Hearing Aid Market Conditions in the US Before the OTC Hearing Aids Rule

Are you having trouble hearing in your daily life? Actually, there are many people are suffering from hearing loss in the world beyond your expectation. According to the study--Hearing Loss in the U.S., the number of people with hearing loss in the worldwide is rising year and year. Millions of Americans suffer from hearing loss, which is a serious and widespread health problem. Approximately 15% of American adults (37.5 million) age 18 and over report some trouble hearing. However, despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid use one.  

High Cost

The expensive cost of the hearing devices was one of the main obstacles to using hearing aids. In 2018, the average cost of a pair of prescription hearing aids costs in the US was over $4,700, making them unaffordable for many people, particularly those are in low incomes or no insurance. What’s more, consumers had to pay out of pocket for their hearing needs under the majority of insurance plans, including Medicare, because they did not cover hearing aids or related services. The high cost of hearing aids also discouraged some consumers from replacing or upgrading their devices when their hearing loss get worse.

Limited Access

Another obstacle of hearing aid usage was the limited access to the hearing devices and healthcare service. Before the OTC hearing aids rule, consumers have to visit clinic in-person to examine their hearing loss between different audio frequency and obtain prescriptions from licensed audiologists They also had to see a hearing health specialist for a fitting and programming of the device. All these parts increase the labour service mark up on the expensive hearing device, which make it even more unacceptable for vulnerable groups. It also results in a shortage of qualified providers and limited the availability and variety of products in the market.

Monopoly and Transparency

The structure of the hearing aid market also posed challenges for consumers and innovation. The market was dominated by five major manufacturers that controlled about 90% of the global market share with consolidated gross margin are up and down in the 55-75% range, which profits are quite inflated. They market their products through interest groups of audiologists, lobbyists, and retailers that added markups to the prices. This market was also highly regulated by the FDA, which imposed strict standards and requirements for safety, effectiveness, labeling, and user instructions. These factors created high entry barriers, which increase monopoly of the market.

In addition, there are some manufacturers of low visibility and less expensive hearing aids that took up a small portion of the market share. However, most of them were unable to obtain FDA-approved, which meant that they were unlicensed by the FDA as medical devices and fail to meet the cumbersome clinical trial requirements, all these making it difficult to defend customer rights.

As we mentioned above, obstacles like high cost and lack of time to see a hearing professional can make it challenging for people to get the help and hearing device they need. Because hearing amplifiers can be more convenient and inexpensive to purchase, many people with hearing loss opt for these instead.  Hearing amplifier is also known as a personal sound amplifier or a PSAP, these hearing devices are regulated by consumer good and require no prescription and audiologist involved. What’s more, the white label hearing amplifier are varies in different price and they may even make your hearing worse.

Based on the table from the Healthline website, we will explain why hearing amplifiers are not recommended for people with hearing loss. Hearing amplifiers are not meant to treat hearing loss. PSAPs amplify all sound, while hearing aids amplify specific frequencies. PSAPs only make every sound louder, without distinguishing between background noise and specific sounds. This can interfere with hearing speech and other important sounds, and can also harm the ear by exposing it to loud noises. What’s more, hearing amplifiers are not regulated by the FDA as medical devices, which may pose potential risks such as ear infections, or worsening of hearing loss if used improperly or excessively. Additionally, hearing amplifiers are not customized or fitted to the individual’s ear shape, size, or hearing profile. They may not provide adequate or appropriate amplification for people with severe or profound hearing loss. They may also cause squealing feedback if they do not fit well in your ears.

So is there any possible that we can achieve a dynamic balance between the over-regulated prescription hearing aids and the laissez-faire PSAP? That is the reason why people keep argue for a brand new regulated category: over the counter hearing aids.

 “Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.” Released by official website of the United States government-- FDA NEWS.

Are you interested in how the OTC rule influence the whole industry? We will review more critical story about the new regulations on the next blog, see you next time!


1.FDA OTC hearing aid rule impact on states (2022) American Speech-Language-Hearing Association. Available at: https://www.asha.org/news/2022/fda-otc-hearing-aid-rule-impact-on-states/ (Accessed: 09 September 2023).

2.Ellerby, D., Kovac, S. and Groux, C. (2022) Over-the-counter hearing aids are available now-what to know before buying, according to reviewed experts, USA Today. Available at: https://www.usatoday.com/story/money/reviewed/2022/08/18/fda-over-counter-hearing-aids-what-laws-mean-where-buy/10356745002/ (Accessed: 09 September 2023).

3.Over-the-counter hearing aids (2022) National Institute of Deafness and Other Communication Disorders. Available at: https://www.nidcd.nih.gov/health/over-counter-hearing-aids (Accessed: 09 September 2023).

4.Kesser, B. (2022) What consumers should know about the limits and risks of over-the-counter hearing aids, PBS. Available at: https://www.pbs.org/newshour/health/what-consumers-should-know-about-the-limits-and-risks-of-over-the-counter-hearing-aids (Accessed: 09 September 2023).

5.FDA issues landmark proposal to improve access to hearing aid technology for millions of Americans (2021) U.S. Food and Drug Administration. Available at: https://www.fda.gov/news-events/press-announcements/fda-issues-landmark-proposal-improve-access-hearing-aid-technology-millions-americans (Accessed: 09 September 2023).

 6.What’s the difference between hearing amplifiers and hearing aids?(2022a) Healthline. Available at: https://www.healthline.com/health/hearing-amplifiers-vs-hearing-aids (Accessed: 11 September 2023).

 7.Team, H. (2022) What you should know about hearing amplifiers and hearing aids, Hearing Planet. Available at: https://www.hearingplanet.com/blog/post/hearing-amplifiers-hearing-aids-what-you-should-know (Accessed: 11 September 2023).