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Over-the-Counter Sale of Hearing Aids

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.

  • Active OTC hearing aid legislation:
    • The AAO-HNS continues to monitor H.R. 1652/S. 670, the “Over-the-Counter Hearing Aid Act of 2017.”
      • The legislative language included in H.R. 1652/S. 670 has been added to the Food & Drug Administration User Fee Reauthorization bills in both the U.S. House of Representatives and U.S. Senate.
        • 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).
      • Final passage of the Food & Drug Administration Reauthorization Act (FDARA), including the OTC hearing aid provisions, is expected in July.

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