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Push for cheaper hearing aids leads to ease in FDA regulations

Some of the regulations for hearing aids by the Food and Drug Administration have been dropped in a push for cheaper products on the market. There has been pushback for the proposal, though, and it has come from audiologists. They claim that inexpensive hearing aids will not help patients who have serious hearing loss.

The FDA made an announcement that it would stop enforcing its requirement that anyone buying a hearing aid receive a medical checkup first or sign a waiver declining the checkup. According to professionals in the field, this will not affect how hearing aids are sold.

The FDA is looking into creating over-the-counter hearing aids that can be purchased without ever seeing a doctor or signing a waiver. This is where the concern from audiologists comes into play.

"Consumers have been saying for a long time that getting lower-cost instruments is important to them," Vanderbilt University Medical Center researchers said. "Addressing ways to bring down the cost, particularly to people with mild or moderate hearing loss, is important. There absolutely is an unmet need."

On the other side of the aisle, though, are audiologists who are concerned about patients with serious hearing loss.

"You need to have somebody to look in your ear to see if there is a medical issue going on and that there is no wax accumulation," said the executive director of the nonprofit Speech and Hearing Center in Chattanooga, Tennessee. "How are you going to self administer a hearing test? It is difficult to be accurate."

A report published last year by the President's Council of Advisors on Science and Technology said that an estimated 30 million Americans over the age of 60 suffer from some form of hearing loss.

Support for over-the-counter hearing aids has come in the form of the Over-the-Counter Hearing Aid Act of 2016, which was created in December by Congress. The bill would require the FDA to create rules and regulations for over-the-counter hearing aids.

Will over-the-counter hearing aids cause patients problems? That remains to be seen. An experienced products liability attorney will be able to explain your rights and help you with defective medical devices issues when they arise.

Source: Time Free Press, "Experts wary as FDA eases regulations in push for cheaper hearing aids," Steve Johnson, Jan. 04, 2017

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