Hearing aid and preparation method and use method thereof

Abstract

The application relates to a hearing aid and a preparation method and use method thereof, the hearing aid comprising a hearing aid component, an ear mold, a small hole and a sound guide pipe, the hearing aid component and the sound guide pipe being embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the inner ear canal; the sound guide pipe is located at the horizontal middle line position in the ear mold, one end of the sound guide pipe is connected with the hearing aid component, and the other end is communicated with the external environment through the small hole on the ear mold, and the small hole is located at the center position of the ear mold facing the ear outside. The hearing aid can be shaped on site according to the shape of the ear canal of a user, and the patient can reshape it again when it is not suitable in the later period, and the plastic method is simple, convenient and easy to operate.

Description

TECHNICAL FIELD

[0001] The present invention relates to the field of molding materials, and more particularly to a hearing aid and its manufacturing and using methods. BACKGROUND

[0002] A hearing aid is a device for the hearing impaired. The basic principle of a hearing aid is to collect the ambient sound, amplify it and then transmit it into the user's ear. The transmission is fixed by a long-term earplug in the user's ear. No matter how the function of the hearing aid is designed and optimized, the comfort of the earplug is crucial. Since the hearing aid needs to be used for a long time, even a slight misfit of the earplug will bring great discomfort to the user. In addition, the misfit of the earplug size can also cause the hearing aid to emit pipi leakage sound (whistling phenomenon).

[0003] Since the shape of each person's ear canal is different, the best method is to customize the earplug of the hearing aid according to the shape of the user's ear canal. At present, the customized earplugs account for a large part of the products of major hearing aid companies in the market. In particular, for the purpose of aesthetic and concealed hearing aids (canal type and deep canal type), only customized earplugs can be used because they need to be hidden in the ear canal.

[0004] In order to manufacture a customized earplug, it is usually divided into three steps. The first step is to insert a solidifiable soft material into the user's ear canal, wait for it to solidify and then take it out to obtain an ear impression; the second step is to use a solidifiable material to shape according to the ear impression to manufacture an ear mold; the third step is to inject the material to be made into the ear mold, wait for the molding to obtain the required shape of the earplug shape. The materials currently used are of the following four types: (1) hard plastic: easy to process, painful swelling, such as polymethyl methacrylate, polyethylene, etc., and also hard silicone; (2) soft plastic: easy to process, easy to deteriorate, such as some silicone rubber; (3) organic matter: easy to process, easy to deteriorate, such as agar and the like; (4) silicone: soft, non-allergic, but not easy to make. At present, the customized earplugs of the actual hearing aid products on the market use the most silicone rubber, most of which are hard, and there are a few soft silicone products.

[0005] The current customized earplug has two shortcomings. The first shortcoming is that it needs to go through two molding processes, and the preparation process is relatively cumbersome, usually requiring the user to personally make the ear impression and send it back to the factory for manufacturing, which takes several to ten working days, so the material cost, labor cost and time cost are relatively large. The second shortcoming is that once the shape of the earplug is fixed, it cannot be changed again, and in fact the shape of the user's ear canal will change slightly with the change of the body state, especially for the elderly, the shape of the ear canal will change obviously in one to three years. At this time, the original earplug no longer matches, which will cause discomfort again, which loses the significance of the customized earplug.

[0006] Therefore, the hearing aid which can be shaped according to the shape of the ear canal of the user on site and reshaped by the user himself / herself when discomfort occurs later is very suitable for the hearing-impaired person to use. SUMMARY

[0007] In view of the problems existing in the prior art hearing aids, one of the purposes of the present application is to provide a hearing aid which can be shaped according to the shape of the ear canal of the user on site and reshaped by the user himself / herself when discomfort occurs later, and the plastic way is simple, convenient and easy to operate.

[0008] To achieve the above-mentioned purposes, the technical solutions adopted by the present application are as follows:

[0009] A hearing aid, comprising a hearing aid component, an ear mold, a small hole and a sound guide tube.

[0010] Preferably, the hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the inner ear canal; the sound guide tube is located at the horizontal midline position inside the ear mold, one end of the sound guide tube is connected to the hearing aid component, and the other end is communicated with the external environment through the small hole on the ear mold, and the small hole is located at the center position of the ear mold facing the outer ear.

[0011] In the above technical solution, the diameter of the small hole is consistent with the outer diameter of the sound guide tube, and the diameter ranges from 0.5 to 3 mm, preferably from 0.7 to 2.5 mm.

[0012] In the above technical solution, the hearing aid component and the sound guide tube are fixed in the ear mold by an adhesive, and the adhesive is selected from at least one of nylon, silicone and polypropylene.

[0013] In the above technical solution, the sound guide tube is made of a hard material, and the bending modulus of the hard material is greater than 1 GPa, preferably greater than 3 GPa; further preferably, it is any one of copper, stainless steel, nylon 6 and polypropylene.

[0014] In the above technical solution, the wall thickness of the sound guide tube is not less than 0.5 mm, preferably 0.7 to 1 mm.

