can be used by the user device 45 or communicated to the server 10a for use in determining a suitable digital audio signal 40. The suitable digital audio signal 40 can then be retrieved from memory on the user device 45 or retrieved from the data store 30a on the server 10a and provided to the user by the user device 45. The data can also be logged over time and used as a user specific profile, for presentation to the user, and optionally to allow better selection of an appropriate digital audio signal 40 for the user associated with the profile. The app may provide an easily accessible user interface, e.g. using slidable inputs as shown in Figure 2, and may display the data, which optionally may include the severity of the tinnitus e.g. using a THI score, and any treatments received in timeline, calendar or other formats, or the like, as shown in Figures 3 to 5.

This server based system 5a described above advantageously allows control of the audio files 35 and selection and provision of appropriate audio files 35 to specific users. For example, a user may be required to register with a provider and the user and/or the user's health care provider(s) supply certain details to the provider such as name, age, address, payment details, details of the user's hearing and/or medical condition, such as tinnitus, and/or medical information associated therewith. This data can be stored in the data store 30a, for example. Optionally, the user is required to log-in to the server with a unique user name / password or other identifier. In this way, an audio file 35 associated with, or appropriate for, the user can be provided and/or valid payment checked. It also allows for monitoring of the user, assessing progress and optionally providing a different audio file 35 and/or audio signals 40, for example, if the user is not showing an expected improvement with a given audio signal 40.

The system 5a is configured to provide a customization module (not shown) for allowing alteration or customization of the audio files 35 or signals 40. A user interface guides the alteration or customization such that the audio file 35 or signal 40 remains within certain parameters such as active frequency range, time, repetition rate and/or the like.

The system 5a implements a timer (not shown), which allows the system 5a to monitor the duration with which the user has listened to an audio signal and permits the system to notify the user when a treatment session has finished or when it is time to receive another treatment session (i.e. to listen to the audio signal 40). The notification can comprise a visual notification, e.g. provided using the display or screen or other visual indicator such as an LED or other light source, and/or an audible notification, e.g. using the speakers 50 or another suitable notification such as a vibrating notification, an e-mail or SMS message e.g. transmitted over the network 25, and/or the like.

The system 5a is configured to store, access, play and/or provide instructions, guides or other data, such as operating instructions, meditation guides or instructions, and/or the like.

In order to provide the user and/or a physician, service provider or advisor of the user with feedback regarding progress of the treatment or other information regarding the user's condition, the system 5a is configured to store or access and provide feedback interfaces and/or other means for assessing a severity or status of the user's condition, e.g. tinnitus. For example, the feedback interface can be configured to present questions to the user and collect responses from the user to allow determination of severity of tinnitus in accordance with the TFI or THI indexes, or any other recognised tinnitus assessment questionnaire. The system 5a determines the severity or other properties of the user's condition from the responses given by the user to the feedback interface and stores, tracks and optionally transmits the severity or other properties of the user's condition over the network 25 to the appropriate recipient. In this way, the user or other party can monitor progress and changes in the user's condition. If required, this also allows identification of when it would be beneficial to alter the treatment, e.g. the audio signal 40.

However, it will be appreciated that variations on the above arrangement are possible. For example, although the system 5a of Figure 1 represents a distributed system in which the audio files 35 are stored in the data store 30a and provided over the network 25 / internet by the server 10a, it will be appreciated that other embodiments may provide the audio files 35 on a physical carrier medium (not shown), such as a CD-rom, DVD-rom, solid state memory device or memory card or chip or flash memory or other persistent storage device, such as an SD card, XD card and/or the like.

In addition, the system 5 need not be a server based system, and instead a standalone system 5b could be used. Figure 6 shows an example of such a stand-alone system 5b. Optionally but not essentially, the stand alone system could be a hearing aid, for example. The system of the present invention may be particularly effective at addressing Tinnitus amongst older people, who may have a higher than average prevalence of hearing aid use. In this way, the hearing aid may be configured to conveniently provide Tinnitus relief at convenient times without having to carry a separate device. Furthermore hearing aids may already comprise some of the components required to implement the system, thereby facilitating shared use of components and reducing costs. However, since tones having very low frequencies may be particularly effective, as detailed above, the hearing aid audio components such as digital signal processors, amplifiers, speaker and the like may have to be specially selected or configured to operate at such low frequencies.

