August 30, 2020

Over The Counter (OTC) hearing aids is a new category of hearing aids designed specifically for people with mild to moderate hearing loss. FDA approved the law on August 18 2017, as part of the FDA Reauthorization Act of 2017, and guidelines were said to be released this August of 2020. These devices are meant to make sounds louder when communicating and participating in recreational activities, and would be able for purchase without a prescription from a hearing care professional. 

In the US, around 48 million people have a hearing impairment today and it is expected to rise to 73 million by 2060. The cost of traditional hearing aids is high and consumers find it difficult to purchase these devices even though they are in need. OTC hearing aids will be a great opportunity for customers to purchase the devices they need with lower price and higher accessibility. 

Over-the-Counter Hearing Aid Act of 2017: What You Need to Know

President Trump signed the OTC hearing act in August 2017 to make hearing aid devices more accessible to consumers by allowing over the counter purchase without a prescription. FDA was expected to publish regulations for this new category by August 18 2020, but it is said that the release date has been delayed until at least Q1 of 2021. According to this act, OTC hearing aids are intended to be used by those with mild to moderate hearing loss. The act removes the requirement of a medical evaluation, so consumers will be able to purchase OTC hearing aids directly from retail or online stores. 

Who OTC Hearing Aids are for?

Over the counter hearing aids are meant to be used by the people who have mild to moderate hearing loss.

If any of the points below rings a bell, you may need an OTC hearing aid:

• You are unable to hear properly in a noisy place, a group environment, or on a phone call.
• You prefer listening to music or watching TV at a higher volume than other people.
• You often ask people to repeat themselves or speak slowly and louder.

Since OTC hearing aids will be able over the counter, you do not have to visit an audiologist before purchase if you experience any of the above signs. However, if you experience tinnitus or sudden hearing loss, you should make sure to seek medical attention, since these may be related to serious medical conditions.

How are OTC Hearing Aids Different from Traditional Hearing Aids?

Currently, the two major categories of hearing enhancement devices available to consumers are  hearing aids and PSAPs (personal sound amplification products). The key difference between the two devices is that hearing aids are medical devices intended for people with hearing loss, and PSAPs are not - they are devices intended for people with normal hearing who want to enhance their hearing to hear better in certain environments. 

PSAPs are intended to be used by people with a full range of hearing. They are perfect for people who want to have better conversation experiences in noisy areas and want boosted sound volumes during recreational activities. PSAPs are easily available on online and in retail stores such as pharmacies and electronics stores.

OTC hearing aids will introduce a third option to the consumer. These devices will still be regulated by the FDA, but will be available to consumers without the need for a prescription by a hearing specialist. That means it will have the ease of access of a PSAP, but with the quality assurance consumers look for in a hearing aid.

Why are OTC Hearing Aids Becoming Available?

In the United States, the number of people with hearing impairment has been increasing year by year. However, consumers are not able to buy medical hearing aids due to the high cost. The average price of a single hearing aid is $2,300, and since they are usually sold in pairs, the average cost is $4,600 for a pair. When insurance usually do not cover these devices, this price point makes it hard for everyone to easily purchase a hearing aid.

This is why the President’s Council of Advisors on Science and Technology (PCAST) and the National Academies recommended to make a new category of hearing aids, OTC hearing aids, to make it easier for people to purchase hearing aids at a lower cost. They recommended the FDA to update regulations for this device so that consumers can get an alternative to traditional hearing aids.

Are OTC Hearing Aids Effective?

Over the counter hearing aids are great options for people with milder forms of hearing loss. Scientific studies are already showing the effectiveness of these devices, and this is reassuring to people who are considering a purchase when they come out.

According to a study published on NCBI, older people tend to underestimate their hearing impairment, while adults tend to overestimate their hearing loss. It is also known that you can slow down the decline of your hearing loss with a properly fitted hearing device. So, young adults may benefit a lot from OTC hearing aids, as they are more accessible compared to traditional devices. OTC hearing aids are perfect for the current generation, where hearing loss is increasing in young adults.

What are the Pros of OTC Hearing Aids?

According to the National Institutes of Health, only one in five who experience hearing impairment actually wears hearing aids. It is vital to note that not wearing hearing aids drastically impacts the social life of individuals with hearing loss. Also, scientific studies show that there are higher chances that these people will develop other health issues such as dementia and depression.

The pros of OTC hearing aids are the accessibility and price. We have already mentioned that they will be more easily available because they do not require prescription. At the same time, since the entire hearing test, fitting, and adjustment process is eliminated from the purchase, OTC hearing aids will most likely be a lot cheaper than current hearing aids. This is another huge benefit from the consumer, who often gives up on buying a hearing aid due to the high price.

What are the Cons of OTC Hearing Aids?

Benefits of OTC hearing aids are certainly strong. The new category will allow many people who didn't have the luxury of traditional hearing aids to hear better and change their lives.

However, there are always cons to a good solution. For OTC hearing aids, the fact that there is no hearing test and fitting process may be a risk for the user - without proper information, they may not be able to get the best device for them. Where a hearing care specialist would have suggested a good fit device, consumers have to chose on their own when it comes to OTC hearing aids.

To avoid such risk, consumers should do their product research and look at customer reviews. Trying products with a trial period or return free policy is also a good idea when it comes to looking for the perfect product.

Should You Count on OTC Hearing Aids?

Over the counter hearing aids is certainly a big market change to look forward to - it will open up many better options to customers, hopefully raising the penetration rate of hearing aid use in people with hearing loss.

However, currently it is unclear when they will be available to consumers, and as mentioned before, untreated hearing loss is very risky. If you are considering a hearing device, make sure you consider it now! 

If you don't have hearing loss and are wondering where to start, try our online hearing test here and see your results!

The information in this guide has been written using the following reliable sources: 

https://www.nidcd.nih.gov/health/over-counter-hearing-aids

http://longevity.stanford.edu/wp-content/uploads/sites/7/2017/02/JAMA-Viewpoint-PDF-June-2.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4272625/

https://journals.lww.com/thehearingjournal/fulltext/2017/06000/Addressing_Hearing_Loss_With_an_Aging_Population.2.aspx

https://www.nidcd.nih.gov/health/hearing-aids#hearingaid_01

https://en.wikipedia.org/wiki/Over-the-Counter_Hearing_Aid_Act_of_2017