August 07, 2020

OTC Hearing Aids and New FDA Regulations | Olive Union

For as long as most of us can remember, Over The Counter (OTC) hearing aids were just a dream. If you needed a hearing aid, you first had to see a hearing health professional, receive an official medical examination, and then purchase a tested and fitted hearing aid. The process was often tedious, and the cost was usually high and out-of-pocket. 

But all that is changing. Now you'll be able to buy hearing aids over the counter, just like personal amplifiers (PSAPs) like the Olive Smart Ear.

New FDA Regulations for OTC Hearing Aids

Come August of this year, the U.S. Food and Drug Administration (FDA) is said to release guidelines for a new OTC category of hearing aids where consumers will be able to buy directly for themselves without any need for an exam, hearing test or office visit.

That’s a huge game-changer and will provide many more people in the US with the chance to obtain a hearing aid.

These new OTC hearing aids will be designed specifically for those with mild-to-moderate hearing loss and will be regulated by the FDA as medical devices. Like traditional hearing aids, OTC hearing aids will make sounds louder, so people with hearing loss can hear more of what they typically would miss. However, unlike traditional hearing aids, consumers will be able to simply purchase these new hearing aids online or at a store.

This new crop of OTC hearing aids will come in many shapes and sizes, with a variety of added functions. For example, some will offer personalized volume control and sound adjustment that used to require the configuration of an audiologist. Along with new features, consumers will most likely be happy to find smaller, more discreet styles that barely resemble the old, clunky behind-the-ear models of decades ago.

OTC Hearing Aids Are a Win for Consumers

Consumers can look forward to many benefits from the FDA’s proposed plan to open up the market to over-the-counter hearing aids. However, you'll still have to stay vigilant to ensure that you don't end up ordering poor quality devices that won't help your hearing at all. 

Stay Home, Order Online, Have Your Hearing Aid Delivered

The new change will come just in time, with COVID-19 still keeping many people from wanting to make extra trips out of the house. The ability to buy online during COVID-19 will make all the difference for vulnerable people suffering from hearing loss.

You won’t have to leave your home, sit in a crowded waiting room, be examined and tested by an audiologist, and purchase a hearing aid in person. Instead, while remaining in the comfort of your home, simply order online and have the hearing aid delivered right to your door.  

More Competition Means Better and More Affordable Options

Up until now the market has been limited to a few hearing aid companies, and audiologists many times only offered one brand exclusively. That left consumers with limited choices and created a market without much price competition.

Many people struggling with hearing loss simply couldn’t afford the expense of hearing aids, especially when they would see price tags of $4,000~$6,000, sometimes even $10,000 or more! Realizing that health insurance rarely covered hearing aid expenses, leading experts in health science, and technology worked with lawmakers to push the FDA to allow for more affordable alternatives, since many people in need were simply priced out of the market.  

The law was established on August 18, 2017, as part of the FDA Reauthorization Act of 2017. The FDA has until August 2020 to release the proposed guidelines.

By opening the market up to OTC hearing aids, the FDA is removing the need for the expense of being seen and tested by an audiologist. This creates a wider marketplace with more options that will serve a wider range of consumers. Also, more competitors being in the market will most likely bring down the price of the devices even more, and improve the overall quality as well.

More Consumers Will Have Access to Hearing Help

In the past, those suffering from mild hearing loss may have been told by an audiologist that their hearing loss was not significant enough to warrant a hearing aid, or they found the proposed options to not fit their needs.

These consumers were left to face daily interference in simple everyday life. from struggling to hear conversations in crowded spaces to blasting the TV and annoying their neighbors and family members. Now, these consumers will have more options and can make their own decision on whether to buy a hearing aid.

OTC Hearing Aids: Are They Right for You?

With the market for hearing aids about to open up to consumers, it’s important to understand whether an OTC hearing aid is right for you, or if you should still go the traditional route and see a trained hearing specialist. OTC hearing aids are recommended for those with mild to moderate hearing loss. What does mild to moderate hearing loss look like in real life? If you answer “yes” to questions such as these, you may have mild to moderate hearing loss and could benefit from an OTC hearing aid.  

Do people comment on how loud you have the TV or stereo volume set?

Do people’s voices sound muffled?

Do you find yourself asking people to repeat something they've said often?

Do you struggle to understand conversations when you’re in a group?

OTC hearing aids are not for children or those with severe hearing loss. That’s because OTC hearing aids might not be able to amplify sounds enough to help those with severe hearing loss.

It’s also important to note that while OTC hearing aids can help with hearing loss, you should see your doctor if you are experiencing pain, vertigo, or fluid in the ear. These can be symptoms of a medical condition that requires medical attention and treatment. 

Promising Results for OTC hearing aids 

For those wondering about the effectiveness of OTC hearing aids compared to traditional prescribed models, there is strong evidence of comparable effectiveness. In a clinical study of over 100 patients reviewed by the FDA, the AARP reports that on average OTC hearing aids were just as effective as devices fitted by a hearing professional. 

Use Caution When Buying OTC hearing aids

Like any other long-term purchase, there are precautions to take when making an investment in your hearing assistance. While more options in the hearing aid market is an overall positive change, it also means that there is more responsibility on the consumer to do their homework to avoid being misled.

Although the FDA will regulate OTC hearing aids, it may be difficult to choose the best quality OTC hearing aid option. Here are some guidelines to follow:

• Read reviews from other customers and look for quality ratings
• Investigate the technology that the hearing aid describes. Specifications can become complicated, so take your time to read the fine print.
• Look at the return policy to make sure you can get a refund if the device does not meet your needs.
• Buy from a reputable website and reliable company.

By giving the consumers the option to buy OTC hearing aids, the FDA has removed one of the biggest barriers that many faced in finding help for their hearing difficulties. Now, you’ll be able to decide what device is right for your needs and purchase one for yourself. 

For a popular and innovative otc hearinf aids whose quality and performance we can guarantee, be sure to check out our own personalized hearing device - the Olive Max.

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

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

https://www.fda.gov/medical-devices/consumer-products/hearing-aids

https://www.aarp.org/health/conditions-treatments/info-2019/otc-hearing-aids.html

https://www.med.unc.edu/ahs/sphs/hcc/our-services/over-the-counter-hearing-aid-act-h-r-1652/