The differences Between OTC Hearing aids and PSAP: Introducion and Explanation

In August 2017, after two years of hard work by several scientific research and administrative authorities in the United States, the “Over-the-Counter Hearing Aid Act of 2017” … officially entered into force. The legal term is short and less than 800 words.
However, the content involved is very important for the hearing industry. For example, for the first time, over-the-counter hearing aids have a clear legal definition. It is determined that these hearing aids have the same core technologies as the hearing aids under the supervision of the US Food and Drug Administration, including air conduction and wireless. propagation.
Make sure that over-the-counter hearing aids can only be used for adults over 18 years of age with mild to moderate hearing loss, not for children or adults with severe hearing loss … Once passed, the bill has aroused great repercussions around the world, especially in China. From academia to the public, from government agencies to industry executives
Fang hearing aids came out with various views and knowledge. In essence, based on medical hearing aids, the United States has legislated to develop another type of health product that belongs to the public health area. Against the background of the global development of healthy hearing, it has undoubtedly added a new legal path for the public to receive hearing rehabilitation. The application of repositioning magnification technology has special significance. Therefore, the author will introduce and discuss some of the core issues involved in over-the-counter hearing aids in this small dictionary.

1. 0TC hearing aid and PSAP personal sound amplifier

There are two key English terms for over-the-counter hearing aids that cannot be bypassed: the first is over-the-counter hearing aids, and the other is personal sound amplification products (PASAP). According to the US Food and Drug Administration’s definition, OTC is a medical product
The scope of sales management. Over-the-counter medicine is often mixed with nonprescription medicine. The US “Over-the-Counter Hearing Aid Act” specifies this: “Over-the-counter hearing aids can be sold directly by mail or online without supervision, prescription or The sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement. Or intervention of a licensed person, to consumers through in-person transactions, by mail, or online). This legal definition clarifies two of the most controversial issues, one is how to sell hearing aids. In addition to the conventional face-to-face physical sales method, hearing aids can also be delivered by mail or online Sales, which solves the dilemma of online hearing aid sales in recent years, especially the recognition of the online sales model of the largest insurance company in the United States, which is considered to be the last door to regulate the sales channel for the hearing aid market. Another Is for over-the-counter Definition. As mentioned earlier, the new law stipulates that OTC hearing aid sales do not require the involvement of any professionals, and consumers can decide and purchase on their own. Eliminating professional intervention, removing barriers affecting the sales channels of hearing aids, and completely defining the legal scope of OTC It directly solves the problems faced by the current hearing aid market.

Regarding personal sound amplification products (PSAP), in 2009, the US Food and Drug Administration stated in the “Industry and Food and Drug Administration Staff Guide: Regulations for the Management of Hearing Aids and Personal Sound Amplifying Devices” that personal sound amplification devices can Amplify sound, but it cannot be used to compensate for hearing loss. It can only be used to amplify sound signals in special acoustic environments, including noise environments, hunting, entertainment, etc.
In the early days, the industry often used these two words together. At that time, OTC hearing aids had not been determined by law. For hearing aids, the emphasis was on the need for no fitting. According to the new law, after 2017, these two terms cannot be mixed. With the introduction of OTC hearing aids, there are more restrictions on the scope of application of PSAP devices. From the perspective of the market, it is not necessary to circumvent the sale of online hearing aids, and it is not necessary to use PSAP for patients with mild hearing impairment to reduce prices and form direct competition with hearing aids. The author believes that this restriction is beneficial to the application of PSAP, which can effectively help normal hearing people to communicate better in different listening environments.

