(19)
(11)EP 3 551 066 B1

(12)EUROPEAN PATENT SPECIFICATION

(45)Mention of the grant of the patent:
07.02.2024 Bulletin 2024/06

(21)Application number: 16819284.7

(22)Date of filing:  09.12.2016
(51)International Patent Classification (IPC): 
A61B 5/256(2021.01)
A61B 5/291(2021.01)
(52)Cooperative Patent Classification (CPC):
A61B 5/6815; A61B 2560/0425; A61B 5/291; A61B 5/256
(86)International application number:
PCT/EP2016/080447
(87)International publication number:
WO 2018/103861 (14.06.2018 Gazette  2018/24)

(54)

GENERIC EAR DEVICE WITH ELECTRODES

GENERISCHE OHRVORRICHTUNG MIT ELEKTRODEN

DISPOSITIF D'OREILLE GÉNÉRIQUE À ÉLECTRODES


(84)Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

(43)Date of publication of application:
16.10.2019 Bulletin 2019/42

(73)Proprietor: T&W Engineering A/S
3540 Lynge (DK)

(72)Inventors:
  • ANDERSEN, Mikael
    3540 Lynge (DK)
  • RANK, Mike Lind
    3540 Lynge (DK)
  • TOFT, Hans Olaf
    3540 Lynge (DK)
  • KIDMOSE, Preben
    8320 Maarslet (DK)
  • KAPPEL, Simon Lind
    8220 Brabrand (DK)

(74)Representative: Bastue, Jens 
Widex A/S Nymoellevej 6
3540 Lynge
3540 Lynge (DK)


(56)References cited: : 
EP-A1- 2 229 882
JP-A- 2013 146 371
US-A1- 2010 331 660
US-A1- 2014 140 567
CN-U- 205 697 764
US-A- 4 706 682
US-A1- 2013 184 552
US-A1- 2014 171 775
  
      
    Note: Within nine months from the publication of the mention of the grant of the European patent, any person may give notice to the European Patent Office of opposition to the European patent granted. Notice of opposition shall be filed in a written reasoned statement. It shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).


    Description

    Background



    [0001] The present invention relates to an ear component for detecting bioelectrical signals. The invention relates more particularly to an ear component for arrangement partly in an ear canal and partly at the ear outside the ear canal (e.g. in the concha or tragus region, and/or in a region behind the ear).

    [0002] Bioelectrical signals are here understood to be electrical potential differences originating from a living body. Well-known examples are Electrocardiogram (ECG) signals and Electroencephalogram (EEG) signals. An ear component for detecting bioelectrical signals at the ear is often made for the detection of EEG signals, but could also be applied for detecting other bioelectrical signals such as ECG, electrooculography (EOG), or muscular activity.

    [0003] EEG signals are electrical signals generated by a person's brain activity. In recent years, EEG monitoring systems, that may be carried or worn continuously by a person to be monitored, have been devised. A goal is to have personal wearable EEG monitors, which can be carried without causing more inconvenience than glasses or a modern small hearing aid, even when carried over several months or years.

    [0004] Such EEG monitors may be applied for different purposes. One example is surveillance of a condition of a person and e.g. for providing an alarm or information in case predetermined conditions are met. The monitor may also be applied for collection of data, e.g. for diagnostic purposes or for research use. Examples of applications are for surveillance of persons having diabetes or epilepsy. Another example is as input to the control or adjustment of a hearing aid.

    [0005] Moreover, in recent years there has been a lot of activities within transcranial neuro-stimulation (e.g. tDCS and tACS). Here, electrodes are used for recording electrical signals, but also for neuro-stimulation. Another application could be measurement of galvanic skin-responses (GSR).

    [0006] Furthermore, electric potentials originating from neural activity in the cranial nerves and in the brain stem may also be measured with ear devices. This is e.g. relevant in assessment of hearing loss, where it is common to measure responses from the cranial nerve (cranial nerve 8) and from the brain stem (as in auditory brain stem responses). But it may also be relevant to measure responses from e.g. the vagus nerve (cranial nerve 10) which have branches out in the external ear. This may e.g. be of relevance in epilepsies.

    [0007] Measuring the EEG signal in the ear canal is known from WO 2011/000383 A1 disclosing an ear plug with EEG electrodes where the ear plug shape is individually matched or customized to the users ear canal.

    [0008] WO 2007/047667 A2 discloses an ear plug made from a compressible material and provided with EEG ear canal electrodes. External ear electrodes are arranged on a measurement device, which is worn behind the ear. Thereby, the housing of the measurement device is shaped/customized to the curved contour of the ear of an individual Other relevant prior art is disclosed in US 2010/0331660 A1, US 4706682, CN 205697764 U, WO 2012/095171, US 2014/0140567 A1, WO 2013/026481. JP 2013-146371 A discloses a headphone with a blood flow sensor on a bendable arm configured to reach the concha region. EP 2229882 A1 discloses a device with an ear canal fitting unit and an ear hook component. The device comprises electrodes to measure a biosignal at the ear.

    Summary



    [0009] One problem with the known solutions is that a customization of the ear plug to the ear canal of the individual user or of the housing of the measurement device to the curved contour of the ear of the individual user is necessary, which produces high costs. It takes time to manufacture customized ear-pieces. First a 3D model must be obtained based on an ear-impression or ear-scanning. Second the individual ear-piece must be modelled and manufactured. This has several consequences: (a) Need for infrastructure (3D-scanners, manufacturing setup for single-device manufacturing, etc.) and trained personal, which is also costly. (b) The user/patient must show up at least twice in the clinic: first to get the ear-impression taken, and second to get the device. This is inconvenient and costly. (c) The time-consuming and cumbersome process is prohibitive for some applications, e.g. for applications where it is intended to measure for a short period of time. One example could be in cases where it is intended to monitor sleep over a few days or weeks. Another example could be in an intensive care unit (ICU) or in an emergency situation. Moreover, customized parts do not necessarily guarantee a satisfying bioelectrical signal in case of ear form changes (e.g. speech, during sleep, etc.), movement of the housing of the measurement device, and/or jaw movements, which are the most severe source for motion artefacts in ear-EEG devices.

