FDA Clears Way for OTC Hearing Aids for People with Mild to Moderate Hearing Loss

The new rules for OTC hearing aids are designed to make amplification devices safe, affordable, and convenient to purchase over the counter and online.

The US Food and Drug Administration today finalized its rules for the creation of a new class of over-the-counter (OTC) hearing aids that is designed to make amplification more affordable and accessible to consumers (ages 18+) with mild to moderate hearing loss. Five years in the making, these new rules provide a path for consumers to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting by a licensed hearing care provider.

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The new class of products will make self-fitting hearing aids more widely available in pharmacies, retail outlets, and online without the requirement of visiting a licensed hearing care professional.

There are about 30 million people in the United States—about 1 out of every 8 adults—who have hearing loss in both ears. A majority have what is considered “mild or moderate” hearing loss and experience hearing problems only in difficult listening situations, like crowded restaurants or bars, or when someone is speaking from a distance. The FDA wants to create a smoother process to get these people the amplification and audibility they need at an earlier stage in their lives, and that involves providing more options besides professionally dispensed hearing aids.

According to the FDA, “the final rule aims to stimulate competition and facilitate the sale of safe and effective OTC hearing aids in traditional retail stores or online nationwide, providing consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.”

A 2018 HearingTracker survey showed that professionally dispensed hearing aids in the United States average around $2400 each, with little to no assistance from private health insurance. Hearing aids are expressly excluded from Medicare. It should be mentioned that there have been some good affordable hearing aid and hearable options available in recent years ranging from $300-1500, in addition to affordable medical-model hearing aids offered by big box stores.

 The new FDA rules limit how loud OTC hearing aids can be, how deeply they can be inserted into the ear canal, and define performance and design standards—which should raise the standard of product quality and help unsuspecting consumers avoid low quality products that are flooding the market today. The rules also call for clearer labeling and packaging instructions so consumers can make safer and better-informed choices on their hearing health.

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The FDA rule distinguishes between two types of OTC hearing aids: a simpler "wear and go" type that offers a volume control and possibly some pre-established settings to choose from, and a more sophisticated "self-fitting" type that relies on a computer and/or mobile phone app, as well as possibly a hearing screening test, that helps personalize the device for your unique hearing loss and also includes a volume control.

The FDA’s OTC hearing aid rule has taken over 5 years. Original OTC Hearing Aid legislation was first passed by Congress and signed by President Trump in August 2017, and it gave FDA a full 3 years to craft the rules, with a deadline of August 2020. However, Covid-19 consumed the FDA’s resources with an “all-hands-on-deck” response to the pandemic, creating a large backlog of approvals and work for the Agency.

FDA issued its proposed rules in October of last year, but as time passed, Congress and the Biden Administration’s patience wore thin. Senators Elizabeth Warren (D-MA) and Chuck Grassley (R-IA), as well as other members of Congress, wrote several letters and even introduce a bill calling out the missed deadlines, as well as a report critical of hearing industry lobbying, in intention of speeding up the process.

Ultimately, the hope is that OTC hearing aids will get amplification into people’s ears much sooner. Previous studies suggest that consumers wait on average 7-10 years before purchasing a hearing aid. Increasing evidence points to how untreated hearing loss is an expensive and debilitating healthcare problem that increases the risk of dementia, negatively impacts general health, increases falls and injuries, degrades aspects of memory and cognitive function and overall quality of life, places burdens on marital/conjugal relationships, negatively impacts income, and is also linked to a variety of chronic illnesses.

It is hoped this new class of OTC hearing aids will allow people to experience better hearing and communication earlier in the aging process, and to seek help from trained hearing care providers should these new devices not work for them and/or their hearing loss becomes more severe or problematic.