[Ohio-Talk] For Those Of Us With Multiple Disabilities

[Maggie Stringer]

FDA Issues Proposed OTC Hearing Aid Rules
Oct 19, 2021 | Over the Counter, Regulation |

The US Food and Drug Administration (FDA) has issued “a landmark proposal
intended to improve access to and reduce the cost of hearing aid technology
for millions of Americans,” according to the agency’s press release. The
agency proposed a rule to establish a new category of over-the-counter
(OTC) hearing aids that, when finalized, is designed to allow hearing aids
within this category to be sold directly to consumers in stores or online
without a medical exam or a fitting by a hearing care professional. The
proposed rule is intended to help increase competition in the market while
also ensuring the safety and effectiveness of OTC and prescription hearing
aids, according to the agency.

The proposed rules are to be officially published in the Federal Registry
October 20, 2021; a PDF is available here. This is to be followed by a
90-day commentary period at https://www.regulations.gov.

To ensure patient safety, the proposed rule 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.

To coincide with the proposed rule, the FDA also issued an updated draft
guidance, Regulatory Requirements for Hearing Aid Devices and Personal
Sound Amplification Products (PSAPs). The draft guidance describes hearing
aids, PSAPs, their respective intended uses and regulatory requirements
that apply to both types of products. The draft guidance is intended to
provide further clarification regarding the differences between PSAPs,
which help people with normal hearing amplify sounds, and hearing aids and
to inform consumers that PSAPs are not considered OTC alternatives for
hearing aids.

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. The OTC
category, when finalized, would apply to certain air-conduction hearing
aids intended for adults age 18 and older who have perceived mild to
moderate hearing loss. Hearing aids for severe hearing loss or for users
younger than age 18 would be prescription devices.

Today’s action follows President Biden’s July Executive Order on Promoting
Competition in the American Economy, which called for the FDA to take steps
to allow OTC hearing aids. This effort also builds on the Biden-Harris
Administration’s goal of expanding access to high-quality health care and
lowering medical care costs for the American public.

“Reducing health care costs for everyone in America is a top priority,”
said Health and Human Services 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.”

Approximately 15% of American adults (37.5 million) age 18 and over report
some trouble hearing. However, despite the high prevalence and public
health impact of hearing loss, only about one-fifth of people who could
benefit from a hearing aid use one. 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.

Many hearing aids can be expensive. The rule aims to facilitate innovation
and increase competition by lowering the barriers to entry for new hearing
aid manufacturers. Under the proposed rule, hearing aids would be sold over
the counter in more traditional brick-and-mortar retail stores or online
(rather than doctors’ offices or specialty retail outlets) and will likely
be less expensive than those currently sold – giving consumers greater
choice at lower prices.

The proposed rule implements a key provision of the Over-the-Counter
Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017.
President Biden’s Executive Order on Competition included a timeline for
action, and the FDA has now issued the proposed rule ahead of that
schedule.

“Hearing loss has a profound impact on daily communication, social
interaction and the overall health and quality of life for millions of
Americans,” said Acting FDA Commissioner Janet Woodcock, MD. “The FDA’s
proposed rule represents a significant step toward helping ensure that
adults with mild to moderate hearing loss have improved access to more
affordable and innovative product options. The new regulatory category will
provide the public with greater control over their hearing aid purchasing
decisions at stores nationwide or online without the need for a
professional hearing exam, fitting adjustment or a prescription.”

Source: FDA

Maggie Stringer
Phone: (443) 750-0070
Email: ravensfan784 at gmail.com
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