OTC hearing aids refer to a new category of air-conduction hearing aids for individuals 18 or older. These devices are specifically intended for use only by adults with perceived mild to moderate hearing loss and can be purchased without consulting any medical professional, such as a physician, audiologist, or licensed hearing aid specialist. The shift to allowing hearing aids to be purchased over-the-counter represents a significant departure by the FDA, which previously rejected calls to create this new category based on safety and efficacy concerns. However, after the FDA Reauthorization Act of 2017 (“FDARA”) was signed into law, the FDA no longer had a choice as doing so was mandated by Congress.
After FDARA was enacted, the American Academy of Audiology, Academy of Doctors of Audiology, American Speech-Language-Hearing Association, and International Hearing Society jointly developed a model regulatory framework to ensure the safety and efficacy of OTC hearing aids. The framework included recommendations for maximum allowable output (volume or loudness), product and package labeling requirements, and strong consumer protections, all of which Amplifon strongly supported. While many of the national hearing care associations’ recommendations were incorporated into the OTC hearing aid regulation, the FDA ultimately rejected the call to limit the maximum amplification of OTC hearing aids to 110 decibels or less. Many leading medical experts expressed concern about this decision, saying that adopting this limitation would ensure users avoid experiencing further hearing loss due to being exposed to overly loud sounds.