[0015] In the above technical solution, the ear mold is made of a copolyester material, and the copolyester material contains copolyester X and copolyester Y; wherein the copolyester X contains aliphatic diacid and / or derivative chain segment, aromatic diacid and / or derivative chain segment and diol chain segment; the diol chain segment includes at least one diol chain segment with a cyclic structure chain segment and at least one aliphatic diol chain segment; wherein the molar percentage content of the aromatic diacid and / or derivative chain segment in the total diacid and / or derivative chain segment is 15 to 60%;

[0016] The copolyester Y comprises aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments, and at least one aliphatic diol segment; the molar percentage of the aromatic diacid and / or its derivative segments relative to the total diacid and / or its derivative segments is 50-95%. The aromatic diacid content of the copolyesters X and Y of the present invention within the above range can improve the rigidity of the copolyesters to varying degrees.

[0017] In the above technical solution, based on 100 parts by weight of the total copolyester, the copolyester X is 50 to 99 parts, preferably 55 to 80 parts. When the content of the copolyester X of the present invention is within the above range, the temperature required for triggering softening of the material can be reduced to varying degrees, thereby increasing the hardness and wear resistance of the material.

[0018] The content of the copolyester Y is 1 to 50 parts, preferably 20 to 45 parts. When the content of the copolyester Y of the present invention is within the above range, the curing time of the copolyester composition material can be reduced to varying degrees.

[0019] In the above technical solution, the molar percentage of the aromatic diacid and / or its derivative segments in the copolyester X to the total diacid and / or its derivative segments is 25-60%, more preferably 30-60%.

[0020] Preferably, the molar percentage of the cyclic diol segments in the copolyester X is 1-60%, preferably 5-25%. The introduction of the cyclic diol segments can increase the rigidity of the copolyester, lower the temperature required to trigger softening, and increase the hardness and wear resistance of the material.

[0021] Preferably, the molar ratio of the total diacid segments to the total diol segments in the copolyester X is (0.8-1):1, preferably (0.9-1):1.

[0022] Preferably, the molar percentage of the aromatic diacid and / or its derivative segments in the copolyester Y to the total diacid and / or its derivative segments is 60-85%.

[0023] Preferably, the molar ratio of the total diacid segments to the total diol segments in the copolyester Y is (0.8-1):1, preferably (0.9-1):1.

[0024] In the above technical solution, the copolyester X and the copolyester Y are each independently at least one of a random copolymer, an alternating copolymer, a block copolymer and a graft copolymer, preferably a random copolymer and / or a block copolymer.

[0025] In the above technical solution, the molecular weight of the copolyester X and the copolyester Y is in the range of 20,000-200,000, preferably 80,000-150,000.

[0026] In the above technical solution, the aliphatic diacid and / or its derivative is selected from at least one of 1,4-butanediol and / or its derivative, and 1,6-hexanediol and / or its derivative.

[0027] The aromatic diacid and / or its derivatives are selected from terephthalic acid and / or its derivatives.

[0028] The diol with a cyclic structure is selected from at least one of 1,4-cyclohexanedimethanol, isosorbide, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol.

[0029] The aliphatic diol is selected from at least one of 1,3-propylene glycol, 1,4-butanediol, and 1,6-hexanediol.

[0030] The introduction of the cyclic diol into the copolyester X alone can reduce the thickness of the copolyester crystals, thereby lowering the melting point of the copolyester and, consequently, the softening temperature of the copolyester material. This further reduces the production time and cost of the copolyester material and increases its ease of use. Furthermore, the introduction of the cyclic diol can reduce the crystallization rate of the copolyester, resulting in an increase in the curing time of the copolyester material.

[0031] Compared to copolyester X alone, copolyester Y has a shorter cure time, but a higher softening temperature and poorer hardness and wear resistance. Therefore, a combination of copolyester X and copolyester Y is used to compensate for the deficiencies of either copolyester X or Y alone. By adjusting the ratio of the two, the combined copolyester achieves the desired softening temperature, hardness, wear resistance, and cure time.

[0032] In the above technical solution, the aliphatic diol segment in the copolyester X is different from the aliphatic diol segment in the copolyester Y; preferably,

[0033] The aliphatic diol chain segment in the copolyester X is derived from 1,4-butanediol; and the aliphatic diol chain segment in the copolyester Y is derived from 1,3-propylene glycol and / or 1,6-hexanediol.

[0034] In the above technical solution, based on 100 parts by total weight of copolyester X and copolyester Y, 0.5 to 10 parts, preferably 1.5 to 8 parts, of fragrance are further included.

[0035] The fragrance is selected from at least one of fruit essence and floral essence; the fruit essence includes but is not limited to strawberry, banana, sweet orange, pineapple, grape and other fragrances; the floral essence includes but is not limited to rose, jasmine, tuberose, lily of the valley, magnolia and other fragrances.

[0036] In the above technical solution, based on 100 parts by total weight of copolyester X and copolyester Y, 1-15 parts of a lubricant are further included, and the lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bisstearamide and low-density polyethylene.

[0037] The method for preparing the copolyester material of the present invention comprises the steps of mixing components including the copolyester X and the copolyester Y and then melt-blending them.

[0038] In the above technical solution, the mixing is carried out under stirring conditions, and the stirring rate is 20-150r / min.

[0039] In the above technical solution, the stirring time is 5-15 minutes.

[0040] In the above technical solution, the melt blending is carried out by extrusion granulation through a twin-screw extruder; preferably, the temperature of the extrusion granulation is 110 to 260°C, more preferably 160 to 220°C.

[0041] The second object of the present invention is to provide a method for preparing the hearing aid. The material obtained by the preparation method is easy to use, degradable, and has a fragrant smell, and the user experience is good.

