Electrode module, hearing assistance device including same, and manufacturing method thereof

Abstract

A hearing assistance device and a manufacturing method thereof are provided. The hearing assistance device according to an aspect of the present invention is a hearing assistance device for assisting hearing, and the hearing assistance device may comprise: a sound processor for converting sound into a predetermined signal; a transmitter provided outside the body to transmit the signal to the outside; a receiver provided inside the body to receive the signal transmitted by the transmitter; and an electrode array including a plurality of electrode modules connected to each other in a ball-joint manner and inserted into the cochlea, and emitting a current corresponding to the signal received by the receiver.

Description

Electrode module, hearing aid device including same, and method for manufacturing same

[0001] The present invention relates to a hearing assistance device and a method for manufacturing the same, and more particularly, to an electrode module that assists hearing by emitting a predetermined current capable of stimulating nerve cells of the cochlea, a hearing assistance device including the same, and a method for manufacturing the same.

[0002]

[0003] For reference, the present invention was made possible through a research project supported by the Ministry of Science and ICT of the Republic of Korea (Project Unique Number: 1711161970, Project Number: 2020R1F1A1074222) and a research project supported by the Ministry of Science and ICT of the Republic of Korea, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety (Project Unique Number: 1711139113, Project Number: KMDF_PR_20210527_0007).

[0004] The human ear consists of the outer, middle, and inner ear, with the cochlea being the main organ of the inner ear. Hair cells located within the cochlea function to convert mechanical stimuli into electrical signals.

[0005] When hair cells are damaged due to congenital or acquired causes, sensorineural hearing loss (SHL) can occur, and patients with damaged hair cells use hearing aids to restore hearing.

[0006] As a hearing aid, a cochlear implant (CI) can be used, which detects external acoustic signals and electrically stimulates the auditory nerve. A key step in the implantation process is inserting an electrode array (CEA) for electrical stimulation into the cochlea.

[0007] At this time, during the process of inserting the electrode array, the inside of the cochlea was damaged by the electrode array, which could cause electrode insertion trauma (EIT), which causes loss of residual hearing.

[0008] Conventional hearing aid devices have used flexible materials such as polymers to form electrode arrays to minimize physical stimulation to the cochlea, but there is still a problem that the inside of the cochlea is damaged by physical stimulation.

[0009] Furthermore, conventional hearing aids have addressed the trauma of electrode implantation, often by implanting a pump and reservoir for drug delivery alongside the cochlear implant, or by coating an electrode array with medication and inserting it into the cochlea. However, these devices have presented challenges, such as the burden of implanting additional components and the difficulty of ensuring continuous drug delivery.

[0010] Accordingly, there has been an urgent need for the development of an electrode module capable of minimizing and treating side effects such as electrode insertion trauma, a hearing aid device including the same, and a method for manufacturing the same.

[0011] The present invention has been conceived in consideration of the above points, and an object of the present invention is to provide an electrode module capable of minimizing physical stimulation to the cochlea, a hearing aid device including the same, and a method for manufacturing the same.

[0012] Another object of the present invention is to provide an electrode module capable of continuously administering a therapeutic drug (or a therapeutic composition) into the cochlea, a hearing aid device including the same, and a method for manufacturing the same.

[0013] The tasks of the present invention are not limited to the tasks mentioned above, and other tasks not mentioned will be clearly understood by those skilled in the art to which the present invention pertains from the description below.

[0014] According to one aspect of the present invention, there is provided an electrode module inserted into a cochlea to assist hearing, the electrode module comprising: a module body having a communication hole formed inside the module body to communicate with the outside and through which a plurality of wires pass, a coupling pin extending outward and a coupling hole formed at an end of the coupling pin are provided on one side, and a coupling groove formed on the other side to which a coupling hole of another neighboring electrode module is coupled; and an electrode provided on the module body and electrically connected to one of the plurality of wires to emit current to the outside, the electrode module being connected to another neighboring electrode module in a ball joint manner.

[0015] At this time, the communication hole may be provided with a fixing part that fixes at least some of the plurality of wires to the inner wall of the communication hole.

[0016] At this time, the module body may be provided with a drug-receiving portion that releases a therapeutic composition to the outside over time.

[0017] At this time, the drug-receiving portion may be formed in multiple numbers along the outer surface of the module body in a grid-like pattern.

[0018] At this time, the therapeutic composition may be formed to continuously release the therapeutic composition for a predetermined period of time, including a biodegradable polymer and a therapeutic substance that can use the biodegradable polymer as a carrier.

[0019] At this time, one end of the above-mentioned communication hole may be formed in the above-mentioned joint, and the other end may be formed in the inner wall of the above-mentioned joint groove.

[0020] At this time, a coupling hole is formed on the other side of the module body, which is connected to the coupling groove and whose diameter increases as it goes outward, and at least a part of the coupling pin of the neighboring electrode module can be positioned in the coupling hole.

[0021] At this time, the one side of the module body may include a curved portion formed to be convex toward the outside.

[0022] At this time, the coupling hole may include a first coupling hole in which at least a part of the coupling pin of the neighboring other electrode module is positioned and a second coupling hole in which at least a part of the curved portion of the neighboring other electrode module is positioned.

[0023] At this time, the inner surface of the second coupling hole may have a shape corresponding to the outer surface of the curved portion.

[0024] According to another aspect of the present invention, a hearing assistance device for assisting hearing is provided, comprising: a sound processor for converting sound into a predetermined signal; a transmitter provided outside the body for transmitting the signal to the outside; a receiver provided inside the body for receiving the signal transmitted by the transmitter; and an electrode array having a plurality of the above-described electrode modules and emitting a current corresponding to the signal received by the receiver.

[0025] At this time, the plurality of wires may be provided in multiple numbers corresponding to the number of electrodes of the plurality of electrode modules.

[0026] At this time, the module body can be connected in series with the module body of another neighboring electrode module.

[0027] At this time, the module body of the electrode module located at the shortest end among the plurality of electrode modules connected in series may have a convex portion formed to be convex toward the outside.

[0028] At this time, each of the plurality of electrode modules may be formed to correspond to the shape of a portion of the cochlea into which the plurality of electrode modules are inserted.

[0029] At this time, the electrode may be provided only in at least some module bodies selected from among the module bodies of the plurality of electrode modules.

[0030] At this time, the module body is provided with a drug receiving portion that releases a therapeutic composition to the outside over time, wherein the plurality of electrode modules include first and second electrode modules, and the therapeutic composition released from the drug receiving portion of the first electrode module may include a first substance, and the therapeutic composition released from the drug receiving portion of the second electrode module may include a second substance different from the first substance.

