"Troublemaker" Of Hearing Aid Market: Listening To The World With Teeth

"Shengtuo" means "Hua Tuo, who brings beautiful sounds to people.". Sonitus, the company we acquired, means "sound" in Latin, while soundbite is translated as "pinyin" as the brand name of the dental bone conduction hearing system. " Recently, in an exclusive interview, Pu qiangling, co-founder and CEO of Shengtuo Medical Co., Ltd., first told the reporter of the 21st century economic report about the source of the company's name.

This is the first time puqiangling started a business. Before turning around, he was the leader of the medical device sector of Fosun Group, and then he worked in a multinational medical device enterprise. Puqiangling told the 21st century economic report that it was a coincidence to buy sonitus and its product soundbite, but it was "amazing" by their products and patents at that time.

Soundbite is a dental bone conduction hearing system. The system has more than 100 invention patents and has been approved by FDA and CE of EU. What's interesting is that this product was jointly created by the original chief scientist and hearing experts. Its technology platform has a history of "0-1" development for nearly 10 years in the United States. The technology covers more than 100 invention patents in the world, which can be used as a substitute It is the traditional gold standard for clinical surgery, bone anchored hearing aid, which is suitable for patients with unilateral hearing loss and conductive hearing loss. However, the high cost of manufacturing in the United States hinders the further commercialization of this technology.

After in-depth understanding, puqiangling sees that sonitus and its products have great market value. It hopes to rebuild this product through China's supply chain and efficiency advantages, reduce production and manufacturing costs and benefit more hearing-impaired patients around the world at affordable prices with the same quality and even better quality than that made in Silicon Valley.

At present, soundbite products have been listed in China, filling the gap in the domestic unilateral deafness market. Under China's strong supply chain system, the price has dropped significantly compared with that in the United States. Puqiangling said that it hopes to continue to deepen its efforts in the field of hearing, and will deploy more bone conduction hearing equipment, even air conduction hearing aids and cochlear implants in the future.

There are a large number of people with unilateral deafness in China, but there are few satisfactory solutions in the market. IC photo

"Picking up leaks"

Puqiangling has more than 30 years of experience in the medical device industry. He has experienced multinational medical device giants such as Kehui medical and Medtronic. Before establishing Shengtuo medical, puqiangling was the leader of the medical device sector of Fosun Pharmaceutical Group. During his tenure in Fosun, he was responsible for the operation and investment of domestic and overseas medical device products.

By chance, puqiangling met soundbite, a dental bone conduction hearing system. With his years of experience and insight into the whole product field of medical devices, he judged that it was a rare good product that could fill the gap in the hearing market in China and even in the world.

Puqiangling told the 21st century economic reporter that this product was originally a dental expert and the original cryptomeric CTO. When communicating with otolaryngologists, he found that teeth are the preferred path to conduct acoustic vibration, which is actually "disruptive innovation".

According to reports, human perception of sound mainly through air conduction and skull conduction. Teeth are the only bone exposed on the body surface. The maxillary teeth are closely inlaid with the skull without passing through soft tissues and joints. Therefore, the vibration energy of sound can be transmitted to the skull efficiently and losslessly, causing cochlear vibration and hearing.

Using this principle, Pinyin skillfully takes the tooth as a "natural and skull integrated" base instead of the titanium nail base implanted in surgery. It can conduct sound through the tooth bone, which can provide a safe and hidden solution for patients with unilateral hearing loss.

When wearing a dental bone conduction hearing aid, the sound does not need to pass through the skin and soft tissue. The clinical hearing effect can be equal to or even better than that of the implanted bone conduction product. It is non-invasive and does not need to be operated on. It is easy to wear, comfortable, invisible and beautiful, and does not affect the normal diet of the wearer.

Pu qiangling told the 21st century economic report that he and some of the company's sales and technical personnel have customized an in mouth machine to wear and show the process of taking and wearing. The whole process is only 2-3 seconds.

This experience is based on the cross-border grinding of the above dental and hearing experts.

It is understood that sonitus company was founded in Silicon Valley in 2006, and began to develop basic technology to assess sound conduction quality and comfort. During this period, sonitus overcame the difficulties of immature dental, chip, battery and material technologies, and finally launched its products in 2012. However, the high price of soundbite in the United States has hindered its further commercialization.

An entrepreneurial heart has already sprouted. Puqiangling sees that sonitus and its products have great market value, and wants to rebuild this product through China's supply chain and efficiency advantages. With the same quality and even better quality than that made in Silicon Valley, puqiangling can reduce the production and production costs, so that this high-tech product can benefit more patients and let them return to high-quality normal life.

Localization

Puqianling admitted that when purchasing the technology, they had carefully analyzed the prospects and market problems, as well as the advantages and disadvantages in China and the United States. For example, in the United States, the advantages are that the product itself has been approved by FDA / CE, there are complete clinical research, the top 10 medical innovation list in the United States (2010), 126 invention patents, and more than 3000 patients are commercially available; the disadvantages are that the products are not covered by medical insurance, and the cost of spare parts and manufacturing is too high, which hinders the entry into the self paid market.

