The United States Food and Drug Administration (FDA) has finalised a rule that will allow hearing aids to be sold over the counter.

The rule allows people with mild to moderate hearing loss to purchase hearing aid over the counter “without the need for a medical exam, prescription or a fitting adjustment by an audiologist,” the FDA said in a statement.

On Tuesday, President Joe Biden announced that the rule would be implemented in mid-October in retail and drug stores. 

“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” Mr Biden said in a statement. “This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing.” 

The FDA’s rule falls in line with Mr Biden’s Executive Order on Promoting Competition in the American Economy, which urged the body to take steps to allow hearing aids to be sold over the counter and set a swift 120-day deadline for action. 

The push for easier access to hearing aids began in 2017 when Congress passed bipartisan legislation requiring the FDA to create a category of over-the-counter hearing aids, but it was not fully implemented until now. 

The FDA notes that about 30 million adults in the U.S. stand to benefit from the new rule when it begins to run in October, acknowledging that any hearing aids can be expensive.

“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 Robert M. Califf, M.D. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighbourhood store or online.”   

The new rule also amends existing legislation that applies to prescription hearing aids, repealing the conditions surrounding the sale of hearing aids, and includes provisions that address some of the effects of the FDA OTC hearing aid regulations on state regulation of hearing aids.

The FDA also issued the Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), which provide clarification on the varying hearing aids, which are medical devices, and PSAPs that help people with normal hearing amplify sounds.