[0042] To achieve the above object, the technical solution adopted by the present invention is as follows:

[0043] A method for preparing a hearing aid comprises sequentially extruding and molding a copolyester material to obtain an ear mold material; preferably, the extrusion is melt extrusion.

[0044] In the above technical solution, the extrusion temperature is 90-230° C., preferably 110-170° C.; the molding method is preferably injection molding and / or compression molding.

[0045] A third object of the present invention is to provide a method for using the above-mentioned hearing aid, comprising heating the ear mold to fully soften it, then quickly cooling it to a temperature acceptable to the human body, wiping it clean, placing it in the ear canal, adjusting the shape of the ear mold according to the morphological characteristics of the patient's ear canal, and waiting for the ear mold to harden after the adjustment is completed.

[0046] Ideally, heat the ear mold to 120-130°C for approximately 10 seconds, then quickly cool to room temperature. Place the ear mold against the ear canal and gently apply pressure to shape the material. Allow the mold to cure for approximately 5 minutes. Remove the mold and allow it to set for approximately 24 hours to fully cure.

[0047] The heating method can be carried out using special instruments. Hot air heating is recommended. Hot oil, hot sand or microwave heating can also be used.

[0048] Ice water is recommended for cooling, but room temperature cold water, ice cubes, or a cold metal mesh are also acceptable. The faster the cooling time, the better the plasticity. Be careful to avoid burns when handling.

[0049] Beneficial effects of the present invention:

[0050] 1. The preparation and use process is simple and the cost is low;

[0051] 2. Improve transparency and beautiful appearance;

[0052] 3. It can change shape according to the changes in the patient's ear canal morphology and has a fragrant smell, providing a good user experience;

[0053] 4. Degradable and environmentally friendly. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 This is a cross-sectional structural diagram of the hearing aid of the present invention.

[0055] Reference numerals: 1. ear mold, 2. small hole, 3. sound guide tube, 4. hearing aid components. The hearing aid shown in the figure includes a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, with the hearing aid component located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. DETAILED DESCRIPTION

[0056] The present invention will be described in detail below with reference to specific embodiments. It is necessary to point out that the following embodiments are only used to further illustrate the present invention and are not to be construed as limiting the scope of protection of the present invention. Non-essential improvements and adjustments made by those skilled in the art to the present invention based on the contents of the present invention still fall within the scope of protection of the present invention.

[0057] It should also be noted that the various specific technical features described in the following specific embodiments can be combined in any appropriate manner without contradiction. To avoid unnecessary repetition, the present invention will not further describe various possible combinations.

[0058] In addition, the various embodiments of the present invention may be arbitrarily combined as long as they do not violate the concept of the present invention. The technical solutions thus formed belong to part of the original disclosure of this specification and also fall within the scope of protection of the present invention.

[0059] Sources of reagents: All reagents used in the present invention are commercially available.

[0060] In the following examples and comparative examples, the weight-average molecular weight of the polymers was measured by gel permeation chromatography (GPC) using tetrahydrofuran (THF) as solvent on a Waters-208 instrument (with a Waters 2410RI detector, a flow rate of 1.5 mL / min, and 30° C.), calibrated with styrene standards.

[0061] The composition of the polyester composition is determined by the feeding of raw materials; the types of reaction raw materials can be adjusted accordingly according to the composition and molecular weight of the target product, and the molecular weight of the product and the content of each repeating unit in the product can be controlled by adjusting the feeding amount and feeding ratio.

[0062] Example 1

[0063] A hearing aid comprises a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube and is 2mm. The hearing aid component and the sound guide tube are fixed to the ear mold with an adhesive selected from silicone. The sound guide tube and hearing aid component are both commercially available products. The sound guide tube is made of copper and has a wall thickness of 0.8mm.

[0064] Hearing aid preparation and use: Under stirring conditions (stirring rate of 30 rpm, time for 10 minutes), 7 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexanedimethanol copolyester X (weight average molecular weight of 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total molar number of terephthalic acid and succinic acid repeating units; the content of 1,4-cyclohexanedimethanol repeating units is 25 mol% based on the total molar number of butylene glycol and 1,4-cyclohexanedimethanol repeating units) particles, 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total molar number of terephthalic acid and succinic acid repeating units) particles, 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene were mixed. The molar ratio of the total diacid segments to the total diol segments in copolyester X is 0.95:1, and the molar ratio of the total diacid segments to the total diol segments in copolyester Y is 0.95:1. The resulting mixture is extruded and granulated through a twin-screw extruder. The screw speed is controlled at 10 rpm and the torque is 20 Nm. The temperatures of the sections from the feed inlet to the extrusion outlet of the twin-screw extruder are sequentially 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to produce copolyester material A1. Copolyester material A1 is softened by heating with boiling water and then rapidly cooled to room temperature in ice water. It is then dried, and the sound guide tube and hearing aid components are embedded therein as shown in the structural diagram and fixed with silicone adhesive to produce hearing aid B1. When using, heat the hearing aid B1 with a hair dryer to soften it, quickly cool it to about 37°C with ice water, wipe it dry, and shape it according to the morphological characteristics of the user's ear canal. After shaping, wait for it to harden.

