Following a federal law passed in 2017 directing the U.S. Food and Drug Administration (FDA), hearing aids were expected to be available over the counter (OTC) as early as August 2020.

However, due to the global pandemic, the FDA hasn’t put forth any guidelines for OTC hearing aids – so these devices are still not classified as medical hearing aids.

Once the law is eventually passed, consumers will be able to buy hearing devices without visiting a professional, without any follow-up care, and without even having their hearing properly tested.

The new over-the-counter devices will cost much less than traditional hearing aids as they can be self-adjusted without the need for a hearing professional.

Why Are Over-The-Counter Hearing Aids Happening?

Congressional leaders and other politicians approved the OTC Hearing Aid Act with the intention of making amplification more accessible to those in rural areas and those that have found traditional forms of amplification cost-prohibitive.

What Are These Devices?

A hearing aid, by definition, is a medical device.  Hearing aids are federally regulated, and the professionals fitting the devices are licensed by state agencies.

In addition to licensing from state agencies and Master’s or Doctoral degrees, audiologists obtain further certifications from national boards and associations. Audiologists provide a level of care reflecting the continuing education, experience, and qualifications needed to satisfy state and federal requirements.

A Personal Sound Amplifying Product, or PSAP, amplifies ambient sounds. PSAPs are not actually meant for those with hearing loss.

These were originally made for hunters so that they could hear more sounds around them. But, many people are now using these as a low-cost stand-in for hearing aids.

An Over-The-Counter Hearing Aid would, conceivably, provide the consumer with a low-cost device (similar to the PSAP) and meant for those with hearing loss (similar to a hearing aid).

What Will Over-The-Counter Hearing Aids Be Like?

The Over The Counter Hearing Aid Act was signed into effect in 2017. This legislation tasked the FDA with redefining “hearing aids” and allowing a single manufacturer to begin working on possible devices to present to the FDA.

It is important to understand these devices will likely be less like a hearing aid and more like a personal sound amplifier. The challenge with OTC devices is there are no regulations for them, and there are no definitions for what they should actually be.

So far, what we have seen is when OTC Hearing Aids exist, it will be meant for those with a mild hearing loss and be a self-fit device. This puts the responsibility of appropriate fitting on consumers alone.

Hearing Aids and Glasses: A Comparison

I personally wear glasses; however, rather than selecting the lens type and strength, I went to an Optometrist. There, I was able to have a vision test, and licensed professionals helped make sure that I’m getting the best vision possible.

Purchasing Over-the-Counter hearing devices would be like buying a random pair of glasses and fitting them yourself without any meaningful eye test.

However, after the second fittings, follow-ups, and on-ear verification measures like “Real-Ear,” the audiologist can ensure the wearer receives between 90-100% of what the hearing loss requires.

Self-fit devices like PSAPs (not meant for hearing loss) and OTC Hearing Aids only reach about 50-60% of the prescription for hearing loss.

The more severe the hearing loss, the poorer the performance of the self-fit devices.

My Biggest Concern With Over-The-Counter Hearing Aids

People who have worn hearing aids in the past will find these devices provide limited benefits compared to their previous traditional hearing aids.

While the OTC Hearing Aid Act intends to provide amplification options sooner to those that would otherwise not seek hearing help, there is a potential backlash.

If a consumer’s first foray into amplification is with an OTC hearing aid of limited benefit, the potentially negative experience of amplification could be off-putting.  This can extend the number of years a consumer may wait to seek the help of a trained audiologist.

OTC Hearing Aids could lead consumers to believe that “hearing aids don’t work for me” or “I’ve tried them before, I’m not eager to try again.”

It is anticipated, though, meant for only a mild hearing loss; OTC hearing aids will be marketed to consumers with any degree of hearing loss. Poorly fit devices could lead to 1 of 2 outcomes for consumers.

An early adopter of self-fitting technology may think, “It’s okay…” or “It’s fine, but it’s not getting me where I’d like to be.  I need to seek more professional hearing health care.” Or, more concerning, a reluctant consumer could be dissuaded from all hearing devices in the future. This consumer may continue for years without the help they need.

Over-The-Counter Hearing Aids: Not All Bad

It is possible Over-The-Counter Hearing Aids can have a positive impact on the hearing industry as a whole.  By providing a lower cost and easily accessible option for hearing devices, conversations about hearing loss and hearing aids will likely occur more frequently.

The new advancements in hearing technology such as Bluetooth and streaming to wireless accessories increase awareness and expand conversation topics beyond amplification.

Increasing the conversations surrounding hearing decreases the stigma of hearing aids. And so, the introduction of OTC devices may reduce the stigma of hearing aids a bit more, making hearing loss and hearing devices a more open conversation.

Over-The-Counter Hearing Aids are something new. As audiologists, our goal is to be knowledgeable about the industry and all forms of hearing devices.

Audiology is always changing, and the audiologists at North Houston Hearing Solutions are here to help guide you to the right solution.  

If you have a question or would like to schedule a hearing assessment, please call us at 281-444-9800.

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Dr Kathryn Crane

Dr. Kathryn Crane, CCC/A, CH-AP, Doctor of Audiology, joined North Houston Hearing Solutions in February 2021. Dr. Crane graduated with a Bachelors in History and a Bachelors in Communication Sciences and Disorders from The University of Texas at Austin and received her Doctorate of Audiology in 2014 from Louisiana State University-Health Sciences Center in New Orleans, Louisiana. Dr. Crane joins North Houston Hearing Solutions after many years at a large ENT practice in the Memorial area of Houston. She has developed significant experience and skills in comprehensive diagnostic audiometry and in the fitting of hearing devices. Though not a native Houstonian, Dr. Crane is a native Texan having grown up in Dallas, Bryan, and Austin. She has lived in Houston since 2013 and considers Houston home.
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