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Hearing aids and amplifiers. There are two key English terms that cannot be bypassed when introducing over-the-counter hearing aids: the first is OTC hearing aids (over-the-counter hearing aids), and the other is personal sound amplification products (PASAP).

Hearing Aids and Amplifiers

In August 2017, the Over-the-Counter Hearing Aid Act of 2017 (OTC Hearing Aid Act of 2017) went into effect after a 2-year effort by several U.S. research and administrative authorities. The law is short and simple, less than 800 words, but the content is very important to the hearing industry, such as the first time to make a clear legal definition of over-the-counter hearing aids, to determine that such hearing aids have the same core technology, including air conduction and wireless transmission, that the U.S.

Food and Drug Administration regulates as hearing aids within the scope of medical devices. It was determined that over-the-counter hearing aids can only be used for adults over the age of 18 with mild to moderate hearing loss, and not for children or adults with severe hearing loss. Once the bill was passed, it caused great repercussions worldwide. In essence, the U.S. legislated another category of health product that falls within the scope of public health care based on medical hearing aids, which undoubtedly added a new legal path for the public to receive hearing rehabilitation in the context of global hearing health development and repositioned amplification technology applications with special significance. Therefore, the author will introduce and discuss some of the core issues involved in over-the-counter hearing aids in this issue of the Little Dictionary.


OTC hearing aids and PSAP personal sound amplifiers

There are two key English terms that cannot be bypassed when introducing OTC hearing aids: the first is OTC hearing aids (over-the-counter hearing aids) and the other is personal sound amplification products (PASAP). According to the definition of the U.S.


Food and Drug Administration, OTC belongs to the management of the sale of pharmaceutical products, over-the-counter medicine is often mixed with non-prescription medicine (nonprescription medicine), the U.S. “Non-prescription Hearing Aid Act” has specific instructions: “Non-prescription The sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed professional (the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed professional). prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online). (or online). This legal definition clarifies two of the most controversial issues, one being how to sell hearing aids.

In addition to the conventional face-to-face physical sales method, the new law also allows hearing aids to be sold by mail or online, which solves the dilemma of recent years in the sale of hearing aids on the Internet, especially in the United States, where the largest insurance companies are recognized for their online sales model, which is considered to be the last door to regulate the sales channel for the hearing aid market was opened. Another is the definition of “over-the-counter”.

As mentioned earlier, the new law provides for the sale of OTC hearing aids without the involvement of any professional, so that consumers can make their own decisions and purchases. This eliminates the need for professional intervention, removes barriers to the distribution of hearing aids, and defines the full legal scope of OTC, directly addressing the problems currently faced in the hearing aid market.

Regarding personal sound amplification products (PSAP), in 2009, the U.S. Food and Drug Administration (FDA) clearly stated in the “Guidance for Industry and FDA Staff: Regulations for Hearing Aids and Personal Sound Amplification Devices” that although personal sound amplification devices can amplify sound, they cannot be used to compensate for hearing loss and can only be used to amplify sound signals in special acoustic environments, including noisy environments, hunting, recreation, etc.



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

To date, the majority of hearing and speech societies, hearing patients, consumers and industry organizations in the United States have been supportive and positive about OTC hearing aid legislation, generally believing that the law will advance the popularity of hearing aids and the development of the hearing industry in the following ways.


First, the introduction of over-the-counter hearing aids will impact the existing hearing aid market, with hearing aid prices dropping by at least 50% from the existing retail price of hearing aids. The largest insurance company in the U.S. sells hearing aids directly through the Internet, with each high-powered behind-the-ear hearing aid dropping from $2,000 to $800, or less than $1,500 for both ears, more than double the price of existing hearing aids. This will have a significant impact on the popularity of hearing aids, especially among patients with mild to moderate hearing loss.


Second, as the distribution channels for hearing aids expand, inexpensive over-the-counter hearing aids will enter the consumer market more quickly, including the fast-growing Internet, which will break the stalemate in hearing aid e-commerce. Mail-order sales are also a major channel in the U.S., where PSAP devices used to be sold, but now hearing aids are being sold as well. Finally, Internet hearing aid sales will lead to various types of patient self-participation services and hearing programs, including Internet hearing self-testing, Internet hearing aid self-fitting and adjustment, promotion of interactive hearing aids, and self-assessment of hearing aid effectiveness.


The over-the-counter hearing aid law establishes the legitimacy and feasibility of patient participation in hearing rehabilitation, and will undoubtedly be an important change for patients, greatly improving the accessibility of hearing testing and fitting. The impact of the birth of over-the-counter hearing aids on hearing services will gradually become apparent in the coming years, and the industry involved will expand rapidly.


We expect that the market penetration of hearing aids will be the first to respond, that the proportion of hearing-impaired people using hearing aids will increase rapidly, that the average age of hearing aid users will decrease, and that we will eventually expect a corresponding increase in hearing aid satisfaction.


Potential problems for over-the-counter hearing aids

The sale of over-the-counter hearing aids will have a major impact on the existing hearing aid sales model, especially on the service model of traditional hearing aid stores. Traditional hearing aid stores are very sensitive to product prices due to high fixed costs and limited promotion channels, and can easily lose customers or even market positions they have operated for years due to cheap internet sales.


Competing with internet sales and mail-in sales requires existing hearing aid boutiques to reposition themselves and develop new service offerings tailored to the needs of their target customers. Ensuring the quality of over-the-counter hearing aids can be foreseen as another challenge for the hearing industry. Low prices inevitably affect the spare parts of the product. Hearing aids as miniature electronic devices have high requirements for speakers, receivers and amplifiers.


In terms of device function and construction, there is little difference between medical hearing aids and over-the-counter hearing aids, and the labor cost of production is not much different. Choosing different components is the main means of cost savings, so quality control is especially important for over-the-counter hearing aids. For this reason, the Consumer Technology Association (CTA) proposed a testing standard for personal sound amplification devices (CTA ANSI/CTA-2051) in early 2017, which they are currently attempting to make the standard for over-the-counter hearing aids.


The standard has not yet been uniformly accepted by the industry due to its lack of definition of the main parameters of hearing aids. The American Hearing Aid Industry Association also wants to use the existing medical hearing aid standard for over-the-counter hearing aid testing.



In summary, although OTC hearing aids and PSAP personal sound amplifiers have many similarities, they are fundamentally different from each other in terms of usage classification, as the former is used for hearing impaired patients below moderate level and belongs to hearing aid instruments, while the latter is used for hearing people and belongs to assistive listening devices.


Although OTC hearing aids are sold without a prescription, their main parameters and scope of use must comply with relevant laws and regulations, while PSAPs are not specifically regulated. The legislation of OTC hearing aids in the US creates a new category of existing hearing aids and provides a new area of hearing services



Hearing Aids Elite’s mission is to provide people with low-cost hearing aids that can help those who struggle with hearing loss enjoy a better quality of life. We not only make some of the world’s highest quality hearing aids but through innovation and uncompromising manufacturing standards, we provide those hearing aids at an accessible, affordable price for all, regardless of economic status.


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