Skeleton housing and method for producing ear stamp
By using the skeleton shell to create customized ear impressions and generate customized extensions that match the ear canal, the shortcomings of existing non-customized ear arthrode wear devices in terms of sealing, retention, comfort and aesthetics, achieving a more efficient acoustic sealing and a more comfortable wearable experience.
Patent Information
- Application Number
- CN202411239684.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-09-07
- Filing Date
- 2024-09-05
- Publication Date
- 2025-03-07
AI Technical Summary
Existing non-customized earring cavity wear devices are difficult to achieve acceptable compromises in terms of sealing, retention, wear comfort and aesthetics, especially due to the height difference in ear shapes and the uniform size of the equipment.
The ear impression is produced by a skeleton shell and corresponding methods, and a customized extension is generated using 3D scanning and modeling software to ensure its optimal matching with the ear canal, thereby improving the customization and adaptability of the equipment.
It achieves higher acoustic sealing, comfort, aesthetics and retention, reduces discomfort pressure points, and improves the fixity and user experience of the equipment in the ear.
Smart Images
Figure CN119584039A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a skeleton shell and a method for taking an ear impression and a method for producing a customized extension (such as a customized ear plug) configured to be connected to the shell of a concha wearing device (such as a hearing device). Background Art
[0002] Non-custom concha-worn devices such as smart earphones (also known as hearables) or hearing aids (one-size-fits-all devices) need to be coupled to the ear in a way that ensures an acoustic seal. In particular, concha-worn devices configured for active noise cancellation (ANC) rely on a good acoustic seal. Acoustic sealing also reduces feedback loop problems for devices with short feedback paths, such as hearables.
[0003] In addition, the concha-worn device needs to be securely held in place. Hearable devices are heavier than traditional hearing instruments, making it easier to lose the device when the body moves or chews.
[0004] Additionally, hearables or hearing instruments are worn for many hours, so they should not impose uncomfortable pressure points.
[0005] Additionally, concha-worn devices are more likely to be accepted if they fit well and flush with the concha and are not too prominent.
[0006] It is known in the art to use domes made of soft materials (e.g., silicone or memory foam) to try to meet these requirements. Due to the "one size fits all" nature of concha wearing devices and the high degree of heterogeneity in ear morphology, a dome approach using only a few dome sizes may not achieve an acceptable compromise in terms of seal, retention, wearing comfort, and aesthetics.
[0007] A possible solution to this problem may be to create a custom connection device through traditional impression taking or direct ear scanning, followed by CAD-like digital ear mold modeling and 3D printing. Although this traditional method can produce a well-shaped custom mold, the relative position between the device and the custom ear impression can only be guessed. Summary of the invention
[0008] An object of the present invention is to provide a novel solution suitable for producing a custom extension (e.g. an ear tip or an ear fin) configured to be coupled to a housing of a concha wearing device (e.g. a hearing device) that fits within the concha of a human ear.
[0009] According to the invention, the above objects are achieved by a skeleton shell, by a method for producing an ear impression and by a method for producing a customized extension, such as an earplug.
[0010] As used herein, the term lateral refers to a direction generally away from the user's body, while the term medial refers to the opposite direction.
[0011] According to the present invention, a skeleton shell is proposed for making an ear impression of a portion of the ear canal and / or at least a portion of the concha cavity of a human ear, the skeleton shell having a shape matching the concha cavity of the ear, the skeleton shell comprising a hollow permeable (or porous) shell that allows viscous impression material to flow through, the skeleton shell comprising an inner opening that is positioned toward or into the ear canal when the skeleton shell is inserted into the concha cavity.
[0012] The impression material may be the same as that used in conventional impression taking for producing a custom mould for the ear canal or a so called ear canal bridge.
[0013] In one exemplary embodiment, the hollow shell is configured as a grid or basket with rings or openings, or is made of a permeable (or porous) material, allowing the viscous impression material to flow through.
[0014] In one exemplary embodiment, the skeleton housing further includes an outboard opening oriented to face in an outboard direction.
[0015] In one exemplary embodiment, the outside opening and / or the inside opening can be larger than any other opening in the permeable shell. In other embodiments, the inside opening can be smaller than the opening in the permeable shell or equal in size.
