里程碑！首个国产3D打印太合金耳内式助听器获医疗器械注册证

日前，3D打印快速制造装备及服务提供商北京三帝科技股份有限公司（简称“三帝科技”）对外宣布，旗下北京环球精博康复辅具技术有限公司（简称“环球辅具”）自主研发的太音·3D打印钛合金耳内式助听器正式获批国家药品监督管理局二类医疗器械注册证。据悉，该产品是我国首个采用自主3D打印技术取得二类医疗器械注册证的助听器产品，标志着国产3D打印助听器建立起自主可控、自主创新的研发、生产体系。该产品的获批，不仅将国内3D打印在助听器领域的应用引领到了世界同等水平，更极大加速了3D打印技术在康复医疗领域的应用发展。

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.
为打破进口品牌的垄断格局，发出中国自主品牌的声音，太音助听器以3D打印硬核科技为支撑，通过航空航天级3D打印技术和医用级钛合金材料的应用，为听障人士提供全系列定制化的助听器产品，令其享受更清晰、舒适、隐形、安全的高端专属听力体验。

太音·3D打印钛合金助听器采用“3D扫描+3D建模+3D打印”的技术工艺，通过公司自研的SLM选区激光熔融金属3D打印机制作钛合金外壳，量耳定制，拥有0.15mm的极致壁厚，佩戴更隐形，长时间佩戴更舒适，无需佩戴适应周期；医用级钛合金材质，安全无毒性，无致敏性，无皮肤刺激性，且较传统树脂材质的强韧度提升了十多倍，声音更保真；12K超宽频响范围，16-20通道有效调节，48-64频段精准调制，第三代反馈抑制技术，可实现360度全域聆听体验；在国内多个城市提供专业的验配、定制服务和完善的售后服务。目前，太音·3D打印钛合金耳内式助听器已取得两项国家发明专利，通过国家级校准验证，经测试，产品性能达到国际先进水平。

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.