[0065] Example 2

[0066] A hearing aid comprises a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, measuring 2.2mm. The hearing aid component and the sound guide tube are fixed to the ear mold with an adhesive selected from nylon. The sound guide tube and hearing aid component are both commercially available products, the sound guide tube is made of copper, and the wall thickness of the sound guide tube is 0.7mm.

[0067] Hearing aid preparation and use: 6.5 kg of terephthalic acid-butylene glycol-adipate-isosorbide copolyester X (weight-average molecular weight of 130,000, wherein the content of terephthalic acid repeating units is 55 mol% based on the total moles of terephthalic acid and adipic acid repeating units; the content of isosorbide repeating units is 20 mol% based on the total moles of butylene glycol and isosorbide repeating units) particles, 3 kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight-average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units) particles, 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene were mixed under stirring conditions (stirring time of 10 minutes at a rate of 30 rpm). The molar ratio of the total diacid segments to the total diol segments in the copolyester X is 1:1, and the molar ratio of the total diacid segments to the total diol segments in the copolyester Y is 1:1. The resulting mixture is extruded and granulated through a twin-screw extruder, with the screw speed controlled at 10 rpm and the torque at 20 Nm. The temperatures of the sections from the feed port to the extrusion port in the twin-screw extruder are 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to produce copolyester material A2. Copolyester material A2 is softened by heating with boiling water and then quickly cooled to room temperature in ice water. It is then dried. The sound guide tube and hearing aid components are embedded in the hearing aid as shown in the structural diagram and fixed therein with nylon adhesive to produce hearing aid B2. When in use, hearing aid B2 is softened by heating with a hair dryer, quickly cooled to approximately 37°C with ice water, dried, and shaped according to the morphological characteristics of the user's ear canal. After shaping, it is allowed to harden.

[0068] Example 3

[0069] A hearing aid comprises a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, measuring 2.5mm. The hearing aid component and the sound guide tube are fixed to the ear mold with an adhesive selected from polypropylene. The sound guide tube and hearing aid component are both commercially available products, the sound guide tube is made of copper, and the wall thickness of the sound guide tube is 0.8mm.

[0070] Preparation and use of hearing aid: Under stirring conditions (stirring rate of 30 rpm, time for 10 min), 6.5 kg of terephthalic acid-butylene glycol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight average molecular weight of 150,000, wherein the content of terephthalic acid repeating units is 30 mol% based on the total molar number of terephthalic acid and succinic acid repeating units; based on the total molar number of butylene glycol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X) was added. The invention further comprises a mixture of 1,2-diol-1,3-tetramethylcyclobutanediol (2,2,4,4-tetramethyl-1,3-cyclobutanediol) particles (containing 20 mol% of 2,2,4,4-tetramethyl-1,3-cyclobutanediol repeating units, based on the total molar number of 1,2-diol repeating units), 3 kg of terephthalic acid-hexanediol-succinic acid copolyester Y (weight-average molecular weight of 100,000, containing 60 mol% of terephthalic acid repeating units, based on the total molar number of terephthalic acid and succinic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene. The molar ratio of the total diacid segments to the total diol segments in the copolyester X is 0.9:1, and the molar ratio of the total diacid segments to the total diol segments in the copolyester Y is 0.9:1. The obtained mixture is extruded and granulated through a twin-screw extruder. The screw speed is controlled to 10rpm and the torque is 20N*m. The temperatures of the sections from the feed port to the extrusion port in the twin-screw extruder are 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A3. The copolyester material A3 is softened by heating with boiling water and then quickly placed in ice water to cool to room temperature. It is then wiped dry. The sound guide tube and hearing aid components are embedded as shown in the structural diagram and fixed therein with polypropylene to obtain a hearing aid B3. When in use, the hearing aid B3 is softened by heating with a hair dryer, quickly cooled to about 37°C with ice water, wiped dry, and shaped according to the morphological characteristics of the user's ear canal. After shaping, it is allowed to harden.

[0071] Example 4

[0072] A hearing aid comprises a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, measuring 2.1mm. The hearing aid component and the sound guide tube are fixed to the ear mold with an adhesive selected from nylon. The sound guide tube and hearing aid component are both commercially available products, the sound guide tube is made of copper, and the wall thickness of the sound guide tube is 0.7mm.

[0073] Preparation and use of a hearing aid: 7 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexane dimethanol copolyester X particles (weight average molecular weight of 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; the content of 1,4-cyclohexane dimethanol repeating units is 25 mol% based on the total moles of butylene glycol and 1,4-cyclohexane dimethanol repeating units), 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y particles (weight average molecular weight of 110,000, wherein the content of terephthalic acid repeating units is 80 mol% based on the total moles of terephthalic acid and succinic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed under stirring conditions (stirring rate of 30 rpm for 10 min). The resulting mixture is extruded by a twin-screw extruder, with the screw rotation speed controlled at 10 rpm and the torque at 20 N*m. The temperature of each section in the twin-screw extruder from the feeding port to the extrusion port is 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A4. After the copolyester material A4 is softened by heating with boiling water, it is quickly cooled to room temperature in ice water, dried, and then embedded with sound guide tubes and hearing aid components according to the structure shown in the structural diagram, and fixed in the ear mold with nylon adhesive to obtain a hearing aid B4. During use, the hearing aid B4 is heated and softened with an electric hair dryer, quickly cooled to about 37°C with ice water, dried, shaped according to the morphological characteristics of the user's ear canal, and hardened after shaping.