[0031] According to another aspect of the present invention, a method for manufacturing a hearing assistance device for assisting hearing is provided, comprising: scanning the structure of a cochlea; analyzing the structure of the scanned cochlea; determining the shape of an electrode module to be inserted into the cochlea based on the analyzed structure of the cochlea; forming a plurality of electrode modules to be inserted into the cochlea based on the determined shape; forming an electrode array by connecting the plurality of electrode modules in a ball joint manner; and combining the electrode array, a sound processor for converting sound into a predetermined signal, a transmitter provided outside the body for transmitting the signal to the outside, and a receiver provided inside the body for receiving the signal transmitted by the transmitter.

[0032] At this time, the step of forming the plurality of electrode modules can be performed by a 3D printing process.

[0033] At this time, the step of analyzing the state of the cochlea; and the step of determining a part of each part of the cochlea where an electrode for emitting current is positioned based on the analyzed state of the cochlea may further include the step of forming the plurality of electrode modules, and the step of forming the electrodes may include the step of forming the electrodes in electrode modules inserted into the parts determined in the step of determining the electrode positions.

[0034] At this time, the step of determining the shape of the plurality of electrode modules can individually determine the shape of each of the plurality of electrode modules to correspond to the shape of a part of the cochlea into which the electrode module is inserted.

[0035] At this time, the electrode module formed in the step of forming the plurality of electrode modules may further include a step of forming a drug-receiving groove on one side and loading a therapeutic composition into the drug-receiving groove.

[0036] At this time, the step of analyzing the state of the cochlea; and the step of determining a part of each part of the cochlea to which a therapeutic composition needs to be applied and the type of the therapeutic composition based on the analyzed state of the cochlea are further included, and the step of loading the therapeutic composition may load the therapeutic composition determined in the therapeutic composition determination step into a drug-receiving groove of an electrode module inserted into a part to which the therapeutic composition determined in the therapeutic composition determination step needs to be applied.

[0037] An electrode module according to an embodiment of the present invention, a hearing aid device including the same, and a method for manufacturing the same are configured such that a plurality of electrode modules inserted into the cochlea are connected to each other in a ball joint manner to provide rotational freedom in all directions, and thus can be arranged in response to the spiral structure of the cochlea, thereby minimizing physical stimulation applied to the cochlea.

[0038] In addition, the hearing aid device including the electrode module according to an embodiment of the present invention and the manufacturing method thereof can minimize physical stimulation applied to the cochlea since each of the plurality of electrode modules is formed to correspond to the shape of a portion of the cochlea into which the electrode module is inserted.

[0039] In addition, the electrode module according to an embodiment of the present invention, the hearing aid device including the same, and the manufacturing method thereof can continuously administer a therapeutic drug (or therapeutic composition) into the cochlea by having the electrode module having a drug receiving portion that continuously releases the drug over time.

[0040] In addition, the electrode module according to an embodiment of the present invention, the hearing aid device including the same, and the manufacturing method thereof can continuously administer a therapeutic drug (or therapeutic composition) into the cochlea by manufacturing the module body of the electrode module by a 3D printing process using a mixture including a biodegradable polymer, a biocompatible photoinitiator, and a therapeutic composition.

[0041] In addition, the electrode module according to an embodiment of the present invention, the hearing aid device including the same, and the manufacturing method thereof are provided with a fixing part for fixing a wire passing through the inside of the electrode module, so that the wire can be prevented from being twisted or kinked even when the electrode module is rotated.

[0042] In addition, a hearing aid device including an electrode module according to an embodiment of the present invention and a method for manufacturing the same are provided with electrodes and / or drug receptacles only in at least some electrode modules selected from among a plurality of electrode modules, thereby reducing manufacturing costs, preventing side effects, and efficiently performing hearing assistance and treatment.

[0043] The effects of the present invention are not limited to the effects described above, and effects not mentioned can be clearly understood by a person having ordinary skill in the art to which the present invention pertains from this specification and the attached drawings.

[0044] FIG. 1 is a schematic drawing showing a state in which a hearing assistance device according to one embodiment of the present invention is mounted on a body.

[0045] Figure 2 is a drawing showing the wiring section of the hearing aid device illustrated in Figure 1 and the electrode array inserted into the cochlea. At this time, a cross-section of a portion of the cochlea is shown so that the inside is visible.

[0046] Figures 3 to 5 are schematic drawings showing the electrode array of the hearing aid device illustrated in Figure 1 inserted into the cochlea. In this case, the configuration visible through the cochlea is indicated by a solid line, and only a portion of the electrode module inserted into the cochlea is shown.

[0047] FIGS. 6 and 7 are perspective views of a portion of the electrode array of the hearing aid device illustrated in FIG. 1 viewed from different angles.

[0048] FIG. 8 is a cross-sectional view of a portion of the electrode array of the hearing aid device illustrated in FIG. 1.

[0049] Fig. 9 is a cross-sectional view taken along line AA of Fig. 8.

[0050] FIG. 10 is a graph showing the relationship between the amount and time of release of a therapeutic substance depending on the composition of the therapeutic composition of the drug receiving portion of the electrode array according to one embodiment of the present invention.

[0051] FIGS. 11 and 12 are diagrams illustrating some examples of modifications of an electrode array of a hearing aid device according to one embodiment of the present invention.

[0052] Figure 13 is a flowchart of a method for manufacturing a hearing assistance device according to one embodiment of the present invention.

[0053] Hereinafter, with reference to the attached drawings, embodiments of the present invention will be described in detail so that those skilled in the art can easily practice the present invention. The present invention may be implemented in various different forms and is not limited to the embodiments described herein. To clearly explain the present invention, parts irrelevant to the description are omitted in the drawings, and the same reference numerals designate identical or similar components throughout the specification.

[0054] The words and terms used in this specification and claims should not be construed as limited to their ordinary or dictionary meanings, but should be interpreted in a way that is consistent with the technical idea of ​​the present invention, in accordance with the principles by which the inventor can define terms and concepts in order to best explain his or her invention.

[0055] In this specification, terms such as “include” or “have” are intended to describe the presence of a feature, number, step, operation, component, part or combination thereof described in the specification, but should be understood not to exclude in advance the possibility of the presence or addition of one or more other features, numbers, steps, operations, components, parts or combinations thereof.

[0056] When a component is said to be "in front of," "behind," "above," or "below" another component, this includes not only being placed "in front of," "behind," "above," or "below" the other component in direct contact with it, but also if there is another component intervening therebetween. Furthermore, when a component is said to be "connected" to another component, this includes not only being directly connected to one another, but also being indirectly connected to one another, unless there are special circumstances.

