Note: Descriptions are shown in the official language in which they were submitted.
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Description
Device for the Treatment of Tinnitus
The invention refers to a device for the treatment of tinnitus with an
operating
panel with a user interface and with at least one earplug connected to the
user interface
for the input of a sound pattern consisting of sounds with sound levels in a
frequency of
more than 30 Hz into the ear's outer auditory canal.
The term "tinnitus" describes a phantom sound which is subjectively perceived
by
a person, although other persons in the vicinity cannot hear this sound. This
tinnitus
sound can be a serious strain for the persons concerned, and it can lead to
concentration
problems, insomnia, depressions and even getting into a state of panic. The
medical
treatment presently knows various approaches, which, at a rule, are focused
upon the
inner ear, the acoustic nerve or the acoustic centre of the cerebral cortex,
the so-called
auditory cortex. Accordingly, various treatment methods have been developed
that each
focus on one of these areas.
DE 690 24 408 T2, for instance, shows an example that discloses a device for
regulating the pressure in a person's acoustic meatus or outer auditory canal.
This device
comprises a body that is dimensioned and formed to be inserted into the
person's outer
auditory canal. It comprises an opening that enables the transport of fluids
into and out
of the acoustic meatus while the device is inserted herein, in order to
generate a pressure
herein. Therein, this device generates a selective static pressure comprising
a lower
absolute value than the ambient pressure. This pressure treatment shall at
least
effectuate a reduction or suppression of the tinnitus. However, a sustained
elimination
of the tinnitus could not be achieved thereby; furthermore this device was
helpful only
for a limited group of people.
The company ANM Adaptive Neuromodulation GmbH follows a different path
with its acoustic CR -Neuromodulation. This method of treatment considers the
reason
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for the phantom sound to be pathologically synchronized, hyperactive
articulated nerve
cells in the brain. In a tightly focused way the sterical arrangement of the
tone frequency
in the auditory cortex is utilized to accomplish the acoustic stimulation in
the affected
area. In alignment with the patient's tinnitus frequency determined in
advance,
appropriate impulses are calculated by means of a specific algorithm and then
are
programmed in a chronological coordination towards each other. Thus, the
synchronous
tinnitus activity in the auditory cortex shall be disturbed. The stimulation
occurs via
medical ear-phones. By de-synchronizing the nerve cells the pathological
behavior of
the nerve cells shall be annihilated.
Also, this treatment method is afflicted by the fact that the actual causes
for a
tinnitus are not conclusively researched and, furthermore, can have different
actuators.
The stimulation of nerve cells by a sound pattern suggested here can be of
help for
patients only to a limited extent. In fact, in practice it shows that each
tinnitus is very
subjective, has its own characteristic and is based on individual causes.
Insofar it still
lacks a holistic approach for the treatment of tinnitus that, furthermore, is
suitable for a
major group of affected persons.
Therefore, the object of the invention is to create a device for the treatment
of
tinnitus that allows for better treatment results for a major group of
affected persons.
This object is achieved by a device with the features of claim 1. It
specifically
distinguishes itself by the fact that the ear-plug is connected via a pressure
tube with a
pressure generator that supplies pressure pulsations with a pulsation
frequency of less
than 10 Hz and with a pressure difference of less than 1 bar via the pressure
tube into
the outer auditory canal of the ear.
The invention is based upon the perception that a successful treatment of
tinnitus
requires a consideration of all interrelations as well as a complete
identification of the
affected areas in the body. Thus, a tinnitus generally affects four areas: the
physical
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hearing organ or ear, the nerve pathways, the physical brain functions and the
logical
brain functions.
With a tinnitus the ear is the obviously affected organ. The oldest analyses
and
research results regarding tinnitus are almost completely focused upon the
ear.
According to today's state of the art there is every reason to believe that a
tinnitus in the
ear can have various reasons or symptoms: Thus, a tinnitus here can be caused
by a
trauma, a defect or an injury, for instance by too loud a noise or an impact,
a shock wave
etc. Alternatively, it is also possible that an inflammation can cause a
tinnitus, or that a
circulatory disorder due to constriction or blockage, respectively acampsia or
hardening
of vessels is the cause of the sound in the ear.
