Over-the-Counter Sale of Hearing Aids

FDA Final Rule Release:

On August 16, the U.S. Food and Drug Administration (FDA) released a final rule titled, “Medical Devices: Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” which establishes regulations for the Over-the-Counter Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017. The final rule is scheduled to take effect in mid-October. The AAO-HNS has prepared a summary and released the following statement on the rule. Patients can learn more about hearing loss and how to find the right hearing aid here, and read important OTC hearing aids FAQs here.

Update:

On January 18, 2022, the AAO-HNS submitted comments to the U.S. Food and Drug Administration (FDA) on a proposed rule titled, “Establishing Over-the-Counter Hearing Aids.” The proposed rule implements a key provision of the Over-the-Counter Hearing Aid Act, as enacted in the FDA Reauthorization Act of 2017. The Academy supported this legislation and worked with Congressional champions to amend it to ensure the inclusion of necessary patient safety protections. The Academy’s comments focused on a number of provisions in the proposed regulations including labeling requirements, equitable access to information, return policies, maximum insertion depth, sales to children, output and gain maximums, state exemptions, and conditions for sale. Additionally, the AAO-HNS expressed support for many of the rule’s components and thanked the FDA for working closely with the Academy and other stakeholders to craft these regulations.

Previous Actions:

On October 19, the Food and Drug Administration (FDA) released its highly anticipated proposed regulations on over-the-counter (OTC) hearing aids. The rule, which implements the Over-the-Counter (OTC) Hearing Aid Act included as part of the FDA Reauthorization Act of 2017, creates a regulatory pathway for a new category of air conduction hearing aids for adults age 18 and older with perceived mild to moderate hearing loss. Following enactment of the final rule, air conduction hearing aids will be available for OTC purchase without a medical exam or fitting. Hearing aids for children under age 18 and adults with higher levels of hearing loss will still require a prescription. The AAO-HNS has long supported establishing a category of “basic” hearing aids available OTC for adults/seniors with bilateral, gradual onset, mild-to-moderate age-related hearing loss. While Academy leadership and staff are currently performing a thorough analysis of the rule’s contents, an initial cursory review demonstrates a commitment by the FDA to include Academy-supported patient protections in the regulation. The AAO-HNS has developed an in-depth summary of the proposed regulations in the coming weeks. Comprehensive comments will be submitted to the agency prior to the close of the 90-day public comment period.

The AAO-HNS met with officials from the FDA in December 2017 to discuss the proposed new category of OTC hearing aids for adults with mild-to-moderate hearing loss and the ensuing regulatory process. Discussion topics also included labeling requirements, manufacturing standards, and the importance of patient/consumer education. The Academy’s discussion points were well-received by the agency officials.

Hearing loss is one of the most common issues faced by individuals as they age, and unfortunately, many adults fail to seek appropriate intervention when symptoms of hearing loss first appear. There are many reasons why those with significant hearing loss are not participants in the current system, including, but not limited to: failure to realize the problem, denial of the problem, perceptions regarding a potentially complex system, and cost. While the AAO-HNS applauds efforts to overcome these barriers by easing entry and reducing costs, new policies must retain necessary patient protections. The AAO-HNS supports establishing a category of “basic” hearing aids available OTC for adults/seniors with bilateral, gradual onset, mild-to-moderate age-related hearing loss. However, prior to a consumer’s purchase of an OTC hearing aid, the AAO-HNS strongly recommends 1) a medical evaluation by a physician to rule out medically-treatable causes of hearing loss, and 2) a standardized hearing test (via a hearing health professional or appropriate online/technological source) to confirm mild-to-moderate hearing loss. In addition, current FDA hearing aid packaging requirements and consumer protections must be retained, if not enhanced.

• Legislative Update/Timeline:
  • H.R. 1652/S. 670, the “Over-the-Counter Hearing Aid Act of 2017,” was included in a broader legislative package to reauthorize the Food and Drug Administration’s User Fee Agreement (FDARA). The FDARA bill (H.R. 2430), was passed by the U.S. House of Representatives (via voice vote) on July 12 and by the Senate (94-1) on August 3. The President signed the bill into law on August 18, 2017.
    • Prior to passage of the bill, the AAO-HNS successfully negotiated amendment language to strengthen the bill’s package/labeling requirements and also instruct the Department of Health and Human Services (HHS) to initiate and submit a study regarding adverse events (re: OTC hearing aids).
• Next Steps:
  • Per the law, the FDA has up to three years to establish the new regulations for over-the-counter hearing aids.
    • Regulations are developed through a two-step rule-making process.
      • The FDA will publish a proposed rule in the Federal Register, and will ask for public comments on the proposal.
      • After comments are considered, the FDA will publish the final rule in the Federal Register and include a date for when the rule goes into effect.
      • The AAO-HNS will submit comments to the FDA as it works through the rule-making process.

Click here to read the AAO-HNS letter re: H.R. 1652/S. 670.