[0057] A hearing aid device and a method for manufacturing the same according to one embodiment of the present invention comprises a plurality of electrode modules connected in a ball joint manner, each of which is inserted into the cochlea and emits current to apply electrical stimulation to nerve cells, and the plurality of electrode modules are inserted and positioned by relatively rotating, so that the hearing aid device and the method for manufacturing the same can be implanted according to the shape of the cochlea having a complex three-dimensional structure.

[0058] Accordingly, the hearing assistance device and the manufacturing method thereof according to one embodiment of the present invention can minimize physical stimulation applied to the inside of the cochlea and prevent damage to the cochlea during the process of implanting the electrode array into the cochlea and the process of performing the hearing assistance function after implantation.

[0059] In addition, the hearing aid device and the method for manufacturing the same according to one embodiment of the present invention have an electrode module inserted into the cochlea and a drug receiving portion that releases a therapeutic composition over time, so that the therapeutic composition can be continuously administered into the cochlea without additional implantation of other components.

[0060] FIG. 1 is a schematic diagram showing a state in which a hearing assistance device according to one embodiment of the present invention is mounted on a body. FIG. 2 is a diagram showing a wiring portion of the hearing assistance device shown in FIG. 1 and an electrode array inserted into a cochlea. At this time, a cross-section of a portion of the cochlea is shown so that the inside is visible. FIGS. 3 to 5 are schematic diagrams showing a state in which the electrode array of the hearing assistance device shown in FIG. 1 is inserted into a cochlea. At this time, the configuration visible through the cochlea is indicated by a solid line, and only a portion of the electrode module inserted into the cochlea is shown.

[0061] Referring to FIGS. 1 and 2, a hearing aid device (1) according to one embodiment of the present invention is a device for assisting hearing that is installed on a body, for example, a head (2), and may include a sound processor (10), a transmitter (20), a receiver (30), a wiring unit (40), and an electrode array (50).

[0062] The sound processor (10) is installed outside the body and performs the function of receiving sound input from the outside, analyzing the required sound, and then converting it into an electrical signal. The sound processor (10) may be composed of a microphone, etc., and may include a mounting part that can be hung on the side of the head (2) or the ear (3) for convenience of wearing.

[0063] The transmitter (20) is installed outside the body and performs the function of converting the electrical signal converted by the sound processor (10) into a predetermined signal, for example, a signal composed of electromagnetic waves, and transmitting the signal to the outside of the transmitter (20). To this end, the transmitter (20) is installed to be electrically connected to the sound processor (10) or to exchange signals via wireless communication. Of course, the transmitter (20) may also be configured to transmit the electrical signal converted by the sound processor (10) to the outside as is without converting it into another signal.

[0064] The receiver (30) can be implanted inside the body through a surgical operation or procedure. The receiver (30) performs the function of receiving a signal transmitted externally by the transmitter (20). For example, the receiver (30) may be equipped to receive a signal emitted externally from the transmitter (20) and transmitted to the skin of the head (2).

[0065] The wiring unit (40) may be composed of a plurality of wires (42) that electrically connect the receiver (30) and the electrode array (50) described below. That is, the receiver (30) converts a signal received from the transmitter (20) into an electrical signal and then transmits it to the electrode array (50) through the wiring unit (40).

[0066] An electrode array (50) is inserted and positioned in the cochlea (8). The electrode array (50) functions to apply electrical stimulation to the nerve cells of the cochlea (8) in place of damaged hair cells by emitting an electric current to the outside. Through this, the hearing aid device (1) according to the present embodiment can assist the user's hearing.

[0067] Referring to FIG. 2, in the present embodiment, the electrode array (50) includes a plurality of electrode modules (51) that are connected in series to each other. The plurality of electrode modules (51) can be inserted along the cochlea (8) and arranged in a spiral shape.

[0068] Although FIGS. 2 to 5 illustrate that a plurality of electrode modules (51) are inserted and positioned throughout the outer portion (8a), middle portion (8b), and inner portion (8c) of the cochlea (8), the plurality of electrode modules (51) may be partially positioned in a predetermined portion of the cochlea (8). In this case, the predetermined portion may be a portion where hair cells are damaged and nerve cells need to receive electrical stimulation by the electrode array (50).

[0069] For example, the length of the electrode array (50) may be formed to be shorter than the entire length of the cochlea (8), so that the electrode module (51) may be inserted into the outer part (8a) and the middle part (8b) of the cochlea (8), but the electrode module (51) may not be inserted into the inner part (8c).

[0070] Referring to FIGS. 3 to 5, an electrode module (51) according to one embodiment of the present invention is connected to another neighboring electrode module (51) using a ball joint method. This ball joint method of connection can grant the electrode module (51) a degree of freedom that allows it to rotate relative to another neighboring electrode module (51) in all directions.

[0071] More specifically, referring to FIG. 3, the ball joint connection method can grant the electrode module (51) and another adjacent electrode module (51) a degree of freedom to rotate relative to each other by a predetermined angle around an axis perpendicular to the upper and lower surfaces of the electrode module (51) and an axis perpendicular to the side surface, and can grant the degree of freedom to rotate relative to each other completely (i.e., 360 degrees) around an axis parallel to the arrangement direction of the electrode module (51).

[0072] Referring again to FIGS. 3 to 5, the cochlea (8) has a three-dimensional spiral structure. The radius (R) of the cochlea (8) decreases (i.e., the curvature increases) from the outer portion (8a) to the inner portion (8c). In addition, the height (H) of the cochlea (8) increases from the outer portion (8a) to the inner portion (8c). In other words, the cochlea (8) has a three-dimensional tubular structure formed along a spiral (S), and this structure varies from individual to individual.

[0073] According to the present embodiment, since the plurality of electrode modules (51) are given the freedom of relative rotation in all directions, when the electrode array (50) is inserted into the cochlea (8), the plurality of electrode modules (51) can be inserted along the spiral (S) while appropriately rotating relative to the shape of the cochlea (8).

[0074] That is, since the electrode array (50) can be inserted into the cochlea (8) only by relative rotation between a plurality of electrode modules (51) without deformation of the shape of each electrode module (51), in the process of inserting the electrode array (50) into the cochlea (8), only a force for relative rotation of the electrode modules (51) is applied to the inner wall of the cochlea (8), and no force due to deformation of the shape of the electrode module (51) body is applied.

[0075] In addition, even after the electrode array (50) is inserted (or transplanted) into the cochlea (8), the plurality of electrode modules (51) can maintain an arrangement corresponding to the spiral (S) of the cochlea (8) by relative rotation without an external force (i.e., without shape deformation due to an external force). Therefore, no continuous pressure is applied to the inner wall of the cochlea (8) by the electrode array (50).

[0076] In this way, according to the hearing aid device (1) according to the present embodiment, it is possible to minimize and prevent damage to the cochlea (8) during the process of inserting the electrode array (50) and after the insertion (or implantation) is completed.