According to the current state of research the affected areas in the ear are
in the
inner ear. In the cochlea the hair cells or stereocilia, that are affected or
damaged by the
causes mentioned. They form the interface towards the nerve cells or to the
nerve
pathway. Already upon consideration of the ear and the causes and the
correlation with
the tinnitus it has to be established that often several symptoms and causes
can apply,
wherein it is very difficult to determine the exact correlation between cause
and
symptom.
Another affected area is the acoustic nerve that relays the hearing impulse of
the
hearing organ to the brain. Overstraining and/or inflammation of the acoustic
nerve are
considered one cause or one symptom of tinnitus.
Furthermore, also the physical brain function is affected. The relevant area
in the
brain is the auditory cortex, located laterally in the temporal lobe and
processing the
hearing impulse transmitted via the acoustic nerve. According to the current
state of
research this area is massively affected by a tinnitus. Possibly, even the
cause of the
tinnitus may be located here.
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Moreover, also the logical brain function is of importance. Very early on it
had
been realized that tinnitus is not only caused by physical events, but that
particularly
mental aspects play an important role. Thus, stress is known to be a cause of
tinnitus.
Within the framework of the invention it was realized that for a complete cure
from tinnitus the interaction of all these affected areas has to be
considered. Therein the
complex interrelations are to be considered, in particular since with a
chronic tinnitus all
four areas in the body are affected simultaneously. Furthermore, then as a
rule what is
the actual cause of the tinnitus and what is now the symptom can no longer be
established. From experience it has been realized that the symptoms can also
take over
the role of the cause, once they are developed. Then the symptom becomes the
new
cause, and the cause becomes the symptom.
This becomes clear with a concrete example: Stress can lead to overstraining
the
auditory cortex and the acoustic nerves, or to an inflammation and a
circulatory disorder
of the acoustic organ. On the other hand, a trauma in the acoustic organ can
lead to
overstraining the auditory cortex and the acoustic nerves and thus even to
stress and
depressions. These interactions are manifold and are also verified by studies.
With the device according to the invention, for the first time all affected
areas are
treated simultaneously. Therein the invention utilizes the following treatment
components: air pressure massage of the acoustic organs, acoustic massage of
the
acoustic organs, stimulation of the acoustic nerves and of the acoustic cortex
and a
mental relaxation. In practical tests it turned out that with the combinatory
interaction of
these treatment components the healing results are particularly positive.
Therein the healing effect of the individual treatment components is of
particular
importance. Thus, the air pressure massage of the acoustic organs represents a
physical
massage that mobilizes hardened and stiffened vessels. Thereby it increases
the blood
circulation and mobility and has a soothing effect on the patient.
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The acoustic massage of the acoustic organs has a similar effect. However, it
achieves the same in a different frequency range and with a finer structure.
Thus, it also
increases the blood circulation, has a soothing effect on the nerves and on
the mental
condition of the patient. It supplements the effect of the massage on the
cochlea that is
achieved by the air pressure massage, but it does not replace the same.
The feeling of pressure and the acoustic signals additionally stimulate the
acoustic
nerves and the acoustic cortex by aiming at the frequency ranges of the
tinnitus.
Finally the feeling of pressure by the air pressure massage increases, among
others, the pouring out of endorphins and thus the mental relaxation of the
patient. It
also distracts him from the tinnitus noise. In particular with stress and a
patient's
propensity to depression this treatment component is of particular importance,
as has
been realized in the framework of the invention. Therein, particularly the
acoustic
signals have a relaxing effect.
At the same time the device according to the invention combines all those
treatment components in one single apparatus, so that a very simple and
practical
application of this treatment method can be achieved. In particular, the
device according
to the invention allows for a very stress-free and relaxed application.
Another advantage is that the device according to the invention can be taken
along
anytime and can be operated by any user.
Therefore, the device according to the invention enables a holistic treatment
of
tinnitus, thus being suited for virtually any patient and achieving reliably
good therapy
results.
