October 20, 2021 – The U.S. Food and Drug Administration (FDA) yesterday proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids in the category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist.
Although nearly 37.5 million American adults report some trouble hearing, but about one-fifth of people who could benefit from a hearing aid use one, the FDA says.
The proposed rule aims to address barriers to use, including cost, access, social stigma related to hearing loss, perceived value of the devices or certain state and federal regulations.
“Reducing health care costs for everyone in America is a top priority,” said Health and Human Services (HHS) Secretary Xavier Becerra. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”
The FDA says that the proposed rule will “increase competition in the market while also ensuring the safety and effectiveness of OTC and prescription hearing aids.”
The rule aims to facilitate innovation and increase competition by lowering the barriers to entry for new hearing aid manufacturer, the agency claims.
The proposed rule would also amend existing rules that apply to hearing aids for consistency with the new OTC category, repeal the conditions for sale for hearing aids and address state regulation of hearing aids.
To ensure patient safety, the proposed rule also addresses a maximum output (volume) limit for OTC hearing aids that would prevent injuries from overamplification of sound. In addition, the proposed rule includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits (how quickly an OTC hearing aid processes, amplifies and relays a sound), the range of frequencies that the device can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids.