Regulators standing in way of less expensive hearing aids

The ring of a smartphone nestled at the bottom of a purse. A quiet conversation in a crowded restaurant. The sound of an alarm clock telling you it’s time to rise. If you suffer from hearing loss, you often don’t know what you’re missing around you.

In response, the tech industry is hard at work developing solutions for the 48 million Americans who complain of hearing loss. Yet only 23 percent of Americans with significant hearing loss use hearing aids, in large part due to the high cost of these devices.

ADVERTISEMENT
Despite rapid improvements in miniaturization of batteries, microphones and other components, hearing aids can cost more than $2,000 apiece, putting these devices out of reach for many people. Others choose not to take advantage of hearing aids because of the stigma attached to these devices. That’s why companies like Etymotic Research and Able Planet, both of which exhibited at the 2014 International CES®, have been developing low-cost, technically-sophisticated assistive hearing devices called personal sound amplification products, or PSAPs, that can help people hear without hurting their pocket books.

Once relegated to late-night TV ads, these products have matured, offering many features equal to or exceeding the standards for hearing aids. But fifteen years after PSAPs first entered the market, manufacturers continue to struggle to gain traction. The six hearing aid manufacturers that dominate the multi-billion-dollar business and the audiologists that dispense hearing aids see innovative PSAP technology as disruptive, and that makes them nervous.

Worse, the market restrictions that the Food and Drug Administration (FDA) places on assistive listening devices have remained mostly unchanged since the late 1970s, despite advances in PSAP technology. Marketing their products to consumers could mean regulatory restrictions for PSAP manufacturers, since the FDA would probably treat the devices like hearing aids.

Ignoring what consumers want and need, the FDA has repeatedly sided with hearing aid manufacturers when it comes to innovation. In 2009, the FDA published a guidance document that purported to distinguish the PSAP market from the hearing aid market. But rather than support the new technology, the document simply reassured the hearing aid industry that its chokehold on the market would remain firmly in place. 

Not all life-enhancing innovations get mired in FDA regulation. There was a time when you could only buy eyeglasses through opticians and optometrists. When they were finally allowed to be sold at retail, in drugstores and elsewhere, many people were able to purchase extremely low-cost reading glasses without having to go to a doctor. This convenience allowed people to save on doctors’ visits and use glasses to enhance vision without paying a lot of money.

Unfortunately, the FDA has been much more opaque when it comes to hearing devices. In November, the FDA released draft guidance that further hinders the advancement of PSAPs by conflating the PSAP and hearing aid markets. Confusingly, the guidance is so broad that more common consumer electronics devices like Bluetooth headsets could be regulated as “hearing aids.” This has created a cloud of uncertainty, preventing PSAPs from bringing low-cost, high-quality hearing assistance to millions of people.

The FDA’s position is misguided. The agency must re-evaluate its position in light of the facts and separate PSAPs into their own distinct category. People who suffer from hearing loss deserve options for regaining their ability to enjoy a concert or dine in a noisy restaurant. PSAPs are affordable and readily-available options for people who don’t have the means to pay for expensive hearing aids.

The hearing loss spectrum is wide and subjective, and Americans suffering from hearing loss should be empowered to decide for themselves what technology will give them the most freedom to live – and hear – as they choose.

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.