Advantageous further embodiments of the device according to the invention are
subject of the dependent claims.
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For instance, the user interface may comprise a pressure controller or
regulator to
control the amount of pressure of the pressure pulsations. Then it is easily
possible for
the user to adjust the device according to the invention, so that he can
achieve the best
possible therapy result.
Further, the pressure difference of the pressure pulsations created by the
pressure
generator can amount to less than 0,5 bar. In practical tests it showed that
here even
better results can be achieved. Therein the pressure difference can preferably
be less
than 0,2 bar and in particular lie between 0,05 and 0,1 bar, where the best
therapy results
have been achieved in the pre-tests.
If the pressure generator generates a pressure pulsation with excess pressure
and
low or negative pressure relative to the ambient pressure, the medicinal
benefit is
extremely good. In particular a very good massage result and thus a
stimulation of the
blood circulation etc. can be achieved. Thereby also the acoustic nerves and
the acoustic
cortex can be particularly well stimulated.
It is of further advantage if the user interface comprises a frequency
controller or
regulator to control the pulsation frequency of the pressure pulsations. Then
a user can
adjust the pulsation frequency specifically to that range that gives him the
best therapy
result. Thus an individual adjustment to the respective patient is possible by
him- or
herself. In practice, however, the suitable pulsation frequency for the
patient is initially
determined and preset by a medical check-up. Thus a particularly tightly
focused and
individual treatment is achievable.
As pre-tests have shown, particularly good therapy results can be achieved
when
the pulsation frequency is less than 5 Hz. Preferably the pulsation frequency
is between
0,25 and 5 Hz, wherein also here particularly good results have been achieved
at a
pulsation frequency of between 0,5 and 2 Hz.
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It is of further advantage if the user interface comprises a control device or
means
for the adjustment of the volume of the sound and/or a specific sound pattern
from a
program matrix. Then a suitable and individual adjustment of the device for
the
respective patient is possible, wherein he can make additional individual
adjustments in
the course of the utilization.
Since the device according to the invention comprises a selection of ear-plugs
of
different sizes and/or shapes from which the user chooses the appropriate or
adequate
ear-plug, this is universally sellable merchandise. Each user can then make
his/her
individual adjustment without having to acquire additional elements. Therein
an ear-
plug is particularly well-suited for a user if it is adjusted to the form of
the ear or the
shape of the concha, resulting in best possible wear comfort at simultaneously
optimized
tightness.
It is further advantageous if the device according to the invention comprises
a
support means with which the at least one ear-plug is held in the user's ear.
Thus the
user's comfort is increased further. Therein the support means is preferably
adjustable to
the size of the user's ear and/or head. This still further increases the
user's comfort. In
addition a particularly reliable function of the device according to the
invention is
achieved.
Here it is advantageous if the support means is a head holder encompassing the
user's head; then a particularly good wear comfort can be achieved.
Furthermore, the at
least one ear-plug is held in the user's ear particularly reliably.
Preferably, here two ear-
plugs are applied, so that on both sides an impact on the user's ear is
attained. Thus
particularly good therapy results can be achieved.
Hereafter the invention is explained in more detail by means of the figures of
the
drawing. Therein
Fig. 1 shows a schematic view of the device according to the invention;
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=
Fig. 2 shows a detailed view in the area of an ear-plug;
Fig. 3 shows a detailed view of the connection in a partly assembled state;
Fig. 4 shows the connection according to Fig. 3 in the totally assembled
state; and
Fig. 5 shows the connection according to Fig. 4 with the ear-plug attached.
According to the depiction in Fig. 1 a device 1 for the treatment of tinnitus
comprises a operating panel 2 as well as a head holder 3. These are connected
via a
speaker cable 4 and a flexible pressure tube 5.
The operating panel 2 comprises a housing 21 that is shown only schematically.
On the top surface of the housing 21 a user surface or interface with various
controllers
for the individual setting of the desired parameters is arranged.
