The present invention relates to a method and apparatuses for Tinnitus release.

Tinnitus is a condition where a sound with no external source is heard in the head. This phenomenon can be with a very low intensity where it is not really felt as a problem , and can be an unbearable suffering situation where a human being can literally get mad.

According to market figures, more than 10% of the world population suffer from Tinnitus in some degree of intensity or another, and the numbers grows rapidly , only in the USA, every year, 1 million people are added to the Tinnitus suffering list ! it is a real epidemic of the 21 century.

Tinnitus origin can be from illness, but in the most cases of Tinnitus are created due to excessive noise exposure and as a post-trauma side effect. There are a lot of researches and solutions offered for this problem, however, most of therapist in this field know that there is a limited success in curing Tinnitus. Some methods were tested like applying soft laser energy or magnetic energy to the afflicted ear(s). They were all with very limited results. Due to the poor results of those curing methods, habituation to and masking of the Tinnitus is the main prescription today.

TRT - Tinnitus Retraining Therapy is the most common treatment for Tinnitus. TRT aim is habitation. The results of this method are not satisfying enough and the process takes very long time , 18 month is a common treatment duration. The TRT is not suitable for most people.

The presented invention is appropriate for every one suffering from Tinnitus since it is based on a the natural and simple procedure. Also this invention affects the sufferer very quickly relatively to TRT and good and stable results are expected to be in few months in the worse case.

The second popular solution is to take the attention of the mind from the Tinnitus by using few kind of masking methods. By applying calming sounds to the hearing system, like water fall sound, the mind move its attention from Tinnitus to the more enjoyable sound and feel some relief. The main drawback of the masking method is the short lived effect of this treatment. The Tinnitus usually appear again after the masking sound is stopped. This invention is superior on masking since it has a lasting effect over time and consistently reduces the Tinnitus.

An interesting phenomena that is related to the masking method is the RI- Residual Inhibition. After a session of some period of masking treatment, the Tinnitus disappears for a short time, hi the WO 02/096154 JENSEN , an attempt was done to use constructively that effect by appealing a sequential of masking sounds. In the [resent invention, the sounds are not masking sounds and are designed to be heard with the Tinnitus with equal attention on the sound and the Tinnitus. The "no sound" periods are replaced with total deep silence with mechanical and cosmetic means to create such a silence periods.

Detailed description of the invention:

The aim of this invention is to release or even cure Tinnitus by training the brain and mind to use its inherent capabilities to inhibit Tinnitus permanently.

It is well known that part of Tinnitus sufferers are cured spontaneously during their first year of Tinnitus. This means that the brain knows how to cure Tinnitus and learning this process of this natural cure can have immense benefit for further researches.

The idea beyond this invention is that if the brain could distinguish between the Tinnitus sound and other normal sound and consider the Tinnitus as an internal noise, it could reduce the Tinnitus influence in the same way as it does with the SOAE. The SOAE — Spontaneous Oto Acoustic Emission, is a hearing phenomena that every one can experience when exposed to a very quiet environment like in a sound booth, it is a internal noise like Tinnitus but a lot quieter. Since most of us are not exposed to this extreme low noise situation, the SOAE is not a problem. The motivation beyond this special method of this invention is to use this brain effect were the brain "knows" how to constantly reduces internal noise as it those with SOAE

A major part of this invention is to expose the Tinnitus patient to short periods of total silence. During this silence periods, the Tinnitus is heard clearly and accompanied with the SOAE. In this situation ,the brain do not hear the natural sounds from the outside.

A natural similar effect is felt in prior-to-sleep time were the environment is relatively quiet and the Tinnitus is heard more intensively . This invention uses this phenomena that Usually is not welcomed by Tinnitus patients, for short period of time hearing the Tinnitus strongly for few seconds has only the positive effect on the patients.

