Over the Counter Hearing Aids: What Are They and Should You Buy Them?
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Over the Counter Hearing Aids: What Are They and Should You Buy Them?

Published On: May 22, 2019

Over the Counter Hearing Aids: What Are They and Should You Buy Them?

over the counter hearing aids

35 million Americans suffer from hearing loss. More than 25 million of them don’t wear hearing aids.


Because they’re expensive. A recent survey found that the average hearing aid costs $2,560. That does include the fitting, device, and follow-up care with an audiologist.

But most people wear two. The survey found that the price goes down to $2,336 each. That’s $4,672.

It’s no wonder people go without or try other devices!

But that’s all about to change. Or is it? In this guide, we explain everything you need to know about over the counter hearing aids and the law passed last year to make them accessible.

History Of Hearing Aids

It may seem hard to believe, but hearing aids have been around for hundreds of years. In fact, they were first mentioned in John Baptista Porta’s 1558 classic, Natural Magick.

In the book, Porta describes wooden hearing aids whittled into the shape of animals’ ears that had superior hearing. Sure, it may seem like a silly notion to us now, but in the 16th century, they thought it would help.

Beethoven and His “Trumpet”

Over the next two centuries, scientists developed hearing aid “trumpets,” which were very popular. Ludwig van Beethoven was one of the most famous trumpet-wearers during this time.

The device looked and worked exactly as it sounds. It was a cone that took in sounds at the larger end and fed them into a person’s ear from the smaller end.

The hearing aid trumpet took several iterations. It was first made from seashells, animal products, and glass. Later, copper and brass were the materials used.

There was a breakthrough in the late 1700’s when Beethoven discovered “bone conduction.” This was a game changer that affected the future of hearing aids.

Bone conduction is the process of vibrations in our skulls transmitting to the brain, thus producing sound. High-pitched sounds vibrate individually and low-pitched sounds vibrate the entire skull.

Beethoven ditched the trumpet and began biting on a rod that attached to his piano. He felt the vibration and knew what sounds he made when he pressed the keys.

The 19th-21st Centuries: Concealing is Key

Due to Beethoven’s discovery, the way hearing aids got made changed. Scientists began to focus on the vibrations, so behind-the-ear devices that looked like fans became popular. But they were still quite large.

In the late 1800’s, the introduction of electricity, as well as Alexander Graham Bell’s telephone, ushered in new forms of hearing devices for the turn of the century. Worn around the neck, these new devices amplified sound electronically using a carbon microphone and a battery.

They were large boxes, though, and the batteries that powered them were heavy. To make them more cumbersome, they only lasted a few hours.

Over the next 50 years, batteries got smaller and so did hearing aids. If Beethoven’s discovery of bone conduction was the first breakthrough, and Thomas Edison and Bell’s inventions were the second, the transistor was the third.

Two years before the first transistor radio, hearing aids were tiny transistors with a simple on and off switch. The more transistors a hearing aid had, the more functions it could perform.

Companies began making hearing aids out of different materials. The transistors were silicon and the hearing aids were plastic.

The technology changed too. In the ’90s, digital circuitry allowed hearing devices to get customized for the user. Sounds were amplified, reduced, directed, and filtered according to the wearer’s preference.

The high cost of traditional hearing aids created Personal Sound Amplification Products (PSAP). The internet and late-night infomercials made PSAPs a hit. They were more affordable and readily available to anyone who called a 1-800 number or logged onto a site.

That brings us to August 2017.

The Law on Over the Counter Hearing Aids

Senators Elizabeth Warren (D-Massachusetts) and Chuck Grassley (R-Iowa) introduced the Over-the-Counter Hearing Aid Act of 2017. The bill calls for the Food and Drug Administration to regulate a new classification of hearing aids. These new hearing aids will then be available over the counter instead of by a trained professional.

Although President Trump signed the bill in August 2017, experts estimate it will take years to come to fruition. In essence, this law allows anyone who is hearing impaired to bypass an audiologist and pricey fitted hearing aids.

It will also introduce a new category of hearing aids that the FDA hasn’t yet announced. It’s assumed the new OTC hearing aids will cost less. But some also assume the devices will be lesser quality than traditional aids.

The FDA Reauthorization Act of 2017 stipulates the new OTC hearing aids will:

  • Use the same fundamental scientific technology as current hearing aids
  • Be available OTC without supervision, prescription, referral, or recommendation from an auditory professional
  • Be available to adults only
  • Provide amplication for mild-to-moderate hearing loss
  • Have user-controlled functions, including customizations

They also stipulated the new OTC hearing aids may include self-assessment tests and wireless technology.

There are many questions about OTC hearing aids. The main question is “What constitutes a hearing aid?” It may sound like a strange question, given their history of starting out as a wooden replica of an animal ear, but you’ll soon see it’s actually valid.

What Is a Hearing Aid?

An actual hearing aid as we know it is more than its name leads you to believe. Despite all devices used as aids for hearing, this doesn’t make all devices hearing aids.

A hearing aid is a hearing device prescribed by a hearing specialist. In most cases in the U.S., this is an audiologist — a doctor who has studied hearing, balance, and other audiological fields.

They prescribe and fit hearing aids, recommend implant devices (like cochlear), and diagnose hearing loss. When we say “prescribed,” we mean that the hearing aid gets programmed with an individualized program for the user.

After the hearing aid gets programmed, the audiologist makes sure it fits, fine tunes any adjustments, and performs regular follow-up care.