[0016] In an exemplary embodiment, the shape of the skeleton shell can make the cavity concha slightly deformed when it is inserted into the cavity concha. In other embodiments, the skeleton shell may not deform the cavity concha.
[0017] In an exemplary embodiment, the shape of the skeleton shell is similar to the shell of a concha cavity wearing device (e.g., a hearing device) having a nozzle that matches the inner opening. The form of the inner opening of the skeleton shell can be selected so that it can surround the nozzle.
[0018] In one exemplary embodiment, the inside opening is larger than the tube mouth to allow for customizing the wall thickness of the top piece.
[0019] In an exemplary embodiment, the hollow shell is configured to be at least almost completely permeable or only permeable near the inner opening, and has a closed surface at other locations except the outer opening and / or the inner opening.
[0020] According to one aspect of the present invention, a method for producing an ear impression using a skeleton shell (in particular the skeleton shell described above) is provided, the method comprising the following steps:
[0021] A) inserting the skeleton shell into the concha cavity of the human ear, with the inner opening facing the ear canal or entering the ear canal, for example, toward the inner direction,
[0022] B) injecting the impression material into the ear canal to fill the ear canal towards the cavum concha (optionally, the cavum concha may also be at least partially filled),
[0023] C) curing the impression material to form an ear impression at least partially embedded in the skeleton shell, the ear impression comprising the ear canal and a shell portion at least partially embedded in the skeleton shell,
[0024] D) The ear impression with the skeleton shell removed from the ear.
[0025] The amount of impression material filled may be selected to be sufficient to at least partially embed the skeleton shell.
[0026] Curing may simply mean waiting for a period of time and allowing the impression material to cure thereby. In other embodiments, curing may include using at least one curing agent.
[0027] The skeleton shell may further include an outer opening, which may face in an outward direction when the skeleton shell is inserted into the concha cavity.
[0028] The impression material may further be filled into the skeleton shell through the outer opening, wherein the impression material may be filled through the inner opening and the adjacent permeable shell.
[0029] The ear canal portions may include those portions of the impression material that have flowed out of the medial opening and adjacent permeable shell into the ear canal.
[0030] In an exemplary embodiment, step A can be performed before step B, and the impression material is injected through the outer opening of the skeleton shell or the outer opening into the skeleton shell, wherein the impression material flows through the inner opening and the adjacent permeable shell, or wherein the impression material is injected through the outer opening and the inner opening.
[0031] In another exemplary embodiment, step B may be performed before step A.
[0032] In one exemplary embodiment, when the skeleton shell is inserted into the concha cavity, the protrusion on the skeleton shell can be positioned between the tragus and the anti-tragus.
[0033] In an exemplary embodiment, the supply of impression material is stopped when the impression material has filled the ear canal (eg, through the medial opening) and has accumulated in the cavum concha and / or in the skeleton shell, or even outside the lateral opening.
[0034] In an exemplary embodiment, the ear canal is filled with impression material beyond the first bend.
[0035] According to one aspect of the present invention, a method for producing a customized extension (such as an earplug) is provided, wherein the customized extension is configured to be coupled to a shell of a concha cavity wearing device (such as a hearing device), the shell having a shape to be mounted in the concha cavity of a human ear, and the customized extension having a shape matching the ear canal of the ear, the method comprising one of the above-mentioned methods for producing an ear impression, and further comprising the following steps:
[0036] -3D scanned ear impression with embedded skeleton shell,
[0037] - In the modeling software, the 3D scanned ear impression and the embedded skeleton shell are registered with the 3D geometry of the shell with the orifice, and the orifice is registered with the medial opening,
[0038] - A custom extension is modeled to resemble the shape of the ear canal portion of the ear impression and contains a connector positioned and oriented to couple to the nozzle.
[0039] In another embodiment, an alternative or additional customized extension may be provided as an ear fin configured to fit within the cavum cymba portion of the ear. In another embodiment, an alternative or additional customized extension may be provided as an extension of a standard cavum cymba wearing device configured to fit anywhere between the housing of the cavum cymba wearing device and the ear skin surface. To produce such an alternative customized extension, the skeleton housing may include another opening that points in the direction in which the extension should extend from the housing rather than into the ear canal, and through which the impression material must be filled into the portion of the ear.
