The U.S. Food and Drug Administration issued a rule Tuesday that establishes a new category of over-the-counter hearing aids, enabling consumers with mild to moderate hearing impairment to purchase hearing aids from stores or online retailers without a medical exam, prescription, or a fitting adjustment by an audiologist.
The action follows an executive order from President Biden, which 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, which the FDA met.
In 2017, Congress passed legislation requiring the FDA to create a category of OTC hearing aids, but it wasn’t carried out until now.
Consumers could see OTC hearing aids available in retail and drug stores as soon as mid-October when the rule takes effect.
“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra said in a statement.
About 30 million adults in the United States could benefit from hearing aid use. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate with others.
Many hearing aids can be expensive. Some estimate the new, OTC aids will cost between $200 and $800.
“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 neighborhood store or online.”
The OTC category established in the rule applies to some air-conduction hearing aids intended for people 18 years of age and older who have mild to moderate hearing impairment. Hearing aids that don’t meet the requirements for the OTC category, for example, because they’re intended for severe hearing impairment or users younger than age 18, are prescription devices.
The FDA finalized the rule after receiving and reviewing more than 1,000 public comments on the proposed rule issued on Oct. 20, 2021.
Do research when buying an OTC hearing aid because there’s a lot to consider, including battery life, fit, sound clarity, and more.
A recent article by Consumer Reports reported on a survey of members in which 16 hearing aid companies were rated. Costco came out on top.
Also be aware that some companies may use high-pressure sales. Check out any company you’re considering dealing with on the Better Business Bureau website.