    [0010] The present invention is thus directed to provide an ear device for detecting bioelectrical signals at low costs and at short time scales, whereby the ear device constantly delivers satisfying bioelectrical signals when in use.

    [0011] The present invention is defined in claim 1. Preferred embodiments are defined in the dependent claims.

    [0012] A solution to the above problem has been found by an ear device for arrangement at an ear of a person and provided with at least two electrodes for having skin contact and detecting a bioelectrical signal when in use, the ear device comprises a deformable ear canal part adapted to be arranged in an ear canal of the person, and an external ear part adapted to be arranged at the ear external to the ear canal and being provided with at least one external ear electrode for detecting a bioelectrical signal, the external ear part comprises at least one bendable arm which is connected to the ear canal part and is adapted to exert a pressure such that the at least one external ear electrode is pressed against the skin when in use.

    [0013] One advantage of the solution is that a customization of the ear device is not necessary due to the deformable ear canal part and the bendable arm. In other words, generic ear canal parts and generic bendable arms can be used for different users. This significantly reduces the time it takes to adapt a device, makes it less cumbersome for both dispenser and user, requires less infrastructure and less training of personal, and in consequence reduces cost. Furthermore, a user may use the ear device immediately, which saves time and is cost-efficient. Moreover, the deformable ear canal part as well as the bendable arm constantly press against the skin when in use such that a satisfying contact between the electrodes and the skin is provided. Even when the form of the ear changes (e.g. during sleeping), the elastic properties of the deformable ear canal part and the bendable arm compensate said form change such that a constant contact of the electrodes with the skin is provided, which thus constantly delivers satisfying bioelectrical signals when in use. Further advantages of the claimed subject-matter are: Easy to adapt to the individual ear, good and reliable electrode contact, high comfort, easy to use (user-friendly) and unobtrusive to normal life activities, no occlusion of the ear. Thereby, the ear canal part further stabilizes the position of the external ear part. Moreover, different materials for the ear canal part and the external ear part may be used, preferably rubber, silicone, compounds of different shore hardness, etc.

    Detailed Description



    [0014] Embodiments of the invention will now be explained in further detail with reference to the figures.

    Figure 1 illustrates an example of an ear device having electrodes.

    Figure 2 illustrates an ear with an example of an ear device arranged in the ear canal and in the concha.

    Figures 3 and 4 illustrate an example of an ear canal part of the ear device.

    Figures 5 to 13 illustrate another example of an ear device.

    Figure 14 illustrates an example of an ear device having a bendable arm with a concha part and a bendable arm with a behind the ear part.



    [0015] The detailed description set forth below is intended as a description of various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The appended drawings are incorporated herein and constitute a part of the detailed description. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. However, it will be clear and apparent to those skilled in the art that the subject technology is not limited to the specific details set forth herein and may be practiced without these specific details.

    [0016] According to a further embodiment, the ear canal part is provided with at least one ear canal electrode for detecting a bioelectrical signal, the at least one ear canal electrode is arranged at a structure adapted to be deformed when the ear canal part is arranged in an ear canal, such that the at least one ear canal electrode is pressed against the skin of the ear canal. Thereby, the measurement of the bioelectrical signals may be based on the ear canal part and the external ear part. Due to the distance between these two parts, the measurement quality of the bioelectrical signals is further improved in comparison with a measurement of the bioelectrical signals based only on the ear canal part.

    [0017] According to a further embodiment, the ear canal part is formed such that it only has contact to an upper part of the ear canal when in use. Thereby, the force applied to the upper part of the ear canal is then balanced by an opposing force from the external ear part. This embodiment provides several advantages: (a) The upper part (superior) of the ear canal is the most shape-stable part of the ear-canal because it is following the shape of the skull. The bottom part (inferior) and the sides (posterior and anterior) are to a large extent influenced by the position of the jaw. Therefore, the upper part is less influenced by jaw movements, and consequently less prone to motion artefacts. (b) The upper part of the ear canal is closer to the brain, and therefore electrodes in the upper part may be better for EEG signal recording, (c) In most applications it is desirable to have an acoustical transparent device. By minimizing the size of the ear canal part there will be less occlusion.

    [0018] According to a further embodiment, at least a part of the bendable arm is a concha part adapted to be arranged in a concha region of the ear and further adapted to follow the shape of the concha. The concha region is highly suitable to receive the bendable arm.

    [0019] The bendable arm can thus easily and securely press against the protrusions of the concha region (e.g. the antehelix), whereby a secure fixing of the bendable arm and thus an improved contact between the external ear electrode and the skin is provided. Thereby, the bendable arm is preferably extending from the ear canal part to at least a point in the concha, where the at least one external ear electrode is held.

    [0020] According to a further embodiment, the bendable arm may comprise a cutoff portion, which is removable from the bendable arm. Thereby, the bendable arm purposefully is made too long, and the bendable arm can easily be shortened for example by cutting with a scissor. This facilitates the fitting of one ear device to a multitude of users.

    [0021] According to a further embodiment, at least a part of the bendable arm is a tragus part adapted to be arranged in a tragus region of the ear and further adapted to follow the shape of the tragus, wherein preferably the bendable arm is extending from the ear canal part to at least a point at the tragus, where the at least one external ear electrode is held. The tragus region of the ear is preferred since this region allows for extra pressure without compromising comfort. This can be achieved by adding additional material to the bendable arm. Moreover, the tragus region often has a different potential than the concha region, as shown by measurements. This further improves the measurement of the bioelectrical signal.

    [0022] According to a further embodiment, the ear device comprises a detachable connection to a unit holding a bioelectrical signal processor and a power supply. Thereby, the ear device can easily be connected to said unit.

    [0023] According to a preferred embodiment, the bioelectrical signal is an EEG signal.

    [0024] According to a preferred embodiment, the bendable arm is adapted to hold the at least one external ear electrode. When the at least one external ear electrode is directly arranged on the bendable arm, a particularly good contact between the skin and the electrode is provided, which further improves the signal quality.