The system 5b of Figure 6 comprises an integrated device 55 comprising a processor 15 and a data store 30b within a housing 60. The integrated device 55 also comprises and/or is configured to communicate with at least one speaker 50. Although the example shown in Figure 6 comprises a speaker 50 within or supported by the housing 60, it will be appreciated that the speaker may be remote from the integrated device 55, e.g. provided in earbud type earphones, headphones, such as over the ear headphones, a Bluetooth speaker system, loudspeaker and/or the like. The speaker 50 of the integrated device 55 in this example is arranged to be provided in-ear, akin to an earbud style earphone. The integrated device 55 is optionally but not essentially configured, e.g. shaped and/or dimensioned, to fit on, behind or in the ear of the user. However this need not be the case and the integrated device 55, in examples, is configured to be remote from the ear, e.g. to be worn in a pocket or on a belt, and usable with an earbud style earphone or a set of over-ear headphones and/or the like.

The system 5b can be provided with a screen (not shown) and at least one user input device (such as a touch screen, one or more buttons, a track pad, and/or the like).

Similarly to the embodiment of Figure 1 , the datastore 30b of the integrated device 55 stores one or more audio files 35 representing the audio signal 40. The processor 15 transmits one or more of the audio files from the datastore 30b to the speaker 50 upon a user request (e.g. pressing of a button or operating other user input means, neither of which are shown for clarity). The speaker 50 is then driven to produce and propagate sounds representative of the audio signal 40 encoded in the audio file 35, i.e. into the ear of the user.

As shown in Figure 7, the audio signals 40 are each representative of a series of pure tones 65, e.g. each tone 65 being at substantially at one constant frequency. The series of tones 65 is such that only one tone 65 is played or provided at any given moment in time, i.e. the tones 65 are individual tones and are generally not provided simultaneously. In other words, the tones 65 are provided sequentially. The series of tones 65 comprises a plurality of tones 65a-65h of consecutively increasing frequency (e.g. each respective tone is higher in frequency than a preceding tone) followed by a plurality of tones 65i-65o of consecutively decreasing frequency (e.g. each respective tone is lower on frequency than a preceding tone). Each tone 65 is provided for between two and thirty seconds, e.g. for between five and ten seconds. The total audio signal 40, i.e. the whole series of tones 65a- 65o lasts for at least two minutes and less than 20 minutes, preferably between 4 and 6 minutes, e.g. approximately 5 minutes. Alternatively or additionally, the audio signal 40 can be repeated or provided together with other audio signals in order to provide the required treatment duration.

Beneficially, the tones 65 are low frequency tones, e.g. less than 20kHz, optionally less than 500Hz and preferably between 50 and 120Hz.

The audio signal 40 comprises consecutive tones 65 from different frequency bands

70a-70h. The frequency bands 70a-70h may have the same or different frequency bandwidth (e.g. 5Hz and/or 10Hz), and/or may be overlapping or non-overlapping in frequency. In one particular example, the audio signal 40 comprises a first tone 65a having a frequency in a band 70a of between 50 and 60Hz, followed by second tone 65b in a band 70b of between 60 to 70Hz and then subsequent tones 65c to 65h in bands 70c-70h of 65 to 75Hz, 70 to 80Hz, 80 to 90Hz, 95 to 100 Hz, 100 to 1 10Hz then 1 10 to 120 Hz respectively. Thereafter, a series of consecutive tones 65i-65o from bands 70g-70a of successively decreasing frequency are provided, which are the same frequency bands 70a-70h as the increasing frequency portion of the audio signal 40 but in a reverse order (i.e. the frequency decreases between subsequent tones 65 and bands 70).

For mild or temporary tinnitus, the audio signal 40 can be played as a one-off. However, for persistent or permanent tinnitus, the audio signal 40 can be advantageously provided repeatedly over an extended period. For example, listening to the audio signal 40, i.e. the series of tones 65a-65o spread over a low frequency range (e.g. 50 to 120Hz), for approximately 5 minutes each day for at least four or more weeks has been found to provide a significant reduction in tinnitus over a control group, as measured by both the Tinnitus Functional Index (TFI) and the Tinnitus Handicap Inventory (THI) measures, as shown in table 1 below.

