Van Hollen, Warren and Grassley urge FDA to finalize over-the-counter hearing aid rule without delay

February 15, 2022

U.S. Senators Chris Van Hollen (D-Md.), Elizabeth Warren (D-Mass.), and Chuck Grassley (R-Iowa) sent a letter to Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration , expressing support for the key provisions of the FDA’s proposed rule to regulate over-the-counter (OTC) hearing aids. The rule proposed by the FDA is the direct result of the Over-the-Counter Hearing Aids Actwhich lawmakers helped pass with broad bipartisan support in 2017.

The comment period on the FDA’s draft rule ended on January 18, 2022. With the public comment period now closed, the senators call on the FDA to finalize the rule without delay and in a manner consistent with the intent of Congress. Once published, the final rules will come into effect after 60 days. The senators urge the FDA to rule out any unnecessary restrictions that hinder access to over-the-counter devices or limit their effectiveness for Americans with mild to moderate hearing loss.

“Maintaining these provisions will ensure that the final settlement will successfully increase competition, spur innovation and lower prices for consumers, while meeting high standards of safety, manufacturing protection and consumer labeling. required for all medical devices”, wrote the lawmakers.

The letter was also signed by Senators Patrick Leahy (D-Vt.), Marsha Blackburn (R-Tenn.), Maggie Hassan (DN.H.), Rick Scott (R-Fla.), Lindsey Graham (RS. C.), Bernie Sanders (I-Vt.), Kevin Cramer (RN.D.) and Rand Paul (R-Ky.).

Over 38 million Americans suffer from some degree of hearing loss. Older Americans are particularly affected, with nearly half of adults 75 or older reporting hearing difficulties. Despite the prevalence of hearing loss, only one in five people who could benefit from a hearing aid use one, mainly due to high costs. Hearing aids are generally not covered by private health insurance plans or traditional health insurance and can cost thousands of dollars, making them prohibitively expensive for many Americans.

A copy of the letter can be found here and below.

Dear Acting Commissioner Woodcock:

We are pleased that the U.S. Food and Drug Administration (FDA) has released the proposed rule for the “establishment of over-the-counter hearing aids” (File No. FDA-2021-N-0555), as noted by the Over-the-Counter Hearing Aids Act. With the public comment period now over, we are writing to urge the FDA to finalize the rule without delay and in a manner consistent with Congressional intent.

Over 38 million Americans suffer from some degree of hearing loss. Older Americans are particularly affected, with nearly one in three people between the ages of 65 and 753 and about half of adults 75 or older reporting hearing difficulties. Americans who are hard of hearing are at greater risk of developing Alzheimer’s disease and Alzheimer’s-related dementias, and they are also more likely to experience feelings of loneliness and isolation, than the COVID-19 pandemic 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 main reasons for this is cost. Hearing aids are generally not covered by private health insurance plans or traditional health insurance and can cost thousands of dollars, making them prohibitively expensive for many Americans.

President Trump signed into law the Over-the-Counter Hearing Aids Act in 2017. The legislation, based on the bill led by Senators Warren, Grassley, Hassan and Isakson, removes outdated regulations blocking consumer access to hearing aids. affordable hearing aids and authorizes certain types of over-the-counter (OTC) hearing aids for Americans with mild to moderate hearing loss. By introducing more competition to the hearing aid market, the law, when properly implemented, will provide consumers with more options at an affordable price.

To ensure that the final rule meets congressional intent, we urge the FDA to exclude any unnecessary restrictions that impede access to over-the-counter devices or limit their effectiveness for Americans with mild to moderate hearing loss. . For these reasons, we strongly support:

  • Maintain the maximum sound pressure level identified in the proposed rule and prevent the introduction of any gain limits. These standards were appropriately based on guidance from the American National Standards Institute (ANSI), the National Institute for Occupational Safety and Health (NIOSH), the National Academies of Sciences, Engineering, and Medicine (NASEM), and other stakeholder input sessions described in the proposed rule. Additionally, these standards will ensure maximum efficiency and innovation of OTC devices without compromising consumer safety.
  • Maintain federal preemption over state laws governing the servicing, marketing, sale, distribution, use, customer support, or distribution of OTC products, which is necessary to ensure that consumers can access these devices without interference. This was based on advice from the Presidential Council of Advisors on Science and Technology (PCAST) and NASEM. would otherwise be helped by this law. We note that this provision is consistent with the intent of Congress because it does not prejudge the ability of any state or local government to establish or maintain professional licensing requirements.

Maintaining these provisions will ensure that the final settlement will successfully increase competition, spur innovation and lower prices for consumers while meeting the high standards of safety, manufacturing protection and consumer labeling required to all medical devices.

It has been over four years since the Over-the-Counter Hearing Aids Act was enacted. We appreciate President Biden’s commitment to promoting over-the-counter hearing aids for Americans who are hard of hearing, as outlined in his Executive Order on Promoting Competition in the American Economy, and we are encouraged that the FDA has taken this critical step to finally publish a proposed rule. We hope to see a final rule that promotes competition and reflects the best interests of consumers and the public. We ask that you finalize this rule without delay and in a manner consistent with the intent of Congress.

Truly,

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