[0040] In one exemplary embodiment, the custom extension is made of a soft material having a Shore A hardness of at most 30 or 40. In other embodiments, the custom extension may be made of a hard material, such as titanium, acrylic, polyurethane, or any other material suitable for an earplug. If a hard material is used, an additional soft connector may be used to attach the custom extension to the housing of the concha wearing device (e.g., earplug).
[0041] In an exemplary embodiment, the connector has a circular or oval cross-section to connect with a nozzle having a circular or oval cross-section.
[0042] According to another aspect of the present invention, a hearing device is proposed, comprising a housing with a nozzle and the above-mentioned customized extension coupled to the nozzle.
[0043] Further applicability of the present invention will be apparent from the detailed description given below. However, it should be understood that the detailed description and specific examples, although indicating preferred embodiments of the present invention, are given by way of illustration only, because various changes and modifications within the spirit and scope of the present invention will become apparent to those skilled in the art from this detailed description.
[0044] Custom extensions for concha-worn devices may improve comfort, acoustic seal, aesthetics, and / or fixation. BRIEF DESCRIPTION OF THE DRAWINGS
[0045] The present invention will become more fully understood from the detailed description given hereinafter and from the accompanying drawings, which are given by way of illustration only and therefore do not limit the present invention, and in which:
[0046] Figure 1 It is a schematic diagram of the concha cavity and ear canal of a human ear when making an ear impression according to the prior art.
[0047] Figure 2 is a schematic diagram of the cavum concha and the ear canal, wherein a housing of a cavum concha wearing device is located in the cavum concha and a custom extension (e.g., an earplug) is located in the ear canal,
[0048] Figure 3 is a schematic diagram of the cavum concha and the ear canal, wherein the housing of the cavum concha wearing device is located at another position in the cavum concha and the custom extension (e.g., earplug) is located in the ear canal,
[0049] Figure 4 is a schematic diagram of the cavum concha and the ear canal, wherein the housing of the cavum concha wearing device is located at yet another position in the cavum concha, and the customized extension (e.g., earplug) is located in the ear canal,
[0050] Figure 5 is a schematic diagram of a permeable skeleton shell that mimics a shell of a concha cavity wearing device configured to fit within the concha cavity of a user's ear,
[0051] Figure 6 is a schematic diagram of a skeleton shell positioned to fit within the concha cavity of a user's ear,
[0052] Figure 7 is a schematic diagram of a skeleton shell inserted into the ear of a user, wherein an impression material is injected through the skeleton shell,
[0053] Figure 8 is a schematic diagram of a skeleton shell inserted into the ear of a user, wherein an impression material has been injected to fill the ear canal and a portion of the skeleton shell to form an ear impression,
[0054] Fig. 9 is a schematic diagram of an ear impression with a skeleton shell.
[0055] Fig.10 is a schematic diagram of the alignment model of the actual shell and the skeleton shell of the concha cavity wearing device.
[0056] Fig.11 is a schematic diagram of an actual housing of a concha cavity wearing device having a nozzle, wherein the nozzle is directed toward the ear canal of the user's ear, wherein a custom extension (e.g., an earplug) is coupled to the nozzle,
[0057] Fig.12 Schematic diagram of a concha cavity wearing device configured in the concha cavity of the ear.
[0058] In all the figures, corresponding parts are provided with the same reference symbols. DETAILED DESCRIPTION
[0059] Figure 1 1 is a schematic diagram of the concha cavity 11 and the ear canal 14 of the human ear 10 when an ear impression 20 according to the prior art is made by injecting a viscous impression material into the ear 10. In this case, the concha cavity 11 and the ear canal 14 are usually not significantly deformed.
[0060] Figure 2 1 is a schematic diagram of the concha cavity 11 and the ear canal 14, wherein a shell 30 of a concha worn device (e.g., a hearing device) is located in the concha cavity 11, and a custom extension (e.g., an earplug 40) having a connector 41 is located in the ear canal 14, wherein the connector 41 is coupled to the nozzle 31 of the shell 30. If the shell 30 is larger than the concha cavity 11, the concha cavity 11 will deform locally, for example, at the position 16 shown. However, this deformation and the resulting position and orientation of the shell 30 in the concha cavity 11 can only be guessed by the operator of the 3D modeling software: the operator only sees two rigid shapes, but he ignores the actual softness of the ear and the wearing comfort of the inserted device at the selected position. Figure 3 and Figure 4 Similar schematic diagrams are further shown with different estimates of deformation of the cavum concha 11 and the resulting position and orientation of the shell 30 in the cavum concha 11. Because these estimates do not adequately reflect the actual situation in the ear, the correct relative position of the customized extension 40 and its connector 41 with respect to the shell 30 and its nozzle 31 cannot be reliably determined. When the modeling software generates the customized extension 40 based on these estimates, it may result in a non-ideal relative position of the customized extension 40 and its connector 41 with respect to the shell 30 and its nozzle 31, resulting in uncomfortable pressure points on the user's ear, insufficient fixation and / or retention of the device, and unsightly appearance.