Thus, a pressure controller or regulator 22 is arranged at the user interface,
by
means of which the pressure of the pressure pulsation can be adjusted. In the
example
shown a pressure difference of the pressure pulsation can be infinitely
adjusted between
0 and 0,5 bar. This pressure regulator 22 interacts with a pressure generator
(not shown)
that provides a corresponding pneumatic pressure. Here the pressure generator
is
arranged in the operating panel 2.
Furthermore, a frequency controller or regulator 23 is positioned at the user
interface, by means of which the pulsation frequency of the pressure pulsation
is
adjustable. In the shown embodiment the frequency regulator 23 allows for a
pulsation
frequency of up to 5 Hz.
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Furthermore a volume control 24 is arranged at the surface of the operating
panel
2, by means of which the volume of the sounds and/or of a specific sound
pattern from a
program matrix is adjustable.
Furthermore, for this a program selection control 25 is provided, by means of
which a user can freely select a specific sound or a specific sound pattern
from a preset
program matrix.
On the surface of the operating panel 2 furthermore a data connection 26 is
arranged which in this case is formed as a USB-connection. Hereto, for
instance, an
MP3 player can be connected, if the pre-set sound pattern of the program
matrix is not
accessed.
The operating panel 2 is dimensioned in such a way that it can be taken along
without any problem. For this it is furnished with a clip (not shown) for
fastening at a
belt or the like. It is battery-operated, wherein additionally a connection
for direct access
to a power supply system in the normal household area is provided. Thus the
device 1
can also be used stationary, respectively a recharge of the batteries or the
accumulators
in the operating panel 2 is possible.
The speaker cable 4 and the pressure tube 5 lead from the operating panel 2;
they
each split in the shown embodiment and are connected with both sides at the
head
holder 3. The latter comprises a mounting bracket or support means 31 as well
as
conchas 32 and 33. Thus, the head holder 3 is formed similarly to a
conventional head
holder for music systems or the like. However, the conchas 32 and 33 are
formed in
such a way that they comprise specific ear-plug receptions 34 and 35. Therein
ear-plugs
36 can be inserted, of which only one is shown in Fig. 1. These ear-plugs 36
are locked
in the conchas 32 and 33 such that they are positioned in a suitable manner in
the
acoustic meatus of the ear.
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From Fig. 2 it is obvious that such an ear-plug 36 is connected with the
pressure
tube 5 and the speaker cable 4 via a connection 6. Therein the ear-plug 36 is
formed in
such a way that the air-pressure provided by the pressure tube 5 can act
through the
same into the acoustic meatus or outer auditory canal. Therein the pressure
tube 5 is
designed to be flexible and generally does not expand with the applied
pressure.
To apply the device 1 for treatment of tinnitus a user selects suitable ear-
plugs 36,
fastens them at the ear-plug receptions 34 and 35 and by the connection 6
connects them
with the speaker cable 4 and the pressure tube 5. Then he attaches the head
holder 3.
Thereafter he activates the device 1 by means of a switch (not shown) and
selects the
desired program from the program matrix with the program selection regulator
25. By
means of the pressure regulator 22, the frequency control 23 and the volume
control 24
he then adjusts these parameters in order to optimize the therapy result.
Thus the user receives an air pressure massage as well as an acoustic massage
of
the acoustic organs. Furthermore, the acoustic nerves and the acoustic cortex
are
stimulated and a mental relaxation is achieved.
In Figs. 3 to 5 the area of the connection 6 is shown in more detail. Therein
Fig. 3
shows a partly assembled state of the connection 6. Here it can be recognized
that the
speaker cable 4 leads to a speaker 7. The latter is of a particularly small
size, in order to
be suitable for the intended use. The pressure tube 5 ends with an open end
next to the
speaker cable 4 in the area of the speaker 7. Therein the speaker cable 4 and
the pressure
tube 5 are joined by a heat shrink tube 61.
