OTC Hearing Aids: A Primer for Health Plans

A special series examining the introduction of OTC hearing aids and implications for health plans
Last update on Feb, 20, 2024

Authored By:

Michael Belaen, J.D.

Senior Vice President, Regulatory Affairs & Deputy General Counsel for Amplifon

Michael is responsible for planning, developing, and achieving Amplifon's strategic government relations, regulatory affairs initiatives, and priorities across the Americas.

Entering a new era of hearing care

Hearing health care in the United States has entered a new era. On August 17, 2022, the U.S. Food and Drug Administration (“FDA”) implemented rules allowing for the sale of over-the-counter (“OTC”) hearing aids to adults with perceived mild to moderate hearing loss. Consumers may purchase OTC hearing aids without involvement of a hearing care professional or the need to undergo any sort of objective hearing assessment. 

At Amplifon Hearing Health Care, we believe that the availability of OTC hearing aids has significant implications for health plans and their members. In this article series, our regulatory, clinical, and hearing benefit experts will address key questions, including:

  • What are OTC hearing aids, who are they intended for and what’s the rationale behind them?
  • What are the pros and cons of making OTC products available to health plan members?
  • For health plans that decide to move forward with an OTC hearing aid benefit, how should it be designed and delivered?

The basic facts about OTC hearing aids

OTC hearing aids refer to a new category of air-conduction hearing aids for individuals 18 or older. These devices are specifically intended for use only by adults with perceived mild to moderate hearing loss and can be purchased without consulting any medical professional, such as a physician, audiologist, or licensed hearing aid specialist. The shift to allowing hearing aids to be purchased over-the-counter represents a significant departure by the FDA, which previously rejected calls to create this new category based on safety and efficacy concerns. However, after the FDA Reauthorization Act of 2017 (“FDARA”) was signed into law, the FDA no longer had a choice as doing so was mandated by Congress.

After FDARA was enacted, the American Academy of Audiology, Academy of Doctors of Audiology, American Speech-Language-Hearing Association, and International Hearing Society jointly developed a model regulatory framework to ensure the safety and efficacy of OTC hearing aids. The framework included recommendations for maximum allowable output (volume or loudness), product and package labeling requirements, and strong consumer protections, all of which Amplifon strongly supported. While many of the national hearing care associations’ recommendations were incorporated into the OTC hearing aid regulation, the FDA ultimately rejected the call to limit the maximum amplification of OTC hearing aids to 110 decibels or less. Many leading medical experts expressed concern about this decision, saying that adopting this limitation would ensure users avoid experiencing further hearing loss due to being exposed to overly loud sounds. 


Two Types of OTC Hearing Aids

Ultimately, the FDA’s regulatory changes created two types of OTC hearing aids: self-fitting and non-self-fitting OTC devices. The difference between these two types of OTC hearing aids comes down to the degree of customization of the device in question, as well as the intended use of the device and the marketing claims made by the seller. In essence, self-fitting OTC devices enable the user to adjust or fine-tune the devices to a greater degree, allowing the wearer to program the device to better meet his or her individual needs. Importantly, this type of OTC hearing aid requires the manufacturer to comply with heightened regulatory requirements, including completing clinical studies and obtaining premarket clearance from the FDA prior to bringing the device to market. Non-self-fitting OTC hearing aids, by contrast, typically feature a limited number of standardized amplification settings and offer less ability for the user to customize the device.

In establishing the new OTC category, the FDA sought to make hearing aids more accessible and affordable for consumers. As health plans explore benefits related to OTC hearing aids, it is important to keep the following in mind:

The intent of OTC hearing aids

OTC hearing aids are only intended for adults with perceived mild to moderate hearing loss. As we will explain in the next article in this series, how people perceive their level of hearing loss often varies significantly from what is measured clinically.

Be wary of bad actors

With the advent of the OTC hearing aid category, there is a growing number of unscrupulous actors, particularly online. For example, the Vermont Attorney General filed a lawsuit against an online hearing aid company for allegedly deceptively marketing low-quality hearing aids and PSAPs as high-quality hearing aids, as well as directing its sales staff to persuade dissatisfied consumers into keeping their devices beyond the point when the device could be returned for a full refund.

OTC is not a replacement for prescription devices

As part of the FDA’s regulatory changes, non-OTC hearing aids have been reclassified by the FDA from “restricted medical devices” to “prescription medical devices.” Accordingly, non-OTC hearing aids now require a prescription or other order from a state-licensed practitioner before they can be dispensed to a patient. OTC hearing aids should not be mistaken as a replacement for prescription hearing aids, which are customized and finely tuned by licensed professionals to meet the individual needs of patients. 

Lastly, it is important to remember that while OTC hearing aids may now be purchased without involvement of a hearing care professional, consumers should consider undergoing an objective hearing evaluation prior to using any amplification device to ensure its safety and efficacy. In the next article, we will discuss safety and efficacy concerns raised by professional organizations, providers, medical experts, and even health insurers as it relates to OTC hearing aids. 

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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.

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