The U.S. Food and Drug Administration (FDA) has issued a final rule designed to improve consumer access to hearing aids in the United States. The August 16 announcement detailed how the new rule could save Americans millions of dollars.
According to the FDA, the final ruling establishes a new category of hearing aids designed to be sold over the counter. This will allow consumers with mild to moderate hearing impairment to purchase hearing aids directly from stores or online retailers without the requirements of medical exams, prescriptions, or fitting adjustments by an audiologist. The agency has emphasized that this rule will implement conditions that confirm the safety and effectiveness of over-the-counter hearing aids while “fostering innovation and competition in the hearing aid technology marketplace.”
The FDA has stated that nearly 30 million adults in the U.S. potentially stand to benefit from over-the-counter hearing aid use. The approved hearing aids are capable of increasing the volume of speech and sounds which improve the individual’s ability to communicate effectively with other people.
This new category established by the FDA rule has a narrow application. Only air conduction hearing aids for people 18 or older with mild to moderate hearing impairment qualify for over-the-counter sale. If a hearing aid is designed for minors, people with severe hearing impairment, or utilizes a mechanism other than air conduction, it will be classified as a prescription device.
FDA Commissioner Dr. Robert M. Califf M.D. spoke about the over-the-counter hearing aid rule, stating, “Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions.”
Commissioner Califf stated that the new regulatory category will allow people with mild to moderate hearing loss to have a convenient way to access a variety of safe, effective, and affordable options for hearing aids from their local stores or online.
Also weighing in on the rule was Health and Human Services Secretary Xavier Becerra. Secretary Becerra stated that the rule was part of a wider effort to reduce healthcare costs in America. He stated in the FDA announcement that the rule “represents a significant milestone in making hearing aids more cost-effective and accessible.”
With the new rule finalized, consumers could begin to see over-the-counter hearing aids in retail and drug stores as soon as mid-October.