Grassley, Warren Express Support For Key Provisions In Proposed FDA Rule On OTC Hearing Aids, Urge Immediate Action

Letter

Dear Acting Commissioner Woodcock:

We are pleased the U.S. Food and Drug Administration (FDA) issued the proposed rule for
"Establishing Over-the-Counter Hearing Aids" (Docket No. FDA-2021-N-0555), as set forth by the Over-the-Counter Hearing Aid Act. We write to urge the FDA to finalize the rule without delay. To ensure the final regulation is consistent with congressional intent, it must not contain any unnecessary restrictions that hinder access to over-the-counter (OTC) devices or their utility for Americans with mild or moderate hearing loss. For these reasons, we strongly support
maintaining the maximum sound pressure level identified in the proposed rule and oppose the
introduction of any limits on gain. In addition, we believe that federal preemption of state laws
governing the servicing, marketing, sale, dispensing, use, customer support, or distribution of
OTC products is necessary to ensure consumers can access these devices without interference, as
the Over-the-Counter Hearing Aid Act established. Maintaining these provisions will ensure that
the final regulation successfully increases competition, spurs innovation, and brings down prices
for consumers, while meeting the high standards of safety, manufacturing protections, and
consumer labeling required of all medical devices.

More than 38 million Americans experience some degree of hearing loss. Older Americans are
particularly affected, with nearly one in three people between the ages of 65 and 753
and around half of adults 75 or older reporting difficulty hearing. Americans with hearing loss are at a greater risk of developing Alzheimer's Disease and Alzheimer's Disease Related Dementias,
and they are also more likely to experience feelings of loneliness and isolation, which the COVID-19 pandemic has only exacerbated. Despite the prevalence of hearing loss, only one in five people who could benefit from a hearing aid use one. One of the primary reasons for this is
cost. Hearing aids are not generally covered by private health insurance plans or traditional
Medicare and can cost thousands of dollars, making them prohibitively expensive for many
Americans.

President Trump signed the Over-the-Counter Hearing Aid Act into law in 2017. This law, based
on our bill with Senators Hassan and Isakson, removes outdated regulations blocking consumer
access to affordable hearing aids and allows certain types of hearing aids to be made available
over-the-counter to Americans with mild to moderate hearing loss. By introducing more
competition into the hearing aid market, the law, once properly implemented, will provide
consumers with more options at a price they can afford.

We write to convey our support for key provisions of the FDA's proposed rule and to ensure that
the final regulation is aligned with congressional intent. Specifically, we agree with the FDA's
proposed maximum 120 decibel (dB) sound pressure level (SPL) for an OTC hearing aid that
implements input-controlled compression and a user-adjustable device volume control. The
proposed 120 dB SPL ensures maximum consumer access to OTC hearing aids, while providing
assurances of safety and effectiveness. As the FDA's proposed rule suggests, such a device
should only reach the maximum permissible limit of 120 dB SPL for a brief period to allow for
maximum effectiveness in certain circumstances (e.g., listening to a symphony) without
distorting the original sound or compromising consumer safety. We agree that the standard set
forth is appropriate based on the guidance from the American National Standards Institute
(ANSI), National Institute for Occupational Safety and Health (NIOSH), National Academies of
Sciences, Engineering, and Medicine (NASEM), and other stakeholder-driven input sessions
described in the proposed rule.

We also support the FDA's conclusion not to include a gain limit for OTC hearing aids,
consistent within NASEM's recommendation in its 2016 report. The maximum output limit of
120 dB SPL already provides a standard for safety and effectiveness to protect the consumer. We
agree that establishing a gain limit will only restrict the ability for innovation and design of an
effective device for people with mild to moderate hearing loss.

Finally, we agree with FDA's proposed federal preemption provisions on state and local
government laws, regulations, orders, or other requirements pertaining to hearing products that
would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support,
or distribution of OTC hearing aids. The Over-the-Counter Hearing Aid Act established clear
lines on federal preemption, and the FDA accurately reflects congressional intent in this
proposed rule. The President's Council of Advisors on Science and Technology's (PCAST) 2015
letter report on hearing loss identified that "complex state regulations restrict the distribution
channels for hearing aids" and recommended that FDA "preempt State requirements that the
OTC devices be sold by credentialed dispensers." They conclude that "the net benefit [of this
approach] to the public would be large and positive." NASEM also advised the federal
government to "preempt any future state laws and regulations seeking to limit over-the-counter
access." We note that this provision is in alignment with congressional intent as it does not
preempt a state or local government's ability to establish or continue in effect professional
licensing requirements.

It has been over four years since the Over-the-Counter Hearing Aid Act was passed into law. We
appreciate President Biden's commitment to promoting over-the-counter hearing aids for
Americans with hearing loss, as outlined in his Executive Order on Promoting Competition in
the American Economy, and we are encouraged that FDA has taken this critical step to finally
issue a proposed rule. As we have written FDA leadership before, we hope to see a final rule that
promotes competition and reflects the best interests of consumers and the public. We ask you
finalize this rule without delay and in a manner that is consistent with congressional intent.

Sincerely,

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