    [0025] According to a further embodiment, at least a part of the bendable arm is a bendable behind the ear part adapted for extending to a behind the ear area, i.e. to the side of the auricle facing the head, when in use. Said bendable behind the ear part may be also provided as a further bendable arm. Said bendable behind the ear part further improves the fixing of the ear device at the ear of the person as well as the contact stability between electrodes and skin without the need of customization.

    [0026] According to a preferred embodiment, the behind the ear part comprises at least one behind the ear electrode, and the behind the ear part is adapted to exert a pressure such that the at least one behind the ear electrode is pressed against the skin of the external ear and/or the head when in use. Thereby, a further electrode for measuring bioelectrical signals is provided at a larger distance to the at least one ear canal electrode, which further improves the signal quality without the need of customization. Likewise, the fixing of the ear device at the ear of the person as well as the contact stability between electrodes and skin is further improved without the need of customization.

    [0027] According to a further embodiment, the external ear part comprises a cavity, in which an electrical wiring for connecting the external ear electrode and/or the behind the ear electrode is routed. Thereby, the cavity provides a particularly good and easy installation of the electrical wiring. Moreover, the cavity allows a simplified bending of the external ear part such that the external ear part with its at least one external ear electrode and/or at least one behind the ear electrode may easily apply a pressure against the skin, which further improves the signal quality without the need of customization.

    [0028] According to a further embodiment, an angle between an axis of the ear canal part along the ear canal and a plane defined by the external ear part, in particular of the bendable arm, is adjustable according to the ear of the person. Thereby, the fitting of the ear device can be better adjusted to the specific form of the ear of the person. Preferably, said angle is lockable such the angle remains constant to ensure an improved and stabilized fitting of the ear device at the ear of the person. This further ensures the stable contact between electrodes and skin.

    [0029] According to a further embodiment, the ear device further comprises an acoustic alarm module, which is configured to output an acoustic alarm signal depending on at least one detected bioelectrical signal. For example, in case of hypoglycemia, the person wearing the ear device can thus be warned about a low blood glucoselevel.

    [0030] According to a further embodiment, there may be other sensor modalities included in the ear device (e.g. accelerometers, temperature sensors, body-coupled microphones, optical pulse oximetry, NIRS,etc.). Moreover, the ear device may comprise means for communicating with external devices.

    [0031] According to a further embodiment, there is provided a set of ear devices, wherein the shape of the devices within the set is the same, but the sizes of the different devices are different. For example, an audiologist or another fitting person can thus easily select the best generic size of the device for a person wearing the device. The device can then finally be adapted to the specific ear form of the person by the deformable ear canal part and the bendable arm as described above. Thereby, providing a set of ear devices having different sizes but the same shape avoids customization of the ear device for a specific person.

    [0032] In a preferred embodiment, a hearing assisting device or a headset comprises the ear device as defined in either one of the claims.

    [0033] In another preferred embodiment, a bioelectrical signal monitor comprises the ear device as defined in either one of the claims.

    [0034] Figure 1 shows an embodiment of an ear device 1 of the invention. The ear device 1 comprises an ear canal part 20, which is adapted to be arranged in an ear canal of an ear 10 of a person, see figure 2. The ear canal part 20 comprises at least one ear canal electrode 22. As shown in figure 3, the ear canal part 20 may comprise two ear canal electrodes 22. In principle, the number of ear canal electrodes 22 depends on the bioelectrical signal to be measured by the ear device 1. In general, preferred bioelectrical signals are for example EEG signals. However, the present invention may also be used in all the applications mentioned in the background section. Figure 4 shows a side view of the ear canal part 20.

    [0035] As shown in figure 1, the ear device 1 further comprises also an external ear part 30, which is adapted to be arranged external to the ear canal. The external ear part 30 comprises at least one external ear electrode 32. As shown in figure 1, the external ear part 30 may comprise two external ear electrodes 32. In principle, the number of external ear electrodes 32 depends on the bioelectrical signal to be measured by the ear device 1. In general, preferred bioelectrical signals are for example EEG signals.

    [0036] Thereby, it is mentioned that the ear canal electrode 22 is optional in this embodiment. Using the ear canal electrode 22 and the external ear electrode 32 provides nevertheless an increased distance between the electrodes for measuring the bioelectrical signal. By this increased distance, the signal quality can be improved.

    [0037] As shown in figure 1, the external ear part 30 comprises a bendable arm 34, which is connected to the ear canal part 20. As shown in figure 2, the bendable arm 34 provides a concha part, which is adapted to follow the shape of a concha 12 of the ear 10. Thereby, the concha part of the bendable arm 34 fits closely to at least one protrusion of the concha 12 and exerts thereby a pressure such that at least one of the external ear electrodes 32 is pressed against the skin of the person when in use. Moreover, a dislocation of the ear canal part 20 is thereby prevented, too.

    [0038] As shown in figure 1, the external ear part 30 may further comprise a stabilizing arm 36, which may likewise be bendable as the bendable arm 34. The stabilizing arm 36 is adapted to further stabilize the bendable arm 34 such that the bendable arm 34 exerts a sufficient pressure against the concha 12.

    [0039] Another example of the ear device 1 as shown in figures 5 to 13. Thereby, the reference signs correspond to the features as explained with respect to figures 1 to 4.

    [0040] Figures 5 to 13 show further an ear canal part wiring 40. Moreover, figure 10 shows an external ear part wiring 42. These wirings 40 and 42 may be in contact with a detachable connection to a unit holding a bioelectrical signal processor and/or a power supply (not shown).

    [0041] Thereby, figure 10 further shows that the external ear part wiring 42 is routed in a cavity 28 of the external ear part 30. The cavity 28 provides a particularly good and easy installation of the external ear part wiring 42. Moreover, the cavity 28 allows a simplified bending of the external ear part 30 such that the external ear part 30 with its at least one external ear electrode 32 may easily apply a pressure against the skin, which further improves the signal quality without the need of customization.

    [0042] In summary, the ear device 1 can be arranged in the concha region 12, exerting a slight pressure in the concha 12 in order to both establish a good electrical contact between at least one of the electrodes 32 and the skin of the ear 10.