[0061] To solve this problem, the following solutions are proposed:
[0062] Figure 5 is a schematic diagram of a skeleton shell 1 , which simulates a shell 30 of a concha cavity wearing device inserted into the ear 10 of the user, wherein the skeleton shell 1 has no connection device with the ear canal 14 of the ear 10 of the user, such as a dome.
[0063] The shape of the skeleton shell 1 corresponds mostly to the shell 30 of the actual concha cavity wearing device. The skeleton shell 1 is designed as a hollow permeable skeleton shell, which is permeable to the viscous impression material at least in the area where the customized extension will be connected to the shell of the concha cavity wearing device. The shape of the skeleton shell can be designed in the form of a grid or a basket (with rings), or it can be designed to generally have openings to allow the viscous impression material to flow through when it is filled into the skeleton shell 1. In order to facilitate the filling of the impression material, the skeleton shell 1 may include an outer opening 2, which, when the skeleton shell 1 is inserted into the user's concha cavity 11, faces the outer direction, that is, away from the user, or toward the outside of the ear 10.
[0064] In addition, the skeleton shell 1 includes a medial opening 3, which faces the ear canal 14 or the medial direction when the skeleton shell 1 is inserted into the user's cavum conchae 11. The medial opening 3 is configured to allow the impression material to flow into the ear canal 14 when the impression material is filled into the skeleton shell 1. The outer opening 2 and / or the medial opening 3 can be larger than any other opening on the skeleton shell. In other embodiments, the outer opening 2 and / or the medial opening 3 can be smaller than the opening on the permeable shell or be equal in size.
[0065] After the impression material is applied, the skeleton shell 1 is partially embedded in the cured impression material, so that a rigid connection is formed between the skeleton shell 1 and the ear impression 20 .
[0066] The impression material may be filled by placing the nozzle of a syringe containing the impression material into the ear canal through the outer opening 2, and optionally through the inner opening 3 or the adjacent permeable shell, and moving the impression material from the syringe to fill the ear canal toward the concha cavity. As the ear canal is filled, the syringe may also be retracted to fill the skeleton shell. Optionally, the concha cavity may also be at least partially filled.
[0067] The skeleton shell 1 is enlarged at the position of the inner opening 3 relative to the actual shell 30 of the concha cavity wearing device at the position with the tube opening 31, so as to ensure that sufficient clearance is left for the connector 41 of the custom extension piece 40 to be manufactured during the processing. This at least ensures that there is enough space for the wall thickness of the custom extension piece 40.
[0068] like Figure 5As shown, the skeleton shell 1 can be constructed to have openings (such as a grid) almost entirely. In other embodiments, the skeleton shell 1 can be constructed to have openings (such as a grid) only near the inner opening 3, and other positions are closed surfaces. This can ensure that the impression material can enter and fill the ear canal 14. The entire skeleton shell 1 or most of it is constructed with openings (such as a grid), which can improve the shape fit between the impression material and the skeleton shell 1.
[0069] Furthermore, the skeleton shell 1 may include a protrusion 4 , the shape and position of which may be adapted to fit between the tragus 12 and the anti-tragus 13 of the ear 10 of the user.
[0070] By placing the skeleton shell 1 into the ear 10, the position of the shell 30 in the deformed ear 10 can be determined, which will achieve the best wearing comfort, fixation and / or retention, and aesthetics. Since the skeleton shell 1 does not include any connecting devices, i.e., there is no dome, the positioning is not limited by the ear connecting device, but is only determined by the skeleton shell 1, which is basically non-deformed. Therefore, the ear impression 20 is made based on the best or desired position of the skeleton shell 1 in the ear 10 in terms of wearing comfort, fixation and / or retention, and aesthetics. In this position, the customized extension 40 manufactured in this process using the data obtained from the ear impression 20 will not cause uncomfortable pressure points on the user's ear 10.
