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计程表碑!首例国产货3D打印制作文件太合金类耳内式老年助听器获整形产品备案证

Release time:August 24, 2023
之前,3d复印机出技术文件迅速制作而成机械及办事效率实现供给充足商首都三帝现代社会股分无线工司(代称“三帝现代社会”)境内外施行刊出,齐名首都举世精博病愈辅具工艺活无线工司(代称“举世辅具”)自强研制的太音·3d复印机出技术文件铝合金属耳内式助听正式宣布获准我国医用耗材窃听网上办理局一类医用商品注册申请公司证。我局,该生成物这是我国首条敞开心扉自强3d复印机出技术文件工艺活刷出一类医用商品注册申请公司证的助听生成物,符号着国产车3d复印机出技术文件助听设立起自强可控制、自强立义的研制、产地系統。该生成物的获准,不只将国际性3d复印机出技术文件在助听层面的应用带动来到了天下游戏划一因素,更巨大缩短了3d复印机出技术文件工艺活在病愈医用层面的应用成长发育。

The World Health Organization pointed out in the World Hearing Report 2021 that about 1.5 billion people around the world are currently suffering from hearing impairment. According to some statistics, there are about 72 million hearing impaired people in China, among which there are about 60 million elderly people, but the market coverage of hearing aids is less than 5%. The reason for this is that at present, most of the domestic hearing aid market is monopolized by imported brands, which account for about 90% of the market share; the local hearing aid enterprises are generally small in scale, lack of independent product innovation, and the competition of homogeneity and low price is serious, which makes it difficult to meet the market demand for miniaturized, personalized and intelligent hearing aid products; moreover, at present, there are about 1.5 billion people suffering from hearing impairment worldwide. Market demand for miniaturized, personalized, intelligent hearing aid products; In addition, the current market of hearing aid products, shell materials are mostly based on UV curing materials (polymers containing vinyl), the optional relatively single, wearing comfort is low, and equipped with better performance of the metal shell (eg, titanium alloy) of the hearing aid products are temporarily monopolized by foreign brands, and the price is high.
为突破入口品牌的把持款式,收回中国自立品牌的声响,太音助听器以3D打印硬核科技为支持,经由过程航空航天级3D打印手艺和医用级钛合金资料的利用,为听障人士供给全系列定制化的助听器产物,令其享用更清楚、温馨、隐形、宁静的高端专属听力休会。

图:太音·3D打印钛合金耳内式助听器


太音·3D打印钛合金助听器接纳“3D扫描+3D建模+3D打印”的手艺工艺,经由过程公司自研的SLM选区激光熔融金属3D打印机制作钛合金外壳,量耳定制,具有0.15mm的极致壁厚,佩带更隐形,永劫间佩带更温馨,无需佩带顺应周期;医用级钛合金材质,宁静无毒性,无致敏性,无皮肤安慰性,且较传统树脂材质的强韧度晋升了十多倍,声响更保真;12K超宽频响规模,16-20通道有用调理,48-64频段精准调制,第三代反应按捺手艺,可完成360度全域凝听休会;在国际多个都会供给专业的验配、定制办事和完美的售后办事。今朝,太音·3D打印钛合金耳内式助听器已获得两项国度发现专利,经由过程国度级校准考证,经测试,产物机能到达国际进步前辈程度。


In 2022, the State Council incorporated ear and hearing health into the "14th Five-Year Plan" for national health. At the same time, with the acceleration of the aging process of the domestic population, the popularization of hearing health education and the enhancement of the consumption level of residents, the domestic market demand for hearing aids has begun to be released in large quantities. According to statistics, the market size of China's hearing aid market was 6.86 billion yuan in 2022, with a compound annual growth rate of 8.6% from 2018 to 2022.The relevant market analysis suggests that in the next 5 to 10 years, the penetration rate of China's hearing aid market will increase significantly, with a huge market space of 500-800 billion yuan.


In the face of broad market prospects, SANDI Technology, based on the core technology support of rapid manufacturing of high-end precision metal parts, years of experience in 3D printing 1.0 equipment and applications, and mastery of 3D printing 2.0 core equipment, materials and process technology, has been actively expanding the innovative application of 3D printing technology in the field of rehabilitation and medical care. Through the wholly-owned merger and acquisition of the rehabilitation medical enterprise Global Auxiliary, the company carries out the research and development and application of "3D printing + rehabilitation medical" products, and develops and innovates more scientific and technological recreational products using 3D printing technology and new materials and processes in response to the market demand of personalization, intelligence and precision, so as to promote the development of intelligent recreation and health care and the cause of universal health. At present, the company has obtained dozens of Class I and Class II rehabilitation medical products for the record (covering more than a hundred categories), dozens of patents and copyrights, and passed the certification of ISO9001 quality management system and ISO13485 quality management system for medical devices. We have led and participated in the formulation of many national and industry standards for rehabilitation medical care. Our products and services have achieved full coverage of sunshine procurement and centralized purchasing platforms in more than ten provinces nationwide. We have also established cooperation with hospitals, medical institutions, rehabilitation centers and disabled persons' federations in many cities in China.


[About SANDI TECHNOLOGY
Beijing SANDI Technology Co., Ltd. is a high-tech enterprise focusing on 3D printing green rapid manufacturing equipment and services, the business covers the development and production of 3D printing equipment, rapid manufacturing services for finished metal parts, the research and development and production of 3D printing raw materials, and has established a more complete 3D printing rapid manufacturing industry chain, which is widely used in the aerospace and military industry, automotive, rail transportation, ship pumps and valves, Engineering machinery, education and scientific research, sculpture and cultural creation, rehabilitation and medical care and other industries.

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ICP Record: 京ICP备15051811号-1
里程碑!首个国产3D打印太合金耳内式助听器获医疗东西注册证 - 三帝科技股分无限公司 里程碑!首个国产3D打印太合金耳内式助听器获医疗东西注册证 - 三帝科技股分无限公司
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