    [0043] Furthermore, the ear device 1 may include or be in close connection with an electronic module for amplifying, performing analogue to digital conversion and e.g. filtering in order to improve the signal to noise ratio (not shown). The wiring 42 and 40 for guiding the bioelectrical signals from the electrodes and to this electronic module, is preferably shielded, e.g. in the form of a coax cable.

    [0044] Such a wiring may be embedded, fully or partly, in the material forming the ear canal part. This will save space in the ear canal part, and will provide protection for these thin cables.

    [0045] In general, the external ear part 30, which is adapted to be arranged at the ear external to the ear canal, can have different forms and shapes.

    [0046] In one form, it can be arranged in the concha region as shown in figure 2, exerting a slight pressure in the concha in order to both establish a good electrical contact between an electrode and the skin.

    [0047] In another form, the external ear part can extend towards or into the helix, triangular fossa, crura of antihelix or Scapha region where an electrode may be arranged. Furthermore, an electrode placement at Tragus is preferred since this area allows for extra pressure by adding additional material to the bendable arm. Moreover, the tragus region often has a different potential than the concha region, as shown by measurements. This further improves the measurement of the bioelectrical signal.

    [0048] In another form as shown in figure 14, the external ear part 30 may comprise a bendable behind the ear part 35 extending to the behind the ear space, i.e. to the cleft between the ear and the head. The bendable part 35 extending to behind the ear may be countered by a concha part, and these two parts of the thus branched, bendable arm 34 in combination may clamp the ear slightly in order to ensure a good electrical contact. The electrode can be arranged at either of two clamping parts, the part extending behind the ear (as at least one behind the ear electrode, not shown) and/or at a part in the concha (as external ear electrode 32). Thereby, the at least one behind the ear electrode may arranged on the bendable behind the ear part 35 such that this electrode contacts the ear and/or the head. For simplification, the ear canal part 20 is not shown in figure 14. Moreover, it is also possible that the external ear part 30 is only formed by the bendable behind the ear part 35.

    [0049] In other words, the external ear part 30 may thus be formed to have several arms (like a spider). Some of the bendable arms may only serve the purpose of creating a counterforce to the force applied by the other arms. One embodiment is for example to have a fork-like structure in the Cymba cavity region, where one of the arms applies a pressure downwards and another arm applies a pressure upwards.

    [0050] Having at least four electrodes offers the advantage of eliminating the risk that two or maybe three electrodes being arranged at the same equipotential line/surface such that no signal can be detected. The risk is small when three electrodes are provided, but can be eliminated when applying four or more electrodes.

    [0051] Moreover, the optimal electrode positions depends on what it is intended to measure (because different physiological phenomenon's have different potential fields in the ear.) and/or the anatomical shape of the ear (in order to get a good and reliable contact). Thereby, there may be large inter-subject variation in both anatomy and physiology. Therefore, it may be advantageous to provide ear device 1 with a multitude of electrodes, and then select the optimal sub-set of electrodes to be used, when the device is fitted to the patient/user.

    [0052] Often, the external ear part will extend in one plane. The ear canal part will typically extend along an axial direction approximately orthogonal to the plane defined by the external ear part. In this regard, figures 7 shows that the external ear part 30 defines a plane P (dashed line), in which the external ear part 30 is arranged, and the ear canal part 20 defines an axis A (dotted line) along the ear canal. An angle α between this plane P and the axis A should preferably be adjustable, such that it can be adapted easily to an individual who needs to carry the device. Thereby, the ear canal part is preferably flexible, which means that it can be hinged around angles (2-DOF). Thereby, the comfort during wearing the ear device is further improved and a customization is not necessary as generic and adjustable parts may be used for different persons.

    [0053] In general, the ear canal part 20 and the external ear part 30, in particular the bendable arm 34 and the bendable behind the ear part 35, are preferably made of elastic or viscoelastic and biocompatible materials, such as silicone or rubbers, and may also be coated with foams or other suitable coatings. "Bendable" is thereby to be understood as elastic and flexible. These components are thus adapted to exert a pressure such that the corresponding electrodes are pressed against the skin when in use. Thereby, a customization is not necessary as generic parts may be used for different persons as discussed above.

    [0054] This further allows to provide a set of ear devices 1, which have the same shape but different sizes (not shown).

    [0055] Furthermore, the acoustic alarm module may preferably be received in the ear canal part.

    [0056] Finally, the ear device 1 can be used within a hearing assisting device (not shown). Thereby, a transducer, a DSP or any other components of a hearing device may for example be provided together with the ear canal part 20 in the ear canal. If needed, components of the hearing device may also be provided behind the ear 10.


    Claims

    1. An ear device (1) for arrangement at an ear of a person and provided with at least two electrodes (22, 32) for having skin contact and detecting a bioelectrical signal when in use, the ear device (1) comprises

    - a deformable ear canal part (20) adapted to be arranged in an ear canal of the person, the ear canal part (20) being provided with at least one of the at least two electrodes (22, 32), this at least one electrode being an ear canal electrode (22) for detecting a bioelectrical signal, where the at least one ear canal electrode (22) is arranged at a structure adapted to be deformed when the ear canal part (20) is arranged in an ear canal, such that the at least one ear canal electrode (22) is pressed against the skin of the ear canal, and

    - an external ear part (30) adapted to be arranged at the ear external to the ear canal and being provided with at least one of the at least two electrodes (22, 32), this at least one electrode being an external ear electrode (32) for detecting a bioelectrical signal, the external ear part comprising at least one bendable arm (34) which is connected to the ear canal part and is adapted to exert a pressure such that the at least one external ear electrode (32) is pressed against the skin when in use, wherein at least part of the bendable arm (34) is at least one of a concha part and a tragus part adapted to be arranged in at least one of a concha region and a tragus region of the ear, further adapted to follow the shape of at least one of the concha and the tragus, wherein preferably the bendable arm (34) is extending from the ear canal part (20) to at least a point at least one of in the concha and at the tragus, where the at least one external ear electrode (32) is held.