[0074] Example 5

[0075] A hearing aid, comprising a hearing aid component, an ear mold, a small hole, and a sound guide tube, wherein the hearing aid component and the sound guide tube are embedded in the ear mold, the hearing aid component is located on the side of the ear mold close to the inner ear canal, the sound guide tube is located at the horizontal center line inside the ear mold, one end of the sound guide tube is connected to the hearing aid component, and the other end of the sound guide tube communicates with the external environment through the small hole on the ear mold, and the small hole is located at the center of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, and the size is 2.5 mm; the hearing aid component and the sound guide tube are fixed in the ear mold with an adhesive, and the adhesive is selected from silicone; wherein the sound guide tube and the hearing aid component are commercially available products, the sound guide tube is made of copper, and the wall thickness of the sound guide tube is 0.8 mm.

[0076] Preparation and use of hearing aid: Under stirring conditions (stirring rate of 30 rpm, time for 10 min), 7 kg of terephthalic acid-butylene glycol-succinic acid-2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X (weight average molecular weight of 150,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total molar number of terephthalic acid and succinic acid repeating units; based on the total molar number of butylene glycol and 2,2,4,4-tetramethyl-1,3-cyclobutanediol copolyester X) was added. The present invention also prepares a mixture of 2.5 kg of terephthalic acid-propylene glycol-succinic acid copolyester Y (having a weight-average molecular weight of 100,000 and a terephthalic acid repeating unit content of 60 mol%, based on the total molar number of terephthalic acid and succinic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene. The molar ratio of the total diacid segments to the total diol segments in the copolyester X is 1:1, and the molar ratio of the total diacid segments to the total diol segments in the copolyester Y is 0.9:1. The obtained mixture is extruded and granulated through a twin-screw extruder. The speed of the screw is controlled to be 10 rpm and the torque is 20 N*m. The temperatures of the sections from the feed port to the extrusion port in the twin-screw extruder are 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A5. The copolyester material A5 is softened by heating with boiling water and then quickly placed in ice water to cool to room temperature. It is then wiped dry. The sound guide tube and hearing aid components are embedded as shown in the structural diagram and fixed therein with silicone adhesive to obtain a hearing aid B5. When in use, the hearing aid B5 is softened by heating with a hair dryer, quickly cooled to about 37°C with ice water, wiped dry, and shaped according to the morphological characteristics of the user's ear canal. After shaping, it is allowed to harden.

[0077] Example 6

[0078] A hearing aid comprises a hearing aid component, an ear mold, a small hole, and a sound guide tube. The hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the internal auditory canal. The sound guide tube is located at the horizontal midline of the ear mold. One end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through a small hole in the ear mold. The small hole is located at the center of the side of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube and is 2mm. The hearing aid component and the sound guide tube are fixed to the ear mold with an adhesive selected from polypropylene. The sound guide tube and hearing aid component are both commercially available products. The sound guide tube is made of copper and has a wall thickness of 0.8mm.

[0079] Preparation and use of a hearing aid: 7 kg of particles of terephthalic acid-butylene glycol-succinic acid-isosorbide copolyester X (weight average molecular weight of 130,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; and the content of isosorbide repeating units is 5 mol% based on the total moles of butylene glycol and isosorbide repeating units), 2.5 kg of particles of terephthalic acid-propylene glycol-succinic acid copolyester Y (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed under stirring (stirring rate of 30 rpm for 10 min). The mixture is then extruded by a twin-screw extruder at a screw rotation rate of 10 rpm and a torque of 20 N*m, and the temperature of each section of the twin-screw extruder from the feeding port to the extrusion port is 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A6. The copolyester material A6 is heated and softened by boiling water, and then quickly cooled to room temperature in ice water. After being dried, the sound guide tube and the hearing aid components are embedded and fixed in the ear mold according to the structure shown in the schematic diagram, and the ear mold is fixed by polypropylene adhesive to obtain a hearing aid B6. In use, the hearing aid B6 is heated and softened by an electric hair dryer, and then quickly cooled to about 37°C by ice water. After being dried, the hearing aid B6 is shaped according to the morphological characteristics of the user's ear canal, and then hardened.

[0080] Comparative Example 1

[0081] A hearing aid, comprising a hearing aid component, an ear mold, a small hole, and a sound guide tube, wherein the hearing aid component and the sound guide tube are embedded in the ear mold, the hearing aid component is located on the side of the ear mold close to the inner ear canal, the sound guide tube is located at the horizontal center line inside the ear mold, one end of the sound guide tube is connected to the hearing aid component, and the other end of the sound guide tube communicates with the external environment through the small hole on the ear mold, and the small hole is located at the center of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, and the size is 2.2 mm; the hearing aid component and the sound guide tube are fixed in the ear mold by an adhesive, and the adhesive is selected from silicone; wherein the sound guide tube and the hearing aid component are commercially available products, the sound guide tube is made of copper, and the wall thickness of the sound guide tube is 0.7 mm.