[0077] The ball joint connection method will be described in detail later with reference to Fig. 8.

[0078] FIGS. 6 and 7 are perspective views of a portion of the electrode array of the hearing aid device illustrated in FIG. 1 from different angles. FIG. 8 is a cross-sectional view of a portion of the electrode array of the hearing aid device illustrated in FIG. 1. FIG. 9 is a cross-sectional view taken along line AA of FIG. 8. FIG. 10 is a graph showing the relationship between the amount and time of release of a therapeutic substance depending on the composition of the therapeutic composition of the drug receptacle of the electrode array according to one embodiment of the present invention.

[0079] Referring to FIGS. 6 to 8, another electrode module (51) according to the present embodiment may include a module body (52), an electrode (54) for emitting a current that electrically stimulates nerve cells, and a drug receiving portion (55) for emitting a therapeutic composition (55b) over time.

[0080] The module body (52) is a structure having a hexahedral shape and can provide a base on which an electrode (54) and a drug-receiving portion (55) are formed. The shape of the module body (52) is not particularly limited and can have various shapes. At this time, the module body (52) can be formed with rounded corners to reduce physical stimulation applied to the inner wall of the cochlea (8).

[0081] Meanwhile, the module bodies (52) of the plurality of electrode modules (51) do not necessarily all have to have the same shape. Referring to FIGS. 6 and 7, in the present embodiment, the module body (52) of the electrode module (51) located at the outermost side among the plurality of electrode modules (51) connected in series has a convex portion formed on one side that is formed to be convex outward. The convex portion may have a semicircular or semi-elliptical cross-section, but is not limited thereto.

[0082] Accordingly, according to the present embodiment, when the electrode array (50) is inserted into the cochlea (8), the physical stimulation that may occur when the electrode module (51) located at the outermost side among the plurality of electrode modules (51) enters the inside of the cochlea (8) can be minimized.

[0083] The electrode (54) is a plate-shaped conductive object having a thin thickness, and may be provided on one side of the module body (52), for example, the lower side based on FIG. 7. In FIG. 7, the electrode (54) is illustrated so that its surface is exposed to the outside, but it may also be provided so as to be mounted inside the module body (52). The electrode (54) emits current in response to an electrical signal generated from the receiver (30). The emitted current applies an electrical stimulus to the nerve cells inside the cochlea.

[0084] The electrode (54) may be made of platinum (Pt), gold (Au), titanium nitride (TiN), etc., but is not limited thereto, and may be made of various conductive materials having properties suitable for the body.

[0085] Referring to FIG. 8, a module body (52) of an electrode module (51) may be formed with protrusions (56, 58) and insertions (57, 59) to be connected in a ball joint manner to a module body (52) of another neighboring electrode module (51).

[0086] More specifically, on one side of the module body (52), for example, on the right side, a protrusion (56, 58) protruding outward is formed, and on the other side of the module body (52), for example, on the left side, an insertion portion (57, 59) into which a protrusion (56, 58) of another neighboring module body (52) can be inserted is formed.

[0087] In this embodiment, the protrusions (56, 58) and the insertions (57, 59) are arranged in a parallel manner with the module body (52) as the center, but this is not limited thereto, and if the electrode array (50) can be easily inserted into the interior of the cochlea (8), the protrusions (56, 58) and the insertions (57, 59) may be arranged at a predetermined angle and misaligned.

[0088] The protrusions (56, 58) may be formed of a coupling pin (56) and a coupling hole (58). The coupling pin (56) extends outward from one side of the module body (52). At this time, the coupling pin (56) may have a tapered shape in which the diameter decreases as it goes outward, but is not limited thereto. A coupling hole (58) is provided at the outer end of the coupling pin (56).

[0089] The insertion portion (57, 59) may be formed of a joining hole (57) and a joining groove (59). The joining groove (59) is formed in a shape corresponding to the shape of the joining member (58). The joining hole (57) has one end connected to the joining groove (59) and the other end connected to the outside, and has a shape in which the diameter increases as it goes outward.

[0090] A coupling hole (58) of another neighboring electrode module (51) is coupled to the coupling groove (59), and at least a part of a coupling pin (56) of another neighboring electrode module (51) is positioned in the coupling hole (57).

[0091] When the coupling hole (58) of another neighboring electrode module (51) is rotated in a predetermined direction while being coupled to the coupling groove (59), the coupling pin (56) of another neighboring electrode module (51) rotates inside the coupling hole (57), and the other neighboring electrode module (51) rotates relatively.

[0092] At this time, so that the coupling pin (56) can rotate freely inside the coupling hole (57), the outer surface of the coupling pin (56) and the inner surface of the coupling hole (57) have a similar shape overall, but the inner diameter of the coupling hole (57) (i.e., the diameter of the cross-section of the coupling hole (57)) is formed to be larger than the outer diameter of the coupling pin (56) at the corresponding position (i.e., the diameter of the cross-section of the coupling pin (56)).

[0093] Referring to FIG. 1 and FIG. 8 together, a first opening (58a) is formed in the coupling member (58), a second opening (59a) is formed in the inner wall of the coupling groove (59), and a communication hole (53) connecting the first opening (58a) and the second opening (59a) is formed inside the module body (52). That is, the communication hole (53) is communicated with the outside through the first and second openings (58a, 59a).

[0094] A plurality of wires (42) pass through the communication hole (53) and the first and second openings (58a, 59a). At this time, the communication hole (53) may be formed of a first communication hole (53a) positioned adjacent to the electrode (54) and a second communication hole (53b) formed along the length direction inside the protrusion (56, 58). At this time, the first and second communication holes (53a, 53b) are connected to each other.

[0095] A plurality of wires (42) are provided corresponding to the number of electrodes (54) of the plurality of electrode modules (51). Each wire (42) electrically connects an electrode (54) of one of the plurality of electrode modules (51) and a receiver (30).

[0096] Among the plurality of wires (42) passing through the communication hole (53) of the electrode module (51), the wire (42) connected to the electrode (54) of the electrode module (51) branches off from the plurality of wires (42). The branched wires (42a, 42b) extend toward the electrode (54) of the electrode module (51) to electrically connect the electrode (54) and the receiver (30).

[0097] According to the present embodiment, both ends of the communication hole (53) (i.e., the first and second openings (58a, 59a)) are positioned on the inner walls of the coupling port (58) and the coupling groove (59), respectively, so that the communication hole (53) can be directly connected to the communication hole (53) of another neighboring electrode module (51). Accordingly, the plurality of communication holes (53) can form a path that is generally parallel to the arrangement direction of the plurality of electrode modules (51).

