Dr. Gary Breaks It Down: What Does the FDA’s Ruling on Over-the-Counter (OTC) Hearing Aids Really Mean For You? was last modified: November 26th, 2022 by Gary Johnson


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Dr. Gary Breaks It Down: What Does the FDA’s Ruling on Over-the-Counter (OTC) Hearing Aids Really Mean For You?

Sep 11, 2022

FDA Ruling OTC Hearing AidsIn 2017, Congress passed bipartisan legislation requiring the FDA to create a category of over-the-counter (OTC) hearing aids, but it was not fully implemented until August of 2022. As a result, consumers may see OTC hearing aids available in traditional retail and drug stores as soon as mid-October. Dr. Gary explains what this all means.


The OTC Hearing Aid Rules – Five Years in the Making

It’s finally here, and we have clarity. On August 16, 2022, the FDA finalized and released its rules to implement OTC hearing aid legislation that they had been working on since 2017.

So, what took so long?

For one thing, the FDA took its time to carefully listen to hundreds of comments and testimonies from concerned citizens, professional organizations, hearing loss awareness groups, medical groups, as well as industry professionals. It carefully organized and evaluated all opinions and took the time to consider all angles for implementation.

Then an unprecedented worldwide pandemic hit and slowed the progress practically to a halt.

Sometime in mid-October, Americans can finally purchase OTC Hearing Aids without the intervention of a provider and without a hearing test.; However, the devices are not for everyone and there are pros and cons to discuss.


Should You Buy OTC Hearing Aids?

One of the things the FDA did well was addressing the labeling on the product, making it very clear for whom the OTC aids are designed for.

OTC Hearing Aids Can Be Used By

  •       People with perceived mild to moderate hearing loss
  •       People over the age of 18

OTC Hearing Aids Should NOT Be Used By

  •       People experiencing tinnitus
  •       People with asymmetric hearing loss
  •       People experiencing dizziness, vertigo, imbalance
  •       People with perceived moderately severe to profound hearing loss


How Prevalent is Hearing Loss?

The FDA estimates that 30 million Americans – or 60,000 million ears – suffer from hearing loss. Sadly only 1/5 (around six million) of those seek treatment for their hearing loss.

What are the other 4/5 of Americans doing that have hearing loss that are not seeking treatment? Unfortunately, they are doing nothing. They are ignoring the problem, which is precisely why the OTC Hearing Loss Bill came about.

This is especially striking when you consider that of that 1/5 of Americans who treat their loss, they almost never fall into the mild to moderate category. The 1/5 that get treated are normally people who wait until their hearing loss is moderately severe, severe, or even profound before they feel they have enough hearing loss to warrant treatment.

In other words, Americans put off treating their hearing loss as long as possible. And this is not at all a good thing.  


Hearing Loss and Dementia – Why Early Treatment is Key



Did you know that research suggests that the number one mitigating risk factor in age-related cognitive decline is the treatment of an existing hearing loss? In other words, hearing loss is one of the top risk factors of dementia

Seems pretty simple, huh? If you continue to ignore your hearing loss, your mental health will likely decline at a much faster rate than it would if you treated (or mitigated) your hearing loss sooner.

Since early hearing loss treatment is vital to lessening cognitive decline, the main goals of the bill were as follows:

  1. Provide increased access to OTC hearing aids to Americans
  2. Encourage earlier entry in the hearing aid market – or earlier treatment of their hearing loss
  3. Lowering the cost of hearing aids

Let’s review what I believe the rules (and benefits) of the bill will accomplish in more detail.


1. Increased Access to Some Kind of Hearing Aids

This bill (and the rules and comments associated with this bill) will absolutely increase the access for people to obtain hearing aids.

For the first time ever, people with perceived mild to moderate hearing loss will be able to purchase these OTC hearing aids:

  • At a lower cost
  • Without a prescription
  • Without medical clearance
  • Without a hearing test

Again, we need to talk about the difference between perceptual hearing loss and diagnosed hearing loss, but for right now, the new rules will absolutely meet that goal.

