Hearing Aids: Reviews, Research, & Technology

Put simply, this is a new kind of hearing aid sold “over the counter” to adults who perceive a mild to moderate hearing loss and who do not want the traditional clinical services that are part of “prescription” hearing aids.

But this can be a little confusing as there have been many OTC hearing aid-like devices on the market for years… so what is different about these new devices?

First, a little background information is needed.

Back in 2017, the FDA Reauthorization Act (FDARA; Pub. L. 115-52) was signed into law with the goal of improving access to hearing aid technology for Americans. This was intended to save money by lowering the cost of hearing devices for a segment of the hearing-impaired population without the need for professional services. As of October 2022, the FDA finalized its regulations for OTC hearing aids, and they have just now become fully available.

As of October 2022, the FDA finalized its regulations for OTC hearing aids, and they have just now become fully available. Check out the FDA regulations on this for more information.

What you need to know:

OTC hearing aids are suitable only for adults who perceive a mild to moderate hearing loss.

Only devices labeled as an “OTC” or an “over the counter” hearing aid and have FDA approved labeling are actual OTC hearing aids. Anything else is either not FDA approved, or it’s what we call a “PSAP,” which is a “personal sound amplification product,” and is very different (and lower quality). See the comparison of OTC hearing aids with PSAPs below.

OTC hearing aids are intended for adults (18 years old and older) only. They are not FDA approved for use by children. However, you will not need proof of age to purchase one of these devices.

“PSAP” is an acronym for “personal sound amplification product” and represents a category of devices that have been available for a long time. Before the FDA approved the sale of OTC hearing aids, PSAPs were the only option for consumers who wanted something over the counter, without professional services.

PSAPs were not allowed by the FDA to be labeled as “hearing aid(s).” Also, these devices were severely restricted in power output and customization.

For many years, consumers purchased PSAPs from Walmart and other similar box stores, or online. The brands that were known for manufacturing these devices were not the ones we normally associate with quality audio products. Therefore, the prices for PSAPs generally remain very low; however, the quality also remains quite poor (with only a few notable exceptions).

Though we do not recommend PSAPs for most consumers, we do have a few suggestions for these products on this website worth considering.

At this moment, it is actually quite difficult to know if a device is actually FDA approved as an OTC hearing aid. But here are some tips to help for now.

1. Look at the labeling. If a device is FDA approved, it should be described as being so in the advertising, or somewhere on the packaging. Also, if there is a label saying that the device is not for use by children (or persons under the age of 18 years old)—this is a good sign.
2. Stick with brands you trust. If you see brand names, such as Bose, Sony, Jabra, Samsung, Apple, etc… you are likely getting an authentic product as these companies have a lot to lose if they get slapped with a lawsuit or federal injunction for mislabeling.
3. Check this website! We will be providing updated information on all FDA approved OTC hearing aids hitting the market.
4. Ask a hearing care professional. As a licensed audiologist, I am biased that those in my profession are best suited to help you. But there are many licensed hearing aid dispensers who are not necessarily audiologists who definitely know their stuff. My highest recommendation? Seek an audiologist staffed at a hospital/medical center or university.
5. Make sure you can get at least a partial refund on your purchase if not satisfied. So far, the name brand OTC hearing aids on the market are generally available with a trial period. This is not required by the FDA, but you will find this associated with quality products and ethical sellers.

First, let’s look at what the FDA recommends.

OTC hearing aids are appropriate for consumers at least 18 years old, who perceive a mild to moderate hearing loss, and who do not want to be seen by a hearing care professional.

However, just because OTC hearing aids may be appropriate for you, that does not mean that they are the only option. There are plenty of prescription hearing aids that are perfect for people with mild or moderate hearing loss. The downside is that prescription devices, which typically include clinic service fees, will be more expensive than OTC devices.

The hardest part is knowing whether you have a “mild to moderate” hearing loss.

According to the National Institute on Deafness and Other Communication Disorders (NIDCD), which is available at: https://www.nidcd.nih.gov/health/over-counter-hearing-aids, you qualify for OTC hearing aids if:

1. Speech or other sounds seem muffled.
2. You have trouble hearing when you’re in a group, in a noisy area, on the phone, or when you can’t see who is talking.
3. You have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
4. You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.