[0082] Preparation and use of a hearing aid: 9.5 kg of terephthalic acid-butylene glycol-succinic acid-1,4-cyclohexane dimethanol copolyester X (weight average molecular weight of 120,000, wherein the content of terephthalic acid repeating units is 60 mol% based on the total moles of terephthalic acid and succinic acid repeating units; and the content of 1,4-cyclohexane dimethanol repeating units is 25 mol% based on the total moles of butylene glycol and 1,4-cyclohexane dimethanol repeating units), 0.2 kg of jasmine essence, and 0.3 kg of low-density polyethylene are mixed under stirring conditions (stirring rate of 30 rpm for 10 min). The resulting mixture is extruded and granulated by a twin-screw extruder, with the screw rotation speed controlled at 10 rpm and the torque at 20 N*m. The temperature of each section in the twin-screw extruder from the feeding port to the extrusion port is 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A7. After the copolyester material A7 is softened by heating with boiling water, it is quickly cooled to room temperature in ice water, dried, and then embedded with sound guide tubes and hearing aid components according to the structure shown in the schematic diagram and fixed with silicone adhesive to obtain a hearing aid B7. During use, the hearing aid B7 is heated and softened with an electric hair dryer, quickly cooled to about 37°C with ice water, dried, shaped according to the morphological characteristics of the user's ear canal, and hardened after shaping.

[0083] Comparative Example 2

[0084] A hearing aid comprising a hearing aid component, an ear mold, a small hole, and a sound guide tube, wherein the hearing aid component and the sound guide tube are embedded in the ear mold, the hearing aid component is located on the side of the ear mold close to the inner ear canal, the sound guide tube is located at the horizontal center line inside the ear mold, one end of the sound guide tube is connected to the hearing aid component, the other end of the sound guide tube communicates with the external environment through the small hole on the ear mold, and the small hole is located at the center of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, and the size is 2 mm; the hearing aid component and the sound guide tube are fixed in the ear mold with an adhesive, and the adhesive is selected from polypropylene; wherein the sound guide tube and the hearing aid component are commercially available products, the sound guide tube is made of copper material, and the wall thickness of the sound guide tube is 0.7 mm.

[0085] Preparation and use of the hearing aid: under stirring (stirring rate 30 rpm for 10 min), 9.5 kg of terephthalic acid-butylene glycol-adipic acid-isosorbide copolyester X (weight average molecular weight 130,000, wherein the content of terephthalic acid repeating units is 55 mol% based on the total moles of terephthalic acid and adipic acid repeating units; and the content of isosorbide repeating units is 20 mol% based on the total moles of butylene glycol and isosorbide repeating units), 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene were mixed. The molar ratio of total diacid segments to total diol segments in the copolyester X is 0.9:1. The resulting mixture was extruded by a twin-screw extruder, the screw speed was controlled at 10 rpm, the torque was 20 N*m, and the temperature of each section in the twin-screw extruder from the feeding port to the extrusion port was 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A8. After the copolyester material A8 was softened by heating with boiling water, it was quickly cooled to room temperature in ice water, dried, and the sound guide tube and hearing aid components were embedded according to the structure shown in the schematic diagram and fixed in the ear mold with polypropylene adhesive to obtain a hearing aid B8. In use, the hearing aid B8 was heated and softened with a hair dryer, quickly cooled to about 37°C with ice water, dried, shaped according to the user's ear canal morphology, and hardened after shaping.

[0086] Comparative Example 3

[0087] A hearing aid, comprising a hearing aid component, an ear mold, a small hole and a sound guide tube, the hearing aid component and the sound guide tube are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold close to the inner ear canal; the sound guide tube is located at the horizontal center line position inside the ear mold, one end of the sound guide tube is connected to the hearing aid component, and the other end communicates with the external environment through the small hole on the ear mold, and the small hole is located at the center position of the ear mold facing the outside of the ear. The diameter of the small hole is consistent with the outer diameter of the sound guide tube, and the size is 2 mm; the hearing aid component and the sound guide tube are fixed in the ear mold with an adhesive, and the adhesive is selected from silicone; wherein the sound guide tube and the hearing aid component are commercially available products, the sound guide tube is made of copper material, and the wall thickness of the sound guide tube is 0.7 mm.

[0088] Hearing aid preparation and use: 6.5 kg of terephthalic acid- butanediol-succinic acid copolyester Y particles (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 25 mol% based on the total moles of terephthalic acid and succinic acid repeating units), 3 kg of terephthalic acid- butanediol-adipic acid copolyester particles (weight average molecular weight of 100,000, wherein the content of terephthalic acid repeating units is 65 mol% based on the total moles of terephthalic acid and adipic acid repeating units), 0.2 kg of jasmine essence and 0.3 kg of low-density polyethylene were mixed under stirring conditions (stirring rate of 30 rpm for 10 min). The resulting mixture was extruded and granulated by a twin-screw extruder, the screw rotation speed was controlled at 10 rpm, the torque was 20 N*m, and the temperature of each section in the twin-screw extruder from the feeding port to the extrusion port was 150°C, 160°C, 170°C, 170°C, 170°C, and 170°C, respectively, to obtain copolyester material A9. After the copolyester material A9 was softened by heating with boiling water, it was quickly cooled to room temperature in ice water, dried, and the sound guide tube and hearing aid components were embedded according to the structure shown in the schematic diagram and fixed with silicone adhesive to obtain hearing aid B9. During use, the hearing aid B9 was heated and softened with a hair dryer, quickly cooled to about 37°C with ice water, dried, shaped according to the user's ear canal characteristics, and hardened after shaping.

[0089] Softening temperature test of test example 1

[0090] The copolyester materials obtained in Examples 1-6 and Comparative Example 3 were placed in hot water at different temperatures to soften them, and the temperatures required to trigger the softening of the copolyester materials were recorded, respectively. The results are shown in Table 1.

