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What is an OTC hearing aid

August 20, 2019

What is an OTC hearing aid?

The general thinking of an OTC hearing aid is that any person can go to a pharmacy and buy a hearing aid which accommodates their hearing loss. The shopper can bypass a possibly lengthy and pricey appointment, in favor of a simple 15 minute purchase.

These non-prescription hearing aids are mass-produced, and are theoretically a “one size fits all” fix to any and all hearing aids needs. But the question is: should hearing aids be sold over the counter?

As we know hearing aids are expensive, they are not covered by many health plans and are used by only a small percentage of those who need them.

New legislation signed into law on Friday aims to make the medical devices cheaper and more widely used by ensuring high-quality products are available over-the-counter and without a doctor’s involvement.

Under the law, the Food and Drug Administration must propose regulation for over-the-counter hearing aids in the next three years to make sure the products are safe and effective. The over-the-counter products are specifically for adults with mild-to-moderate hearing loss.

More than 35 million Americans have some degree of hearing loss, and the numbers are only expected to grow as the U.S. population ages.

The price of a hearing aid — more than $2,000 on average, with some people needing two — has long been a bone of contention.

Though much of hearing loss is age-related, Medicare doesn’t cover hearing aids especially the new style rechargeable hearing aids, nor do many private health insurers. The process of obtaining a hearing aid can also be bulky and complicated, involving trips to up to several doctors; hearing aids can also only be bought through licensed sellers.

All this translates into an estimated 67% to 86% of those who might benefit from hearing aids not using them.

Meanwhile, consumers have long been able to buy personal sound amplification products over the counter, which are similar to hearing aids but regulated differently.

PSAPs work to amplify environmental sounds and aren’t supposed to be used as hearing aids, according to the FDA, while hearing aids help with impaired hearing.

Good PSAPs, though, appear to work almost as well as hearing aids, according to a small study published in the medical journal JAMA in May.

“The PSAP market is kinda like the Wild West right now,” said Nicholas Reed, an instructor at Johns Hopkins University School of Medicine and a lead author of the May study. “You have really fantastic devices out there made by really competent people. But then at the same time you have — I don’t want to use the word junk, but they’re really not good products for compensating for mild hearing loss.”

Lower prices are likely to be a major advantage of over-the-counter hearing aids, though it’s hard to know yet to what degree.

One PSAP used in Reed’s study was priced around $30, and others ranged between $270 and $350, he said.

Critics, however, are concerned about hearing aids being available without a doctor’s involvement, especially if a person’s hearing loss is being caused by something that needs to be treated, such as a tumor on the auditory nerve.

The over-the-counter hearing aid bill was proposed by Sens. Elizabeth Warren (D-Mass.), Chuck Grassley (R-Iowa), Maggie Hassan (D-NH) and Johnny Isakson (R-Ga.).

It was signed into law as part of the FDA Reauthorization Act, which extends agreements with industry that fund regulation of drugs and medical devices and allows the agency to continue operating for the next several years.

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