Also from the NIDCD: https://www.nidcd.nih.gov/health/over-counter-hearing-aids:

“If you have trouble hearing conversations in quiet settings—or have trouble hearing loud sounds, such as cars or trucks, noisy appliances, or loud music—consult a hearing health professional. These are signs that you might have more severe hearing loss and that OTC hearing aids won’t work well for you. A hearing health professional can help you determine if a prescription hearing aid or other device can help you hear better.”

As mentioned above, OTC hearing aids are for consumers who are at least 18 years old, perceive a mild to moderate hearing loss, and want a device that is sold “direct to consumer,” or without the help of a hearing healthcare professional.

The real difference between OTC and prescription devices can be summarized as: Power, Performance, Price and the Professional.

Power

Probably the single most defining difference between OTC and prescription hearing aids is the power output of the devices.

This is like comparing reading glasses to prescription glasses. Sure, reading glasses can help magnify the text of a book, but there is a limit as to how strong the glasses can be.

According to the FDA, OTC hearing aids have an output limit of 117 dB SPL for aids employing input compression (suppresses loud sounds before being amplified)—without this, the limit is 111 dB SPL. You can find a more detailed explanation directly from the Federal Register here: https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids.

Performance

Since OTC hearing aids are “self-fit,” there is a significant restriction on how complex the calculated outputs can be.

Also, prescription hearing aids generally utilize the most state-of-the-art sound processing to help with comfort and speech understanding in noisy situations.

One of the hallmarks of hearing loss is difficulty hearing in noise. Use of hearing aids has traditionally not helped with this issue. But, for the past decade, prescription hearing aids have evolved and now use fast processors and are running algorithms in real-time to help individuals hear better in both quiet and noisy situations.

OTC hearing aids utilize some of these technologies, but they are currently limited in processing power.

One super beneficial feature available on some OTC hearing aids is their Bluetooth connectivity and rechargeable options. These features do make OTC hearing aids attractive and can greatly increase how individuals use their devices, but they are limited compared to what we generally see in prescriptive hearing aids.

One last point to consider: OTC hearing aids are much less customizable in the way they fit your ears. As an audiologist, I can say that there are just some ears that are difficult to fit devices to and require some level of customization. This may be in the way of a custom ear mold, or an all in-the-ear hearing device. OTC hearing aids are generally “one size fits most” by design.

Price

Most OTC hearing aids have a lower price point than prescription hearing aids. But this is not always the case.

You may be surprised to learn that there are many prescription hearing aids on the market that are competitive with OTC hearing aids.

At present, we are seeing OTC devices costing between $300 to $1000 (or more) for a pair. (This will likely change as more products enter the market throughout the next year or two.)

For a similar, or slightly higher price, depending on the clinic charge structure, an economy set of prescription hearing aids can be obtained that have a higher level of power and performance… as well as improved customization, compared to OTC devices.

Also, prescription hearing aids are dispensed based on a precise hearing test and otoscopic exam (looking in the ear) to verify that ear wax or infection is not an issue. Most audiology clinics also utilize assessments, like REAL EAR, to verify the outputs of the aids in your ears.

Nonetheless, OTC hearing aids do not involve clinic fees and are, overall, less expensive than prescription hearing aids.

The Professional

The role of a hearing healthcare professional goes way beyond “selling” you a hearing aid.

Audiologists and hearing aid dispensers are both licensed by their states to dispense hearing aids based on a set of professionally regulated standards of care.

Most audiologists hold a doctoral degree (Au.D., Doctor of Audiology or a Ph.D., Doctor of Philosophy) in their field and work in a diverse number of settings, from universities, to hospitals, ENT clinics and privately owned practices.

Some audiologists hold additional professional certifications and can bill insurance for hearing and balance assessments, and sometimes for hearing aid related services (depending on the insurer).

Hearing aid dispensers are not academically trained in their field, but they do undergo training as hearing instrument specialists, and carry the credential BC-HIS (which means board certified hearing instrument specialist). Their training is less rigorous, but that does not mean some hearing aid dispensers are not top of their game.

Bottom line is that dispensing hearing aids involves the technical know-how to appropriately set the device outputs to the correct prescription, and to modify that prescription to best suit the patient.