2. The impact of over-the-counter hearing aids on the hearing service industry

At first, the American Hearing and Speech Professional Association and the Industry Association had different opinions on the over-the-counter hearing aid bill. With the passage of the bill, most professional associations have adopted an attitude of participation and support. For example, the American Academy of Audiology proposed that in the new scene, the Society insisted on Position opinions, elaborated five positions I3l from professional opinions to patient protection, including encouraging universal hearing services, improving their accessibility, supporting self-audit testing and evaluation under the guidance of professionals, and encouraging patients to actively participate in hearing rehabilitation management, Support the reduction of various costs involved in the use of hearing aids, and strengthen hearing education.
According to the American Academy of Audiology, the impact of over-the-counter hearing aids on hearing services is multifaceted. The first major issue is the labeling of over-the-counter hearing aids and how they differ from conventional hearing aids. Due to the narrow range of use of over-the-counter hearing aids and restrictions on the people who use them, they believe that it is necessary to clearly mark the acoustic performance of over-the-counter hearing aids, the scope and nature of hearing loss, and the people who use them to avoid misunderstandings.
At the same time, the American Hearing, Speech and Language Association (ASHA), another well-known national and influential academic organization in the United States, has publicly opposed the establishment of the 2017 OTC Hearing Aid Act. The government excludes organizations outside of industry consulting agencies and cannot participate in subsequent discussions and opinions on over-the-counter hearing aid bills. After the passage of the bill, the American Academy of Hearing and Speech Language publicly issued a position statement of “Uncovering the Mystery of Over-the-Counter Hearing Aids” I4), and strongly expressed the views of the organization on three issues: One is that the American Hearing and Speech Society does not Support the over-the-counter hearing aid bill, and in particular do not support the bill to extend the scope of hearing loss from mild to moderate; the second is that the American Hearing Language Institute does not support the opening of the bill to hearing aid sales, insisting that hearing loss is a medical health problem, The use of hearing aids must involve the participation of professionals; the third is that even if the bill is passed, the role of the audiologist in the entire process cannot be ignored and removed. The position of the American Society of Hearing, Speech and Language represents the opinions of a part of academia and industry, especially about the role and participation of audiologists. These previously mentioned issues touch on the key points of the industry involved in current over-the-counter hearing aids. We believe that these debates will continue after the over-the-counter hearing aid practice has obtained a large amount of data and phased results.
So far, most of the American Hearing and Speech Society, hearing patients, consumers, and industry organizations have supported and actively adopted over-the-counter hearing aid legislation. It is generally believed that the law will promote the promotion of hearing aids and the development of the hearing industry in the following areas.

First of all, the introduction of over-the-counter hearing aids will impact the existing hearing aid market, and the price of hearing aids will be at least 50% lower than the existing retail price of hearing aids. The largest insurance company in the United States directly sells hearing aids through the Internet. Each high-power BTE hearing aid has dropped from US $ 2,000 to US $ 800, and both ears have less than US $ 1,500.
It is twice as cheap as existing hearing aids. This has a significant impact on the popularity of hearing aids, especially in patients with mild to moderate hearing loss.
Secondly, with the expansion of hearing aid sales channels, cheap over-the-counter hearing aids will enter the consumer market more quickly, including the rapid development of online sales, which will break the deadlock in which hearing aid e-commerce is located. In the United States, mail order is also a major channel. In the past, PSAP devices were mainly sold, and now hearing aids are also being sold.
Finally, online hearing aid sales will drive various types of patients’ self-participating services and hearing projects, including online hearing self-tests, Internet hearing aid self-assessment and commissioning. Promotion of interactive hearing aids, self-assessment of hearing aid effects, etc. The over-the-counter hearing aid method determines the legitimacy and feasibility of patients participating in hearing rehabilitation. No doubt for patients, this will be an important change, which will greatly improve the accessibility of hearing testing and fitting.
The impact of over-the-counter hearing aids on hearing services will gradually emerge in the next few years, and the industry involved will also expand rapidly. We expect that the market penetration rate of hearing aids will be reflected in the first time. The proportion of hearing-impaired people using hearing aids will increase rapidly. The average age of hearing-aid users will also decline. Eventually, we expect that the satisfaction of hearing aids will also increase .