[0098] Accordingly, the wire (42) can be bent along the arrangement direction of the plurality of electrode modules (51) without excessive deformation, and the electrical signal generated from the receiver (30) can be stably transmitted to the electrode (54).

[0099] Meanwhile, referring to FIGS. 8 and 9, a fixing member (44) for fixing a plurality of wires (42) passing through the communication hole (53) may be provided on the inner wall of the communication hole (53). As a result, even if the electrode module (51) rotates relative to another neighboring electrode module (51), twisting and distortion of the wires (42) passing through the interior of the electrode module (51) can be prevented.

[0100] At this time, in the present embodiment, the fixing part (44) is provided on the inner wall of the second communication hole (53b). In this way, the fixing part (44) is positioned in the second communication hole (53b) which is located further from the electrode (54) than the first communication hole (53a), so that the remaining wires (42) can be stably fixed to the inner wall of the communication hole (53) without interfering with the wiring of the wires (42a, 42b) branched to be connected to the electrode (54).

[0101] Referring to FIGS. 6 and 8, a drug receiving portion (55) is provided on the upper side of the module body (52). The drug receiving portion (55) includes a drug receiving groove (55a) formed in the inner direction of the module body (52) and a therapeutic composition (55b) received in the drug receiving groove (55a). The therapeutic composition (55b) refers to a composition in which a plurality of substances are mixed.

[0102] At this time, the drug receiving portion (55) is formed to continuously release the therapeutic composition (55b) to the outside of the module body (52) for a predetermined period of time as time passes. To this end, the plurality of materials include at least one of a biocompatible material, a biodegradable material, and a therapeutic material that uses a biocompatible material and / or a biodegradable material as a carrier. At this time, the ratio between the biodegradable material (and / or, biocompatible material) and the therapeutic material is not particularly limited.

[0103] Biocompatible materials refer to materials that are substantially non-toxic to the human body, chemically inert, and non-immunogenic, and biodegradable materials refer to materials that can be decomposed in the body by body fluids or microorganisms.

[0104] The therapeutic substance is a substance administered for the treatment of tissue or nerve cells of the cochlea (8), and may include at least one of a steroid drug such as dexamethasone (DEX), an aminoglycoside antibiotic such as neomycin, and a neurotherapeutic drug such as brain-derived neurotrophic factor, but is not limited thereto.

[0105] The biodegradable polymer may include, but is not limited to, at least one of polylactic acid (PLA), polylactic-co-glycolic acid (PLGA), polyethylene glycol (PEG), polyethylene glycol diacrylate (PEGDA), polypyrrole (PPY), and pentaerythritol diacrylate (PETA).

[0106] A therapeutic substance using a biodegradable polymer as a carrier, which may include at least one of the above-mentioned dexamethasone, neomycin, and brain-derived neurotrophic factor, but is not limited thereto.

[0107] At this time, in this embodiment, the module body (52) can be manufactured using a 3D printing method using a mixture of a biocompatible polymer and a biocompatible photoinitiator as a photoresist. At this time, the ratio between the biocompatible polymer and the biocompatible photoinitiator is not particularly limited.

[0108] The biocompatible polymer may include a silicone elastomer, and the biocompatible photoinitiator may include, but is not limited to, at least one of irgacure 369, irgacure 2959, and 1,4-bis(4-(N,N-bis(6-(N,N,N-trimethylammonium)hexyl)amino)-styryl)-2,5 dimethoxybenzene tetraiodide (WSPI).

[0109] At this time, the therapeutic composition structure can be manufactured using a 3D printing process using the Direct Laser Writing (DLW) method, which forms a structure by irradiating the photoresist with a laser of a specific wavelength to induce a chemical reaction. Since the DLW method of 3D printing is suitable for forming fine structures, it can be used to manufacture the therapeutic composition structure according to the present embodiment.

[0110] More specifically, in this embodiment, the therapeutic composition structure can be manufactured by a 3D printing process using the DLW method, which causes two-photon polymerization (2PP).

[0111] Meanwhile, the mixture (or photoresist) used to manufacture the module body (52) using a 3D printing method may further include a therapeutic substance. Accordingly, the therapeutic substance may be configured to be continuously released from the module body (52) for a predetermined period of time.

[0112] Additionally, the mixture (or photoresist) used to manufacture the module body (52) using a 3D printing method may further include a biodegradable polymer in addition to the therapeutic substance. Accordingly, as the module body (52) biodegrades, the therapeutic substance may be formed to be continuously released from the module body (52) for a predetermined period of time.

[0113] Meanwhile, a therapeutic composition (55b) can be loaded into the drug receiving home (55a) using inkjet printing.

[0114] Figure 10 is a graph illustrating the cumulative amount of dexamethasone released from a photoresist prepared by mixing a biocompatible photoinitiator, a biodegradable polymer, and dexamethasone as a therapeutic agent, and forming an experimental example using a 3D printing process using the prepared photoresist, over time. In this case, a mixture of PEGDA and PETA in a volume ratio of approximately 7:3 was used as the degradable polymer.

[0115] Referring to Figure 10, (1) shows the cumulative amount of dexamethasone released from Experimental Example 1 over time after mixing dexamethasone at 0.3 wt% with the photoresist and manufacturing Experimental Example 1 in a cube shape.

[0116] (2) This shows the cumulative amount of dexamethasone released from Experimental Example 2 over time after mixing dexamethasone with photoresist at 1.0 wt% and manufacturing Experimental Example 2 in a cube shape.

[0117] (3) This shows the cumulative amount of dexamethasone released from Experimental Example 3 over time after mixing dexamethasone with photoresist at 0.3 wt% and manufacturing Experimental Example 3 in the form of a scaffolder.

[0118] (4) This shows the cumulative amount of dexamethasone released from Experimental Example 4 over time after mixing dexamethasone with photoresist at 1.0 wt% and manufacturing Experimental Example 4 in the form of a scaffolder.

[0119] When comparing (1) and (2), as the weight of dexamethasone mixed into the photoresist increased, the weight of the released dexamethasone increased. Similarly, when comparing (3) and (4), as the weight of dexamethasone mixed into the photoresist increased, the weight of the released dexamethasone increased.

[0120] These results demonstrate that the amount of therapeutic agent released per unit time can be controlled by controlling the amount of therapeutic agent mixed into the photoresist. For example, to increase the amount of therapeutic agent released per unit time, the amount of therapeutic agent mixed into the photoresist can be increased.

[0121] Meanwhile, comparing (1) and (2) with (3) and (4), in Experimental Examples 3 and 4 manufactured in a scaffold shape, the weight of the released dexamethasone continuously increased, but in Experimental Examples 1 and 2 manufactured in a cube shape, the weight of the released dexamethasone increased for a certain period of time, but dexamethasone was no longer released after a certain period of time.