     
    2. The ear device (1) according to claim 1, wherein the ear canal part (20) is formed such that it only has contact to an upper part of the ear canal when in use.
     
    3. The ear device (1) according to claim 1, comprising a detachable connection to a unit holding a bioelectrical signal processor and a power supply.
     
    4. The ear device (1) according to claim 1, wherein the bioelectrical signal is an EEG signal.
     
    5. The ear device (1) according to claim 1, wherein the bendable arm (34) is adapted to hold the at least one external ear electrode (32).
     
    6. The ear device (1) according to claim 1, wherein at least a part of the bendable arm (34) is a bendable behind the ear part adapted for extending to a behind the ear area, i.e. to the side of the auricle facing the head, when in use.
     
    7. The ear device (1) according to claim 6, wherein the behind the ear part comprises at least one behind the ear electrode, and the behind the ear part is adapted to exert a pressure such that the at least one behind the ear electrode is pressed against the skin of the external ear and/or the head when in use.
     
    8. The ear device (1) according to claim 1, wherein the external ear part (30) comprises a cavity, in which an electrical wiring for connecting the external ear electrode (32) and/or the behind the ear electrode is routed.
     
    9. The ear device (1) according to claim 1, wherein an angle between an axis of the ear canal part along the ear canal and a plane defined by the external ear part, in particular of the bendable arm (34), is adjustable according to the ear of the person, wherein preferably said angle is lockable.
     
    10. The ear device (1) according to claim 1, wherein the ear device further comprises an acoustic alarm module, which is configured to output an acoustic alarm signal depending on at least one detected bioelectrical signal.
     
    11. A set of ear devices (1) according to claim 1, wherein the shape of the devices within the set is the same, but the sizes of the different devices are different.
     
    12. The ear device (1) according to claim 1, wherein the ear canal part (20) is provided with at least one ear canal electrode (22) for detecting a bioelectrical signal, the at least one ear canal electrode (22) is arranged at a structure adapted to be deformed when the ear canal part is arranged in an ear canal, such that the at least one ear canal electrode (22) is pressed against the skin of the ear canal, wherein the ear canal part (20) is formed such that it only has contact to an upper part of the ear canal when in use.
     
    13. The ear device (1) according to claim 1, wherein at least a part of the bendable arm (34) is a concha part adapted to be arranged in a concha region of the ear and further adapted to follow the shape of the concha, wherein preferably the bendable arm (34) is extending from the ear canal part (20) to at least a point in the concha, where the at least one external ear electrode (32) is held and wherein at least a part of the bendable arm (34) is a bendable behind the ear part adapted for extending to a behind the ear area, i.e. to the side of the auricle facing the head, when in use, wherein preferably the behind the ear part comprises at least one behind the ear electrode, and the behind the ear part is adapted to exert a pressure such that the at least one behind the ear electrode is pressed against the skin of the external ear and/or the head when in use.
     
    14. The ear device (1) according to claim 1, wherein at least a part of the bendable arm (34) is a tragus part adapted to be arranged in a tragus region of the ear and further adapted to follow the shape of the tragus, wherein preferably the bendable arm (34) is extending from the ear canal part (20) to at least a point at the tragus, where the at least one external ear electrode (32) is held and wherein at least a part of the bendable arm (34) is a bendable behind the ear part adapted for extending to a behind the ear area, i.e. to the side of the auricle facing the head, when in use, wherein preferably the behind the ear part comprises at least one behind the ear electrode, and the behind the ear part is adapted to exert a pressure such that the at least one behind the ear electrode is pressed against the skin of the external ear and/or the head when in use.
     
    15. The ear device (1) according to claim 1, wherein the ear canal part (20) is formed such that it only has contact to an upper part of the ear canal when in use, and wherein at least a part of the bendable arm (34) is a concha part adapted to be arranged in a concha region of the ear and further adapted to follow the shape of the concha, wherein preferably the bendable arm (34) is extending from the ear canal part (20) to at least a point in the concha, where the at least one external ear electrode (32) is held, and wherein at least a part of the bendable arm (34) is a tragus part adapted to be arranged in a tragus region of the ear and further adapted to follow the shape of the tragus, wherein preferably the bendable arm (34) is extending from the ear canal part (20) to at least a point at the tragus, where the at least one external ear electrode (32) is held, and wherein at least a part of the bendable arm (34) is a bendable behind the ear part adapted for extending to a behind the ear area, i.e. to the side of the auricle facing the head, when in use, wherein preferably the behind the ear part comprises at least one behind the ear electrode, and the behind the ear part is adapted to exert a pressure such that the at least one behind the ear electrode is pressed against the skin of the external ear and/or the head when in use.
     
    16. A hearing assisting device or a headset comprising the ear device (1) according to claim 1.
     
    17. A bioelectrical signal monitor comprising the ear device (1) according to claim 1.
     


    Ansprüche

    1. Ohrvorrichtung (1) zum Anordnen an einem Ohr einer Person und die mit mindestens zwei Elektroden (22, 32) zum Hautkontakt und zum Erfassen eines bioelektrischen Signals bei Gebrauch versehen ist, wobei die Ohrvorrichtung (1) umfasst

    - ein verformbares Gehörgangsteil (20), das dazu angepasst ist, in einem Gehörgang der Person angeordnet zu werden, wobei das Gehörgangsteil (20) mit mindestens einer der mindestens zwei Elektroden (22, 32) versehen ist, wobei diese mindestens eine Elektrode eine Gehörgangselektrode (22) zum Erfassen eines bioelektrischen Signals ist, wobei die mindestens eine Gehörgangselektrode (22) an einer Struktur angeordnet ist, die dazu angepasst ist, sich zu verformen, wenn das Gehörgangsteil (20) in einem Gehörgang angeordnet ist, so dass die mindestens eine Gehörgangselektrode (22) gegen die Haut des Gehörgangs gepresst wird, und

