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    Home > Medical News > Pharmaceutical Marketing > Strong demand needs to be met The blue ocean value of the OTC hearing aid market is highlighted

    Strong demand needs to be met The blue ocean value of the OTC hearing aid market is highlighted

    • Last Update: 2022-10-25
    • Source: Internet
    • Author: User
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    In August, the U.
    S.
    Food and Drug Administration (FDA) issued a new over-the-counter (OTC) hearing aid regulation, announcing the creation of a new category of OTC hearing aids, effective
    October 17 this year.
    With the release and implementation of the new regulation, many traditional prescription hearing aid manufacturers and consumer electronics manufacturers around the world are actively deploying the OTC hearing aid field
    .
    The development of this emerging market may drive down the price of hearing aids, benefiting a large number of people with hearing loss, especially those with mild to moderate hearing loss
    .
    At the same time, China's hearing aid companies and consumer electronics manufacturers are expected to usher in better development opportunities
    .
     
    The low penetration rate of hearing aids worldwide is the main reason for the high price
     
    Hearing is a major public health problem
    worldwide.
    According to the World Report on Hearing released by the World Health Organization (WHO) in March 2021, hearing loss currently affects more than 1.
    5 billion people worldwide, of whom 430 million have moderate or above hearing loss; Nearly 2.
    5 billion people are expected to suffer from some degree of hearing loss by 2050, and at least 700 million of them will require hearing rehabilitation services
    .
     
    Hearing aids are one of
    the effective aids to improve hearing loss.
    However, the current global penetration rate of hearing aids is low
    .
    According to the World Report on Hearing, only 17% of the world's population who can benefit from hearing aids actually use them
    .
    Among them, the penetration rate of hearing aids in the United Kingdom and France is more than 40%, the United States is about 27%, and China is only about
    5%.
    The global penetration rate of hearing aids is low mainly due to the following three reasons: hearing patients are still less aware of the need for hearing aids, that is, many patients are not aware of hearing loss, do not fully understand hearing aids or are unwilling to accept hearing interventions; Channels and services need to be improved, that is, many patients lack convenient channels to learn about hearing aid products and obtain corresponding services; Hearing aids are expensive, and many patients cannot afford them
    .
     
    Compared with other diseases, ear diseases such as hearing loss have not received enough attention in many countries and regions, and the corresponding professionals and services are relatively lacking, which makes patients unable to have sufficient understanding and attention to
    this type of disease.
    At the same time, because the main wearing group of hearing aids is the elderly, and people generally believe that hearing loss is a natural phenomenon, the importance of hearing loss and other diseases is not high, which also affects the popularity of
    hearing aids.
    In addition, for a long time, patients with ear diseases such as hearing loss have often been classified as disabled, and many patients are resistant to using hearing aids
    .
     
    Although the United States has a strong sense of user demand and more developed product channels, the penetration rate of hearing aids is also not ideal
    .
    At the end of the day, high cost is the main reason why
    it is impossible to expand the audience of hearing aids.
     
    In the United States, buying a traditional prescription hearing aid requires a prescription from a doctor (audiologist) and a prescription
    .
    This strict regulatory approach does help ensure that patients are safe and effective in the use of hearing aids, but it also means that the hearing aid market is somewhat closed
    .
     
    At present, a few companies such as Swiss Fongli, Denmark's Oticon, Denmark's Resound, the United States' Starkey and Denmark's WS Audiology occupy the vast majority of the global hearing aid market share, and the gross profit margin is at a high level, which largely leads to high hearing aid prices
    .
     
    The new regulations on OTC hearing aids to better meet the needs of people with mild to moderate hearing loss have reference significance for China
     
    In order to solve the above problems, the US FDA has established a new OTC hearing aid
    for people with mild to moderate hearing loss.
    Such products need to pass FDA medical device approval
    before they are marketed.
    However, when patients purchase OTC hearing aids, they do not need a doctor's prescription, do not need to go through a complicated and cumbersome fitting process, and can directly purchase
    through online or offline channels.
     