Table 1 : Reduction in tinnitus between groups receiving an active multi-tone audio signal versus a control group using both the TFI and THI measures

Table 1 shows data from a randomised controlled trial (RCT) in which candidates were randomly assigned to either a control group or an experimental group receiving the audio signal 40 according to the above regimen. Delivery of the audio signal 40 took place online with an MP3 audio file 35 comprising the audio signal 40 being sent to the active treatment group. Candidates were asked to pick a device 45 of their choosing for listening to the audio signal 40, for example an MP3 player, laptop, iPhone or the like, and to use only that one device 45 over the course of the four week treatment period. THI surveys were taken at the beginning of the trial and then once a week for four weeks.

From the above, it will be appreciated that there is evidence that using the above low frequency sound method for five minutes a day for at least a month significantly reduces tinnitus severity in persistent or permanent tinnitus sufferers. After much experimentation, the inventors have found the treatment using low frequency audio tones as described above to be particularly advantageous for this purpose. Supplementary analysis

Models under consideration

Four basic statistical models were investigated. These models can be viewed as being progressively more sophisticated. In all cases, the effect of treatment group interacting with week is of interest. If this term in the model is found to be significant, then this indicates that over the course of the study, the treatment has had an effect on the level of tinnitus suffered by an individual.

Firstly, the effect of treatment group interacting with week on THI score (Model 1 ) and TFI score (Model 2) was considered. Then the scores were jointly considered, and the effect of treatment group interacting with week and type of score (Model 3) was considered. Finally, this model was extended to control for additional variables age, work noise, time with tinnitus, exposure to loud music and level of hearing loss (Model 4). These models are listed in Table 2.

Two types of analysis were applied to each of these models: a multi-way, within- subjects analysis of variance (ANOVA), and a mixed effects ANOVA. Without going into too much detail, both of these analyses control for the fact that individuals were measured repeatedly in the study. In practical terms, this means that we would expect the TFI and THI scores of the same individual over the course of the trial to be more closely related than those of another individual. Thus the assumption in a standard one-way ANOVA, that all errors are independent, is unrealistic, and more sophisticated models are used instead.

Table 2: overview of different models

Model 1: THI = Group x week

Model 2: TFI = Group x week

Model 3: Score = Group x Week x type

Model 4: Score = Group x Week x type = age + work noise +

tinnitus + loud music + hearing loss. Results.

Here we report the main findings from multi-way, within-subjects ANOVA and a mixed effects ANOVA applied to all four models. These are shown in Tables 3 and 4 respectively. In all cases, a statistically significant effect at the 5% level was found.

Table 3: Most relevant output for multiway within-subjects ANOVA for all four models. (N.B., this output for Model 3 and 4 are the same in this case.) Demonstrating the statistical significance of the results.

Table 4: Most relevant output for mixed effects ANOVA for all four models. Demonstrating the statistical significance of the results.

Additional Analysis

The main findings in this section are that:

• Size of effect for TFI is higher than for THI.

• Power analyses suggest that a per group sample size of between 75 (80% power) and 150 (99% power) could reasonably be used to determine an effect in the change of TFI score. Therefore the sample size used in this study could reasonably be used to determine an effect in the change.

• Within the treatment group, the number of missed days of treatment did not have a significant effect on the reported score. This was probably due to the fact that only a relatively small number of individuals reported missing more than a few days of treatment over the course of the four weeks.

• Within the treatment group, there was some evidence at the 5% level that a relationship existed between the amount that individuals enjoyed using the treatment and whether they felt the treatment helped, and their overall score.

Power analysis.

In this section we discuss what sample sizes might be required, given the observed effect size from this trial. Effect size here indicates (μ1 -μ2)/σ, and is not to be confused with the similarly named observed effect of treatment which is discussed in Section 2. Before the trial began, it was found that for an effect size of 0.5, and power =95%, a sample size per treatment group of n = 105 would be required. This is the estimated sample size for a two sample t-test. While the models which were used in this study were more sophisticated, power analysis for a two sample t-test and one way ANOVA will be used as reference points.

