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Navigating the Changing Landscape: The 2017 OTC Act and the Hearing Aid Industry

The signing of the 2017 Over-The-Counter (OTC) Act has ignited discussions within the hearing aid industry. The act holds the potential to reshape the industry by allowing the direct sale of medical-grade hearing aids to consumers. During the “2019 New Audiovisual Hearing Industry Summit,” JINGHAO examined the implications of the OTC Act and how it will impact the hearing aid market. In this article, we delve into the interpretation of the act, the biggest obstacles facing OTC hearing aid sales, and the anticipated timeline for its implementation.

Decoding the 2017 OTC Act

The 2017 OTC Act holds significance as it paves the way for the direct sale of medical-grade hearing aids to end-users. The act requires the FDA to establish a new product classification and set standards for OTC hearing aids. This development aims to increase accessibility and affordability for consumers, while also encouraging the emergence of new products and services within the industry.

Overcoming Obstacles in Hearing Aid Sales

Despite the prevalence of hearing loss, the penetration rate of traditional hearing aids remains low. The high average retail price, often reaching $2,400, has led consumers to seek alternative solutions such as Personal Sound Amplification Products (PSAPs). By making hearing aids more accessible and affordable through the OTC model, barriers to adoption can be reduced, enabling more individuals to benefit from appropriate hearing amplification.

Timeline for Implementation

Since the signing of the OTC Act in August 2017, the FDA has been working diligently to complete the necessary tasks for the effectiveness of OTC hearing aids. It is anticipated that all relevant work will be finalized by 2020. While the hearing aid industry initially responded with skepticism, the passage of the bill highlights the need for innovative solutions and increased accessibility. The OTC model offers consumers a wider range of options, promoting competition and ultimately driving advancements in hearing aid technology.


As the hearing aid industry prepares for the implementation of the 2017 OTC Act, JINGHAO remains committed to providing cutting-edge hearing solutions that align with the evolving needs of consumers. We recognize the significance of this legislation and the transformative potential it holds. JINGHAO will continue to innovate and develop OTC in-ear hearing aids that combine superior quality, affordability, and accessibility. Embrace the changing landscape of the hearing aid industry with JINGHAO, as we strive to empower individuals with improved hearing experiences and a renewed connection to the world of sound.

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