    At the same time, the hearing aid circulation channels that were originally controlled by a few hearing aid giants have also been liberalized to a certain extent, which has greatly increased
    the enthusiasm of new enterprises entering the field of hearing aids 。 For example, many consumer electronics brands have entered the hearing aid market: a hearing aid product owned by the well-known headphone brand Jabra was approved by the FDA in February this year; In September this year, consumer electronics giant Sony announced a cooperation with WS Audiology, a world-renowned hearing aid company in Denmark, to jointly develop OTC hearing aids and plan to promote them
    in the United States.
    It is foreseeable that the release and implementation of the new OTC hearing aid regulations in the United States will be conducive to promoting orderly competition in the industry and promoting the price reduction
    of hearing aid products.
     
    The new OTC hearing aid regulations of the US FDA have good reference significance
    for China.
     
    Basically consistent with the global hearing aid market, the above five global hearing aid companies such as Swiss Fengli also basically occupy a monopoly position in the Chinese market, which leads to the price of domestic hearing aids is also very high
    .
    Depending on the performance of the product, the price of hearing aids ranges
    from thousands of yuan to tens of thousands of yuan.
     
    At present, the domestic hearing aid purchase channels are mainly divided into online and offline, online refers to the purchase through the e-commerce platform, offline mainly refers to receiving fitting services in hearing aid testing stores or hospitals and purchasing related products
    .
    In recent years, the e-commerce sales model of medical device products in China has been continuously promoted, which has driven the sales
    of a large number of lower-priced entry-level hearing aid products.
    Although these entry-level products may not meet the treatment needs of patients, this is enough to show that there is a huge unmet need
    for hearing loss intervention in China.
     
    Some people in the medical hearing industry said that the new OTC regulations of the US FDA will not only help promote the technological innovation of hearing aid products, but also are expected to promote the establishment of a new channel service model to provide a new purchase channel
    for patients who are unwilling to go to the hospital or hearing aid fitting stores.
    For example, patients can take a hearing test through a smartphone, purchase hearing aids directly according to the test results, and adjust their hearing aids
    according to their hearing condition.
    For the domestic market, where professional audiologists are relatively scarce, the OTC hearing aid sales model may promote more hearing loss patients to accept hearing aids
    .
     
    Some industry insiders said that the new OTC hearing aid regulations of the US FDA have made everyone realize that the current traditional hearing aids do not meet the needs of people with mild to moderate hearing loss well, and the emerging market of OTC hearing aids is expected to be valued and developed
    .
    At the same time, the regulations are relatively strict, and the safety and efficacy of OTC hearing aids are well regulated, which has good reference significance
    for China to formulate hearing aid product requirements and regulate market order.
    For example, the regulation clearly states that OTC hearing aids are only available to people over the age of 18, ensuring that the risk of use by people under the age of 18 is kept low
    .
    In addition, the regulation reduces the safety risk
    of product use by limiting the maximum output sound pressure.
     
    The potential of emerging markets remains to be tapped
     
    Opportunities and challenges coexist
     
    In recent years, the scale of China's hearing aid market has grown rapidly
    .
    According to the report "2019-2025 China Hearing Aid Industry Development In-depth Survey and Future Trend Forecast" released by Industry Research Network, the scale of China's hearing aid market has increased from 2.
    84 billion yuan in 2015 to 5.
    51 billion yuan in 2019, with an average annual compound growth rate of about 18.
    02%; It is estimated that by 2025, the market size will reach 8.
    07 billion yuan
    .
    The advent of OTC hearing aids may further promote the rapid development of China's hearing aid industry, and this field is expected to become a new blue ocean market
    .
     
    For a long time, China's hearing aid market has been dominated by foreign giants
    .
    Due to the late start, local traditional hearing aid manufacturers generally do not have a large scale of enterprises, and their core technology research and development capabilities are not strong, and they have not made good breakthroughs
    .
    However, once the hearing aid track begins to involve the field of consumer electronics, the situation may be much
    more optimistic.
     
