The FDA Should Make Way For Better Hearing

Gary Shapiro President and CEO, Consumer Technology Association
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If you were diagnosed with hearing loss and had the choice of a $1,000-to-$6,000 hearing aid or a device that could improve your hearing for just one tenth of that price, I am confident you would choose the latter. Not surprisingly, a new survey from the Consumer Electronics Association (CEA) finds there is strong demand for these lower-priced devices, called Personal Sound Amplification Products (PSAPs).

Our research shows nearly two-in-five Americans with hearing loss are interested in less costly over-the-counter products to help them hear better. More than two-thirds of survey respondents want greater convenience in their ability to purchase hearing-assistance products. And a significant majority also prefers retailers such as drug stores or discount stores as outlets where they could buy a non-prescription hearing device.

“Despite these consumer preferences for easy-to-buy, hearing-assistance options, the federal agency that oversees hearing aids – the Food and Drug Administration (FDA) – says lower-cost options like PSAPs cannot be marketed to people with any degree of hearing loss. But when consumers are asked about PSAPs, they say they would purchase these devices if they knew that PSAPs were readily available.”

Consumers want hearing-improvement options similar to the low-cost reading glasses that are now available to those with mild sight impairments. Unlike traditional hearing aids, which are costly, PSAPs offer consumers an entry point at about ten percent of the cost of hearing aids, from $100 to $600 for each device. For example, Sound World Solutions is providing consumers with a $300 PSAP option. The company uses Bluetooth technology to link a new device to a smartphone, where consumers can adjust the level of the device through an app to compensate individually for their mild hearing loss.

Hearing health care professionals are well aware of PSAPs’ potential to help. Dr. Frank Lin, a professor of public health and ear surgeon at Johns Hopkins University, says a device such as Sound World’s would benefit those with mild-to-moderate hearing loss and is better for consumers than going without a hearing aid at all. Dr. Patricia Gaffney, an associate professor of audiology at Nova Southeastern University in Florida, says patients who have simple listening needs, very minimal hearing loss, would use the device for a short period of time or a limited number of hours a day, or have low perceived hearing loss but can’t afford a hearing aid might be potential PSAP users.

But companies like Sound World and others such as Audicus, iHear, and Neutronic Ear are unable to market their PSAPs to those with mild hearing loss, because government regulations prevent them from being marketed to consumers as devices that improve hearing – for fear that consumers will not see a doctor to treat their hearing loss. Yet consumers are not shy about getting help. Our survey indicates almost half of PSAP users are most likely to seek help for their hearing difficulties in the next 12 months.

The FDA’s current stance is that PSAPs are “not intended to compensate for impaired hearing” and cannot be sold or marketed as “hearing improvement” devices such as hearing aids. This is despite the fact the FDA’s most recent guidance acknowledges the technology and functionality of hearing aids and PSAPs may be similar. It says the only differentiation between hearing aids and PSAPs is their intended use – hearing aids are medical devices to compensate for hearing, and PSAPs are electronic devices used mainly in recreational pursuits for those with normal hearing. But this differentiation would be evident by the “labeling or promotional materials that make claims or include language that suggest the use of a PSAP for hearing-impaired consumers.”

The FDA’s guidance prevents PSAP companies from effectively marketing their devices by restricting PSAP use to non-hearing impaired consumers with a very limited set of recreational needs – bird watching or hunting, for example. As a result, even consumers with only very minimal or mild hearing loss are not able to benefit from these more affordable options.

It’s time the government eases federal marketing restrictions on PSAPs and allows consumers to access affordable and readily available hearing solutions.

According to our research, about 98 million Americans report having some level of hearing loss but the National Institute on Deafness and Other Communication Disorders says only one in five people who would benefit from a hearing aid actually uses one. The fact that so many Americans are willing to forgo costly hearing aids and medical care – at the expense of better hearing – shows that PSAPs are sorely needed. I urge the FDA to clarify its proposed PSAP guidance, so those with mild hearing loss are given the freedom they deserve to improve their hearing and their lives.

Gary Shapiro is president and CEO of the Consumer Electronics Association (CEA)®, the U.S. trade association representing more than 2,000 consumer electronics companies, and author of the New York Times best-selling booksNinja Innovation: The Ten Killer Strategies of the World’s Most Successful Businesses and The Comeback: How Innovation Will Restore the American Dream. His views are his own. Connect with him on Twitter: @GaryShapiro.