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Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids rule (2022)

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The Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids rule is a significant rule issued by the Food and Drug Administration (FDA) effective October 17, 2022, that, pursuant to the Federal Food, Drug, and Cosmetic Act of 1938, established a regulatory category for [over-the-counter] hearing aids that aimed to improve accessibility to hearing technology.[1]

HIGHLIGHTS
  • Name: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
  • Code of Federal Regulations: 21 CFR 800, 801, 808, and 874
  • Agency: Food and Drug Administration (FDA)
  • Action: Final rule
  • Type of significant rule: Economically significant rule

    • Timeline

    The following timeline details key rulemaking activity:

    Background

    See also: Federal Food, Drug, and Cosmetic Act of 1938

    Though an estimated 30 million Americans experience hearing loss or are hard of hearing, only an estimated 1 out of 5 seek help or devices to improve the condition of their hearing, according to the rule. The FDA cited barriers to seeking help as "high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price)," but said there could be more barriers. The Federal Food, Drug, and Cosmetic Act of 1938 provided the FDA with the authority to address this phenomenon and directed the FDA to— through rulemaking— establish over-the-counter hearing aids for those who face financial, technological, or resource-related barriers to medical professionals relating to their hearing.[1]

    Summary of the rule

    The following is a summary of the rule from the rule's entry in the Federal Register:

    “ The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.[1][4] ”

    Summary of provisions

    The following is a summary of the provisions from the rule's entry in the Federal Register:[1]

    “ FDA is establishing a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans. OTC hearing aids are intended to address perceived mild to moderate hearing loss in people aged 18 or older. Along with the OTC category, we are finalizing multiple related changes to the overall regulatory framework for hearing aids to harmonize existing rules with the new OTC category. We have determined that the requirements set forth in this rulemaking will protect the public health by providing reasonable assurance of safety and effectiveness for hearing aids, as well as promote the hearing health of Americans by lowering barriers to access and fostering innovation in hearing aid technology.


    Among other things, FDARA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the authorities to establish the OTC category of hearing aids among provisions that are, by definition, general controls. We are finalizing general controls for OTC hearing aids consistent with FDARA.


    We are finalizing lower output limits than we proposed but have not substantially changed the other electroacoustic performance requirements for OTC hearing aids. We have simplified the phrasing throughout the required labeling and have restated the maximum insertion depth for OTC hearing aids in terms of a fixed measurement. However, we are not realigning the air-conduction hearing aid classification regulations as proposed.


    This rulemaking also affects other regulations that applied to hearing aids. FDA had established device restrictions for hearing aids that included labeling requirements as well as conditions for sale. We are removing these device restrictions for hearing aids and establishing a new regulation for prescription hearing aid labeling. Further, FDA had by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are removing the regulations codifying these decisions and establishing other regulations clarifying some of the effects of statutory preemption under FDARA.[4]

    		”

    Significant impact

    See also: Significant regulatory action

    Executive Order 12866, issued by President Bill Clinton (D) in 1993, directed the Office of Management and Budget (OMB) to determine which agency rules qualify as significant rules and thus are subject to OMB review.

    Significant rules have had or might have a large impact on the economy, environment, public health, or state or local governments. These actions may also conflict with other rules or presidential priorities. Executive Order 12866 further defined an economically significant rule as a significant rule with an associated economic impact of $100 million or more. Executive Order 14094, issued by President Joe Biden (D) on April 6, 2023, made changes to Executive Order 12866, including referring to economically significant rules as section 3(f)(1) significant rules and raising the monetary threshold for economic significance to $200 million or more.[1]


    The text of the Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids rule states that OMB deemed this rule economically significant under E.O. 12866.

    “ This rule is an economically significant regulatory action as defined by Executive Order 12866.[4] ”

    [1]

    Text of the rule

    The full text of the rule is available below:[1]

    See also

    External links

    Footnotes

    1. ↑ 1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 Federal Register, "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids", November 1, 2023.
    2. ↑ U.S. Food and Drug Administration, "A History of Medical Device Regulation & Oversight in the United States", November 1, 2023.
    3. ↑ U.S. Food and Drug Administration, "Part II: 1938, Food, Drug, Cosmetic Act", November 1, 2023.
    4. ↑ 4.0 4.1 4.2 Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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