FDA finalizes rule for over-the-counter sale of hearing aids

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The devices could be on store shelves by mid-October

The U.S. Food and Drug Administration (FDA) has cleared the way for the over-the-counter sale of some hearing aids. The move is expected to lower the cost of hearing aids by opening the industry to more competition.

The FDA issued a final rule that establishes a new category of hearing aids, enabling consumers with mild to moderate hearing impairment to buy hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist. 

Congress passed bipartisan legislation five years ago that required the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. The agency said consumers could see hearing aids on store shelves in traditional retail and drug stores as soon as mid-October when the rule takes effect.

Consumers have long complained about the high cost of hearing aids and exams, largely because they are not covered by basic Medicare and are not usually included in health insurance coverage.

Pricey devices

The cost of the hearing aids themselves can range from $1,000 to $6,000 per ear, meaning some people who could benefit from them can’t afford them. Sometimes multiple appointments with an audiologist are required to achieve the correct calibration and fitting.

“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.

“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

Who could benefit

The Hearing Loss Association of America (HLAA), while applauding the move, points out that OTC hearing aids will not be for everyone. The group says people who have difficulty hearing conversations in quiet environments will likely need the professional services of an audiologist.

It says examples of “mild to moderate” hearing loss would include not being able to fully understand conversations in groups, with background noise, or when you can’t see who is talking; hearing telephone conversations; or if you frequently ask people to repeat themselves.

People who are considering the purchase of OTC hearing aids should ask if there is a free trial period or a money-back return policy. If the devices require an app or smartphone, that should be determined before the purchase.

The HLAA says other questions to ask concern Bluetooth capability, volume controls, and how the device is recharged.

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