3. Potential problems with over-the-counter hearing aids

As mentioned earlier, although over-the-counter hearing aids can have a positive impact on hearing services, we must see their potential problems. As the American Academy of Hearing Speech Language emphasizes, the sale of hearing aids that do not require the involvement of an audiologist is not the same as the need for audiologist services. Hearing loss and the use of hearing aids are a very complex “engineering” rather than a simple product sale. The characteristics of hearing loss determine that the hearing loss needs and debugging of people with the same hearing loss will be completely different. Such different hearing requirements under the same conditions determine the complexity and difficulty of hearing aid use. When the hearing is not clear, patients who lack knowledge of audiology cannot decide which parameters need to be adjusted to achieve the desired effect, and disorderly changes in hearing aid parameters often lead to problems such as reduced sound quality, changed clarity, and increased discomfort, which affects Hearing aid effect. In the face of many over-the-counter hearing aid brands, due to the lack of assistance from an audiologist, it is difficult for hearing loss patients to objectively choose a suitable hearing aid. As with buying other consumer products, the price alone may ultimately lead to the selection of an inappropriate hearing aid .
How to combine audiologist services with the sale of over-the-counter hearing aids will be a major challenge for the hearing industry. This, in turn, is an opportunity for the development of the hearing industry. The author believes that audiologists can play an important role in pre-sales consultation and after-sales service. Separating the sales price of hearing aids from the price of services may encourage patients to seek valuable consulting services, including hearing aid debugging, use problem solving, and replacement of hearing aids, etc. These services will bring new value-added space for audiologists and further Determine the essential role of audiologists in the entire industry chain.
The sale of over-the-counter hearing aids will have a greater impact on the existing sales model of hearing aids, especially the service model of traditional hearing aid stores. Due to the high fixed cost and limited promotion channels, traditional hearing aid stores are very sensitive to product prices, and it is easy to lose customers due to cheap online sales, and even to maintain market position for many years. Competing with online sales and mail sales requires the existing hearing aid stores to be repositioned and new service content tailored to the needs of target customers.
It is foreseeable that ensuring the quality of over-the-counter hearing aids is another challenge for the hearing industry. The low price is bound to affect the spare parts of the product. As a miniature electronic device, hearing aids have higher requirements for speakers, receivers and amplifiers. From the perspective of the function and structure of the device, there is not much difference between medical hearing aids and over-the-counter hearing aids, and the labor costs for production are not much different. Choosing different components is the main means of cost savings, so the quality of over-the-counter hearing aids Control is especially important. To this end, the Consumer Technology Association of the United States in early 2017 proposed a test standard for personal sound amplification devices (CTA ANSI factory CTA-2051), 5), they are currently trying to make it a non-prescription hearing aid standard. Due to the lack of definition of the main parameters of hearing aids, the standard has not been uniformly recognized by the industry. The American Hearing Aid Industry Association also hopes to use existing medical hearing aid standards for the testing of over-the-counter hearing aids. It is conceivable that it is difficult to reach consensus on technical standards for OTC hearing aids in the short term, so the quality problems of OTC hearing aids will persist for a long time.

4 .Conclusion

In summary, although there are many similarities between OTC hearing aids and PSAP personal sound amplifiers, from the perspective of use classification, the former is used for hearing-impaired patients with moderate to substandard hearing aids, and the latter is used for hearing-impaired people. Listening equipment, there is a fundamental difference between the two. From a regulatory perspective, the two are also different. Although OTC hearing aids do not require prescription sales, their main parameters and scope of use must comply with relevant laws and regulations, while PSAP has no specific regulations. OTC hearing aid legislation in the United States has created a new category for existing hearing aids, and also provided a new field of hearing services, which will also have an impact on China’s hearing practice. China’s Food and Drug Administration’s supervision of hearing aids is similar to that of the United States. Hearing aids are Class II medical devices. In recent years, the supervision has been increasing. Especially, the production control of hearing aids has become more stringent, and the quality of hearing aids has been improved. Whether it is necessary for China to also set up non-prescription hearing aids must be cautious, because China’s national conditions are different from the United States, we are still establishing and improving a hearing aid fitting personnel system and fitting mechanism with basic skills. Prior to this, any practice of selling hearing aids will be released. Will fundamentally impact the existing system, the consequences of which are incalculable.

Author: Jiang Tao
Chinese Scientific Jornal of Hearing and Speech Rehabilitation

Link:Difference between OTC hearing aids and PSAP personal amplifiers

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