    - ein Außenohrteil (30), das dazu angepasst ist, am Ohr außerhalb des Gehörgangs angeordnet zu werden und mit mindestens einer der mindestens zwei Elektroden (22, 32) versehen ist, wobei diese mindestens eine Elektrode eine Außenohrelektrode (32) zum Erfassen eines bioelektrischen Signals ist, wobei das Außenohrteil mindestens einen biegsamen Arm (34) umfasst, der mit dem Gehörgangsteil verbunden ist und angepasst ist, einen Druck auszuüben, so dass die mindestens eine Außenohrelektrode (32) bei Gebrauch gegen die Haut gepresst wird, wobei mindestens ein Teil des biegsamen Arms (34) mindestens eines von einem Concha-Teil und einem Tragus-Teil ist, das dazu angepasst ist, in mindestens einem von einem Concha-Bereich und einem Tragus-Bereich des Ohrs angeordnet zu werden, das weiter angepasst ist, der Form mindestens eines von der Concha und dem Tragus zu folgen, wobei sich der biegsame Arm (34) vorzugsweise vom Gehörgangsteil (20) bis zu mindestens einem Punkt in mindestens einem von in der Concha und am Tragus erstreckt, wo die mindestens eine Außenohrelektrode (32) gehalten wird.


     
    2. Ohrvorrichtung (1) nach Anspruch 1, wobei das Gehörgangsteil (20) so gebildet ist, dass es bei Gebrauch nur Kontakt zu einem oberen Teil des Gehörgangs hat.
     
    3. Ohrvorrichtung (1) nach Anspruch 1, umfassend eine lösbare Verbindung zu einer Einheit, die einen bioelektrischen Signalprozessor und eine Stromversorgung hält.
     
    4. Ohrvorrichtung (1) nach Anspruch 1, wobei das bioelektrische Signal ein EEG-Signal ist.
     
    5. Ohrvorrichtung (1) nach Anspruch 1, wobei der biegsame Arm (34) dazu angepasst ist, die mindestens eine Außenohrelektrode (32) zu halten.
     
    6. Ohrvorrichtung (1) nach Anspruch 1, wobei mindestens ein Teil des biegsamen Arms (34) ein hinter dem Ohr biegsamer Teil ist, der so angepasst ist, dass er sich bei Gebrauch bis zu einem Bereich hinter dem Ohr erstreckt, d. h. zu der dem Kopf zugewandten Seite der Ohrmuschel.
     
    7. Ohrvorrichtung (1) nach Anspruch 6, wobei der Teil hinter dem Ohr mindestens eine Elektrode hinter dem Ohr umfasst und der Teil hinter dem Ohr angepasst ist, einen Druck auszuüben, so dass die mindestens eine Elektrode hinter dem Ohr bei Gebrauch gegen die Haut des Außenohrs und/oder den Kopf gepresst wird.
     
    8. Ohrvorrichtung (1) nach Anspruch 1, wobei das Außenohrteil (30) einen Hohlraum umfasst, in dem eine elektrische Verkabelung zum Anschluss der Außenohrelektrode (32) und oder der hinter dem Ohr liegenden Elektrode verlegt wird.
     
    9. Ohrvorrichtung (1) nach Anspruch 1, wobei ein Winkel zwischen einer Achse des Gehörgangsteils entlang des Gehörgangs und einer durch das Außenohrteil, insbesondere den biegsamen Arm (34), definierten Ebene entsprechend dem Ohr der Person einstellbar ist, wobei der Winkel vorzugsweise arretierbar ist.
     
    10. Ohrvorrichtung (1) nach Anspruch 1, wobei die Ohrvorrichtung weiter ein akustisches Alarmmodul umfasst, das konfiguriert ist, abhängig von mindestens einem erfassten bioelektrischen Signal ein akustisches Alarmsignal auszugeben.
     
    11. Satz von Ohrvorrichtungen (1) nach Anspruch 1, wobei die Form der Vorrichtungen innerhalb des Satzes gleich ist, die Größen der verschiedenen Vorrichtungen jedoch unterschiedlich sind.
     
    12. Ohrvorrichtung (1) nach Anspruch 1, wobei das Gehörgangsteil (20) mit mindestens einer Gehörgangselektrode (22) zum Erfassen eines bioelektrischen Signals versehen ist, wobei die mindestens eine Gehörgangselektrode (22) an einer Struktur angeordnet ist, die dazu angepasst ist, sich zu verformen, wenn das Gehörgangsteil in einem Gehörgang angeordnet ist, so dass die mindestens eine Gehörgangselektrode (22) gegen die Haut des Gehörgangs gepresst wird, wobei das Gehörgangsteil (20) so gebildet ist, dass es bei Gebrauch nur Kontakt zum oberen Teil des Gehörgangs hat.
     
    13. Ohrvorrichtung (1) nach Anspruch 1, wobei mindestens ein Teil des biegsamen Arms (34) ein Concha-Teil ist, das dazu angepasst ist, in einem Concha-Bereich des Ohrs angeordnet zu werden und weiter dazu angepasst ist, der Form der Concha zu folgen, wobei sich vorzugsweise der biegsame Arm (34) vom Gehörgangsteil (20) bis zu mindestens einem Punkt in der Concha erstreckt, wo die mindestens eine Außenohrelektrode (32) gehalten wird, und wobei mindestens ein Teil des biegsamen Arms (34) ein biegsames, hinter dem Ohr liegendes Teil ist, das angepasst ist, sich bei Gebrauch zu einem Bereich hinter dem Ohr, d. h. zu der Seite der Ohrmuschel, die dem Kopf zugewandt ist, zu erstrecken, wobei das hinter dem Ohr liegende Teil vorzugsweise mindestens eine hinter dem Ohr liegende Elektrode umfasst und das hinter dem Ohr liegende Teil angepasst ist, einen Druck auszuüben, sodass die mindestens eine hinter dem Ohr liegende Elektrode bei Gebrauch gegen die Haut des Außenohrs und/oder den Kopf gepresst wird.
     