Between those short periods of silence, a normal sound, Usually in a lower frequency then the Tinnitus frequency and in a similar intensity as the Tinnitus is applied to the ears. When the brain observe the Tinnitus sound without external noise and with the SOAE ₅ it can "decide" that the Tinnitus is an additional kind of SOAE and the brain starts to reduce it the same way it does always with SOAE and any undesired sounds, keeping it in a low and unnoticed sound level. The presence of natural sound between the silent periods strengthen the effect by creating a contrast effect and accelerates the good results. The basic procedure of the treatment according to this invention is to put A earmuff or earplug with good sound isolation structure on the patients ears for a short period - Usually for 10 to 30 seconds, and then open totally to environmental sounds for also a short periods. This sequence is applied for a session that is long enough for the patient to notice an reduction of his Tinnitus.

A different way is to use custom made sound isolating earplugs with a sound path like a small pipe , that can be opened and closed sequentially to the environment sounds by the finger tip.

The invention in details: In order to explain the invention , Fig 1 , Fig 2 and Fig 3 are referred.

As seen in (Fig 2), there are two kind of the system states in this invention.

In State 1 (The normal state) there are 3 sub states. In the sound sub-state 201 The ears sound path opened to the environment sounds or to a Generated sound like white noise, audio single tone , FM verbal or even verbal sound. In the Tinnitus sub- state 202, the Tinnitus is heard because the sound is not masking the Tinnitus. In the SOAE sub-state 203 ,The internal SOAE is not heard by the patient. In State 2 (The Silence state) There are those 3 sub-states perceived differently.

In the sound sub-state 204 , the hearing channel is sound isolated from all external sounds. In the Tinnitus sub-state 205, the Tinnitus is heard more clearly. In the SOAE sub-state 206, The SOAE can be heard. The system is moving sequentially between those 2 states.

A cycle Fig 1 103 is a sequence of one normal state 101 following one silence state 102.

The duration of the normal state is Tl (seconds) and the duration of the silence state is T2 (seconds).There are N cycles 104 that together build the treatment session.

As Seen in Fig 3A, usually the Tinnitus is on the high frequency of the sound spectra. In Fig 3B it can be seen that in state 1 304 the Tinnitus and the external sound are heard together, the sound (natural or artificial ) frequency is lower then of Tinnitus frequencies but in the same amplitude so the brain can notice both. In state 2 the Tinnitus and internal natural sounds (SOAE) are heard together. There are 3 modes of The normal state (state 1) that are part of this invention:

Mode 1 :If the environment sounds have reasonable sound level, like in an office, the sounds coming from the outside can serve as the stimulus of the normal mode. To achieve this mode the ear is totally opened to the environment during the normal state 1 period.

Mode 2 : If the normal environmental sound level is too low (a quiet place like at home for example), Or the environmental sound level can not be considered reliable, the system supplies a pre-recorded sound in the normal state 1 period. Mode 3 :If the environment sound is too high but consistent, (like in a noisy airport) a possible way to generate sound is to attenuate the environmental sound. The apparatuses are adjusting the sound intensity reaching the ear by controlling the aperture of the sound path with a acoustic valve. If it is too load, the Acoustic valve is totally closed and an internal sound is generated.

It is important the treatment can be done in any place since the apparatuses are portable and the treatment events must be in a daily routine basis.

An important part of this invention is to apply those two states for at least one cycle of treatment 103 , The T2 silence period must be relative short in order to be bearable and comfortable for the patient since the Tinnitus perception in more intense in this state . The Parameters of the System are adjusted individually in a calibration initial session.

In order to achieve the treatment in a automatic practical way, the Tinnitus apparatuses designs are presented. There are few different versions based on the same method. One version is to use a earplug like apparatus and the second version is to use earmuffs apparatus. And the third version is a hearing aid. The Tinnitus part of the hearing aids device can be integrated in most of the existing hearing aids like those of Siemens , This Hearing Aid arrangement bring additional benefit because the battery, the processor, the small microphones and small speakers, the recorded sound memory and amplifiers are the same parts. The earmuff like apparatuses can be integrated to existing standard and ANR electronic earmuffs.

The two presented apparatuses are based on almost the same electronics - hardware and software. The differences in the cosmetics and acoustics are also described later.