The advantages of China are high cost-effective supply chain, talent advantages, strong team execution, and large number of patients, but there are also disadvantages, that is, the ability of original creation is weak.

Puqiangling does not only rely on purchased product technology and patents, but also insists on continuous R & D, innovation and development.

In order to solve the problem of continuous innovation, puqiangling "Wugu Maolu" invited scientists and experts from the listening industry as the scientific consultant of Shengtuo medical science, such as Dr. Gerald R. Popelka, MD / Professor, Department of Otolaryngology, Stanford University, former director of the hearing center, is one of the inventors of the world's first all digital hearing aids. His patent constitutes the basis of digital hearing aids now widely used. His research covers a wide range of fields, including Otolaryngology, neurology, neurosurgery and engineering.

Dr. Reza kassayan, M.D., has rich experience in cross-border product development, is good at integrating new technologies into practical applications, has presided over the design of many world-class original products, and is also a famous audiologist in China.

At the same time, China's potential market is huge. According to the relevant statistics of the United States, the total number of people suffering from hearing loss is 48.1 million. Among them, 3% are 21-34 years old, 6% are 35-44 years old, 11% are 44-54 years old, 25% are 55-64 years old, and 43% are 65-84 years old. The number of patients with unilateral deafness is about 9 million, with an increase of 60000 every year.

At present, there is no official statistics in China. However, according to the estimates of experts from Peking Union Medical College Hospital, Beijing Tongren Hospital, Shanghai otolaryngology hospital and Beijing hearing association, the number of patients with unilateral deafness and conductive hearing loss in China is estimated to be more than 28 million, while according to the U.S. data, it is more than 50 million.

"Our products have completed 0-1 in Silicon Valley, and dental and audiology experts have completed clinical verification after 10 years of technical feasibility exploration. We have inherited the existing technology platform, and it is important to further develop and commercialize 1-N by taking advantage of China's advantages. " For the Chinese market, puqianling is full of confidence, but they need to solve the problem of supply chain.

In fact, the development advantages of China's smart phone industry have also contributed to the supply chain of high-end electronic products. Under the huge advantages of China's supply chain, the cost of Shengtuo medical products has decreased significantly.

However, at that time, suppliers of Shengtuo medical were not easy to find, because the technology content was too high, and the general suppliers could not meet the technical requirements. "What we give our suppliers are powder materials, and we need them to synthesize them. Because it's in the mouth, safety, waterproof, biocompatibility and so on are very high." Pu qiangling pointed out.

It's not easy to find a suitable supplier in China. By chance, a project manager who is also a patient with unilateral deafness was met. The person in charge of Shengtuo Medical Co., Ltd. introduced Shengtuo's patented technology and products to him. Finally, the supplier was moved by the patent, products and feelings. The processing cost of high-end circuit board dropped to 1 / 10 of that of the United States.

"At first, I felt that the sharp decrease in cost could not guarantee the quality, but after a long-term strict test, it was found that the quality could fully meet the standard, and similar substitutes could be made." Pu said.

After a series of "foreshadowing", the third generation product soundbite / Pinyin dental bone conduction hearing system developed and produced by Shengtuo technology obtained the medical device registration certificate issued by the State Food and Drug Administration in March 2020, filling in the blank of domestic unilateral deafness market products. In addition, the product has also been approved by the U.S. FDA, which is the only dental bone conduction hearing system approved for marketing in the world.

In June 2020, the above-mentioned products were officially launched in China, comparable to the "gold standard" surgical implant effect, but the price was only one third of its.

It is understood that the products of Shengtuo Medical Co., Ltd. are also starting to be re listed in the United States, because the United States is a more mature hearing market.

Puqiangling gave an example to the 21st century economic report reporter that a Filipino American patient with bilateral conductive deafness purchased soundbite's second-generation product in 2012. Due to the lack of battery life for more than six years, he needed to replace a new generation of products. After many inquiries and many twists and turns, he finally contacted Shengtuo medical, and flew to Shanghai with his wife to Shengtuo medical We need to buy the latest third generation bone conduction hearing equipment of Shengtuo. The patient found that the third-generation product was better than the second-generation product, and he was also the first foreign patient in Zhangjiang, Shanghai, who came to seek Chinese medical devices from a foreign country.

In fact, unilateral deafness and conductive deafness seem not serious, but they affect all aspects of life: unable to distinguish the direction, suffer from tinnitus all the year round, can only use one ear to answer the phone, and can't distinguish the size of their own voice.

Other studies have shown that for patients with deafness and disability, especially those with unilateral deafness, it will cause brain remodeling for a long time. Compared with normal people, it is difficult to distinguish sound in communication, which is easy to lead to mental dispersion. Long term use will reduce their understanding ability and memory, depression and loneliness, which will affect physical and mental health.