[0071] The impression may be taken following best practices known in the hearing instrument industry, for example, an otoscope may be used to inspect the ear canal 14 and a foam block 53 may be placed in the ear canal 14 to restrict the flow of impression material in a medial direction.
[0072] Figure 6 Schematic diagram of a skeleton shell 1 positioned to fit in the concha cavity 11 of the ear 10 of a user, with the protrusion 4 placed between the tragus 12 and the antitragus 13 of the ear 10, wherein the outer opening 2 faces the outer direction. The inner opening 3 ( Figure 6 not visible) towards the ear canal 14 ( Figure 6 ) or protrudes slightly into the ear canal 14.
[0073] Figure 7 1 is a schematic diagram of a skeleton shell 1 inserted into an ear 10 of a user, wherein impression material is injected, for example using a syringe, through the correctly placed skeleton shell 1. As soon as the still viscous impression material covers a sufficiently large part of the skeleton shell 1, the injection of the impression material can be stopped.
[0074] Figure 8Schematic diagram of a skeleton shell 1 inserted into a user's ear 10, wherein impression material has been injected to fill the ear canal 14 and a portion of the skeleton shell 1, and optionally a portion of the concha cavity, to form an ear impression 20. For example, when the impression material has filled the ear canal 14 through the inner opening 3 and accumulated in the skeleton shell 1 or even outside the outer opening 2, the supply of the impression material can be stopped.
[0075] In another embodiment, the ear impression 20 is made using the skeleton shell 1 in a slightly different manner, including the following steps:
[0076] - injecting the impression material into the ear canal 14 to fill the ear canal 14 towards the cavum concha 11 and optionally at least partially fill the cavum concha 11,
[0077] - inserting the skeleton shell 1 into the still uncured or liquid impression material in the ear canal 14 and optionally the concha cavity 11 , with the inner opening 3 facing or entering the ear canal 14 ,
[0078] - Curing the impression material to form an ear impression 20 at least partially embedded in the skeleton shell 1 .
[0079] In this case, the skeleton housing 1 does not necessarily have to include the outer opening 2 , but the method is also applicable to the outer opening 2 .
[0080] Once cured, the combination of the skeleton shell 1 and the ear impression 20 is removed from the ear and 3D scanned. Fig. 9 is a schematic diagram of an ear impression 20 with a skeleton shell 1. The ear impression 20 includes an ear canal portion 21 having a shape of a portion of the user's ear canal 14, wherein the ear canal portion 21 includes those portions of the cured impression material that have flowed into the ear canal 14, for example, portions that flowed into the ear canal 14 from the inner opening 3 and adjacent openings (such as a grid) of the skeleton shell 1. In addition, the ear impression 20 includes a skeleton shell portion 22 that is at least partially embedded in the skeleton shell 1. Another portion of the ear impression 20 that may exist outside the outer opening 2 due to overfilling is redundant and may not be required in subsequent processes. In subsequent processes, the shape of the ear canal portion 21 will be used to form a customized extension 40 having a connector 41 that is configured to be connected to a shell 30 of a concha cavity wearing device that is similar in shape to the skeleton shell 1.
[0081] The 3D scanned combination of the skeleton shell 1 and the ear impression 20 can be registered with the 3D skeleton shell geometry in the modeling software.
[0082] Since the relative orientation of the skeleton shell 1 and the actual shell 30 of the concha-wearing device is known, the position and orientation of the 3D device geometry will be implicitly given in the modeling software. Therefore, the position and orientation of the connector 41 of the custom extension 40 and the actual shell 30 of the concha-wearing device have now been determined.
[0083] Fig.10 It is a schematic diagram of how to obtain the skeleton shell 1 from the actual shell 30. In the position where the skeleton shell 1 may contact the skin, the skeleton shell 1 is similar to the actual shell 30. At the position of the inner opening 3 of the skeleton shell 1, the actual shell 30 has a nozzle 31 as an interface with the connector 41 of the customized extension 40.
