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Statement from American Academy of Otolaryngology–Head and Neck Surgery on FDA Final Rule on Over-the-Counter Hearing Aids

Statement from American Academy of Otolaryngology–Head and Neck Surgery on FDA Final Rule on Over-the-Counter Hearing Aids

August 16, 2022 – Alexandria, Virginia – In response to the Food and Drug Administration’s (FDA) release today of the final rule enabling access to over-the-counter (OTC) hearing aids for millions of Americans, the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) released the following statement by James C. Denneny III, MD, Executive Vice President and CEO:

“The American Academy of Otolaryngology–Head and Neck Surgery commends the FDA for working with the public and hearing healthcare community to issue a final regulation for over-the-counter hearing aids that puts patient safety at the front and center. The Academy’s recommendations focused on patient-safety and education measures. We are particularly pleased that the regulation establishes safeguards to prevent patients from inserting hearing aids too far into their ear, thus minimizing the risk of injury to ear structures. Additionally, the rule provides maximum device output limitations which protect patients from additional noise-induced hearing loss.

The public will soon be offered a more accessible, cost-effective, and safe treatment option for patients with mild-to-moderate hearing loss. Achieving better hearing for as many patients as possible has been a guiding principle for otolaryngologists for centuries. With the availability of OTC hearing aids, we come closer to that goal with the hope that as many people as possible will now be able to engage more fully with family, friends, school, work, and so much more. This is a long-awaited win for patients and their loved ones.”

The AAO-HNS has long supported establishing a category of hearing aids available OTC for adults with mild-to-moderate hearing loss. The Academy and the hearing health community worked with Congress to enact the law that allows OTC sales and subsequently collaborated with the FDA to help create the regulatory pathway.

About AAO-HNS

The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) is one of the world’s largest organizations, with approximately 13,000 members, representing specialists who treat the ears, nose, throat, and related structures of the head and neck. Otolaryngologist–head and neck surgeons diagnose and treat medical disorders that are among the most common affecting patients of all ages in the United States and around the world. Those medical conditions include chronic ear disease, hearing and balance disorders, hearing loss, sinusitis, snoring and sleep apnea, allergies, swallowing disorders, nosebleeds, hoarseness, dizziness, and tumors of the head and neck as well as intricate micro-surgical procedures of the head and neck.

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