Using the mean difference in TFI score = 5.2 between control and treatment groups, and pooled variance = 10.3, we get an observed effect size of 0.51 , surprisingly close to the estimated effect in the a priori analysis. Using this effect size suggests a sample size of n = 105 would be required for a study with power = 95%. The relationship between power and sample size for a range of sample sizes is shown in Figure 8.

Missing days and patient evaluation.

Within the treatment group, the number of missed days of treatment did not have a significant effect on the reported score. This was probably due to the fact that only a relatively small (17%) number of individuals reported missing more than three days of treatment over the course of the four weeks. Table 5 shows the number of days missed by survey respondents. There appears to be a small amount of evidence that there is an association between respondents enjoyment of the treatment (F-i;108 = 5:58; p = 0:02) and whether they felt the therapy helped (F-i;108 = 4:84; p = 0:03), with their overall reported score. Table 5: Number of days missed by respondents. Only 17% of respondents missed more than 3 days of treatment over a four week period.

Summary

Confirmatory Analysis.

• Several analyses all report a statistically significant result at the 5% level for the

impact of treatment on TFI and THI scores, when the scores were considered both separately and collectively.

· Combining the scores in a single analysis, the interaction of treatment and week was found to be significant using a mixed treatment multiway ANOVA (F1 ;945; p = 0:001 1 ) and mixed effect model (F1 ;1409; p = 0:0001 ).

• Effect size of treatment after five weeks is estimated to be 6.5 for TFI and 3.1 for THI using mixed effects model.

· This result is robust to controls for age, noise levels at work, duration of time with tinnitus, exposure to loud music, and hearing loss levels. See extended report for full tables.

Additional Analysis.

• Power analyses suggest that a per group sample size of between 75 (80% power) and 150 (99% power) could reasonably be used to determine an effect in the change of TFI score. See Figure 8.

• Within the treatment group, there was some evidence at the 5% level that a relationship existed between the amount that individuals enjoyed using the treatment and whether they felt the treatment helped, and their overall score. It should be understood that the embodiments described herein are merely exemplary and that various modifications may be made thereto without departing from the scope of the invention. For example, although examples are shown above in which a distributed network based system 5a is provided (Figure 1 ), and a stand-alone system 5b is used (Figure 6), it will be appreciated that one or more components (e.g. data store 30a, 30b, processor 15 and/or speaker 50) may be combined in the same unit or module or distributed / spaced apart from one or more of the other components and communicate via a suitable physical and/or wireless network or other connection. Furthermore, whilst using a network based system 5a offers certain advantages, it will be appreciated that the invention may be implemented by providing the audio files 35 on a physical carrier medium or loaded onto an audio playing device 5b, 45.

While various examples of audio playing devices 5b, 45, 60 are given above, e.g. earbud type earphone, headphones, devices that at least partially locate "in-ear" similar to a hearing aid and so on, it will be appreciated that the speakers 60 are not limited to such types of devices and that other speaker systems such as computer or tablet or phone speakers, speakers of a music system, e.g. a hi-fi or stereo system, and/or the like may be used.

In addition, whilst examples of audio signals 40 having certain properties are provided, it will be appreciated that the audio signal 40 need not have the exact properties given above. In particular, whilst certain frequency bands 70a-70h are given above, it will be appreciated that other frequency bands 70a-70h may be used. In addition, although a series of consecutive tones 65a-65h of successively increasing frequency followed by consecutive tones 65i-65o of successively decreasing frequency are described above, it will be appreciated that at least some of the tones 65 may be provided at the same frequency, i.e. repeating tones and/or the tones may have successively decreasing frequency followed by successively increasing frequency, or randomly increasing and decreasing frequencies or other patterns.

As such, variations on the specific examples given above are contemplated, within the general concept of providing a series of low frequency tones, at least two of which have differing frequency in order to treat persistent tinnitus or similar hearing or ear related condition.

It will also be well understood by persons of ordinary skill in the art that whilst certain embodiments may implement certain functionality by means of software, that functionality could equally be implemented solely in hardware (for example by means of one or more ASICs (application specific integrated circuit) or Field Programmable Gate Arrays (FPGAs)), or indeed by a mix of hardware and software. As such, the scope of the present invention should not be interpreted as being limited only to being implemented in software.