[0122] These results demonstrate that the duration of sustained release of a therapeutic agent can be controlled by controlling the shape of the structure manufactured using 3D printing. For example, to ensure that the therapeutic agent is continuously released for a predetermined period of time, followed by a tendency for no further release, the shape of the manufactured therapeutic composition structure can be based on a cube shape, but with a partial scaffold shape incorporated.

[0123] Accordingly, according to the present embodiment, it is possible to continuously administer a drug (or a therapeutic composition (55b)) to the cochlea (8) without additional components such as a pump and a storage device, thereby performing efficient treatment.

[0124] Referring again to FIGS. 3 to 5, in the hearing aid device (1) according to one embodiment of the present invention, each of the plurality of electrode modules (51) may have a shape corresponding to the shape of the portion of the cochlea (8) into which each electrode module (51) is inserted.

[0125] The inner diameter of the cochlea (8) decreases from the outer portion (8a) to the inner portion (8c). Correspondingly, the width and / or height of the module body (52) of the electrode module (51) positioned at the inner portion (8c) is formed to be smaller than the width and / or height of the module body (52) of the electrode module (51) positioned at the outer portion (8a). That is, the plurality of electrode modules (51) can be formed to have the width and / or height of the module body (52) decrease from the outer portion (8a) to the inner portion (8c) of the cochlea (8).

[0126] Meanwhile, the curvature of the cochlea (8) increases from the outer portion (8a) to the inner portion (8c). Correspondingly, the length of the module body (52) of the electrode module (51) positioned at the inner portion (8c) is formed to be shorter than the length of the module body (52) of the electrode module (51) positioned at the outer portion (8a). That is, the plurality of electrode modules (51) can be formed to have the length of the module body (52) become shorter as they go from the outer portion (8a) to the inner portion (8c) of the cochlea (8).

[0127] Of course, in order to increase the range in which the coupling pin (56) of the neighboring electrode module (51) can rotate inside the coupling hole (57) in response to the change in curvature, the difference between the inner diameter of the coupling hole (57) and the outer diameter of the coupling pin (56) at the corresponding position may be formed to increase from the outer side (8a) to the inner side (8c) of the cochlea (8).

[0128] In this way, according to the present embodiment, by forming the shape of each of the plurality of electrode modules (51) to correspond to a part of the cochlea (8) into which the electrode module (51) is inserted, the physical stimulus applied to the cochlea (8) can be minimized.

[0129] Referring again to FIGS. 3 to 5, in the present embodiment, the electrode (54) may be provided only in at least some of the module bodies (52) selected from among the plurality of electrode modules (51).

[0130] Hair cells of the cochlea (8) may be damaged only in a portion of the cochlea (8) due to congenital or acquired causes, while other portions retain their original function. In this case, electrical stimulation by the electrode array (50) needs to be applied only to the portion where the hair cells are damaged.

[0131] At this time, the electrode (54) may be selectively provided only in the module body (52) located in the part where electrical stimulation needs to be applied among the plurality of electrode modules (51). For example, if only the hair cells in the inner part (8c) and the outer part (8a) of the cochlea (8) are damaged and the hair cells in the middle part (8b) maintain their original function, the electrode (54) may be provided only in the module body (52) of the electrode modules (51a, 51c) located in the inner part (8c) and the outer part (8a) among the plurality of electrode modules (51), and the electrode (54) may not be provided in the module body (52) of the electrode module (51b) located in the middle part (8b).

[0132] Accordingly, according to the present embodiment, the user's hearing can be efficiently assisted, the manufacturing cost of the hearing assistance device can be reduced, and side effects due to electrical stimulation being applied to unnecessary parts can be prevented.

[0133] Likewise, in the present embodiment, the drug receiving portion (55) may be provided only in at least some of the module bodies (52) selected from among the plurality of electrode modules (51).

[0134] The shape of the cochlea (8) varies from person to person and is not standardized. For example, the cochlea (8) may include a first portion with a sharply increasing curvature or a decreasing diameter, and a second portion with a gentler curvature or a larger diameter than the surrounding area.

[0135] In this case, administration of a large amount of the therapeutic composition (55b) is required in the first part, and administration of the therapeutic composition (55b) is not required in the second part.

[0136] At this time, the drug receiving portion (55) may be selectively provided only in the module body (52) located in the portion where administration of the therapeutic composition (55b) is required. In a similar manner, different amounts of the therapeutic composition (55b) may be loaded into the drug receiving portions (55) of multiple electrode modules (51).

[0137] Accordingly, according to the present embodiment, the manufacturing cost of a hearing aid device can be reduced, side effects caused by administering a therapeutic composition (55b) to an unnecessary part can be prevented, and efficient and intensive treatment can be performed.

[0138] Meanwhile, in the present embodiment, the plurality of electrode modules (51) include first and second electrode modules (51), but the therapeutic composition (55b) mounted on the drug receiving portion (55) of the first electrode module (51) and the therapeutic composition (55b) mounted on the drug receiving portion (55) of the second electrode module (51) may contain different materials.

[0139] For example, in the case where the outer part (8a) of the cochlea (8) has intact hair cells but needs to be administered antibiotics due to physical stimulation by the electrode array (50), and the inner part (8c) of the cochlea (8) has damaged hair cells but needs to be administered antibiotics due to little physical stimulation by the electrode array (50), a therapeutic composition (55b) containing an antibiotic such as neomycin may be loaded into the drug receiving portion (55) of the electrode module (51) located in the outer part (8a), and a therapeutic composition (55b) containing a substance for nerve healing such as a brain-derived neurotrophic factor may be loaded into the inner part (8c).

[0140] In this way, according to this embodiment, the manufacturing cost of the hearing aid device can be reduced, side effects caused by administering a different type of therapeutic composition (55b) to the area requiring treatment can be prevented, and efficient and intensive treatment can be performed.

[0141] Hereinafter, a modified example of the electrode array of the hearing assistance device according to one embodiment of the present invention will be described.

[0142] FIGS. 11 and 12 are diagrams illustrating some examples of modifications of an electrode array of a hearing aid device according to one embodiment of the present invention.

[0143] Here, the same reference numerals as in the previously illustrated drawings indicate identical components with the same functions. In the following description of modified examples of the present invention, descriptions of configurations that can be formed identically to the configuration described above will be omitted.

[0144] Referring to FIG. 11, in this modified example, a plurality of drug-receiving portions (155) are formed, and the plurality of drug-receiving portions (155) are arranged in a grid pattern along the outer surface of the module body (152).

[0145] According to this modified example, the drug receiving portion (155) can be in direct or indirect contact with the cochlea through a higher surface area, so that the therapeutic composition can be efficiently administered from the drug receiving portion (155) to the cochlea.