Audiologists typically go further than just dispensing hearing aids. They provide rehabilitation therapy through counseling. This involves training the patient in best practices to improve communication and working with psycho-social issues related to hearing loss, such as social stigma, anxiety, and interpersonal relationships.

Also, as mentioned above, audiologists routinely use REAL EAR assessments to verify hearing aid performance.

The purchase of an OTC hearing aid side-steps the role of the hearing healthcare professional.

This is not necessarily a bad thing as most professionals would prefer a “reluctant” patient to try something they’re comfortable with trying… even if that means trying a “self-fit” OTC device.

OTC hearing aids just might be the beginning of something fantastic for someone who wouldn’t otherwise make an appointment with a clinic.

Yes, hearing aids have the reputation for being way overpriced. And to an extent this is true. However, there is evidence that prescription hearing aid prices have been coming down as there are more options available to consumers than ever before. One of those options is the OTC hearing aid.

Nonetheless, most consumers are confused about hearing aid prices, and this is not their fault as much as it’s the fault of the hearing aid industry. Let’s break it down:

1) Not covered by insurance (usually).

One big reason prescription hearing aids have remained in the “expensive” category is simply because there is little to no financial support from Medicare or private insurers. This includes a lack of support for the cost of the devices as well as many of the services provided by a professional.

For years, audiology and hearing aid dispenser professional organizations have lobbied State and Federal governments to expand coverage for prescription hearing aids and the rehabilitative clinical services provided by these same professionals.

Though we have seen improvements in coverage for children through state Medicaid programs, there are still very few options for adults.

Despite this, more people are indeed getting coverage than ever before; however, the percentage is still around 25% for those who received some support, and only around 5% for those who received full support.

Tip: Check with YOUR insurer to verify if you have coverage or not—as these days you never know until you ask.

In the past ten years there has been a near doubling of insurance options for hearing services provided to consumers in the U.S. Nonetheless, most consumers (around 75%) find themselves paying for devices and professional services out-of-pocket. . Click here for a summary of insurers covering hearing aids and related services by state: https://www.hearingtracker.com/hearing-aid-insurance-coverage.

All this just means that hearing devices and the services to dispense them are generally bundled into a single cost to the consumer. If insurance, especially Medicare, covered hearing aids and/or the services to dispense hearing aids, we would not hear as many complaints about the cost.

2)Supply and demand.

In other words, the people generally interested in obtaining hearing aids are only those people who have a perceived hearing problem. This is just a segment of the larger population (though it is a bigger segment than you might think it is).

Compare this to the iPhone. Just about everyone you know has one (or an Android smartphone). This allows the manufacturers of these devices to operate with smaller profit margins.  Also, the larger scale of production results in decreasing cost per device. And there is more competition in the market as there is a high number of “sellers.”

Hearing aids are high-tech devices that are often “made to order”- at least this is true for custom products- and dispensed by licensed professionals. From an economics point-of-view, this results in a limited market (less competition from relatively small number of “sellers”) and fixed demand.

What is “fixed demand?”

This is when a buyer needs a product or service bad enough to be willing to pay higher than expected prices for it. Fixed demand is one of the many factors driving healthcare costs in the US and many other countries.

Does this make hearing aids “expensive” or “overpriced?”

Simply, hearing aids can be expensive for a few understandable reasons (as mentioned in this article). However, overpricing does happen when a clinic, or “seller,” has access to an affluent community and there is little to no competition from other clinics in the area. In addition to this, the clinics in these “posh” areas may have higher operating costs, resulting in higher prices leveraged against the consumer.

Put simply, the fairest prescription hearing aid prices are found in university clinics and hospital outpatient facilities.

3) Regulation.

Prescription hearing aids are regulated by various agencies that provide consumer protection and ensure licensure of professional audiologists and dispensers.

Regulators include state health agencies, professional associations, and the federal government.

Though this regulation generally ensures that a consumer is being dispensed a safe and effective product by a certified and licensed professional, it does increase the cost significantly.

Audiologists, for example, obtain a four-year doctoral degree from an accredited college or university, then they apply and pay for certification through a professional association, and then they apply and pay for a state license to practice.

This is in addition to the yearly continuing education costs of professionals, malpractice insurance, and the expensive equipment that needs to be purchased just to run a clinic… (among other costs).