In the depiction according to Fig. 4 the heat shrink tube 61 and the speaker 7
are
furthermore covered by a sliding tube 62, so that the connection 6 is
complete. Thus the
speaker 7 as well as the open end of the pressure tube 5 are provided in a
suitable
manner at the free end of the connection 6. Finally, according to the
depiction in Fig. 5 a
medical ear-plug 36' is attached thereon, that is formed differently from the
ear-plug 36
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shown in Fig. 2. Now this arrangement can be inserted into one of the ear-plug
receptions 34 and 35 respectively at the head holder 3.
The device 1 according to the invention for the treatment of tinnitus allows
for
further approaches at embodiments along with the embodiment explained above.
In a simplified embodiment it is therefore also possible to waive the pressure
regulator 22. Then the device always works with the factory-provided pressure
of the
pressure pulsation.
Further, in specific applications it can also be appropriate to provide the
pressure
difference of the pressure pulsation with a higher value than 0,5 bar. Here
the individual
requirements of the person to be treated have to be considered. Generally it
can also be
appropriate in specific applications to apply a pressure difference of less
than 0,05 bar.
In a preferred embodiment of the invention the pressure generator provides a
pressure pulsation with excess pressure and low pressure relative to the
ambient
pressure. However, this is not necessary. The device 1 can also be operated
exclusively
in the low pressure range or the excess pressure range towards the ambient
pressure.
Then the pressure pulsation is generated by build-up of pressure and discharge
of
pressure by the pressure generator.
In another simplified embodiment the device 1 can also be used without the
frequency control 23. Then the factory-provided pre-set pulsation frequency
applies.
Also with a view to the pulsation frequency it is possible with a view to the
very
different people affected by tinnitus, to apply a value of more than 5 Hz, if
this should
be appropriate in a particular case.
Further it is also possible to waive the volume control 24 in the framework of
a
simplified embodiment of the device 1. Then a factory-provided pre-set volume
applies.
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Also the program selection control 25 can be omitted in a simplified version
of the
device. Then a factory-provided pre-set sound or a certain pre-set sound
pattern applies.
As is obvious from these explanations, individual or several or even all
controls
22 to 25 can be omitted at the operating panel 2. However, in the embodiment
according
to Fig. 1 all controls 22 to 25 are installed.
Furthermore, it is also possible to apply a sound pattern from the most
different
to external sources. This is not limited to the MP3 Player mentioned above,
but can also
use other data sources, like USB-sticks, internet connections or the like,
wherein the
data connector 26 can also be equipped for different data connection systems
than USB,
like for instance SD etc. As an alternative, it is, however, also possible to
waive the data
connector 26.
In an alternative embodiment it is also possible to install two or more
separate
elements instead of one single operating panel 2. Thus, the pressure generator
with its
control elements can form a separate unit, as well as the sound source with
its assigned
control elements. Here it is only essential that in the user's ear region the
pressure as
well as the sound are available and take effect together.
In a preferred embodiment the device 1 comprises a selection of ear-plugs of
different sizes and/or shapes, from which the user can choose the adequate ear-
plug.
However, this is not mandatory. Also a standard ear-plug can be applied here.
In a simplified embodiment of device 1 it is not essential to provide a head
holder
3. Furthermore, one single ear-plug 36 can be sufficient, which is the case in
particular
if the tinnitus of the user appears only one-sided. Then this individual ear-
plug 36 can be
directly inserted into the ear without using a concha 32 or 33 or a mounting
bracket 31.
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On the other hand, with the application of the mounting bracket with the
conchas
32 and 33 the physical form can be created such that these elements are
customized to
the head shape, as is known already from music systems. Furthermore, mounting
brackets can be offered in various sizes.
Additionally it is also possible for an application of the device 1 on one
side to
equip the mounting bracket 31 with an ear-plug 36 only one-sided, so that the
application is directed only to the one affected ear. On the other hand, it is
also possible
to treat the user's both ears not simultaneously, but alternately, which is
advantageous
for certain forms of tinnitus. Ultimately, the user's specific clinical
picture is relevant
for the specific application of device 1.
To support the treatment it is also possible to combine the application of the
device 1 with the intake or infusion of medical substances or with stress-
reducing
measures.
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