FDA allows hearing aids to be sold over the counter

Hearing aids can be purchased over the counter without the need for costly medical exams or prescriptions, according to the Food and Drug Administration.

The FDA's move establishes a new category of over-the- counter hearing aids that can be sold directly to consumers. It only applies to hearing devices for adults with mild to moderate hearing problems, excluding devices for more severe hearing loss, which will still require a prescription.

The goal is to make hearing aids cheaper and more widely available to tens of millions of people in the United States, mostly older adults, who suffer from hearing loss.

The National Council on Aging, an advocacy group, says that standard hearing aids can cost as much as $7,000 per pair without insurance.

Health and Human Services Secretary Xavier Becerra said Tuesday on a call with reporters that the high cost of the devices discourages people from seeking help.

He said today s action should help make hearing aids more accessible and more affordable.

Consumer advocates have complained that the cost of hearing devices is too high in the U.S. and want regulators to implement new rules that allow over-the- counter devices.

In 2017, Congress passed legislation that required the FDA to create a category of over-the- counter hearing aids, but it is only now being implemented.

The FDA Commissioner Dr. Robert Califf said about 30 million Americans in the U.S. have some form of hearing impairment but only about 1 in 5 have sought care.

People with mild to moderate hearing problems could see over-the- counter hearing aids available online and in drugstores as early as mid-October, when the rule is scheduled to take effect, he said.

Califf said the agency is working with manufacturers to make sure the devices are of good quality and meet the agency's performance criteria.

The rule includes labeling requirements for devices, including information on age limits, reported adverse events and symptoms of hearing loss, which should prompt a consultation with a health care provider.

Brian Deese, the director of the White House National Economic Council, said the rule will save consumers about $1,400 per individual hearing aid or more than $2,800 per pair.