Add all of this to the fact that insurance agencies typically do not pay for devices and professional services, and what you get are a bunch of costs all piled on top of the actual hearing aid purchase.

Remember, some of these devices are “made to order.”

Imagine the cost to the manufacturer of building a custom hearing aid, only to have it returned to them for a refund. Generally, it is estimated that returns are less than 20% of all prescription hearing aids sold, nationwide. Nonetheless, that has an impact on cost as the factories who manufacture the aids, as well as the clinics that dispense them, try to recoup some of that lost revenue.

It’s never a bad idea to see a hearing care professional if you have any concerns at all about your hearing, tinnitus (ringing or other noises in your ears) or dizziness.

Conversely, it’s not a bad idea—though there are some exceptions outlined below– to try an OTC hearing aid, either. If you feel motivated to try an OTC hearing aid first, then just make sure you purchase a product from a company that offers at least a partial refund after a generous “trial period.” This should be no less than two weeks—but a longer trial period is even better.

According to the National Institute on Deafness and other Communication Disorders (NIDCD; https://www.nidcd.nih.gov/health/over-counter-hearing-aids), if you have the following problems, you should see a licensed physician [or audiologist] promptly:

• Fluid, pus, or blood coming out of your ear within the previous 6 months.
• Pain or discomfort in your ear.
• A history of excessive ear wax or suspicion that something is in your ear canal.
• Episodes of vertigo (severe dizziness) with hearing loss.
• Sudden hearing loss or quickly worsening hearing loss.
• Hearing loss has fluctuated, getting more and then less severe within the last 6 months.
• Hearing loss or tinnitus (ringing) in only one ear, or a noticeable difference in how well you can hear in each ear.

If you see a physician for any of these problems, it is best to see an Ear, Nose and Throat (ENT) specialist, unless there is not one accessible to you. In that case, a family physician can at least assess whether a referral to an ENT is needed. Some patients start with seeing an audiologist. This is also a good plan as audiologists are trained to identify issues that require ENT assessment.

There are 6 features that you should look for in any quality OTC hearing aid:

This is essential as you do not want to pay money for a device you do not use. If you do not perceive benefit, or you decide that using an OTC device is just not for you… then you should be able to return the device for a refund.

• FDA approved labeling.

This one is a little difficult to assess by external product packaging. However, there should be a substantial amount of information inside the packaging that provides guidance on who is best suited to use OTC hearing aids and when you should consider seeing a hearing healthcare professional.

• A name brand that you trust.

If a name brand company is using the term “OTC” or “Self-fit” hearing aid, then you can generally trust the product is authentic. That does not mean the product is the best one on the market, but at least you can trust it is an actual OTC device and NOT a PSAP.

• Customization (physical fit and sound quality).

Everyone’s ears are different. You should be provided with different options to accommodate small and large ears. This could be a set of domes of different sizes, or receiver wires of different lengths.

Again, check with this website for more guidance on these topics!

• Smartphone compatible app.

An OTC hearing aid is not required by the FDA to be adjustable by a smartphone or tablet; however, there are guidelines established by the FDA for manufacturers who provide these kind of product options. As a consumer you have the option of “fit and go” or “digitally adjustable” OTC hearing aids.

Digitally adjustable devices will be more expensive but will offer more features to the user.

Fit and go devices are just that… You put the aid in your ear and just use it as it is. There may be rudimentary adjustments you can make on the device with a miniature screwdriver tool, but otherwise, there is very little adjustment and customization.

• Beneficial features such as Bluetooth connectivity and rechargeability.

As mentioned, these are not required features on all OTC hearing aids. However, Bluetooth connectivity and whether the aids use disposable batteries or are rechargeable are important features to consider. If these features appeal to you, and the devices are at a comfortable price for you, then you will likely receive an overall better experience with use of these.

Other details to considering when shopping for an OTC hearing aid:

• Online reviews of the products
• Customer care provided by the manufacturer, including remote support
• Product warranty for servicing repairs and/or replacements
• Wild claims by the manufacturer—do not trust a company that claims that their device(s) will restore normal or better than normal hearing
• And, whether you are able to use your Health Savings Account (HSA) and/or your Personal Spending Account (PSA), which are often part of an employer’s healthcare group benefits plan.