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FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans

Charles M. Carlsen

Published April 23, 2024
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Did you know that an estimated 37.9 million Americans have some form of bilateral hearing loss? That makes up about 11.6% of the population. And while 24.9 million of these have mild hearing loss, another 13.0 million have a moderate or worse hearing loss situation.(1)
These numbers stress the fact that hearing loss is a worrying public health concern in the country. If left unaddressed, it will continue to affect the quality of life of a significant number of Americans, even in their day-to-day social interactions.
Additionally, there are indications that hearing loss is undertreated, and one of the reasons for this is the high cost of hearing aids.
Fortunately, a recent FDA rule on access to over-the-counter (OTC) hearing aids has sparked a ray of hope for people with perceived hearing loss.
So, what’s this rule about? Keep reading to find out.

The New OTC Hearing Aids Regulatory Category

The road to affordable OTC hearing aids for Americans can be traced back to the 2017 Congress bipartisan legislation that directed the FDA to establish a new regulation of OTC hearing aids.
It seemed that this road had reached a dead end.
However, in July 2021, a presidential executive order on Promoting Competition in the American Economy directed the FDA to facilitate the easy availability of affordable hearing aids. The agency had to do this within 120 days from the order date.
In compliance, on August 16, 2022, the FDA established a new regulatory category. The rule was geared at enhancing access to hearing aids by adults 18 years and above with mild or moderate hearing loss. The regulation became effective on October 17, 2022.
To finalize the regulation, the FDA reviewed over 1,000 views to complement its perspective on the proposed regulation. The views came from several categories of people with an interest in the OTC hearing aids, including:
  • The general public (prospective consumers).
  • Hearing aids manufacturers.
  • Professional groups and associations.
  • Members of Congress and state agencies.
  • Public health advocacy groups and organizations.
  • Other interested stakeholders.
The input from these groups served to incorporate changes to the proposed regulation on aspects related to:
  • Reduced maximum sound output of the OTC hearing aids to prevent risks from overamplified sounds.
  • Adapted insertion depth in the ear canal.
  • Inbuilt user-adjustable volume control.
  • Simple and easy-to-understand language on device labeling.
In addition to these specifications, the final regulation gives guidelines on design requirements and performance specs to be followed by manufacturers.

What the New OTC Hearing Aids Regulatory Category Means for Americans

With this regulation, it is now possible for Americans with hearing loss to access OTC hearing aids from a store near them or from online marketplaces. From here on out, Americans with perceived hearing loss won’t need a doctor’s examination or prescription or an audiologist fitting adjustment to access hearing aids.
And there’s better news!
People with hearing loss will now access OTC hearing aids at competitive prices, a move that promotes the Biden-Harris Administration's goal to make high-quality healthcare accessible to every American and at lower costs.
The regulation also comes as a way of controlling the safety and effectiveness of hearing aids sold over the counter. It also encourages competitive innovation in hearing aid technology among manufacturers.
Besides, the regulation will make hearing aids more affordable and readily accessible to the 37.9 million Americans with bilateral hearing loss and those with hearing loss in one ear.
With enhanced hearing, Americans with hearing loss can amplify speech and sounds and promote effective communication in their daily interactions with others. They will also reap other benefits of using hearing aids like increased independence and lower risks of falling.(2)

Additional Info on the OTC Hearing Aids Regulatory Category

The New Rule is the Current Regulation on OTC Hearing Aids
The new OTC hearing aids regulatory category cancels previous rules on the prescription and sale of hearing aids.
To comply with the new regulation, manufacturers of hearing aids previously sold to consumers must comply with the new requirements. Those with manufactured hearing aids not yet in the market must comply with the new regulation before marketing them. That could also mean getting 510 (k) clearance.
The New Rule Applies for People with Mild to Moderate Hearing Loss
The new OTC hearing aids regulation applies to air-conduction hearing aids meant for adults 18 years and above with perceived mild to moderate hearing loss.
Those with severe hearing loss and children below 18 years do not meet the requirements for the new regulation and must use prescription hearing aids.
OTC Hearing Aids are not Personal Sound Amplification Products
Alongside the new OTC hearing regulation, the FDA also released guidance on Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). This move clarifies the difference between the two:
Hearing aids are medical devices used by people with impaired hearing, while PSAPs are devices used by people with normal hearing abilities to amplify sound to their preferences in different situations.(3)
As such, PSAPs are not a replacement for hearing aids. Besides, their sale is regulated in the same way as other electronics, and not as medical devices.

Final Thoughts

The majority of the over 37 million Americans with hearing impairment have mild to moderate hearing loss. That means they may not need the examination and prescription of a doctor to access hearing aids.
With the FDA OTC hearing aids regulatory category coming into effect in October 2022, Americans with mild and moderate hearing loss can now access OTC hearing aids at affordable prices.
The benefits of this are innumerable. The topmost benefit is the possibility of people with hearing impairment to hear sounds and speech clearly, promoting better communication in daily interactions with others.
Article by
Charles M. Carlsen
Hello! I'm Charles, As co-founder of Drsono, I contribute to the DRSONO blog, providing valuable insights and up-to-date information on ultrasound technology and diagnostic imaging.

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