The FDA Reconsiders Hearing Aid Rules 15%-30%

Regulation ▶ The White House wants looser rules on over-the-counter sales ▶ Regulations are “unfair to us and to consumers who might benefit” DATA: EXECUTIVE OFFICE OF THE PRESIDENT

The Bean is a small electronic device that people can put in their ears to help them hear better. Like hearing aids, it automatically amplifies soft sounds and lets loud ones be heard naturally. Unlike hearing aids, which are regulated by the U.S. Food and Drug Administration and can be sold only by licensed hearing experts, the Bean is available over the counter. The cheapest model retails for $299, a little more than one-tenth the price of most prescription hearing aids. But FDA guidelines prohibit Bean manufacturer Etymotic Research from marketing it to people who are hard of hearing. “We’re limited in how we can sell the Bean, and that’s unfair to us and to consumers who might benefit from it,” says Etymotic President Mead Killion, a PH.D. in audiology who holds 90 patents.

In October a scientific panel convened by the White House suggested loosening regulations on hearing aids to encourage the proliferation of lowercost options such as Killion’s. The logic seems straightforward—drugstores sell low-power reading glasses over the counter, so why not “personal sound amplification products,” or PSAPS, like the Bean? The FDA apparently got the message: On April 21 it was scheduled to hold a public workshop on whether its manufacturing standards for hearing aids are overly restrictive. The agency, which has ultimate authority to set regulations, is determined “to better understand how we can overcome the barriers to access and spur development of devices that compensate for impaired hearing,” William Maisel, acting director of the FDA’S Office of Device Evaluation, said in an e-mail.

Killion will be at the hearing, as will representatives of the White House panel. So will representatives of the Big Six hearing aid manufacturers— Siemens, Sonova, Starkey Hearing Technologies, William Demant, GN Resound, and Widex— which control upwards of 95 percent of the $5 billion global market and endorse the FDA’S current hard line on PSAPS.

The old-school manufacturers, unsurprisingly, wish to marginalize PSAPS as a solution for hearing loss. Under existing FDA rules, the devices can be sold only for recreational use, targeting people with normal hearing (think hunters listening for prey, or birders tracking rare breeds by their chirps). “If they worked, most people would be using them,” says Carole Rogin, president of the Hearing Industries Association, a trade group. She says the White House panel, which is made up of academics and business executives— including Eric Schmidt, executive chairman of Alphabet, the holding company for Google—is approaching the problem of undertreated hearing loss the wrong way. “There is no evidence that consumers can self-diagnose and self-treat,” Rogin says. “You run the risk of serious medical conditions going unaddressed.”

Only 15 percent to 30 percent of the roughly 30 million Americans with hearing loss seek help, according to the White House panel’s report, which also asserted that the high cost of medical hearing aids is the biggest reason the number is so low. Conventional hearing aids sell for more than $2,300 apiece on average, and many people need one for each ear. Medicare and most private insurance plans don’t cover hearing aids. And overlapping federal and state regulations have helped stifle competition in the industry. The FDA and states require that consumers obtain a medical evaluation and then purchase hearing aids from a licensed audiologist or other credentialed dispenser. Practitioners typically offer a limited selection of brands and charge a single, bundled fee for the evaluation, the hearing aid, and any follow-up adjustments.

The FDA has cracked down on PSAP manufacturers that compare their over-thecounter gear to hearing aids. Federal agents seized a shipment from China of Neutronicear devices in June 2014 because online ads for the product included customer testimonials saying the device is equivalent to “a regular hearing aid.” Brian Brinker, director of operations for Personal Innovative Products, the company that markets Neutronicear gear, says: “We got rid of the language the FDA didn’t like, and they released our shipment.”

The White House panel pointed out that the technology in PSAPS is often “similar, if not identical, to that in hearing aids.” It urged the FDA to create a new category of “basic” hearing aids that would be registered with the agency but sold over the counter, without any requirement to

Share of Americans with hearing loss who seek help Etymotic’s Bean in-ear amplifier is available over the counter, unlike hearing aids