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.





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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.

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    Erika’s Story

    I’m Erika. I love learning about new technology, particularly with technology designed to help people hear and connect to their families, friends and community. I first learned about the Jabra Enhance Plus 18 months ago in a tech talk related to OTC hearing aids. OTC stands for “over-the-counter”; this was driven by the PCAST report (President’s Council of Advisors on Science and Technology) that was published in 2016 and was rejuvenated by Biden’s Executive to the FDA to develop regulations and labeling on a new classification of non-prescription hearing aids that would be available to purchase by consumers without professional engagement.

    The purpose was to introduce lower cost entry to hearing aids for consumers. This is opening a whole new pipeline of devices from manufacturers of consumer electronics to manufacturers of medical devices to get into the lucrative market of entry level amplification. Bose had launched their new “hearing aid” which was a terrible flop, it didn’t have rechargeability, it had a ton of feedback (whistling), it didn’t even have basic streaming features. Signia launched a product, Apple Air pods added transparency mode and developed an app to “test” your hearing to apply mild gain to your Air Pod Pros, and Resound’s research team partnered with GN’s consumer electronic group that makes Jabra products to develop a hybrid hearing aid/consumer electronic sometimes referred to as a Hearable, PSAP (Personal Sound Amplifier), or and OTC hearing aid. Other companies have come out with products that they are marketing as hearing aids, the FDA has been playing whack-a-mole with these illegally labeled products. Whatever you may call the widget, it is an electronic device that is not programmed by a licensed hearing health care professional.

    I was awarded a slot to participate in a pilot project to evaluate the Jabra Enhance Plus product before it was released commercially to the public. I have been wearing the device for the last 10 days. I have about 4 pages of feedback for the developers for the app and also the device itself. Here is my pro/con list.

    Pros: The size and fit. It doesn’t look anything like a hearing aid, it is like a small button Bluetooth or wireless earbud. There is nothing hanging out of the ear to catch on masks. The green, faded yellow and red indicator lights on the device and the charger are intuitive ways to alert to battery life. The little charging case holds a charge even when it is not plugged in. It is easily portable, fits great in a pocket of my purse so I have them with me. The streaming is pretty seamless. The app controls are deceivingly simple, it seems like there should be more, but it is really just the volume up and down. They were a lot more comfortable to wear while reclining and listening to streaming audio than other wireless earbuds that I have used. It was easy to switch to a call while streaming. They enhanced listening when I was watching TV.

    Cons: The built-in personalization didn’t seem to customize the sound; The filter setting was something that I wanted to change frequently, but it is a buried feature in the app. The fit was sort of uncomfortable in one ear and the selection of domes were not adequate. The occlusion effect for my own body noises was significant. My voice sounded too far away for people on the other end of the phone call. The sound quality for phone calls and streaming audio was inferior to other wireless earbuds that I use. I struggled in noisy situations to hear other people over my own body sounds. They move a lot in my ears with talking. They don’t connect to my computer, so going between zoom meetings and phone calls or other activities was cumbersome and I have to switch devices.
    My overall assessment is that there is a place in the consumer electronic world for these cute little hearing enhancers, but they will not yet replace my wireless earbuds. I look forward to future software updates that will hopefully improve and expand usability (like connecting to my PC for zoom calls).

    Tom’s Story

    Tom was not as happy as Donna after his 10 days with the devices. He much preferred his own hearing aids. He did like that his mask never got caught on them. His biggest issue was that he got whistling from them when he turned them up loud enough for him to hear the TV. He did enjoy the streaming capabilities. He struggled the most with pairing the devices, which may have been because he used his Bluetooth a lot for other things and the Jabra devices did not seem to respond well to intermittent connectivity.

    Donna’s Story

    Donna wore the devices for 10-12 hours everyday for ten days. She loved how much better she heard in group settings and in conversations with friends and family.

    She mentioned that after a long day she did notice that her ears would get a little sore and she thought maybe a smaller prescription hearing aid would be better for her long term, but she thought these self fitting hearing aids were great and easy to use. She would definitely consider buying them and even had several of her friends ask where they could buy them.

    Linda’s Story

    Linda wore the Jabra Enhance Plus 5-6 hours a day. Mostly while watching TV. She loved how much easier it was to hear the dialogue on TV. She also enjoyed hearing her husband more easily while they were having conversations. She had little difficulty connecting the devices to her app, the most difficult part of the connection that Linda had was remembering her apple password. She was really impressed with the product and the price.

    Beth Story

    Beth wears the Jabra Enhance Plus about an hour a day, primarily for streaming while exercising. She loves the quality of the streaming for phone calls and listening to audio books. She tried the devices in a restaurant with friends, but really struggled to adapt to her own voice and thought that it was actually harder to focus on the voices she wanted to hear over some of the other environment sounds being amplified. She really didn’t find them helpful in the classroom like she had hoped, but she admitted that only tried them once in that setting.

    Jan’s Story

    I'm Jan. I have enjoyed being part of this new technology. After day two I did experience right ear canal discomfort and was not able to wear the device for a few days. I feel if the device was a little bit smaller it would be more comfortable for me.

    I felt muffled and my own voice was hollow. After a few days I didn't notice it as much. I am not totally comfortable with new technology but found the setup for Jabra to be easy. The charging was easy, and the hearing test was relatively easy. I have normal hearing, therefore did not experience a lot of amplification. I found the app was user friendly. I would recommend them to someone who had a mild to moderate hearing loss that could not afford hearing aids.