    In recent years, domestic brands have developed
    by leaps and bounds in the consumer audio market.
    For example, TWS (Real Wireless Stereo) headphones have developed rapidly since their inception, and domestic brands have played a fairly key role in this field: in terms of brands, Xiaomi, Huawei, OPPO, Wanmo and Rambler are all well-known brands in the field of TWS headphones; In the field of foundry, Goertek and Luxshare Precision are foundries of many internationally renowned electronic brands, including Apple; In the field of chips with high technical barriers, domestic manufacturers such as Hengxuan Technology, Juli and Jeli Technology are actively seizing market share
    .
    The intervention of domestic forces has caused the price of TWS headphones to drop sharply and stimulated a huge market demand
    .
     
    It is worth noting that the fierce market competition has prompted these consumer electronics brands to begin to look for opportunities to enter the medical and health field, and the advent of the new regulations for OTC hearing aids in the United States is undoubtedly a good development opportunity
    for the above brands.
    In fact, as early as 2018, the domestic audio brand Wanmagic launched auxiliary listening headphones
    .
    It should be noted that hearing aids are quite different from OTC hearing aids: first of all, OTC hearing aids belong to medical devices, while hearing aids belong to 3C headphone products; Secondly, the users of hearing aids are mainly for normal hearing people and people with mild hearing loss, while OTC hearing aids are mainly for people with mild to moderate hearing loss; Finally, due to different applicable people, the gain of the headphone amplifier of the two is also different, in general, the gain of the hearing aid headset is within 15dB, while the gain of the OTC hearing aid can reach about
    25dB.
     
    However, hearing aids and OTC hearing aids have technical similarities, both use segmented compression amplification adjustment algorithms
    .
    The algorithm is one of the core technologies that enables the realization of the hearing aid function, which can not only adjust the volume according to different frequency bands, but also amplify the subtle sound and suppress the louder sound according to the different loudness of the sound, so as to enable the hearing loss to hear the sound clearly and protect their hearing
    .
    Therefore, the technical difficulty of improving and transforming hearing aid products into OTC hearing aids is not very difficult, and developers should choose the appropriate production scheme at the beginning of product design to meet the relevant standards
    of OTC hearing aids.
     
    At present, there are many well-known consumer electronics brands in the world to lay out the field of hearing aids, consumers are more familiar with and trust these brands, can no longer rely too much on professionals, more convenient in product selection, conducive to earlier acceptance of hearing intervention
    .
    At the same time, the product iteration speed of consumer electronics brands is faster, which is conducive to rapidly reducing the price of high-performance hearing aids and making patients more
    acceptable.
    In addition, consumer electronics brands also have channel advantages, which is conducive to rapid market expansion
    .
     
    At the same time, some industry insiders said that the development of the OTC hearing aid market will bring great challenges to professional audiologists and dispensers, and how to let consumers get better hearing care services may be the key problem
    they need to solve in the future.
     
    However, it must be admitted that traditional hearing aid companies still have huge advantages
    .
    Traditional hearing aid R&D manufacturers not only have many years of clinical accumulation, but also have experience in the research and development of prescription hearing aids with more complex sound processing performance, and are more familiar with medical services
    in the field of hearing health.
    At the same time, although consumer audio brands have a good foundation for the design and development of consumer electronic products, due to the high threshold of the hearing aid and assistive listening products industry and the need for medical qualifications, consumer audio brands rashly enter the field with greater risk and need to have solid preliminary preparation
    .
     
    For traditional hearing aid companies, with the implementation of the new OTC hearing aid regulations of the US FDA, companies should take the initiative to embrace market changes and accelerate the layout of the OTC hearing aid field
    .
    In this way, traditional hearing aid companies can not only compete with consumer electronics manufacturers in this emerging market to gain a place, but also help consolidate their dominant position
    in the professional prescription hearing aid market.
    In addition, traditional hearing aid companies can also cooperate with consumer electronics brands to jointly develop OTC hearing aid products to achieve a win-win situation
    .
    (Author: Arterial Network)
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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