The US Food and Drug Administration (FDA) on Tuesday (16 August) adopted a final rule to create a new category of over-the-counter hearing aids, which the FDA said will take effect in mid-October and is expected to reduce the cost of purchasing hearing aids for people with mild to moderate hearing loss. These hearing aids can be purchased directly from shops or online stores without the need for a medical exam or fitting adjustment by a dispensing optician.
Secretary of Health and Human Services Xavier Becerra said, “Reducing the cost of health care in the United States has been a top priority for me, and this rule is expected to help us provide affordable health care to millions of Americans in need.”
Nearly 30 million adults in the United States could benefit from the use of hearing aids. People with permanent hearing impairments can use hearing aids to amplify sound and thus improve their social skills, but many are expensive. This final rule is intended to stimulate competition in the marketplace and promote the sale of safe and effective OTC hearing aids in traditional retail shops or online malls, providing patients with mild to moderate hearing loss with better devices to meet their needs and at a lower price than hearing aids currently on the market.