[0084] The custom extension 40 can then be modeled according to best practices in the hearing instrument industry based on the location and orientation of the connector 41. For example, the custom extension 40 can provide a retention lock by bypassing the first bend 15 in the ear canal 14, ensuring optimal wearing comfort and fixation and / or retention in the ear.
[0085] The custom extension 40 can be produced using standard custom batch manufacturing processes, such as 3D printing, post-processing, etc.
[0086] In one exemplary embodiment, custom extension 40 may be made of a soft material, for example, having a Shore A hardness of at most 30 or 40. In other embodiments, custom extension 40 may be made of a hard material, such as titanium, acrylic, polyurethane, or any other material suitable for an earplug.
[0087] The process described allows the frame assembly 1 to be inserted into the ear impression 20 so that the actual shell 30 and the customized extension 40 of the concha wearing device are optimally oriented.
[0088] Unlike the conventional coupling of a hearing or hearing instrument to the ear canal 14 via a dome, the process can provide a retention lock at the first bend 15 of the ear canal 14. The enhanced retention of the device can replace additional retention structures, such as fingers or fins attached to the housing 30. In other embodiments, the process can provide a retention lock at other features of the ear other than the first bend 15, depending on the shape of the device. For example, the custom extension may be shorter and not extend beyond the first bend 15.
[0089] Fig.11 is a schematic diagram of an actual housing 30 of the concha cavity wearing device, wherein a nozzle 31 is directed into the ear canal 14 of the user's ear 10, wherein a custom extension 40 is connected to the nozzle 31 with its connector 41. The nozzle 31 may have a circular or oval cross-section, allowing the custom extension 40 to be aligned in the ear canal 14 when inserted by rotating it around the nozzle 31.
[0090] The method allows the extension 40 to be customized so that the actual shape of the ear canal 14 matches the inserted cavum concha wearing device, while a non-customized dome may not align with the ear canal 14 due to the physical constraints of the actual shell 30 in the cavum concha 11, thereby causing pressure points in the ear canal 14 and thus discomfort, as well as not being able to adequately fit and / or remain and / or be fixed in the ear. With a non-customized dome, pressure points caused by the device will not only appear in the ear canal 14, but also in the cavum concha 11.
[0091] The custom extension 40 allows for a larger sealing area with substantially no change in the acoustic seal. This results in a more stable acoustic performance of the hearable or hearing instrument.
[0092] The visible part of the concha wearing device, ie the actual shell 30, can be placed in the desired position, rather than being forced into a protruding position due to the constraints of the coupling device in the ear canal 14.
[0093] Fig.12 is a schematic diagram of a concha wearing device configured in the concha cavity 11 of the ear 10. The concha wearing device includes a housing 30 with a custom extension 40 (e.g., a custom earplug) in a shape similar to the ear canal portion of the ear impression and including a connector positioned and oriented to couple to a nozzle. Fig.12 Further shown is another custom extension 40' which may alternatively or additionally be provided on the housing 30 and may be made by the method described above. The extension 40' is an ear fin that fits within the cavum cymba portion of the ear. Fig.12 Further shown is another custom extension 40'' which may alternatively or additionally be provided on the housing 30 and which may be made by the method described above. The extension 40'' is an extension of the standard device to fit anywhere between the housing 30 of the device and the ear skin surface.
[0094] The figures explained above mainly show a skeleton shell 1 provided for a user's left ear 10. It goes without saying that alternatively or additionally, a mirror-inverted skeleton shell 1 can be provided for the right ear and used in the same way to produce a customized extension 40 for the right ear.
[0095] List of reference marks
[0096] 1 Skeleton shell
[0097] 2Outer opening
[0098] 3Inner opening
[0099] 10 ears
[0100] 11. Cavity concha
[0101] 12 Tragus
[0102] 13 pairs of tragus
[0103] 14 Ear Canal
[0104] 15 The first turn
[0105] 16 positions
[0106] 20 ear impressions
[0107] 21 Ear canal
[0108] 22 Shell part
[0109] 30 Shell
[0110] 31 pipe mouth
[0111] 40,40',40" custom extensions, custom earplugs
[0112] 41 Connectors
[0113] 53 foam blocks.
