OTC Hearing Aids: A Primer for Health Plans

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?

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. 

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.

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.