    14. Ohrvorrichtung (1) nach Anspruch 1, wobei mindestens ein Teil des biegsamen Arms (34) ein Tragus-Teil ist, das dazu angepasst ist, in einem Tragus-Bereich des Ohrs angeordnet zu werden, und weiter dazu angepasst ist, der Form des Tragus zu folgen, wobei sich der biegsame Arm (34) vorzugsweise vom Gehörgangsteil (20) bis zu mindestens einem Punkt am Tragus erstreckt, wo die mindestens eine Außenohrelektrode (32) gehalten wird, und wobei mindestens ein Teil des biegsamen Arms ( 34) ein biegsames, hinter dem Ohr liegendes Teil ist, das angepasst ist, sich bei Gebrauch zu einem Bereich hinter dem Ohr, d. h. zu der Seite der Ohrmuschel, die dem Kopf zugewandt ist, zu erstrecken, wobei das hinter dem Ohr liegende Teil vorzugsweise mindestens eine hinter dem Ohr liegende Elektrode umfasst und das hinter dem Ohr liegende Teil angepasst ist, einen Druck auszuüben, sodass die mindestens eine hinter dem Ohr liegende Elektrode bei Gebrauch gegen die Haut des Außenohrs und/oder den Kopf gepresst wird.
     
    15. Ohrvorrichtung (1) nach Anspruch 1, wobei das Gehörgangsteil (20) so gebildet ist, dass es bei Gebrauch nur Kontakt zu einem oberen Teil des Gehörgangs hat, und wobei mindestens ein Teil des biegsamen Arms (34) ein Concha-Teil ist, das dazu angepasst ist, in einem Concha-Bereich des Ohrs angeordnet zu werden, und weiter dazu angepasst ist, der Form der Concha zu folgen, wobei sich der biegsame Arm (34) vorzugsweise vom Gehörgangsteil (20) bis zu mindestens einem Punkt in der Concha erstreckt, wo die mindestens eine Außenohrelektrode (32) gehalten wird, und wobei mindestens ein Teil des biegsamen Arms (34) ein Tragus-Teil ist, das dazu angepasst ist, in einem Tragus-Bereich des Ohrs angeordnet zu werden, und weiter dazu angepasst ist, der Form des Tragus zu folgen, wobei sich der biegsame Arm (34) vorzugsweise vom Gehörgangsteil (20) bis zu mindestens einem Punkt am Tragus erstreckt, wo die mindestens eine Außenohrelektrode (32) gehalten wird, und wobei mindestens ein Teil des biegsamen Arms (34) ein biegsames, hinter dem Ohr liegendes Teil ist, das angepasst ist, sich bei Gebrauch zu einem Bereich hinter dem Ohr, d. h. zu der Seite der Ohrmuschel, die dem Kopf zugewandt ist, zu erstrecken, wobei das hinter dem Ohr liegende Teil vorzugsweise mindestens eine hinter dem Ohr liegende Elektrode umfasst und das hinter dem Ohr liegende Teil angepasst ist, einen Druck auszuüben, sodass die mindestens eine hinter dem Ohr liegende Elektrode bei Gebrauch gegen die Haut des Außenohrs und/oder den Kopf gepresst wird.
     
    16. Hörunterstützungsvorrichtung oder Headset, umfassend die Ohrvorrichtung (1) nach Anspruch 1.
     
    17. Bioelektrischer Signalmonitor, umfassend die Ohrvorrichtung (1) nach Anspruch 1.
     


    Revendications

    1. Dispositif auriculaire (1) pour agencement au niveau d'une oreille d'une personne et pourvu d'au moins deux électrodes (22, 32) pour avoir un contact avec la peau et détecter un signal bioélectrique lors de l'utilisation, le dispositif auriculaire (1) comprenant

    - une partie conduit auditif déformable (20) adaptée pour être agencée dans un conduit auditif de la personne, la partie conduit auditif (20) étant pourvue d'au moins une des au moins deux électrodes (22, 32), cette au moins une électrode étant une électrode de conduit auditif (22) pour détecter un signal bioélectrique, où la au moins une électrode de conduit auditif (22) est agencée au niveau d'une structure adaptée pour se déformer lorsque la partie conduit auditif (20) est agencée dans un conduit auditif, de telle sorte que la au moins une électrode de conduit auditif (22) est pressée contre la peau du conduit auditif, et

    - une partie oreille externe (30) adaptée pour être agencée au niveau de l'oreille externe au conduit auditif et étant pourvue d'au moins une des au moins deux électrodes (22, 32), cette au moins une électrode étant une électrode d'oreille externe (32) pour détecter un signal bioélectrique, la partie oreille externe comprenant au moins un bras flexible (34) qui est relié à la partie conduit auditif et est adapté pour exercer une pression de telle que la au moins une électrode d'oreille externe (32) est pressée contre la peau lors de l'utilisation, dans lequel au moins une partie du bras flexible (34) est au moins une parmi une partie conque et une partie tragus adaptée pour être agencée dans au moins une parmi une région conque et une région tragus de l'oreille, en outre adaptée pour épouser la forme d'au moins un parmi la conque et le tragus, dans lequel, de préférence, le bras flexible (34) s'étend de la partie conduit auditif (20) jusqu'à au moins un point dans au moins un de la conque et/ou au niveau du tragus, où est maintenue la au moins une électrode d'oreille externe (32).


     
    2. Dispositif auriculaire (1) selon la revendication 1, dans lequel la partie conduit auditif (20) est formée de telle sorte qu'elle ne présente de contact qu'avec une partie supérieure du conduit auditif lors de l'utilisation.
     
    3. Dispositif auriculaire (1) selon la revendication 1, comprenant une liaison détachable à une unité contenant un processeur de signal bioélectrique et une alimentation électrique.
     
    4. Dispositif auriculaire (1) selon la revendication 1, dans lequel le signal bioélectrique est un signal EEG.
     
    5. Dispositif auriculaire (1) selon la revendication 1, dans lequel le bras flexible (34) est adapté pour maintenir la au moins une électrode d'oreille externe (32).
     
    6. Dispositif auriculaire (1) selon la revendication 1, dans lequel au moins une partie du bras flexible (34) est une partie flexible derrière l'oreille adaptée pour s'étendre jusqu'à la zone derrière l'oreille, à savoir jusqu'au côté du pavillon faisant face à la tête, lors de l'utilisation.
     
