According to the US Food and Drug Administration, approximately 15 percent of U.S. adults age 18 have some sort of hearing impairment, or more than 30 million people.

But according to the FDA, only about one in five who could benefit from a hearing aid actually use one, with reasons varying from social stigma to cost. 

Hearing aids are expensive.

Hearing loss increases with age, and with many people 65 and older on tight budgets, the cost can be prohibitive for older adults.

The U.S. Food and Drug Administration issued a final rule permitting the sale of over-the-counter hearing aids, which offers and enables more people to access the devices.

The FDA ruling establishes a new category of over-the-counter hearing aids for consumers with mild to moderate hearing impairment directly from stores or online retailers without needing a medical exam, prescription, or fitting adjustment by an audiologist. 

President Biden's executive order called for the FDA to take steps to allow hearing aids to be sold over the counter and set a 120-day deadline for action.

Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

“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.

Hearing aids intended for severe hearing impairment or users younger than age 18 will still require prescription devices. 

Difficulty hearing can have major impacts on an individual’s ability to interact with others and can adversely affect the quality of life, including higher risks of depression or dementia, according to Johns Hopkins University.