The applicant hereby discloses in isolation each individual feature described herein and any combination of two or more such features, to the extent that such features or combinations are capable of being carried out based on the present specification as a whole in the light of the common general knowledge of a person skilled in the art, irrespective of whether such features or combinations of features solve any problems disclosed herein, and without limitation to the scope of any claims. The applicant indicates that aspects of the invention may consist of any such individual feature or combination of features. In view of the foregoing description it will be evident to a person skilled in the art that various modifications may be made within the scope of the invention, and that the description provides only one example embodiment of how the invention may be implemented.

Claims

1 . A system for treating an ear related or hearing condition, such as tinnitus, the system comprising a processing system configured to provide a plurality of audio tones and/or an audio signal indicative of the plurality of tones, wherein at least one of the tones has a different frequency to at least one other of the tones, and the system comprises and/or is connected or connectable or configured to communicate with one or more sound generators for producing sound representative of the plurality of tones.

2. The system of claim 1 , wherein the audio signal comprises control or operating data for controlling or operating the one or more sound generators.

3. The system of claim 1 or claim 2, wherein the tones are or comprise pure tones having substantially a single constant frequency.

4. The system of any preceding claim, wherein the audio signal is indicative of a series of tones and at least part of the series of tones comprises:

two or more consecutive tones that respectively increase or are higher in frequency relative to a preceding tone; and/or

at least one tone that consecutively decreases or is lower in frequency relative to a preceding tone.

5. The system of claim 4, wherein the series of tones of respectively increasing frequency or higher in frequency relative to a preceding tone is provided before or immediately preceding the series of tones of respectively decreasing frequency or lower in frequency relative to a preceding tone, or vice versa.

6. The system of any preceding claim, wherein at least one or each tone resonates or is arranged to resonate, the basilar membrane, and/or has a frequency that corresponds to a resonant frequency of the basilar membrane

7. The system of any preceding claim, wherein:

one or more or each of the tones may have a frequency below 20kHz, such as below 200Hz; and/or

one or more or each of the tones may have a frequency above 20Hz, such as above 50HZ; and/or one or more or each of the tones may have a frequency between 20 and 200Hz, such as between 50 and 120Hz.

8. The system of any preceding claim, wherein at least two or more or each of the tones are tones from different frequency bands.

9. The system according to any preceding claim, wherein two or more or each tone are separated by at least 5 Hz, e.g. 10Hz, or more.

10. The system according to claim 8 or any claim dependent thereon, wherein the tones comprise tones in at least two or more or each of the following frequency bands: 50 to 60Hz, 60 to 70Hz, 65 to 75Hz, 70 to 80Hz, 80 to 90Hz, 95 to 100 Hz, 100 to 1 10Hz, 1 10 to 120 Hz.

1 1 . The system according to any preceding claim, wherein the duration of one or more or each tone is in a range from 2 to 30 seconds such as from 5 to 10 seconds.

12. The system according to any preceding claim, wherein the duration of the audio signal is:

less than 15 minutes, such 7 or 5 minutes or less; and/or

at least 2 minutes, e.g. at least 3 minutes, such as 5 minutes or more; and/or between 2 and 15 minutes, such as between 3 and 7 minutes, e.g. substantially 5 minutes.

13. The system according to any preceding claim, wherein the system comprises, or the processing system is configured to access, a memory or data storage; and the processing system is configured to provide or generate the audio signal based on data from the memory or data storage.

14. The system according to any preceding claim, wherein the system comprises a network or interface module that is connected or connectable to a network connection or data carrier, and the system or processing system is configured to transmit or otherwise provide the audio signal via the network or interface module.

15. The system according to any preceding claim, wherein the system is or comprises or is comprised in an in-ear and/or on-ear device that is at least partially or wholly provided in or on the ear in use.

16. An audio signal for treating a hearing or ear related condition, such as tinnitus, the audio signal being provided, generated, transmitted, stored or otherwise used or usable by the system of any of claims 1 to 15, the audio signal comprising a plurality of tones.

17. The audio signal of claim 16, wherein the audio signal comprises control or operating data for controlling or operating the one or more sound generators to produce the plurality of tones.

18. The audio signal according to claim 16 or claim 17, wherein the tones are or comprise pure tones each having substantially a single constant frequency.

