Biden’s New Executive Orders Regarding Hearing Aids

07/23/2021 | Hearing Aids, Industry News, Patient Resources

In a recent executive order, Biden stated that “hearing aids are so expensive ($5,000+/pair) that only 14% of approximately 48 million Americans with hearing loss use them.”  This statement is somewhat inaccurate, as the prevalence of hearing loss in the United States is approximately 14%, not all hearing losses are best managed by hearing aids alone.

Of those that would benefit from hearing aids, 34.1% opted to pursue hearing aids. This compared to countries that cover the cost of hearing aids at 100% through their socialized healthcare programs which have a 41% hearing aid adoption rate.

Due to this, Biden will direct the Department of Health and Human Services (HHS) “to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.”

What Is An Over-The-Counter Hearing Device?

Currently, there is no definition for an over-the-counter hearing aid. This means that anything that is currently sold over the counter marketed toward improving hearing is personal amplifier.

They do not follow any sort of regulatory oversight regarding what it does, how much it amplifies, how it is designed, or any other safety features.

The FDA has not released its definition of an over-the-counter hearing aid, so there is no such thing yet.

The general plan from the feds is to create a category of hearing aid that can be marketed and sold as a lower-level medical device over the counter, possibly through pharmacies or approved retailers.

However, that is speculation at this point, as there is no defined parameter of what makes up an over-the-counter hearing aid.

Here’s The Difference Between An OTC And A Professionally Prescribed Hearing Aid

An FDA medical device, such as a hearing aid, can only be fit by a licensed hearing healthcare professional such as a physician, an audiologist, or a licensed hearing aid dispenser.

Anything purchased online, through a magazine, or off a shelf in a consumer electronics department or pharmacy is NOT a hearing aid. As such, it’s not held to any standard or regulation regarding its settings, amplification, or compression.

There is a product that Bose is selling direct to consumers. They have been working on it with members of Congress and the FDA to eventually be approved as an over-the-counter hearing aid.

This is a test case with Congress and the FDA to work directly with a manufacturer (Bose). The goal is to put out a product designed to be available for sale to people diagnosed with a mild to moderate sensorineural hearing loss directly form the manufacturer without professional support or follow up.

There Are Some Downsides To This Executive Order

The biggest downside to an OTC marketplace is that we lose the safety oversight that the FDA was trying to achieve by requiring a diagnostic assessment of your ear and hearing prior to being fitted with a hearing aid.

At the same time, patients have been able to sign a medical waiver to skip this requirement for years. Recently, the requirement for medical clearance to get hearing aids has been completely eradicated.

The downside of an OTC is the same as what I see for anyone getting hearing aids without a real diagnostic assessment.

There is a real risk of missing an underlying medical condition that would respond to treatment or intervention. Examples: cerumen impaction, acoustic neuroma, glomus tumor, multiple sclerosis, ear infections, cholesteatoma.

If You Already Have a Hearing Device/Amplifier, Here’s What You Can Do

If you are not achieving the outcomes you expected from a device that you’ve purchased, then please follow up with the vendor and request better instructions on use and expected benefits.

Check to see if you have a receipt. If you are able to return, exchange, or get service to achieve the goal of the original purchase, then that is my professional advice. Just like any other product you are unhappy with.

For those that have bought online, the same advice applies. If you buy from Amazon, you need to follow Amazon’s terms regarding the purchase.

Seek Assistance From Your Nearest Audiologist

I spent roughly 8 years between undergraduate and graduate school learning about psychoacoustics, how sound works, how our brains process sound, how we develop linguistic and reading skills through sound awareness and listening.

Continuing education is important to me and  I have continued to learn how to help people achieve their communication goals through better hearing.

An audiologist goes beyond just selling you a widget that turns things up. We help you learn how to hear again; we teach you how to maximize communication and really connect with the sounds around you.

We help you to understand the limitations of the auditory system and what can be done to help you achieve your goals.

Our brains are complex. Hearing and listening are brain functions. Having a professional on your side that knows how it all works together is the best way to ensure success.

Introducing The OTC Buy-Back Program

If you are:

  • Not receiving the performance that you hoped for from the devices that you’ve purchased
  • Have been wearing them for at least 60 days
  • Have you truly tried to make them work for you

Then you may qualify for our Buy-Back Program.

We will buy back your hearing devices to help you to restart your journey to better hearing. Alongside a team of audiologists who follows best practices and through a therapeutic methodology, we can get your hearing healthy again.

Our Buy-Back Value is generously set at $850.00 for a limited period. If you have truly tried to make your devices work for you but have not achieved the desired outcome, then this program could be your ideal next step.

To schedule a consultation or to discuss this program to see if it’s right for you, then please call (541) 612-7555 or click here to easily schedule your hearing assessment.





Do you know somebody that needs to see this? Why not share it?

Erika Shakespeare CCC-A

Erika Shakespeare, CCC-A, specializes in pediatric and adult diagnostics and amplification. Working with adults to help manage tinnitus and hearing loss since 2002, she is an expert in both of these areas. Additionally, she is a pediatric audiology mentor and educator for pediatric audiologists across the country and is one of the most respected experts on pediatric audiology.

    Request a Callback

    Don’t want to wait? Call us
    at: (541) 612-7555

    • This field is for validation purposes and should be left unchanged.



    This field is for validation purposes and should be left unchanged.