Milestone! First Domestic 3D Printed Titanium In-Ear Hearing Aid Receives Medical Device Registration Certificate

("SANDI"), a 3D printing additive manufacturing equipment and service provider, announced that its Beijing Global Precision Rehabilitation Auxiliary Technology Co. The 3D printed titanium alloy in-the-ear hearing aid was officially approved by the State Drug Administration Class II medical device registration certificate. It is reported that the product is China's first independent 3D printing technology to obtain Class II medical device registration certificate of hearing aid products, marking the domestic 3D printing hearing aids to establish an independently controllable, independent innovation of the R & D, production system. The approval of this product not only leads the application of domestic 3D printing in the field of hearing aids to the same level in the world, but also greatly accelerates the development of 3D printing technology in the field of rehabilitation and medical applications.

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.
In order to break the monopoly of imported brands and make the voice of China's own brand, Titanium Tone Hearing Aids, supported by 3D printing hardcore technology, provides a full range of customized hearing aid products for the hearing impaired through the application of aerospace-grade 3D printing technology and medical-grade titanium alloy materials, so as to enable them to enjoy the high-end exclusive hearing experience that is clearer, more comfortable, more invisible, and more secure.

Titanium sound-3D printing titanium alloy hearing aids using "3D scanning + 3D modeling + 3D printing" technology process, through the company's self-developed SLM selective laser melting metal 3D printer to produce titanium alloy shell, customized to the ear, with the ultimate wall thickness of 0.15mm, more invisible to wear, more comfortable for long periods of time, no need to wear! Adaptation cycle; medical grade titanium alloy material, safe and non-toxic, non-allergenic, no skin irritation, and more than ten times stronger than the traditional resin material, the sound is more fidelity; 12K ultra-wide frequency range, 16-20 channels effectively adjusted, 48-64 bands of accurate modulation, the third generation of feedback suppression technology, which can realize a 360-degree full-area listening experience; in a number of cities in the country to provide professional fitting, customized service and perfect after-sales service in many cities in China. At present, Titanium Sound-3D printing titanium alloy in-the-ear hearing aid has obtained two national invention patents, passed the national calibration verification, and the product performance has reached the international advanced level after testing.

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.