The bottom line is obvious. More Americans will have access and availability to treat their hearing loss.


2. Earlier Hearing Loss Treatment

Not only can more people treat their hearing loss – they can start treatment earlier.

Lower cost, easier access, and lack of the need for medical interaction, all make the OTC hearing aid products easier to obtain, nearly guaranteeing that at least a certain percentage of people will take advantage of the new rules and purchase an OTC hearing aid who may not otherwise have done so.

And while price is important, making these products readily available at retail stores will only help to reduce the hearing-loss-treatment stigma by not having to go see the doctor to treat this problem. This makes the situation similar to the cheater eye-glass market where people can go to their local pharmacy or supermarket and easily obtain eyeglass readers right off a store rack.

Not only will more people get treatment – now more will get earlier hearing loss treatment.

Remember, the earlier that people treat their hearing loss, the less auditory deprivation they suffer from, and the fewer changes that occur in their brain. Overall, the auditory system will remain healthier if they treat it earlier rather than later. Increasing the number of people who are using hearing aid devices early on in their hearing loss (especially in that mild to moderate category) will help to stave off dementia to at least varying degrees.


3. What Will OTC Hearing Aids Actually Cost?

In my opinion, identifying the cost of these products is going to be interesting. From talking to people in the industry, I am seeing numbers anywhere from $700 for a set of these OTC hearing aids to all the way up to $1,400 for a set.

Remember, that cost does not include professional assistance. It is a do-it-yourself, wear-it-at-home, product.

But I am unsure what the actual cost will end up being over time for a few reasons:

1: We are not sure if the larger consumer electronics companies are going to be getting involved in this industry. Already, one of the larger consumer electronics companies that we thought was going to be spearheading the OTC hearing aid launches (and really running into this industry full force)  closed their hearing aid division.

2: The OTC hearing aid is a self-fit product. We have had self-fit devices (amplifiers) on the market for several years, and we have seen very high return rates. That makes the products less profitable and just seems to cause an industry setback.

In fact, the OTC amplifier market and mail-order hearing aid products have lower levels of satisfaction than professionally fitted hearing aids – and it is mostly due to being self-fitted. After all, if you are uncomfortable, you may not want to wear them. It should be noted that once a patient wears a hearing aid, even an OTC hearing aid, and it is returned, it can be resold but it must be marked as refurbished.

Time will tell if the product costs actually increase or decrease in price – but they should remain lower priced than prescribed hearing aids.


Final Thoughts on OTC Hearing Aid Rules

In summary, I think the FDA did a great job these past five years taking comments and testimonials and incorporating them into a comprehensive report and a solid set of rules. They used some well-thought-out reasoning, and even though they chose not to address some of the issues raised, they at least were thorough and explained what they were thinking and why.

And now that these rules are finalized, and as we can finally get moving here, I have hope that these rules will bring more awareness to the hearing healthcare industry. I will be watching the costs of the products. I’ll be talking to patients about whether they think the accessibility without audiology intervention will reduce the stigma of hearing loss treatment. And I will be reporting more back to you.

Will this all be a flop? I don’t know. We will have to wait and see…

The one thing I do know is, increased awareness regarding hearing health care is always a positive. The sooner you treat your hearing loss, or the sooner your loved one treats their hearing loss, the better it is for your brain, and the more effective treatment you are going to have.


Hearing Aid Specialists in Mesa and Scottsdale, AZ

The hearing aid specialists at Advanced Hearing Group are committed to your hearing health and finding ways to help you hear better. Whether you have questions regarding OTC hearing aids, need a hearing test, want to find the best hearing aids for you, or have another hearing-related concern, we are here for you every step of the way. Simply schedule an appointment with one of our Mesa or Scottsdale audiologists today and get started on the road to hearing better!

Gary Johnson, II, Au.D.

Doctor of Audiology

Dr. Gary Breaks It Down: What Does the FDA’s Ruling on Over-the-Counter (OTC) Hearing Aids Really Mean For You? was last modified: November 26th, 2022 by Gary Johnson

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