OTC Hearing Aids: Examining the Pros and Cons

A special series examining the introduction of OTC hearing aids and implications for health plans
Last update on Feb, 22, 2024
Carrie Meyer, Au.D.

Authored By:

Carrie Meyer, Au.D.

Director of Clinical Programs for Amplifon Hearing Health Care

Dr. Meyer is an audiologist and oversees utilization management and quality initiatives. Her focus is on using clinical best practices to improve member outcomes and increase member satisfaction.

First OTC article

The pros and cons of OTC hearing aids

Over-the-counter (OTC) hearing aids can be a unique opportunity for health plans and their members. The broader availability of OTC hearing aids without the requirement of a prescription from a licensed professional may increase access to hearing health care while driving down costs for health plans and members. However, it may not be that simple. 

Americans need access to hearing health care

An estimated 40 million Americans experience some degree of hearing loss, yet hearing loss is widely undiagnosed and untreated.[1] In fact, only about one-third of individuals who could benefit from hearing aids wear them.[2]

Man at resturant wearing hearing aid

Even more concerning, research has shown untreated hearing loss is a risk factor for costly, life-altering health conditions, including dementia, depression, and falls with injury.

The availability of OTC products could contribute to an increased awareness of the importance of hearing care — and perhaps even boost the adoption of hearing aids — helping to fill the country’s hearing health care gap. 

Additionally, because a prescription isn't required, OTC hearing aids may be available for purchase in retail locations and online, giving consumers a convenient way to access these devices. This added convenience can be especially important in rural areas or communities with limited access to hearing care providers. OTC hearing aids may also be perceived to cost less than prescription hearing aids, potentially encouraging more consumers to address their hearing loss. But consumers need to be aware of the drawbacks of OTC hearing aids.

Potential pitfalls for health plans and members

In evaluating OTC hearing aids and possibly offering an OTC benefit, health plans need to consider the following:

Hearing loss self-diagnosis

Just 9% of consumers could identify “normal” hearing,[3] and 76% were unable to accurately identify their level of hearing loss without professional help.[4] By contrast, 93% of adults aged 50-80 could correctly identify “normal” vision.[5]

Hearing aid selection

Because self-diagnosis is difficult, members may not choose the hearing aids that best match their hearing loss and lifestyle needs. OTC hearing aids have limited flexibility to adjust the hearing aids to match individual communication needs. More importantly, someone who buys OTC products may actually need prescription hearing aids.

Safety concerns

Many OTC hearing aids currently on the market are not properly registered with the FDA and may be personal sound amplifying products (PSAPs) disguised as OTC hearing aids. With basic amplification such as PSAPs and even with OTC hearing aids, improper use could cause over amplification and an increased risk of further hearing loss.


The retail price for OTC products ranges from approximately $200 to more than $3,000 per device. This wide price range raises significant questions: Without the assessment and recommendation of a hearing care professional, can the average consumer select an appropriate OTC hearing aid for their hearing loss? Would a member who is considering a higher priced option be better served with similarly priced, professionally fit prescription hearing aids?

Member satisfaction

Research shows that satisfaction with hearing care is directly tied to consistent hearing aid usage.[6] Selecting the wrong hearing aids or not programming them correctly will likely result in decreased usage and diminished member satisfaction. In addition, members who don’t wear their hearing aids regularly (or at all) will continue to live with untreated hearing loss and its inherent health risks.

Fraud, waste and abuse

An OTC hearing aid benefit without support and the proper controls can be costly to the member and the health plan. For example, members with hearing aids that don’t meet their needs could be wasting their money and health plan funds or could be using their benefit to obtain hearing aids for a friend or family member.  

Keeping these potential risks in mind, health plan leaders should understand that FDA rules allowing the sale of OTC hearing aids provide the opportunity to offer an OTC hearing aid benefit. Health plans who decide to make OTC products available to their members should proceed with great care and deliberation, as we’ll discuss in the next article.

A woman in a garden wearing a hearing aid

On-demand OTC hearing aids webinar

Amplifon experts shed light on key decisions, from the pros and cons of making OTC hearing aids available to your members, to best practices in designing and delivering an OTC hearing benefit.

[1] https://www.nidcd.nih.gov/health/noise-induced-hearing-loss

[2] https://hearingreview.com/uncategorized/marketrak-10-hearing-aids-in-an-era-of-disruption-and-dtc-otc-devices-2

[3] https://pubmed.ncbi.nlm.nih.gov/35061637

[4] https://hearingreview.com/inside-hearing/research/implications-counter-approach-hearing-healthcare-consumer-study

[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8843398/

[6] EuroTrak UK 2018, BIHIMA

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