[0091] It can be seen that the copolyester materials A1-A6 obtained in Examples 1-6 require lower softening temperatures than the copolyester material A9 obtained in Comparative Example 3, with a maximum reduction of 20°C. Reducing the softening trigger temperature of the copolyester material can greatly increase the convenience of using the hearing aid.

[0092] Table 1

[0093]

[0094] Shore A hardness test of test example 2

[0095] The copolyester materials Al-A8 obtained from Examples 1-6 and Comparative Examples 1-2 were melted and then treated at 170°C under 1000 MPa for 5 min, and pressed into plates C1-C8 with a thickness of 4 mm and a side length of 7 cm. The hot plates were taken out and quenched with a cold iron block which had been kept at room temperature for a long time for 1 min and the time zero point was recorded. The quenched plates were subjected to a test of Shore A hardness change with time (measured by a Drickshore A hand-held hardness meter, and the measurement result after 3 s was taken) and the results are shown in Table 2.

[0096] Table 2 Shore A hardness test

[0097]

[0098] As can be seen from the results in Table 2 above, the plates C1-C8 made of the copolyesters Al-A8 obtained from Examples 1-6 and Comparative Examples 1-2 all have a low hardness at the beginning of the test (at a high temperature), and the hardness slowly increases with time after being cooled. The plates C1-C6 made of the copolyesters Al-A6 obtained from Examples 1-6 have a faster curing speed than the plates C7-C8 made of the copolyesters A7-A8 obtained from Comparative Examples 1-2, and the Shore A hardness reaches 50 in about 4 min, while the latter takes about 7 min. The copolyesters Al-A6 obtained from Examples 1-6 have good plasticity and fixity, and a short curing time, and are suitable for making hearing aids.

[0099] Test Example 3

[0100] 1. Waterproofness test

[0101] The plates C1-C6 made of the copolyesters Al-A6 obtained from Examples 1-6 were weighed, measured in size, photographed and observed in appearance. The plates were immersed in water at 25°C for 24 h, and then taken out and dried, and were observed in appearance, weighed, measured in size and photographed. If the appearance of the plate after being immersed in water has no change compared with before being immersed, it is recorded as “no change”, otherwise as “change”. If the size of the plate after being immersed in water has a change within ±5% compared with before being immersed, it is recorded as “no change”, otherwise as “change”. If the weight of the plate after being immersed in water has a change within ±5% compared with before being immersed, it is recorded as “no change”, otherwise as “change”. The results are shown in Table 3.

[0102] 2. Storage time test

[0103] The plates C1-C6 made of the copolyesters A1-A6 obtained in Examples 1-6 were weighed, measured in size, photographed and observed in appearance. Then, the obtained plates were placed in a room temperature (25°C) and normal pressure environment for 2 years, and the plates were weighed, measured in size, photographed and observed in appearance. If the appearance of the plates after being placed for 2 years had no change compared with that before being placed, it was recorded as "no change", otherwise it was recorded as "change". If the size of the plates after being placed for 2 years had no change compared with that before being placed, it was recorded as "no change", otherwise it was recorded as "change". If the weight of the plates after being placed for 2 years had no change compared with that before being placed, the change was within ±0.1%, it was recorded as "no change", otherwise it was recorded as "change". The results are shown in Table 3.

[0104] Table 3 Waterproofness and shelf life test

[0105]

[0106] From the results of Table 3 above, it can be seen that the hearing aid provided by the present application has good waterproofness and dimensional stability, so that it does not need special packaging such as water isolation during storage and transportation; and the shelf life is at least two years under room temperature conditions.

[0107] The present application has been described in detail with reference to specific embodiments and exemplary examples, but these descriptions are not to be construed as limiting the present application. Those skilled in the art understand that various equivalent substitutions, modifications or improvements can be made to the technical solutions and embodiments of the present application without departing from the spirit and scope of the present application, and these all fall within the scope of the present application. The scope of protection of the present application is subject to the appended claims.

Claims

1. A hearing aid, comprising a hearing aid component, an ear mold, a small hole, and a sound conduit, wherein the hearing aid component and the sound conduit are embedded in the ear mold, wherein the hearing aid component is located on the side of the ear mold near the internal auditory canal; the sound conduit is located at the horizontal midline of the ear mold, one end of the sound conduit is connected to the hearing aid component, and the other end of the sound conduit is connected to the external environment through the small hole in the ear mold, wherein the small hole is located at the center of the side of the ear mold facing the outside of the ear; The ear mold is made of a copolyester material, which includes copolyester X and copolyester Y. The copolyester X includes aliphatic diacid and / or its derivative segments, aromatic diacid and / or its derivative segments, and diol segments. The diol segments include at least one diol segment with a cyclic structure segment and at least one aliphatic diol segment. The molar percentage of the aromatic diacid and / or its derivative segments in the total diacid and / or its derivative segments is 15-60%. wherein the copolyester Y comprises an aliphatic diacid and / or its derivative chain segment, an aromatic diacid and / or its derivative chain segment, and at least one aliphatic diol chain segment; wherein the aromatic diacid and / or its derivative chain segment accounts for 50-95% by mole of the total diacid and / or its derivative chain segment; Based on 100 parts by total weight of the copolyester, the copolyester X is 50 to 99 parts; and / or the copolyester Y is 1 to 50 parts.