While the cost is shocking for many people first starting out on their hearing aid journey, many feel it’s justifiable. A good pair of hearing aids will last a decade if the user takes pristine care of them. But a more realistic assessment is five to seven years.

That is, if the hearing loss doesn’t get worse. Obviously, if the hearing loss increases, the user needs a new one or pair.

That’s one of the reasons PSAPs became so popular.

What Is a PSAP?

A Personal Sound Amplification Product is not by technical terms a hearing aid. It doesn’t improve your individual hearing. It amplifies environmental sounds.

A PSAP, let’s call it “I Like Hearing,” bought online by Susan in Sacramento is the exact same product Steve in San Antonio will receive. It has nothing to do with anyone’s hearing loss; it’s all about making sounds louder.

You don’t need to see a hearing care professional, a doctor, or even talk to anyone. You pick up the phone, or go online, and buy it. They’re not classified as medical devices.

They’re also not recommended for moderate-to-profound hearing loss. There’s even some debate if they actually make hearing loss worse or cause damage.

Because hearing aids get programmed for the individual, Susan’s hearing will improve by wearing them but not all the sounds around her will be louder. In other words, they target her auditory deficiency and act as an improvement aid via a microphone, amplifier, and speaker.

If Steve has a PSAP, it’s not doing anything to improve his hearing. It only amplifies the sound around him. All the sound around him.

Despite PSAPs being generalized, the National Academy of Sciences said that these devices can help some people who are mild-to-moderately hearing impaired.

But there are variables that go along with PSAPs. The quality of its components, workmanship, and longevity all play a role in their effectiveness.

The cost of PSAPs is low. A high-end pair costs $500. That’s a $4,000 difference compared to a pair of hearing aids.

There are less expensive prescription hearing aids on the market. For example, Costco sells hearing aids. They sell many different brands including:

  • Bernafon Zenera 9
  • Kirkland Signature 8.0
  • Phonak
  • ReSound Forte
  • Rexton legato

Unless you’re familiar with hearing aid manufacturers, those names may not mean much. But these are five of the best brands on the market.

The success of Costco’s hearing aid program could be one of the reasons for the new OTC hearing aid law.

What Is an OTC Hearing Aid?

The answers to this question vary, because the FDA hasn’t announced what classifications they’re using to define an OTC hearing aid.

One non-profit research and education institute thinks it all hogwash. The American Consumer Institute called OTC hearing aids a “myth.” They believe that OTC hearing aids will be nothing more than FDA-regulated PSAPs.

The Hearing Loss Association of America supports the Over-the-Counter Hearing Aid Act. But, organizations on both sides should take pause.

In a July 2018 letter, the FDA warned manufacturers against marketing their products as OTC hearing aids. The FDA also reminded recipients that they have until August 18, 2020 to “publish proposed regulations.”

Until the FDA gives a definitive definition of OTC hearing aids, it’s a wait-and-see situation.

Will OTC Hearing Aids Help?

Say it turns out that OTC hearing aids are just advanced PSAPs. People with mild-to-moderate hearing loss will likely experience improved hearing. Whether it’s due to amplified sound or the device is magnifying sound vibrations and converting them into neural signals remains unknown.

For those with hearing loss that can’t afford prescription hearing aids, the OTC version is a wonderful option. Because most insurance and Medicare plans don’t cover hearing aids, millions more will have access to hearing devices.

But, some professionals applaud the bill but warn people with hearing loss not to use OTC hearing aids as a replacement for traditional ones. However, a study by Indiana University (and supported by the National Institute on Deafness and Other Communication Disorders) found benefits to one OTC hearing aid model.

154 adults, aged 55 to 79 years, with mild-to-moderate hearing loss took part in the research. The participants got divided into three groups. The first was a control group who wore fake hearing aids, a second group wore prescription hearing aids, and a third group wore the OTC model.

The OTC and prescription group had the same hearing aids. The difference was their delivery and professional care.

The group with the traditional hearing aids went to an audiologist and had the hearing aids programmed to their specific needs. They also received the normal follow-up care from the audiologist.

The OTC model group ordered pre-programmed hearing aids that they received directly. They reported similar benefits to the group who wore hearing aids prescribed by an audiologist.

While the National Institute of Health called for more studies on OTC, this preliminary study is promising.

Are You a Candidate for OTC Hearing Devices?

If you’re affected by hearing loss and waiting to find out what the parameters are that classify OTC hearing aids, it’s smart to consider all options.

All studies, research, and even doubters say OTC hearing aids will benefit those with a mild-to-moderate hearing loss. As far as moderate-to-profound hearing impairment, that is less of a certainty.

If you’re hearing impaired and curious if OTC hearing aids will work for you, you should visit your doctor and have your hearing screened. Talk to them about your hearing concerns, including any insurance or Medicare questions.

Your doctor may advise you to visit an audiologist for further testing. If you choose this option, listen to their advice on what devices will help you the most.

You’re Not Alone

When your hearing is impaired, whether you were born that way or lost your hearing over time, it can be scary. You can’t hear your spouse call your name. You can’t hear the TV even though everyone around you says it’s blaring.

It’s not only scary, but also frustrating and confusing, especially when it comes to navigating all your options.

We hope our guide to understanding over the counter hearing aids relieved some of your confusion. But if you need more guidance, we’re here to help.

Visit our news section for more articles that explain what you need to consider when buying hearing aids. We also can help you with your hearing loss questions.

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