19. The audio signal according to any of claims 16 to 18, wherein the audio signal is indicative of a series of tones and at least part of the series of tones comprises:

20. The audio signal according to any of claims 16 to 19, wherein the series of tones comprising the series of tones of respectively increasing frequency or higher in frequency relative to a preceding tone is provided before or immediately preceding the series of tones of respectively decreasing frequency or lower in frequency relative to a preceding tone, or vice versa.

21 . The audio signal according to any of claims 16 to 20, wherein:

one or more or each of the tones may have a frequency above 20Hz, such as above 50HZ; and/or

one or more or each of the tones may have a frequency between 20 and 200Hz, such as between 50 and 120Hz.

22. The audio signal according to any of claims 16 to 21 , wherein at least two or more or each of the tones may be tones from different frequency bands.

23. The audio signal according to any of claims 16 to 22, wherein two or more or each tone are separated by at least 5 Hz, e.g. 10Hz or more.

24. The audio signal according to claim 22 or any claim dependent thereon, wherein the tones comprise tones in at least two or more or each of the following frequency bands: 50 to 60Hz, 60 to 70Hz, 65 to 75Hz, 70 to 80Hz, 80 to 90Hz, 95 to 100 Hz, 100 to 1 10Hz, 1 10 to 120 Hz.

25. The audio signal according to any of claims 16 to 24, wherein the duration of one or more or each tone is in a range from 2 to 30 seconds such as from 5 to 10 seconds.

26. The audio signal according to any of claims 16 to 25, wherein the duration of the audio signal is:

less than 15 minutes, such 7 or 5 minutes or less; and/or

27. A processing system for use in the system of any of claims 1 to 15 for treating a hearing or ear condition such as tinnitus, the processing system being configured to provide an audio signal according to any of claims 16 to 26.

28. A carrier medium comprising, storing or encoding an audio signal according to any of claims 16 to 26 and/or configured for use in or with the system of any of claims 1 to 15.

29. A memory or data store comprising, storing or encoding an audio signal according to any of claims 16 to 26 and/or configured for use in or with the system according to any of claims 1 to 15.

30. A network comprising or configured for use with the system according to any of claims 1 to 15 and/or comprising or carrying or transmitting or using or being configured to carry, transmit or use an audio signal according to any of claims 16 to 26.

31 . A method of transmitting an audio signal according to any of claims 16 to 26, the method comprising providing the audio signal on a carrier medium and/or transmitting the audio signal over a network from a system according to any of claims 1 to 15 to a user device.

32. A method of generating an audio signal according to any of claims 16 to 26, the method comprising providing an audio file comprising, encoding or defining the audio signal.

33. A method of alleviating or treating a hearing or ear related condition, such as tinnitus, the method comprising providing an audio signal or a series of tones wherein the audio signal is or comprises an audio signal according to any of claims 16 to 26.

34. The method of claim 33, comprising applying the audio signal for:

up to 30 minutes, e.g. less than 15 minutes, such 7 or 5 minutes or less, e.g. at least once a day; and/or

at least 2 minutes, e.g. at least 3 minutes, such as 5 minutes or more, e.g. at least once a day; and/or

between 2 and 15 minutes, such as between 3 and 7 minutes, e.g. substantially 5 minutes, e.g. at least once a day.

35. The method of claim 33 and/or claim 34, comprising applying the audio signal daily.

36. The method of any of claims 33 to 35, comprising applying the method for at least two weeks, e.g. at least three weeks, advantageously for four weeks or more.

37. A system for treating an ear or hearing condition, such as tinnitus as shown in the drawings and/or described in relation thereto.

38. An audio signal as shown herein in relation to the drawings and/or described in relation thereto.

39. A carrier medium or memory comprising or encoding the audio signal of claim 38.

40. A method of treating a hearing condition, said method comprising administering to a subject in need thereof, a plurality of audio tones and/or an audio signal indicative of a plurality of tones.

41 . The method of claim 40, wherein the subject is a subject suffering from

non-noise and/or stress/sleep deprivation based tinnitus.

42. The method of claims 40 or 41 , wherein the subject is over 45 years of age.

43. The method of claims 40, 41 or 42, wherein the subject has been suffering from tinnitus for less than 5 years.

44. A plurality of audio tones and/or an audio signal indicative of a plurality of tones for use in (or for use in a method of) treating a hearing condition.

