As OTC hearing aids become more popular, it's important to remind ourselves that these devices are often a one-size-fits-all solution and don't offer the necessary follow-ups.

Do You Need A Prescription Hearing Aid Or An Over-The Counter Hearing Aid?

by | May 17, 2023 | Hearing Aids, Patient Resources

In the year and a half since the FDA regulations regarding over-the-counter (OTC) hearing aids were first proposed back in October 2021, the landscape of hearing assistance has significantly changed. This article, updated for 2023, seeks to clarify the ongoing debate around these two types of hearing aids—prescription and over-the-counter—and provide insights on the best option for you.

Since the release of the proposed FDA regulations around over-the-counter devices back in October 2021, there has been confusion around the different types of hearing aids available and which are the better solution.

The confusion has come from OTC devices being labeled “hearing aids”—which has led to traditional hearing aids (medical-grade devices) being described as “prescription hearing aids.”

I want to help local people in our Greensville community understand the two devices now categorized as hearing aids and how you can determine which option is right for you.

What Are Prescription Hearing Aids?

As a society, we look at prescriptions in reference to medication and glasses. We don’t often think about medicating ourselves or allowing ourselves to just fix our eyesight without an exam.

Sadly, hearing is looked at so much differently.

Most people think hearing aids are all about turning the volume up and down, but nothing could be further from the truth. People need to have a proper examination that allows a hearing care professional to understand how they are hearing and understanding speech.

The most important part of a hearing test is understanding how someone processes the information. We focus on the individual’s ability to process speech in noise and how fast they can or can’t understand speech.

It’s so important to have hearing aids that are the correct prescription to focus on the processing speed of the hearing aid. This is so we can focus on the speed of a person’s ability to understand speech.

Comprehensive hearing assessment

What Are Over-the-Counter Hearing Aids?

Treating OTCs like prescription hearing aids is similar to getting a pair of cheaters at CVS and expecting them to work just as well as prescription lenses.

In the time following the FDA’s decision, numerous OTC hearing aids have flooded the market, creating an environment of overwhelming choice and variances in quality.

When you purchase OTCs it’s down to you to ensure they fit right and are adjusted to your needs—which is not possible without a comprehensive hearing assessment with an audiologist.

Key Differences Between Prescription and OTC Hearing Aids

The crucial difference between prescription hearing aids and over-the-counter hearing aids is about giving people options.

The key to all of this is for us to make sure individuals are aware that hearing aids are not created equal.

In the rapidly changing landscape of hearing aid technology, it’s important to keep in mind that while OTC devices offer a degree of convenience and affordability, they cannot provide the comprehensive, personalized care and ongoing support that prescription devices can offer.

It’s essential to trust the professionals and not forget that when we get hearing aids, they need to be maintained. More importantly, the individual needs to know how the hearing aids work for them.

We need them to see how much better they can hear and understand. The value of devices is understanding how we can have a better quality of life if we have the right technology for us.

In my opinion, working with a professional is the difference between the two devices. I have seen many patients become frustrated with the lack of support they receive from their OTC company—support that was promised and then not delivered.

Types of OTC Hearing Aids

There are two types of OTC hearing aids: self-fitting and non-self-fitting. 

Self-fitting devices

Self-fitting devices can be programmed to suit the user’s hearing needs, often through an online hearing test provided by the manufacturer or on an app.

Non-self-fitting OTC hearing aids

Non-self-fitting OTC hearing aids come with volume control and a few predetermined settings.

FDA Regulation

The FDA regulates OTC hearing aids.

  • For self-fitting devices, manufacturers must demonstrate to the FDA that the hearing aids have been
  • tested and shown to be safe (with volume control and output limits, for example) and effective for
  • adults with mild to moderate hearing loss.
  • Non-self-fitting OTC hearing aids must be registered with the FDA, but device makers are not required
  • to demonstrate that the devices are safe. The registration is essentially a claim that the device meets FDA standards.

Cost of OTC Hearing Aids

Despite being less expensive than prescription hearing aids, OTC hearing aids are still pricey, starting at about $500 to $1,000 per pair. It’s expected that as more technology emerges, prices might become more competitive.

Who Are OTC Hearing Aids Suitable for?

