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News -- August 17, 2022: A final rule was published by the U.S. Food and Drug Administration
to increase hearing aid access is expecte to lower costs for millions of Americans.
This action creates a new category of over-the-counter (OTC) hearing aids, allowing consumers with a perceived mild to moderate hearing impairment to buy hearing aids directly from retailers in-person or online without the need for a physical examination, a prescription, or an audiologist's fitting adjustment.
The Biden-Harris Administration's objective of increasing access to high-quality healthcare and bringing down healthcare expenses for the American people will be furthered by the rule, which is anticipated to cut the cost of hearing aids. It is intended to promote innovation and competition in the market for hearing aid technology while ensuring the safety and efficacy of OTC hearing aids.
Following President Biden's Executive Order on Promoting Competition in the American Economy, which required the FDA to take steps to permit hearing aids to be sold over the counter and set a short 120-day deadline for action. The FDA complied with the requirements of the Executive Order. Bipartisan legislation mandating the FDA to establish a category of over-the-counter hearing aids was passed by Congress in 2017, but it wasn't completely implemented until today. Once the rule is in place and in typical retail and drug stores, consumers may start to see OTC hearing aids there as early as mid-October.
Health and Human Services Secretary Xavier Becerra declared, "Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need. Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.” The FDA's decision from today marks a big step toward improving the affordability and accessibility of hearing aids.
Nearly 30 million adult Americans could benefit from using hearing aids. Hearing aids can assist people who have persistent hearing loss communicate more successfully with others by boosting speech and other noises. The cost of many hearing aids can be high. The final regulation aims to promote competition and make it easier for OTC hearing aids to be sold in regular retail locations or online nation-wide, giving people who believe they have mild to moderate hearing loss better access to affordable devices that can suit their needs.
According to FDA Commissioner Robert M. Califf, M.D., “Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” . “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
Certain air-conduction hearing aids designed for people 18 years of age and older with a perceived mild to moderate hearing impairment fall within the OTC category defined by this final rule. Prescription devices include hearing aids that do not fit the criteria for the OTC category (for instance, because they are meant for users under the age of 18 or those with severe hearing impairment).
After receiving and studying more than 1,000 public comments on the proposed rule that was released on October 20, 2021, the FDA finalized the regulation. The final regulation summarizes the comments received from consumers, trade organizations, hearing aid producers, public health organizations and advocacy groups, members of Congress, state agencies, and other stakeholders and includes the FDA's answers. The final rule incorporates several changes from the proposed rule in response to public comments and to ensure the safety and efficacy of OTC hearing aids, including lowering the maximum sound output to reduce the risk to hearing from over-amplification of sound, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the language throughout the necessary device labeling to ensure The final rule also includes parameters for device performance and guidelines for OTC hearing aid design.
The measure taken today also repeals the requirements for hearing aid sales, modifies the prescription hearing aid rules to be consistent with the new OTC category, and includes provisions that address some of the consequences of the FDA OTC hearing aid regulations on state regulation of hearing aids.
In addition to publishing the final rule, the FDA also published the final guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to explain the distinctions between PSAPs, which are consumer goods that assist people with normal hearing in amplifying sounds, and hearing aids, which are medical devices.
The final rule takes effect 60 days after it is published in the Federal Register. After the final rule's publication, manufacturers of hearing aids sold before that date will have 240 days to comply with the new or revised rules. Before marketing a hearing aid that hasn't been put up for sale before the effective date, compliance with the new or revised requirements must be attained, including, if necessary, getting 510(k) approval.
WNCTIMES by Marjorie Farrington
