OTC Hearing Aids: Designing and Delivering an OTC Benefit

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

Authored By:

Scott Kosinski

Vice President of Sales & Account Management for Amplifon Hearing Health Care

Scott leads the national sales and account management teams responsible for building long-term strategic partnerships with health insurance plans, unions, workers’ compensation organizations, and large employers.

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OTC hearing aid benefits

At first glance, over-the-counter (OTC) hearing aids may seem like a straight-forward proposition for health plans and their members. Specifically, the latest U.S. Food and Drug Administration (FDA) rules — coming 50 years after the last federal regulations — allow consumers to obtain OTC hearing aids without professional involvement, making hearing care potentially more accessible and less costly.

However, a closer examination reveals both pros and cons associated with OTC hearing aids and offering an OTC benefit.

On one hand, health plans can make hearing care more accessible to their members. For Medicare Advantage plans, in particular, an OTC hearing aid benefit may enable them to attract and retain more members. 

But there are potential pitfalls as well. Without a hearing care professional’s involvement, for example, individuals may misdiagnose their hearing loss, resulting in OTC hearing aids that do not meet their needs and end up not being worn. Other concerns include the safety of OTC hearing aids and the potential for fraud, waste and abuse. (Click here for a more in-depth look at the pros and cons.)

For health plan leaders who determine that the pros outweigh the cons, the question becomes “How do we design and deliver an OTC benefit that’s an asset to our health plan while building in protections for our members and our organization?”

Moving forward: crucial considerations

First of all, we believe that offering an OTC benefit is not a one-size-fits-all approach for health plans and their members. Health plan leaders should consider their population's health needs and circumstances in addressing the following criteria:

Benefit design

One path is to integrate OTC devices with the supplemental prescription hearing aid benefit. Another path is a stand-alone OTC benefit. Alternatively, plans can simply provide access to a discount program for OTC devices.

Member safety and efficacy

Ensure that the OTC benefit only includes products properly registered with the FDA and that members receive high-quality support, when needed

Delivery model

Ship OTC hearing aids to the clinic for professional involvement and/or directly to the member’s home, where permitted by law

Dispensing criteria

Make it optional or mandatory for members to receive an in-clinic or virtual hearing test to validate hearing loss compatibility with OTC hearing aids

Aftercare services

Maintain quality of care to ensure long-term success with regular hearing aid use by members and satisfaction with the hearing benefit

Recommendations and best practices

Amplifon Hearing Health Care has been planning for the rollout of OTC hearing aids since 2017. Our proactive approach has included advocating for consumer safeguards and developing virtual services to support members with OTC and prescription hearing aids.


While the FDA does not require health plans to offer OTC hearing aids, here are four key recommendations for those considering the option:

Implement safeguards

Implement safeguards to protect members. We advise health plans to start with a well-designed offering that includes select OTC products evaluated by a clinical committee experienced in managed hearing health care. We also recommend requiring, at minimum, an online hearing test to ensure OTC products are compatible with the member’s hearing loss. Also, keep in mind that 91% of adults 50 to 80 years old cannot correctly identify “normal” hearing.[1]



Establish coverage criteria

Establish coverage criteria that requires some level of professional involvement, especially for first-time hearing aid wearers, while maintaining convenient access to OTC hearing aids. Ship-to-clinic should be the primary option, with ship-to-home used sparingly (e.g., for members who purchase through an OTC vendor or live in rural areas). Health plans can elevate quality of care through other benefit features, such as virtual visits with a remote care team and making an optional aftercare package available to members for purchase. These measures will help promote regular hearing aid usage — a key contributor to positive health outcomes and consumer satisfaction with hearing care.[2]

Mitigate risks to the health plan

Act to mitigate risks to the health plan. For example, a carefully designed OTC product offering not only reduces the risk of hearing damage from overamplification, but it protects the health plan from possible litigation. In addition, health plans can prevent fraud, waste and abuse through a controlled delivery model, professional evaluation, validated online assessments and other measures. Health plans must also educate members on the unethical and even illegal practices occurring in the marketplace, such as the sale of products labeled as “hearing aids” without meeting FDA requirements.

Educate members about OTC hearing aids

Educate members about OTC hearing aids and their limitations, especially compared to prescription hearing aids. Unlike other benefits, such as vision or dental, hearing benefits are not widely understood by health plan members, so answers to their questions and ongoing support are very important. Be sure to stress the importance of professional involvement in the hearing care journey and the benefits of consistent hearing aid use.

Now is the time to carefully weigh the potential value of an OTC offering for your members. Amplifon can help you evaluate if an OTC hearing benefit is right for your plan.

Woman wearing hearing aid having coffee with a friend

Looking for more?

Visit the link below for more details about recommendations and best practices for OTC hearing aid benefits as well as links to the first two articles in this series and our on-demand webinar.

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

[2] EuroTrak UK 2018, BIHIMA

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