    7. Dispositif auriculaire (1) selon la revendication 6, dans lequel la partie derrière l'oreille comprend au moins une électrode derrière l'oreille, et la partie derrière l'oreille est adaptée pour exercer une pression de telle sorte que la au moins une électrode derrière l'oreille est pressée contre la peau de l'oreille externe et/ou la tête lors de l'utilisation.
     
    8. Dispositif auriculaire (1) selon la revendication 1, dans lequel la partie oreille externe (30) comprend une cavité, dans laquelle est acheminé un câblage électrique pour connecter l'électrode d'oreille externe (32) et/ou l'électrode derrière l'oreille.
     
    9. Dispositif auriculaire (1) selon la revendication 1, dans lequel un angle entre un axe de la partie conduit auditif le long du conduit auditif et un plan défini par la partie oreille externe, en particulier du bras flexible (34), est réglable selon l'oreille de la personne, dans lequel, de préférence, ledit angle est verrouillable.
     
    10. Dispositif auriculaire (1) selon la revendication 1, dans lequel le dispositif auriculaire comprend en outre un module d'alarme acoustique qui est configuré pour émettre un signal d'alarme acoustique en fonction d'au moins un signal bioélectrique détecté.
     
    11. Ensemble de dispositifs auriculaires (1) selon la revendication 1, dans lequel la forme des dispositifs de l'ensemble est la même, mais les tailles des différents dispositifs sont différentes.
     
    12. Dispositif auriculaire (1) selon la revendication 1, dans lequel la partie conduit auditif (20) est pourvue d'au moins une électrode de conduit auditif (22) pour détecter un signal bioélectrique, la au moins une électrode de conduit auditif (22) est agencée au niveau d'une structure adaptée pour se déformer lorsque la partie conduit auditif est agencée dans un conduit auditif, de telle sorte que la au moins une électrode de conduit auditif (22) est pressée contre la peau du conduit auditif, dans lequel la partie conduit auditif (20) est formée de telle sorte qu'elle ne présente de contact qu'avec une partie supérieure du conduit auditif lors de l'utilisation.
     
    13. Dispositif auriculaire (1) selon la revendication 1, dans lequel au moins une partie du bras flexible (34) est une partie conque adaptée pour être agencée dans une région conque de l'oreille et en outre adaptée pour épouser la forme de la conque, dans lequel, de préférence, le bras flexible (34) s'étend depuis la partie conduit auditif (20) jusqu'à au moins un point dans la conque, où la au moins une électrode d'oreille externe (32) est maintenue et dans lequel au moins une partie du bras flexible (34) est une partie flexible derrière l'oreille adaptée pour s'étendre jusqu'à une zone derrière l'oreille, à savoir jusqu'au côté du pavillon faisant face à la tête, lors de l'utilisation, dans lequel, de préférence, la partie derrière l'oreille comprend au moins une électrode derrière l'oreille, et la partie derrière l'oreille est adaptée pour exercer une pression de telle sorte que la au moins une électrode derrière l'oreille est pressée contre la peau de l'oreille externe, et/ou la tête lors de l'utilisation.
     
    14. Dispositif auriculaire (1) selon la revendication 1, dans lequel au moins une partie du bras flexible (34) est une partie tragus adaptée pour être agencée dans une région tragus de l'oreille et en outre adaptée pour épouser la forme du tragus, dans lequel, de préférence, le bras flexible (34) s'étend depuis la partie conduit auditif (20) jusqu'à au moins un point dans le tragus, où la au moins une électrode d'oreille externe (32) est maintenue et dans lequel au moins une partie du bras flexible (34) est une partie flexible derrière l'oreille adaptée pour s'étendre jusqu'à une zone derrière l'oreille, à savoir jusqu'au côté du pavillon faisant face à la tête, lors de l'utilisation, dans lequel, de préférence, la partie derrière l'oreille comprend au moins une électrode derrière l'oreille, et la partie derrière l'oreille est adaptée pour exercer une pression de telle sorte que la au moins une électrode derrière l'oreille est pressée contre la peau de l'oreille externe et/ou la tête lors de l'utilisation.
     
    15. Dispositif auriculaire (1) selon la revendication 1, dans lequel la partie conduit auditif (20) est formée de telle sorte qu'elle ne présente de contact qu'avec une partie supérieure du conduit auditif lors de l'utilisation, et dans lequel au moins une partie du bras flexible ( 34) est une partie conque adaptée pour être agencée dans une région conque de l'oreille et adaptée en outre pour épouser la forme de la conque, dans lequel, de préférence, le bras flexible (34) s'étend depuis la partie conduit auditif (20) jusqu'à au moins un point dans la conque, où la au moins une électrode d'oreille externe (32) est maintenue, et dans lequel au moins une partie du bras flexible (34) est une partie tragus adaptée pour être agencée dans une région tragus de l'oreille et adaptée en outre pour épouser la forme du tragus, dans lequel, de préférence, le bras flexible (34) s'étend depuis la partie de conduit auditif (20) jusqu'à au moins un point dans le tragus, où la au moins une électrode d'oreille externe (32) est maintenue, et dans lequel au moins une partie du bras flexible (34) est une partie flexible derrière l'oreille adaptée pour s'étendre jusqu'à une zone derrière l'oreille, à savoir jusqu'au côté du pavillon faisant face à la tête, lors de l'utilisation, dans lequel, de préférence, la partie derrière l'oreille comprend au moins une électrode derrière l'oreille, et la partie située derrière l'oreille est adaptée pour exercer une pression de telle sorte que la au moins une électrode derrière l'oreille est pressée contre la peau de l'oreille externe et/ou la tête lors de l'utilisation.
     
    16. Dispositif ou casque d'aide auditive comprenant le dispositif auriculaire (1) selon la revendication 1.
     
    17. Dispositif de surveillance de signal bioélectrique comprenant le dispositif auriculaire (1) selon la revendication 1.
     




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    Cited references

    REFERENCES CITED IN THE DESCRIPTION



    This list of references cited by the applicant is for the reader's convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.

    Patent documents cited in the description