Claims
1. A skeleton shell (1) for making an ear impression (20) of a portion of an ear canal (14) and / or at least a portion of a cavum concha (11) of a human ear (10), the skeleton shell (1) having a shape matching the cavum concha (11) of the ear (10), the skeleton shell (1) comprising a hollow permeable shell allowing a viscous impression material to flow through, the skeleton shell (1) comprising an inner opening (3), and when the skeleton shell (1) is inserted into the cavum concha (11), the inner opening (3) is positioned to face the ear canal (14) or enter the ear canal (14).
2. The skeleton shell (1) according to claim 1, characterized in that: The hollow shell is constructed as a grid or basket with rings or openings, or is made of a permeable material.
3. The skeleton shell (1) according to claim 1 or 2, characterized in that: It also includes an outer opening (2) positioned toward the outer side.
4. The skeleton shell (1) according to claim 3, characterized in that: The outer opening (2) and / or the inner opening (3) are larger than any other opening in the permeable shell.
5. The skeleton shell (1) according to claim 1 or 2, characterized in that: The skeleton shell (1) is shaped so as to slightly deform the cavum concha (11) when inserted into the cavum concha.
6. The skeleton shell (1) according to claim 1 or 2, characterized in that: The shape of the skeleton shell (1) is similar to the shape of the shell (30) of the concha cavity wearing device, and the concha cavity wearing device is, for example, a hearing device, and the shell (30) has a tube opening (31) adapted to be inside the inner opening (3) of the skeleton shell (1).
7. The skeleton shell (1) according to claim 1 or 2, characterized in that: The hollow shell is configured to be permeable at least almost entirely or only in the vicinity of the inner opening (3), and has a closed surface elsewhere except for the outer opening (2) and / or the inner opening (3).
8. A method for making an ear impression (20) using a skeleton shell (1), the skeleton shell (1) being in particular the skeleton shell (1) according to claim 1 or 2, the method comprising the following steps: A) inserting the skeleton shell (1) into the concha cavity (11) of a human ear (10) so that the inner opening (3) of the skeleton shell (1) faces the ear canal (14) of the ear (10) or enters the ear canal (14), B) injecting impression material into the ear canal (14), wherein, after performing steps A and B, the skeleton shell (1) is at least partially embedded in the impression material, The method further comprises the following steps: C) curing the impression material to form an ear impression (20) at least partially embedded in the skeleton shell (1), the ear impression (20) comprising an ear canal portion (21) and a shell portion (22) at least partially embedded in the skeleton shell (1), D) Removing the ear impression (20) including the skeleton shell (1) from the ear (10).
9. The method according to claim 8, characterized in that Step A is performed before step B, and the impression material is injected into the skeleton shell (1) through the outer opening (2) of the skeleton shell (1), wherein the impression material flows through the inner opening (3) and the adjacent permeable shell, or wherein the impression material is injected through the outer opening (2) and the inner opening (3).
10. The method according to claim 8, characterized in that Step B is performed before step A.
11. The method according to claim 8, characterized in that The auditory canal (14) is filled with the impression material beyond the first bend (15).
12. A method of producing a custom extension (40), the custom extension being, for example, an earplug (40), the custom extension being configured to be coupled to a housing (30) of a concha cavity wearing device, the concha cavity wearing device being, for example, a hearing device, the housing (30) having a shape matching a concha cavity (11) of a human ear (10), the custom extension (40) having a shape matching an ear canal (14) of the ear (10), the method comprising the method according to claim 8, and further comprising the steps of: - 3D scanning of the ear impression (20) with the embedded skeleton shell (1), - aligning the 3D scanned ear impression (20) and the embedded skeleton shell (1) with the 3D geometry of the shell (30) with the orifice (31), aligning the orifice (31) with the medial opening (3), in the modeling software, - A custom extension (40) is modelled to resemble the shape of the ear canal portion (21) of the ear impression (20) and includes a connector (41) positioned and oriented to couple with the nozzle (31).
13. The method according to claim 12, characterized in that The custom extension piece (40) is made of a soft material having a Shore A hardness of at most 30 or 40.
14. The method according to claim 12, characterized in that The custom extension (40) is made of a hard material, such as titanium, acrylic or polyurethane.
15. A hearing device, characterized in that: It comprises a housing (30) and a custom extension (40) produced by the method according to claim 12, wherein the housing (30) is provided with a nozzle (31) and the custom extension (40) is coupled to the nozzle (31).