What Are Prescription Hearing Aids And How Are They Different To Over-the-Counter Devices?

01/20/2022 | Hearing Aids, Industry News, Patient Resources, Technology

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For years, we have been referring to all hearing aids simply as “hearing aids.”

Recently, President Biden has made an executive order to allow another category of hearing aids to be made available to all Americans. This new type is called an “over-the-counter” hearing device.

The Over-The-Counter Hearing Act of 2017 sought to amend the FDA categorization of certain hearing aids. The FDA was provided three years to implement rules and regulations that address which hearing aids would fall under this category.

Unfortunately, due to COVID-19, the FDA was delayed in issuing its guidance.

In 2021, President Biden issued a new executive order to pressure the FDA to finalize the regulation. During this time, many new companies have popped up across the internet selling personal sound amplifiers that they call “hearing aids.”

While the FDA has issued statements stating this is illegal, they have done nothing to stop these predatory practices on consumers.

Prescription Hearing Aids vs. Over-The-Counter Hearing Devices

The term “prescription hearing aids” was created to help the consumer understand the difference between purchasing a hearing aid online or in a store (OTC) versus buying a hearing aid ordered by an audiologist from a reputable hearing aid manufacturer (prescribed hearing aid).

Over-The-Counter (OTC) Hearing Devices

These are not regulated by the FDA, which means there are no standards in regard to power/gain, output limitations, harmonic distortion, or input noise.

There are very limited adjustments to the sound quality that can be made by the end-user. For many consumers, if the device doesn’t work adequately out of the box, their hearing can’t be improved.

Some OTC devices come with an application that allows the end-user to program in their hearing loss and provides for better customization.  However, these devices can be just as expensive as prescription hearing aids.

Prescription Hearing Aids

Prescription hearing aids are devices that require the knowledge and skill of an audiologist to be fitted appropriately.

They are ordered by the audiologist to come with the appropriate gain and output that is tailored specifically to the patient’s hearing loss. Information needed to make an accurate diagnosis is obtained via a comprehensive hearing assessment.

There are many adjustments that can be made while using speech mapping or Real Ear Measurement to precisely dial-in the device to the patient’s prescriptive hearing loss.

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Which Is The Best Option For You?

OTC devices are primarily targeted at patients who need a slight enhancement in their hearing or already know they have a mild hearing loss.

If you find yourself turning up the television or turning up the volume on your cell phone, then an OTC may be right for you.

But, if you are:

  • Turning things up and the sound isn’t getting any clearer
  • You notice that you have to use the speakerphone to understand speech
  • You’re struggling with background noise

Then a prescription hearing aid will be better suited for your needs.

Do You Need To Visit An Audiologist To Get An OTC?

The main reason to see an audiologist prior to purchasing an OTC is to save you money in the long run. An audiologist will rule out whether your hearing difficulties are simply due to earwax or fluid behind the ear, which are both easy to remedy.

Once you have a comprehensive hearing evaluation done, the audiologist can help you pick an OTC that will work with your individual needs, and you will have accurate hearing test results to load into your OTC if that is an option.

Finally, after receiving your OTC, an audiologist can discuss care and maintenance as well as verify that the device meets your hearing targets.

Confused About Your Options?

There are literally hundreds of hearing enhancement products being pushed online and at large retail chains. Many of them cost as much if not more than a basic prescription hearing aid. 

If you’re unsure of which to choose, that is an indication to come in and discuss your individual needs with us. 

Have your hearing tested to ensure that an OTC will even be appropriate for your level of hearing loss prior to spending the money. Many times, a basic prescription hearing aid will be more effective, cost less, and have the professional guidance of an audiologist.

This is especially true when working with a clinic that has an unbundled pricing model such as Flex Audiology.  If you’ve already purchased an OTC, bring it to your appointment so your audiologist can help you navigate how to use it safely, verify its effectiveness, and review maintenance as needed.

As always, if you have any questions, please give us a call and one of our professionals will be happy to assist you. 

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Dr. Person Au.D, CCC-A

Dr. Person has been a private practice owner since 2005. She currently specializes in hearing aids, tinnitus management and vestibular diagnostics, while operating in an unbundled service delivery model. Dr. Person is the host of The Unbundled Audiologist podcast. She serves as the incoming VP of Audiology for ISHA for a three year term. Her greatest accomplishment is creating a life where she can serve others while still spending quality time with her husband and two small children.