The FDA Finalizes Rule to Enable Access to Over-the-Counter Hearing Aids in the US

by | Sep 14, 2022 | Client Resources, Hearing Aids, Industry News, Technology

I’m going to share the positives, negatives, and concerns of this historic ruling, and how I believe this could impact Canada over the coming months and year.

On August 17th, the FDA finally published their ruling on Over-The-Counter Hearing Aids in the US, with their statement sharing that ‘more affordable hearing aids could be in stores as soon as mid-October’.

 Since this announcement, I’ve watched as many major media outlets have reported the news with the move being celebrated by the Biden administration as an agenda win, and this being positioned as great news for the American public.

However, from meticulously researching this new ruling, and from speaking to my peers in the US, I have a mix of emotions. In this article, I’m going to share the positives, negatives, and concerns of this historic ruling, and how I believe this could impact Canada over the coming months and years.

The Positives | Normalizing Hearing Loss

First of all, this feels like a very positive step for the future of hearing healthcare.

That’s because the introduction of over-the-counter will be a key step in helping to normalize the treatment of hearing loss and have more people exploring their options to achieve better hearing.

The data tell us that hearing loss impacts 15% of us, yet only a small percentage of us choose to treat our hearing challenges.

When brands such as Apple, Google, or other technology giants join the market with their reputations/advertising budgets, it’s going to have more people question their hearing and being open to addressing it, which could be the catalyst to removing the outdated stigma of hearing loss and result in more people finally choosing to take action.

The Negatives | The Risks of Self-Prescribing a Solution

My biggest concern is that this move will leave Americans being able to essentially self-prescribe a solution to their hearing loss.

This results in two risks:

Firstly, a hearing loss is not the only reason why somebody may be struggling to hear. When conducting a hearing evaluation, hearing care professionals analyze a client’s overall hearing health and often discover alternative reasons why he or she may be struggling to hear.

These can be as simple as a build-up of earwax that can be easily addressed, to a serious medical condition that requires immediate attention. Without having a hearing evaluation, many people will either be missing a serious medical concern or may incorrectly treat a hearing loss that is actually just a build-up of earwax.

Secondly, it’s concerned that over-the-counter devices are for people with a perceived mild-to-moderate hearing loss. As hearing loss often happens slowly and gradually, it’s almost impossible to know what level of hearing loss that you have until you have a hearing evaluation.

We often see people that believe that they have a mild hearing loss, only to discover that they have a severe hearing loss that requires immediate attention. Over-the-counter hearing aids could be applying a band-aid to a more serious challenge by not requiring a hearing evaluation.

The Concerns | The Confusion

From speaking to fellow hearing care professionals across the US, the biggest challenge that they’re currently experiencing is client confusion.

With many media outlets published stories that focuses on the ‘affordable hearing aids are now available’ element, it’s resulting in prescription hearing aid wearers questioning their decisions and people choosing to delay treatment until the new over-the-counter devices are finally launched.

What the media stories are failing to mention is how these over-the-counter devices will be very different to prescription hearing aids.

The best real-world comparison between over-the-counter hearing devices and prescription hearing aids is the difference between prescription eyeglasses and off-the-shelf readers:

  • One delivers you a highly custom solution tailored to your exact requirements.
  • The other is for situational use for mild eyesight challenges.

As we all know, readers are a short-term support mechanism but are not the genuine solution.

Over-the-counter hearing devices are set to be very similar by offering a level of hearing amplification with some basic adjustment tools via a cell phone app, whereas prescription hearing aids require collaboration with a hearing professional to tailor perfectly for a client’s exact level of hearing loss as well as ongoing adjustments/support/care.

What Does this Mean for Us?

This is something I have been closely monitoring and pondering how this may potentially impact our market.

First, there will undoubtedly be some people that decide to buy these devices from the US and have them shipped across the border

Second, I’m sure this move is being closely monitored by Health Canada.

Although we cannot predict the future, the important lesson with the introduction of over-the-counter hearing aids in the US is that they’re not a magical low-cost solution that replaces that need for prescription hearing aids – they’re the ‘readers’ that will help more people to do something rather than nothing.

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Jennifer Abbott

Jennifer Abbott brings over 25 years of experience in business. She has worked in multiple industries, including insurance brokerage, aviation, and health. Her career journey enabled her to acquire impeccable skills to help people find solutions in any situation. Jennifer is well travelled. She has lived and worked in Dubai for award-winning Emirates Airline. Jennifer has enjoyed working in a multicultural environment. Her offshore work empowered her to learn about various cultures from over 100 different nationalities. Upon her return home, Jennifer pursued her studies as a Hearing Aid Practitioner. While working in a hearing clinic, she became aware of some people’s challenges getting to their appointment. She realized that those people were not getting the proper hearing aid help they needed, which compromised their hearing. People’s struggles inspired her to establish the first unique 100% mobile hearing clinic in the lower mainland. As the founder of Hear at Home Mobile Hearing Clinic, Jennifer’s mission is to improve her client’s quality of life at any age. She has in-depth experience with hearing testing fitting, recommending hearing aids and working with older populations suffering from cognitive decline and Dementia.

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