Detail Blocks in the block diagram of the Tinnitus apparatuses - Fig 4

The block diagram (Fig 4) describes the electronics and electromechanical parts of the apparatuses. The Processor 410 is a Digital microprocessor that operates according to the program installed in it . The On off switch 411 is a switch for start running the treatment programs and for stopping them. The switch Can be any switch and can operate on normal or toggle modes. The Microphone 401 can be any microphone including small microphones that are common in the hearing aid industry and are a good choice. It is placed outside the apparatus to capture the environmental sounds. The Pre Amplifier 402 amplifies the signals created by the microphone. The AfD 403 Analog to digital converter is for interfacing the analog amplified sound to the digital microprocessor. The Real time clock and timer 404 is for setting up the timing like to when to start the treatment and to define the timing of the periods of silence and sounds , Tl 101 and T2 102 (see Fig 1). The timer operation can be created by the software of the processor. The D/A or duty cycle D/A 405 is for interfacing the microprocessor digital sound to the analog amplifier 406 . This amplifier is the driver of the speaker 407 The Stepping motor driver 408 takes digital stimulus and create power to activate the stepping motor 409. The Stepping Motor moves the acoustic valve of the earplug apparatus 702 or the iris acoustic shutter of the earmuffs apparatus 605. The preferred Stepping Motor is a be-directional one with a idle mode just to to save battery (410) power. The Battery 410 is suppling the power to the entire systems. The Wire or wireless communication 414 has few purposes, to communicate between the two ears to synchronize the silence timing, To download updated programs to the processor and to upload data logged during the treatment session. This can be achieved in few communication platforms like FM, Infra red, RP, and by wire connection directly. The Sound recording chip 413 Can be added when mode 2 and 3 are selected. A pre-recorded sound or music is recorded on memory or other media . A possible recording sounds can be a verbal instructions to the user.

The simplest mode of operation (Mode l)is described here. This is the basic and lower cost application of this invention. After putting the special ear-set on the ears

(earmuffs or earplugs) the Switch 411 is operated, the microprocessor 410 with the timing machine 404 activate the stepping motor 408 that activate the acoustic valve 409.

A series of open / close sessions of the valve is activated according to the Tinnitus program treatment. The silence period is followed by a total opening to external sound. The valve in this case is a simple one with on/off option only. This mode is implemented if the treatment is conducted in a quiet room with natural background sounds. This is defined earlier as the Mode 1. Here the program flow chart Fig 5A (Mode 1 ) is described. The Acoustic valve is normally open 502. The on/off power switch 503 is turn to on state then the ear-set is put on the ears / head, hi this state the valve is fully closed 504 and there is a deep silence experienced. Then after a delay time of T2 505, the valve is opened 506 for a Tl period 507 and this sequence is performed N times 508, then the treatment is over 510 after the acoustic valve is opened 509.

The internal sound mode (Mode 2 ) is described :In case the treatment can not be performed in normal life conditions and the environment sound level is not stable, an internal sound generation is provided through the speaker circuit. The advantage of this mode is that the treatment is totally in control. No proportional control valve is needed, only a on/off shutter can replace the more sophisticated valves.

The Hardware configuration (Mode 2) is described here. The sound generator

413 creates sounds that are sent to the Microprocessor 410 during the state 1 of the treatment. During the state 2 the sound is cut off and the Valve 407 is closed by the control of the valve driver 708 for a period of T2, The microphone 401 the pre amplifier

402 and the A/D 403 are used only to measure the environment sound level for calibration purposes.

The program flow chart Fig 5B (Mode 2) is described here. When the power is on 501 the acoustic valve is closed 502. There is silence for T2 503 then the tone generator is on 504 for Tl 505. This sequence is done for N times 506 then the treatment is over 508 after the acoustic valve is open 507. The laboratory mode is part of the beginning of any process Tinnitus treatment , few hearing tests are performed in the auditory laboratory. Usually a hearing test is conducted in the sound isolation booth .Following is a test for Tinnitus tone and pitch. The first session of the Tinnitus treatment method can start just after those tests in the Lab. This can bring a good introduction of the method and a calibration of the apparatuses parameters (Tl, T2 and N) according to the first findings about the patient Tinnitus treatment needs.