[0146] Of course, the plurality of drug-receiving portions (155) may be formed with different densities in each portion of the electrode array (150). For example, in an electrode module (151) positioned in a portion of the cochlea where administration of a therapeutic composition is more required, the plurality of drug-receiving portions (155) may be formed with a higher density and more densely than in other electrode modules (151).

[0147] Referring to Fig. 12, in the electrode array (250) according to the present modified example, an outwardly convex curved portion is formed on one side of the module body (252) of the electrode module (251), on the right side with reference to Fig. 11. A protrusion (56, 58) consisting of a coupling pin (56) and a coupling hole (58) is formed on the curved portion.

[0148] On the other side of the module body (252), the left side as shown in Fig. 11, a protrusion (56, 58) is inserted to form an insertion part (257, 259) for ball joint connection. At this time, the insertion part (257, 259) includes a joining groove (259) and a joining hole (257).

[0149] The coupling groove (259) is formed with a curved surface corresponding to the coupling hole (58) so that the coupling member (58) can be coupled and rotate freely. One end of the coupling hole (257) is connected to the coupling groove (259), and the other end is connected to the outside. The coupling hole (257) has a shape in which the inner diameter increases as it goes outward.

[0150] At this time, the coupling hole (257) is composed of a first coupling hole (257a) and a second coupling hole (257b) located on the outside of the module body (252) relative to the first coupling hole (257a). At least a part of the coupling pin (56) of another neighboring electrode module (251) is located in the first coupling hole (257a), and at least a part of the curved portion of another neighboring electrode module (251) is located in the second coupling hole (257b).

[0151] When the coupling hole (58) of another neighboring electrode module (251) is rotated in a predetermined direction while being coupled to the coupling groove (259), the coupling pin (56) and the curved portion of another neighboring electrode module (251) rotate inside the coupling hole (257), and the other neighboring electrode module (251) rotates.

[0152] At this time, so that the coupling pin (56) can rotate freely inside the first coupling hole (257a), the outer surface of the coupling pin (56) and the inner surface of the first coupling hole (257a) may have a similar overall shape, but the inner diameter of the first coupling hole (257a) may be formed to be larger than the outer diameter of the coupling pin (56) at the corresponding position.

[0153] Likewise, so that the curved portion can freely rotate within the second coupling hole (257b), the outer surface of the curved portion and the inner surface of the second coupling hole (257b) may have a similar overall shape, but the inner diameter of the second coupling hole (257b) may be formed to be larger than the outer diameter of the curved portion at the corresponding position.

[0154] According to this modified example, since the module body (252) of the electrode module (251) has a curved portion, the physical stimulation applied to the cochlea by the electrode module (251) during the process of inserting the electrode array into the cochlea and after insertion can be minimized.

[0155] In addition, in this modified example, at least a portion of the curved portion is inserted into the joining hole (257) of the neighboring electrode module (251) and rotates, so that a plurality of electrode modules (251) can be compactly connected, and physical damage such as tissue of the cochlea being caught in the space between the electrode modules (251) during the process of relative rotation of the plurality of electrode modules (251) can be prevented.

[0156] Hereinafter, a method for manufacturing a hearing aid device according to one embodiment of the present invention will be described. In this case, a detailed description of the content already described in relation to the hearing aid device according to one embodiment of the present invention will be omitted.

[0157] Figure 13 is a flowchart of a method for manufacturing a hearing assistance device according to one embodiment of the present invention. The method for manufacturing a hearing assistance device according to one embodiment of the present invention can be used to manufacture the hearing assistance device described above.

[0158] Referring to FIG. 13, in a method for manufacturing a hearing assistance device according to one embodiment of the present invention, the structure of the cochlea is scanned (S100), and the state of the structure of the scanned cochlea is analyzed (S200).

[0159] At this time, in the step of analyzing the structure of the cochlea (S200), the curvature, height, inner diameter, etc. of the cochlea can be analyzed, and in the step of analyzing the condition of the cochlea (S200), the damaged part of the hair cells can be analyzed, but it is not limited thereto.

[0160] Referring again to FIG. 13, in the manufacturing method according to the present embodiment, the individual shapes of the electrode modules to be inserted into the cochlea are determined based on the structure and condition of the analyzed cochlea (S300). At this time, the shape of each of the plurality of electrode modules can be individually determined to correspond to the shape of a portion of the cochlea into which the electrode module is inserted.

[0161] According to this embodiment, by forming the shape of each of the plurality of electrode modules to correspond to a part of the cochlea into which the electrode module (51) is inserted, the physical stimulation applied to the cochlea can be minimized.

[0162] In addition, in the manufacturing method according to the present embodiment, the part of each part of the cochlea where the electrode for emitting current is positioned is determined based on the structure and state of the analyzed cochlea (S300).

[0163] At this time, the location of the electrode can be determined as a location where hair cells are damaged and electrical stimulation needs to be applied to the nerve cells. Through this, at least one electrode module equipped with an electrode can be selected from among a plurality of electrode modules.

[0164] In addition, in the manufacturing method according to the present embodiment, a step of determining a part of the cochlea to which a therapeutic composition needs to be administered and the type of the therapeutic composition to be administered may be further performed based on the structure and state of the analyzed cochlea.

[0165] Through this, at least one electrode module having a drug-receiving portion among a plurality of electrode modules can be selected. In addition, a therapeutic composition contained in the drug-receiving portion and a therapeutic substance contained in the therapeutic composition can be selected.

[0166] Referring again to FIG. 13, in the manufacturing method according to the present embodiment, a plurality of electrode modules are formed using a 3D printing process based on the determined shape of the electrode module, the position of the electrode, the position of the drug receiving portion, and the type of the therapeutic composition (S400).

[0167] The 3D printing process used to manufacture the electrode module can be a DLW-based 3D printing process utilizing two-photon polymerization. This allows for the easy formation of microstructures for electrode modules inserted into the cochlea, which are microscopic in size.

[0168] The 3D printing process for manufacturing electrode modules may utilize a mixture (or photoresist) comprising a biocompatible polymer (e.g., a silicone elastomer) and a biocompatible photoinitiator in a predetermined ratio. The mixture (or photoresist) may further include a therapeutic composition (or therapeutic agent). Of course, the mixture (or photoresist) may also include a biodegradable polymer.

[0169] Accordingly, the therapeutic composition (or therapeutic substance) can be continuously released from the electrode module over time, thereby enabling continuous administration of the drug (or therapeutic substance) to the cochlea without any additional components.