OTC hearing aids are intended for adults with perceived mild to moderate hearing loss. This category typically includes those who do well in one-on-one conversation in a quiet environment but have difficulty hearing with background noise, at a distance, or in a lecture hall. More challenging hearing loss issues should still warrant a visit to the doctor.

Buying OTC Hearing Aids Requires Research

Despite the ease of obtaining OTC hearing aids, they still represent a significant investment. Thorough research should be undertaken before purchase, comparing device models, features, and prices. It’s also important to consider your ability to operate the aids, and whether you’d prefer preset functions or the ability to make all adjustments yourself.

In any case, be sure to check whether the model you’re considering offers customer support and a trial period to ensure it’s the right fit for you.

How Do I Know Which Option Is Right for Me?

We need to educate people on the difference in technology that is out there. OTC devices have been out for many years. The problem is that most people either:

  • Don’t realize that they have a hearing problem
  • Think that all they need is a simple device to fix the issues

Individuals need to understand that there are major medical connections associated with hearing loss, such as memory loss and balance issues.

Hearing loss is a major medical concern that is not discussed enough. Most people want the OTC since they don’t realize the true implications of their hearing loss. We stand to lose a lot if this is not addressed properly.

I always say the follow-up is more important than the fitting. We need to stay on the lookout for any changes to the patient’s prescription and do everything we can to preserve the way that they are functioning.

As OTC hearing aids become more popular, it’s important to remind ourselves that these devices are often a one-size-fits-all solution and don’t offer the necessary follow-ups.

When you purchase OTCs, there is no follow-up visit.

You’re on your own to figure out how to make the devices work for you, which is impossible without a comprehensive hearing assessment and a hearing care professional to adjust the devices based on your test results.

The First Step Is to Get a Hearing Assessment Done

The key to solving a problem is to understand the problem first so that you can resolve it properly. Doing an online hearing test is like getting half the information and making a decision on half the information.

In the era of advanced technology and internet accessibility, it might be tempting to self-diagnose via an online hearing test. But let’s remember, this can never replace a comprehensive, in-person assessment by a trained professional.

I have learned over the years that best practices in regard to testing and verification of how hearing aids are working is critical. Online tests may be close to getting a person’s understanding of sound, but it doesn’t help to translate how the brain is processing what we hear.

You cannot get that from an online test.

How much does a person need to lose when self-diagnosing the loss they have? It’s really scary, as people will realize that they made the wrong choice. As they lose more hearing, they’ll have more trouble with brain fatigue, brain fog, and cognitive concerns as well as balance issues.

Should I Get an OTC Before a Prescription Hearing Aid?

When in doubt, don’t do anything until you know the truth and are aware of what is really going on with your auditory system.

Hearing loss is not just about lack of hearing; it is more about why your brain is not working well. Could it be that you’re not hearing well because your brain and your ears are not communicating as they should be?

People just need their loss to be explained to them and view this from a medical standpoint as opposed to thinking they just need amplification.

Hearing aids are great if they are the right technology and programmed properly for the individual. There’s a reason why an audiologist goes to school anywhere from six to seven years and has a doctorate in audiology.

Getting the information you need to make that decision all starts with a comprehensive hearing assessment. You can schedule online or give us a call to book or chat further about your hearing.

Education about hearing loss is key. Knowledge is power. If you’re confused, then find someone who will take the time to explain what is wrong. You’re worth it. It is not about the quantity of life but the quality.

Do you know somebody that needs to see this? Why not share it?

Daniel Hewson, M.S. Audiology/Owner

Born and raised in Western New York, Dan Hewson comes to our practice with over 25 years of experience in the field. With a master’s degree in audiology from SUNY Fredonia, Mr. Hewson has extensive experience working in several of the largest Otolaryngology practices in the country, and also as a Regional Manager with Siemens Medical Audiology Division. Father, husband and full time employee with us, Dan is currently a student working to earn his doctorate in audiology. Dan was naturally attracted to the field of audiology because he grew up with moderate to severe sensorineural hearing loss. He has followed hearing aid development, research and rehabilitation. If you want to know what hearing impairment is really about and how hearing devices can change your life, Dan Hewson is the one to ask. He’s been wearing hearing aids since childhood (44 years) and has an intimate understanding of the hearing impaired. His personal hearing device story is fascinating and illuminating for anyone, but especially for those who may be hesitant about the hearing rehabilitation process.

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