45. The method of claims 40-44, or plurality of audio tones and/or an audio signal indicative of a plurality of tones of claim 44, for use of claim 44, wherein at least one of the tones has a different frequency to at least one other of the tones.

46. The methods and/or audio tones/signal for use of any one of claims 40-45, wherein the hearing condition is tinnitus and/or a condition associated with tinnitus or a condition caused or contributed to by tinnitus.

47. The methods and/or audio tones/signal for use of any one of claims 40-46, wherein the tones are or comprise pure tones having substantially a single constant frequency.

48. The methods and/or audio tones/signal for use of any one of claims 40-47, wherein the audio signal is indicative of a series of tones and at least part of the series of tones comprises:

49. The methods and/or audio tones/signal for use of any one of claims 40-48, wherein the series of tones of respectively increasing frequency or higher in frequency relative to a preceding tone is provided before or immediately preceding the series of tones of respectively decreasing frequency or lower in frequency relative to a preceding tone, or vice versa.

50. The methods and/or audio tones/signal for use of any one of claims 40-49 wherein:

one or more or each of the tones may have a frequency below 20kHz, such as below 200Hz; and/or one or more or each of the tones may have a frequency above 20Hz, such as above 50HZ; and/or

51 . The methods and/or audio tones/signal for use of any one of claims 40-50, wherein at least two or more or each of the tones are tones from different frequency bands.

52. The methods and/or audio tones/signal for use of any one of claims 40-51 , wherein two or more or each tone are separated by at least 5 Hz, e.g. 10 Hz, or more.

53. The methods and/or audio tones/signal for use of any one of claims 40-52, wherein the tones comprise tones in at least two or more or each of the following frequency bands: 50 to 60 Hz, 60 to 70 Hz, 65 to 75 Hz, 70 to 80 Hz, 80 to 90 Hz, 95 to 100 Hz, 100 to 1 10 Hz, 1 10 to 120 Hz.

54. The methods and/or audio tones/signal for use of any one of claims 40-53, wherein the tone(s) are selected from the group consisting of:

(i) a tone selected from the band 50 to 60 Hz;

(ii) a tone is selected from the band 60-70 Hz;

(iii) a tone is selected from the band 65-75 Hz;

(iv) a tone from the band 70-80 Hz;

(v) a tone from the band 80-90 Hz;

(vi) a tone from the band 95-100 Hz;

(νϋ) a tone from the band 100-1 10 Hz; and

(viii) an tone from the band 1 10-120 Hz.

55. The methods and/or audio tones/signal for use of any one of claims 40-54, wherein the duration of one or more or each tone is in a range from 2 to 30 seconds such as from 5 to 10 seconds.

56. The methods and/or audio signal for use of any one of claims 40-55, wherein the duration of the audio signal is:

less than 15 minutes, such as 7 or 5 minutes or less; and/or

57. The methods and/or audio signal for use of any one of claims 40-56, wherein the methods and/or audio signal is/are used and/or administered one or more times a day and/or for 1 , 2, 3, 4, 5 or more weeks.

58. The methods and/or audio tones/signal for use of any one of claims 40-56, wherein the step of administering a subject in need thereof comprises delivering the audio tones and/or signal to the ear or ears of the subject optionally using in-ear devices, earbud earphones, hearing aids, speakers, headphones, earphones, and/or earpieces.

59. A hearing aid, the hearing aid comprising a processing system configured to provide a plurality of audio tones and/or an audio signal indicative of the plurality of pure tones, wherein at least one of the pure tones has a different frequency to at least one other of the pure tones, and the hearing aid comprises and/or is connected or connectable or configured to communicate with one or more sound generators for producing sound representative of the plurality of pure tones.

60. A computer program product or computer file configured to at least partially implement the system of any of claims 1 to 15, 27 and/or 37, the audio signal or tones of any of claims 16 to 26, 38 or 41 , the carrier medium of any of claims 28 or 39, the memory or data store of claim 29, the network of claim 30, the hearing aid of claim 59 and/or the method of any of claims 31 to 36, 40, and/or 42 to 58.

61 . A carrier medium comprising or encoding the computer program product or computer file of claim 59.

62. A processing apparatus when programmed with the computer program product of claim 59.