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If you’ve been shopping around for a hearing aid, you might have noticed the claim ‘FDA-registered’ attested by some brands.

This article explains why it’s necessary for hearing aids to be FDA-approved and what devices count as an FDA hearing aid.

FDA Hearing Aids and Accessibility

Accessible hearing aids are important now more than ever. 

Hearing loss is an extremely prevalent health condition in the United States (and worldwide) and should be treated as a public health priority.

More and more Americans are diagnosed with hearing loss every day, yet it remains a fact that only one in four adults that could benefit from hearing aids ever use them. 

This has led hearing healthcare professionals and policymakers to brainstorm effective ways to improve access to hearing loss treatment for all U.S. citizens.

There are multiple regulations in place that research has proven to act as a barrier for those attempting to get help for their hearing loss. Making it easier for everyone to find and access this support by changing these regulations would be an important first step. The biggest hurdles for most people include the high price of hearing aids and the fact that you can’t purchase them Over-the-Counter (OTC), so these seem like obvious targets for improvement.  

Attempts to allow OTC hearing aids are already underway. According to the NIDCD, the FDA Reauthorization Act of 2017 has directed the FDA to create a category of OTC hearing aids for adults who might have mild-to-moderate hearing loss. This requires the FDA to put forward a proposed rule by August 18, 2020, and a final rule after the close of the comment period.

If the FDA created guidelines and quality standards for OTC hearing aids, this would allow hearing aids to be sold cheaply and conveniently. While the cost of prescription aids can cost $5000 or more for a set, new OTC options would hopefully range from $600 to $1000 per set.

This change in accessibility will mean that many more people will be able to treat their hearing loss with a hearing aid. However, steps must be taken to ensure patients continue to receive high-quality treatment.

What Does it Mean if a Hearing Aid is FDA Registered?

The Food and Drug Administration (FDA) is the government agency in the United States responsible for protecting public health. 

They regulate several consumer products, including food, medications, vaccines, all medical devices, and most relevantly in this instance, hearing aids.

The FDA must ensure the safety, efficacy, and security of these products and weigh up their risks. 

In the United States, all hearing aid manufacturers must register their devices with the FDA to be able to sell them in the country. 

What are the FDA Regulations for Hearing Aids?

Hearing aids are restricted devices and sales must follow applicable federal and state requirements. 

FDA hearing regulations define a hearing aid as “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” This includes air conduction and bone conduction devices in their numerous styles.

The FDA regulates hearing aids as they are medical devices. However, it does not consider sound amplifiers to be medical devices when labeled for recreational or other use by individuals with normal hearing. Some safety regulations related to sound output levels still apply to these products.

Whilst Over-the-Counter (OTC) hearing aids are a new category of hearing aids that you will soon be able to buy directly (without visiting a hearing health professional), the OTC hearing aid category, as defined by FDARA section 709 does not exist until the effective date of a published final regulation. 

Until then, no devices that are claimed to address hearing loss are, or can state that they are OTC hearing aids.

There will still be regulations (that are now being established by the FDA) that OTC hearing aids will need to follow. These federal regulations will ensure that these accessible hearing aids are still safe and effective for people with mild-to-moderate hearing loss. They’ll also set standards for clear and informative OTC hearing aid packaging such as making a requirement to include health warnings and advice on when to see a healthcare professional.

What are PSAPs?

What all of this means for you as a consumer, right now, is that the current hearing devices you can buy directly without the advice of a healthcare professional are not intended for people with hearing loss. These hearing devices are not ‘hearing aids,’ but rather, Personal Sound Amplification Products (PSAPs) intended to boost environmental sounds in some situations for people without hearing loss.

While PSAPs are not regulated as medical devices by the FDA, they will regulate the forthcoming OTC hearing aids as medical devices intended for people with mild-to-moderate hearing loss.

They will operate like standard hearing aids, making sounds louder so that people who are hard of hearing will have an easier time hearing and communicating. However, you will fit them yourself and have some adjustment controls that many professionally fitted hearing aids lack.

When available, you’ll be able to buy these FDA-regulated OTC hearing aids directly in stores and online.

Are PSAPs Approved by the FDA?

According to the FDA, PSAPs are not intended to treat impaired hearing. Their purpose is to allow non-hearing-impaired individuals to amplify sounds in the environment for other reasons, such as greater enjoyment in recreational activities (including bird watching, hunting, and watching live performances or speeches).

More than anything, the FDA wants to ensure that PSAPs aren't mistaken or used as substitutes for approved hearing aids recommended by hearing health professionals.

They advise that PSAPs only be used after ruling out hearing loss as a reason for getting one, which requires getting a hearing test by a healthcare professional. The biggest reason for this being that they can lead to more damage to your hearing if there is a delayed diagnosis of a treatable condition.

As PSAPs are not medical devices, there is no regulatory classification, product code or definition for these products, or requirements for listing these products with the FDA.

Manufacturers of PSAPs must comply with the requirements to repurchase, repair, or replace products and must also report defects or adverse effects.

Can You Buy FDA Approved Hearing Aids Over the Counter? 

There are currently no products that can claim to address hearing loss as OTC hearing aids. The FDA has clarified that hearing aids continue to be restricted devices. 

The terms used for hearing aids is confusing at the moment, but the FDA should lay out some clearer OTC guidelines and requirements no later than spring 2021.

Despite all these changes surrounding OTC hearing aids, it’s important to remember that even when these new rules go through, getting your hands on a hearing device is only one part of the process of treating hearing loss. We would always recommend seeing an audiologist for a comprehensive hearing test and to get their expert guidance.

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The information in this guide has been written using the following reliable sources:

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