"Hearing impairment will significantly affect the quality of life and social psychology. With the upgrading of medical consumption, the future hearing market may be like the development of Dentistry, and people will seek higher quality of life needs." Puqianling predicts that China's listening market will rise rapidly in the future.

The sales scale of China's hearing aid market increased from 1.465 billion yuan in 2010 to nearly 5 billion yuan in 2018. It is predicted that the domestic production of hearing aids will be nearly 30 million by 2022.

At present, the hospitals and institutions that Shengtuo medical has entered include the ophthalmology, otolaryngology Hospital of Fudan University, Xinhua Hospital Affiliated to Shanghai Jiaotong University, the Ninth People's Hospital Affiliated to Shanghai Jiaotong University, Beijing Anzhen Hospital, Beijing Friendship Hospital, Guangdong Provincial People's Hospital, the second people's Hospital Affiliated to Sun Yat Sen University, Beijing xiedan Hearing Center, Shanghai Tianlaizhiyin, Lichong hall, etc.

Pinyin has also been recognized by Chinese experts. Yang Jun, director of Otolaryngology, Xinhua Hospital Affiliated to Shanghai Jiaotong University, points out that pinyin is not only a patient with unilateral deafness, but also hearing loss caused by some conductive deafness, such as congenital atresia of external auditory canal, inflammation of middle ear, surgical trauma of middle ear, and even hearing loss caused by some tumors. "Mainly for these two indications, tooth bone conduction products are a better solution."

"Troublemaker"

In the face of the rapid rise of the Chinese market, puqiangling defines Shengtuo medical as a "troublemaker".

Pu qiangling told reporters of the 21st century economic report that the field of listening is actually a relatively closed industry, and its products are basically monopolized by multinational enterprises. It is understood that sonova of Switzerland, William demand of Denmark, sivantos of the United States, GN Resound of Denmark, Starkey technologies of the United States and Widex of Denmark account for more than 90% of the global hearing aid market. Their market share in China is higher, and the remaining 10% is shared by many small and medium-sized enterprises in different regions in China.

The mainstream hearing aids on the market are based on traditional air conduction. The six major international hearing equipment companies basically monopolize the global market and are very expensive. Sound Tuo medicine is a breakthrough in bone conduction.

According to the above data, there are a large number of people with unilateral deafness in China, but there is hardly any satisfactory solution on the market. It is understood that the current treatment methods on the market include traditional air conduction hearing aids and glasses, soft belt bone conduction hearing aids, surgical implantation of bone anchor hearing aids and so on.

However, there are some deficiencies in these treatments. For example, traditional air conduction hearing aids are required to be worn in both healthy and hearing impaired ears, and the sound quality is poor; for some non-surgical bone conduction products, the sound transmission is significantly attenuated after passing through the skin and soft tissue, which also affects the sound quality, and patients will have strong skin pressure and pain after wearing.

The implanted bone anchor hearing aid, which is regarded as the "gold standard", needs invasive surgery. The titanium nail base is implanted after the ear surgery. The patient's wound is easy to be infected and needs long-term care. Moreover, there is an obvious hearing aid device behind the ear, which affects the aesthetics.

At the same time, Shengtuo medical research found that 5% of all hearing loss patients had conductive hearing loss, and 20% of patients with conductive hearing loss could not improve their hearing through ear surgery.

Shengtuo medical has brought Pinyin third generation to the market, benefiting more patients with unilateral deafness and conductive hearing loss, and constantly promoting the research and development of new technologies.

By the end of 2020, Shengtuo medical has 126 invention patents and 2 utility model patents. On the basis of this, Shengtuo medical is also carrying out product iteration. "To be a" troublemaker "in the industry, we need to have a rich product pipeline." Pu qiangling pointed out to the reporter of the 21st century economic report.

It is understood that the R & D of soundbite G4 is progressing smoothly. The prototype will be completed in 2020 as scheduled. At present, the ultra-low power consumption driver circuit and dual microphone design of ear canal are being optimized finally. This project is of strategic significance. In addition to integrating the latest technologies and functions, more importantly, it ensures the continuity and security of its supply chain through the upgrading of core chips.

According to puqiangling, in addition to Pinyin, Shengtuo medical is also cooperating with a European hearing enterprise, which is aimed at children.

At present, the above-mentioned non-invasive bone conduction products for hearing-impaired children have been developed and registered in Shanghai food and Drug Administration in September 2020, and it is expected to be listed in 2021.

At the same time, according to the needs and suggestions put forward by patients in the use of Pinyin, the unique collar clip BTE was developed. The European registration of soundbite G3 is in progress, and CE certificate is expected to be obtained in the first quarter of 2021.

Puqiangling disclosed to the 21st century economic reporter that in its global layout, it will not rule out entering more listening market segments in the future and be a thorough spoiler.