The Earmuff apparatus mechanical and cosmetic is described. As seen in Fig 6 - a earmuff 601 is placed on the patient ear that fully block sounds from the environment.

A 32-40 dB sound isolation is recommended when choosing a earmuff. To open or close the sound path to the ear, a iris like 605 sound shutter is activated by the stepping motor 604. The Iris has 3 modes: Totally open, totally closed and proportional partly open. The proposed iris like shutter is made of sound isolating material and is designed to close totally the sound path to the ears when required. hi the US 6826287, Myers describes a earmuff that has a possibility to open the earmuff to the outside sounds. The advantage of the iris shutter is its big sound control area and it's thin profile.

The microphone 602 is place outside the earmuff to collect environmental sounds. The speaker 606 is placed inside the earmuff to generate pre-recorded sounds for state 2 . All other components of the electronics are placed inside the earmuff in a compact circuit 603.

The Earplug apparatus mechanical and cosmetic description Fig 7 and Fig 8 is described here. A special mold 701 is prepared (impression) according to the outside part of the ear. It fits to the ear so that no sound will reach the auditory canal during the silence periods. The material used is of highly isolating kind as described earlier. An additional pressure can be added by using the C shape earphone holder 806, this can improve the holding of the earplug in place and achieve a better sound isolation. This C shape holder can also make an electric contact between the two ears as described in the block diagram communication block 414. The microphone is placed on to outside part of the mold 804, The speaker is placed in the inside of the mold facing the ear canal 802. The Stepping Motor 805 turns the sound acoustic valve 807 to 3 possible positions. Open 702, close 703 or partly open.

The sound acoustic valve 807 is designed to turn on it's axis and can have a cylindrical or ball shape. The body of the valve is made of highly sound isolating materials. Its internal opening is designed to pass or block sound to the auditory canal

808 depending on his rotating angle. Only 90 degrees of rotation is needed . In the mold or outside it all the electronic parts are located 803.

A Hearing Aid integrated with Tinnitus treatment is described here. The earplug apparatus described in this application can be implemented into a Hearing Aid system. There are few Hearing Aids configurations in the market depending on placement in or out the hearing channel and depending on size and sound signal manipulation. The Hearing Aid has most parts of the electronics in the block diagram Fig 4 but some changes must be implemented in some of the hearing Aid products. The stepping motor driver 408 and the stepping motor 409 are added to the standard hearing aid system block diagram. The Acoustic Valve 702 is implemented to the mold 701 and all the electronics 803 can stay part of the hearing aid. Existing Hearing Aids have no total silence option as part of their functionality. Part of them have sound generators for Tinnitus Masking option. In normal operation, the Hearing channel is open partly to prevent acoustic undesired effects.

The integrated system is Normally in the Hearing Aid mode. The Acoustic Valve is opened and Microphone sounds are amplified processed on the sound level and sent to the Loudspeaker. When switched by the user to the Tinnitus treatment mode, the Acoustic valve is closed and almost no noise can reach the internal ear. Then this stated stays for T2 period and then an internal sound source is activated for Tl period. All of this is performed N times for a full treatment. Then it can be turned back to the Hearing Aid mode.

The EEG Biofeedback Tinnitus cure Model is described here. Recent researches had found a close relationship of the brain neural activity and the Tinnitus subjective activity. Since the Tinnitus treatment described in this application had an immediate noticeable effect on some patients and long term effect on others, A EEG biofeedback system can be integrated to perform an active healing effect with the active participation of the patient.

A possible Biofeedback procedure is described here. The Tinnitus apparatus is placed on the hearing system and the EEG signals collected on from the relevant head regions and are amplified and filtered. A Tinnitus stimuli of the silence period is activated (or a full cycle - 103) , the EEG effect of reducing Tinnitus is displayed as a visual or acoustic stimulus. There are few possibilities to use EEG processed signal for the benefit of the

Tinnitus treatment that are described here. The EEG positive indication of Tinnitus improvements is used for encouraging the patient to continue the treatment, or, the EEG effect control the length of the Tl or T2 or Both and the N parameter or, a long term improvement EEG reduction indicator becomes part and a support for the patient.