What You NEED to Know About Over-The-Counter Hearing Aids | FDA OTC Hearing Aid Act 2017

By: Dr Cliff Olson
August 23, 2019
Video Transcript

In 2017, President Donald Trump signed the FDA Reauthorization Act of 2017 into Law, which we have also been calling, the Over-The-Counter Hearing Aid Act.  This law will require the FDA to create and regulate a new category of hearing aids, designed to treat "perceived" mild to moderate hearing loss, within 3 years of the Act being signed into law.Following a 180 day Comment Period, the law will take effect at some point in 2020, giving consumers with hearing loss, access to an additional treatment option.  But what does this mean for you as a consumer?  

Here are 7 things that you need to know about Over The Counter Hearing Aids.

#1.  It will provide increased access to Hearing Devices.Without the requirement to have a hearing evaluation, you will be able to purchase OTC hearing aids online and in stores like Walmart, Target, & CVS.  This may give individuals, who live far away from Hearing Clinics, access to hearing aids that they wouldn't otherwise.

#2. It will Eventually lead to the creation of new Self-Fitting Hearing Aid Technologies by Consumer Electronics Companies.Companies like Bose, Samsung, and maybe even Apple could eventually get into the OTC hearing aid market.  I say eventually because it may take years of trial and error before these companies develop quality OTC devices.  If we're lucky, we'll see hearing aid companies producing OTC hearing aids.

#3. It could lead to Possible Regulation of Wildly Unregulated Direct To Consumer Hearing Aid Marketplace.I say possible regulation because the FDA does not do a good job of regulating the guidelines that they currently have in place regarding OTC hearing aids.  There are several online companies that claim they sell OTC devices in an effort to cash-in on the headlines about the OTC Hearing Aid Act.  All of this despite the letter the FDA sent out warning manufacturers that the OTC hearing aid category doesn't exist yet.  When reporting these companies to the FDA, they basically issued a form letter explaining that they aren't going to do anything about it.  If the FDA doesn't actually enforce it's own guidelines, it will be nearly impossible to determine which OTC hearing aids are legitimate and which ones are a rip off.

#4. It could put you at risk of improperly treating your hearing loss.OTC hearing aids are intended for "perceived Mild to Moderate Hearing Loss".  It is basically impossible to know your level of hearing loss based on perception alone.  If you underestimate your level of hearing loss, OTC devices won't work for you.  You may also go undetected for a number of hearing losses including Unilateral Hearing Loss, Sudden Hearing Loss, and Conductive Hearing Loss.  All of which could have serious negative health effects beyond just hearing loss alone.  

#5. It will NOT drive down the costs of current hearing aid technology.Consumer electronics companies are not out to save you money.  They are out to make money.  Their products will be cheaper than traditional hearing aids, but they will be more expensive than a set of Bose Headphones.  Besides, the cost of hearing aids is more than just devices alone.  It includes the professional care required to maximize and maintain their performance.

#6. There is no guarantee that your OTC hearing aids will be programmed correctly.The biggest drawback of OTC hearing aids will likely be the lack of verification.  Yes, you will be able to self-adjust the hearing devices, but what sounds "good" to you may not actually be getting what you need.  This is because most individuals with a hearing loss underestimate how much amplification they need, especially in the high frequencies.  This is why Real Ear Measurements (REMs) are so important for ensuring that hearing aids are programmed correctly.  If you don't know what REMs are, you need to watch this video:  https://youtu.be/cHR0Oa6I-wY

#7. OTC will lead to the demise of Bad Hearing Care Providers.There are MANY GREAT Hearing Care Providers out there who earn every penny of what you pay them to Treat your hearing loss.  However, there will most definitely be BAD Hearing Care Providers who will inevitably leave the Hearing Care Industry because they will offer nothing of value beyond what you could get with OTC hearing aids.  The #1 variable of success with hearing aids is if your hearing care provider follows best practices, like Real Ear Measurement.  However, it can be difficult finding these outstanding providers which is why I am launching the Dr. Cliff Approved Provider Network.  Each provider in this network will be personally vetted by Dr. Cliff. Overall, I am in 100% support of OTC hearing aids, as long as the FDA actually does their job.

Dr. Cliff's Thoughts
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