2. The hearing aid according to claim 1, wherein The aperture of the small hole is consistent with the outer diameter of the sound guide tube, and the aperture range is 0.5-3 mm.

3. The hearing aid according to claim 2, wherein The aperture range is 0.7-2.5 mm.

4. The hearing aid according to claim 1, wherein The hearing aid components and the sound guide tube are bonded and fixed in the ear mold with an adhesive, and the adhesive is selected from at least one of nylon, silicone and polypropylene.

5. The hearing aid according to claim 1, wherein The sound guide tube is made of a hard material, and the bending modulus of the hard material is greater than 1 GPa; and / or, The wall thickness of the sound-conducting tube is not less than 0.5 mm.

6. The hearing aid according to claim 4, characterized in that The sound guide tube is made of any one of copper, stainless steel, nylon 6 and polypropylene, and its bending modulus is greater than 3 GPa; and / or, The wall thickness of the sound-conducting tube is 0.7-1 mm.

7. The hearing aid according to claim 1, wherein Based on 100 parts by total weight of the copolyester, the copolyester X is 55 to 80 parts; and / or the copolyester Y is 20 to 45 parts.

8. The hearing aid according to claim 1, wherein The molar percentage of aromatic diacid and / or its derivative segments in the copolyester X accounts for 25-60% of the total diacid and / or its derivative segments; and / or, The molar percentage of the diol segments with cyclic structures in the copolyester X to the total diol segments is 1-60%; and / or, The molar ratio of the total diacid segments to the total diol segments in the copolyester X is (0.8-1):1; and / or, The molar percentage of aromatic diacid and / or its derivative segments in the copolyester Y accounts for 60 to 85% of the total diacid and / or its derivative segments; and / or, The molar ratio of the total diacid segments to the total diol segments in the copolyester Y is (0.8-1):

1.

9. The hearing aid according to claim 8, characterized in that The molar percentage of the diol segments with cyclic structures in the copolyester X to the total diol segments is 5-25%; and / or, The molar ratio of the total diacid segments to the total diol segments in the copolyester X is (0.9-1):1; and / or, The molar ratio of the total diacid segments to the total diol segments in the copolyester Y is (0.9-1):

1.

10. The hearing aid according to claim 1, wherein The copolyester X and the copolyester Y are each independently at least one of a random copolymer, an alternating copolymer, a block copolymer and a graft copolymer; and / or the molecular weight of the copolyester X and the copolyester Y is in the range of 20,000-200,000.

11. The hearing aid according to claim 10, characterized in that The copolyester X and the copolyester Y are each independently a random copolymer and / or a block copolymer; and / or the molecular weight of the copolyester X and the copolyester Y is in the range of 80,000-150,000.

12. The hearing aid according to claim 1, wherein The aliphatic diacid and / or its derivative is selected from at least one of 1,4-butanediol and / or its derivative, 1,6-hexanedioic acid and / or its derivative; and / or, The aromatic diacid and / or its derivatives are selected from terephthalic acid and / or its derivatives; and / or, The diol with a cyclic structure is selected from at least one of 1,4-cyclohexanedimethanol, isosorbide, and 2,2,4,4-tetramethyl-1,3-cyclobutanediol; and / or, The aliphatic diol is selected from at least one of 1,3-propylene glycol, 1,4-butanediol, and 1,6-hexanediol.

13. The hearing aid according to claim 12, characterized in that The aliphatic diol segment in the copolyester X is different from the aliphatic diol segment in the copolyester Y.

14. The hearing aid according to claim 13, wherein The aliphatic diol chain segment in the copolyester X is derived from 1,4-butanediol; and the aliphatic diol chain segment in the copolyester Y is derived from 1,3-propylene glycol and / or 1,6-hexanediol.

15. The hearing aid according to claim 1, wherein The invention further comprises 0.5 to 10 parts of fragrance based on the total weight of the copolyester X and the copolyester Y being 100 parts.

16. The hearing aid according to claim 15, characterized in that The invention further comprises 1.5 to 8 parts of fragrance based on the total weight of the copolyester X and the copolyester Y being 100 parts.

17. The hearing aid according to claim 1, wherein Based on 100 parts by total weight of the copolyester X and the copolyester Y, 1 to 15 parts by weight of a lubricant are further included.

18. The hearing aid according to claim 17, wherein Based on 100 parts by weight of the total weight of copolyester X and copolyester Y, 5 to 15 parts of lubricant are also included. The lubricant is selected from at least one of stearic acid, butyl stearate, oleamide, ethylene bisstearamide and low-density polyethylene.

19. A method for preparing a hearing aid according to any one of claims 1 to 18, comprising sequentially extruding and molding a copolyester material to obtain an ear mold material.

20. The preparation method according to claim 19, characterized in that: The extrusion is melt extrusion, and the extrusion temperature is 90-230°C; The molding method is injection molding and / or compression molding.

21. The preparation method according to claim 20, characterized in that: The extrusion temperature is 110-170°C.

22. A method for using the hearing aid according to any one of claims 1 to 18, comprising heating the ear mold to fully soften it, then rapidly cooling it to a temperature acceptable to the human body, wiping it clean, placing it in the ear canal, adjusting the shape of the ear mold according to the morphological characteristics of the patient's ear canal, and waiting for the ear mold to harden after the adjustment is completed.

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