[0170] At this time, an electrode is mounted on an electrode module (i.e., an electrode module selected to have an electrode) inserted into a portion where an electrode is to be positioned, and a drug-receiving groove is formed on an electrode module (i.e., an electrode module selected to have a drug-receiving portion) inserted into a portion where a therapeutic composition is to be administered.

[0171] In this way, according to the present embodiment, it is possible to efficiently assist the user's hearing, reduce the manufacturing cost of the hearing assistance device, and prevent side effects due to electrical stimulation being applied to unnecessary parts.

[0172] Referring again to FIG. 13, in the manufacturing method according to the present embodiment, a drug (or therapeutic composition) is loaded into the drug-receiving groove formed in the electrode module forming step (S400) (S500). At this time, the drug (or therapeutic composition) may be loaded using an inkjet method.

[0173] The therapeutic composition may include a biodegradable polymer and a therapeutic agent. Accordingly, the therapeutic composition may be continuously released from the drug-receiving compartment for a predetermined period of time.

[0174] Meanwhile, the formed drug-receiving chamber is loaded with a specific type of drug (or therapeutic composition) determined in advance. This reduces the manufacturing costs of the hearing aid, prevents side effects caused by administering other therapeutic compositions to the area requiring treatment, and enables efficient and focused treatment.

[0175] Referring again to FIG. 13, in the manufacturing method according to the present embodiment, a plurality of electrode modules formed in the electrode module forming step (S400) and loaded with a therapeutic composition in the drug loading step (S500) are connected according to the arrangement determined in the step of determining the position of the electrode modules (S300) to form an electrode array (S600), and an audio processor, a transmitter, a receiver, and a wiring section are combined (S700).

[0176] At this time, the plurality of electrode modules are connected in a ball joint manner. Accordingly, according to the present embodiment, the plurality of electrode modules are granted omnidirectional degrees of freedom for relative rotation, thereby minimizing the physical stimulation applied to the cochlea when and after the electrode array is inserted into the cochlea.

[0177] Although one embodiment of the present invention has been described above, the spirit of the present invention is not limited to the embodiment presented in this specification, and a person skilled in the art who understands the spirit of the present invention will be able to easily propose other embodiments by adding, changing, deleting, or adding components within the scope of the same spirit, but this will also be considered to fall within the spirit of the present invention.

Claims

1. An electrode module inserted into the cochlea to assist hearing. A module body having a communication hole formed inside that is connected to the outside and through which a plurality of wires pass, a coupling pin extending outward and a coupling hole formed at an end of the coupling pin are provided on one side, and a coupling groove formed on the other side into which a coupling hole of another neighboring electrode module is coupled; and Including an electrode provided in the above module body and electrically connected to one of the plurality of wires to emit current to the outside, An electrode module connected to another adjacent electrode module in a ball joint manner.

2. In paragraph 1, An electrode module, wherein the above-mentioned communication hole is provided with a fixing member that fixes at least some of the plurality of wires to the inner wall of the above-mentioned communication hole.

3. In paragraph 1, An electrode module, wherein the module body comprises a drug receiving portion that continuously releases the therapeutic substance for a predetermined period of time, the drug receiving portion including a biodegradable polymer and a therapeutic substance that can utilize the biodegradable polymer as a carrier.

4. In paragraph 3, An electrode module in which the above drug-receiving portions are formed in a plurality along the outer surface of the module body in a grid-like pattern.

5. In paragraph 1, An electrode module, wherein one end of the above-mentioned communication hole is formed in the above-mentioned joining hole, and the other end is formed in the inner wall of the above-mentioned joining groove.

6. In paragraph 5, On the other side of the above module body, a joining hole is formed that is connected to the joining groove and whose diameter increases as it goes outward. An electrode module, wherein at least a portion of the coupling pins of the adjacent electrode module are positioned in the coupling hole.

7. As a hearing aid device for assisting hearing, A sound processor that converts sound into a specific signal; A transmitter installed outside the body to transmit the signal to the outside; A receiver provided inside the body for receiving the signal transmitted by the transmitter; and A hearing aid device comprising a plurality of electrode modules according to any one of claims 1 to 6, and including an electrode array that emits current corresponding to the signal received by the receiver.

8. In paragraph 7, The above module body is connected in series with the module body of another neighboring electrode module, A hearing aid device, wherein the module body of the electrode module located at the shortest end among the plurality of electrode modules connected in series has a convex portion formed to be convex toward the outside.

9. In paragraph 7, A hearing assistance device, wherein each of the plurality of electrode modules is formed to correspond to the shape of a portion of the cochlea into which the plurality of electrode modules are inserted.

10. In paragraph 7, A hearing aid device, wherein the electrode is provided only in at least some module bodies selected from among the plurality of electrode modules.

11. In paragraph 7, The above module body is provided with a drug-receiving portion that releases a therapeutic composition to the outside over time, The above plurality of electrode modules include first and second electrode modules, The therapeutic composition released from the drug receiving portion of the first electrode module comprises a first substance, A hearing aid device, wherein the therapeutic composition released from the drug receiving portion of the second electrode module comprises a second substance different from the first substance.

12. A method for manufacturing a hearing aid device for assisting hearing, Step of scanning the structure of the cochlea; A step of analyzing the structure of the scanned cochlea; A step of determining the shape of an electrode module to be inserted into the cochlea based on the structure of the analyzed cochlea; A step of forming a plurality of electrode modules to be inserted into the cochlea based on the determined shape; A step of forming an electrode array by connecting the above plurality of electrode modules in a ball joint manner; and A method for manufacturing a hearing assistance device, comprising the step of combining the electrode array, a sound processor that converts sound into a predetermined signal, a transmitter provided outside the body to transmit the signal to the outside, and a receiver provided inside the body to receive the signal transmitted by the transmitter.

13. In paragraph 12, A method for manufacturing a hearing assistance device, wherein the step of forming the plurality of electrode modules is performed by a 3D printing process.

14. In paragraph 12, A step of analyzing the condition of the above cochlea; and Further comprising a step of determining a part of each part of the cochlea where an electrode for emitting current is positioned based on the analyzed state of the cochlea, A method for manufacturing a hearing aid device, wherein the step of forming the plurality of electrode modules includes the step of forming the electrodes in electrode modules inserted into portions determined in the step of determining the electrode positions.

15. In paragraph 12, A step of analyzing the condition of the above cochlea; A step of determining a part of the cochlea to which a therapeutic composition needs to be applied and the type of the therapeutic composition based on the analyzed state of the cochlea; A step of forming a drug-receiving groove on one side of the electrode module; and A method for manufacturing a hearing assistance device, further comprising a step of loading the therapeutic composition determined in the therapeutic composition determination step into a drug-receiving groove of an electrode module inserted into a portion where the therapeutic composition determined in the therapeutic composition determination step needs to be applied.

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