The U.S. Food and Drug Administration (FDA) has finalized a rule to expand access to hearing aids, potentially reducing costs for millions of Americans. This new rule establishes a category of over-the-counter (OTC) hearing aids, allowing adults with perceived mild to moderate hearing loss to purchase devices from stores or online without requiring a medical exam, prescription, or professional fitting.
This initiative aligns with the Biden-Harris Administration’s goal of making high-quality health care more affordable and accessible. The rule ensures the safety and effectiveness of OTC hearing aids while promoting competition and innovation in the hearing aid market. The action builds on President Biden’s Executive Order on Promoting Competition in the American Economy, which tasked the FDA with enabling OTC hearing aid sales within 120 days – a deadline the agency met. Although Congress passed legislation in 2017 requiring the creation of an OTC hearing aid category, full implementation had not occurred until now. Consumers could see these devices in retail and pharmacy outlets by mid-October when the rule takes effect.
“Reducing health care costs in America has been a priority of mine since Day One, and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra.
Nearly 30 million adults in the U.S. could benefit from hearing aids, which help amplify speech and sound for individuals with permanent hearing loss. However, hearing aids are often prohibitively expensive. The FDA’s rule aims to improve access by encouraging competition and enabling the sale of safe, affordable OTC hearing aids, particularly for adults with mild to moderate hearing loss.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Dr. Robert M. Califf. “This new regulatory category provides greater access to affordable, safe, and effective hearing aids through neighborhood stores and online platforms.”
The rule applies to air-conduction hearing aids for individuals aged 18 and older with mild to moderate hearing impairment. Devices for severe hearing loss or individuals under 18 remain prescription-only. Public comments (over 1,000 in total) from consumers, professionals, manufacturers, and advocates were reviewed before finalizing the rule. To ensure safety, changes to the proposed rule include lowering maximum sound output to prevent over-amplification, setting limits on insertion depth, requiring adjustable volume controls, and simplifying labeling for user clarity.
The new rule also revises existing regulations for prescription hearing aids to maintain consistency with the OTC category. Additionally, the FDA issued guidance distinguishing medical hearing aids from personal sound amplification products (PSAPs), which are consumer devices for sound enhancement but not intended for those with hearing impairment.
The rule takes effect 60 days after publication in the Federal Register. Manufacturers of existing hearing aids will have 240 days to comply with the updated requirements, while new devices must meet the standards before entering the market. Some devices may also require FDA clearance before sale.
