Thursday, April 19, 2018
Health

Say what? Online hearing aid sales against Florida law

LARGO — Denis deVlaming knows a thing or two about the law. The Clearwater attorney has defended murderers, rapists and drug dealers. But about a year ago, he unwittingly collaborated in an Internet crime.

He went on eBay and bought his mother a $7.92 hearing aid.

Evelyn deVlaming, now 98, had lost her previous hearing aid — a custom-fit model that tucked into her ear. "We paid $3,000 for the pair or thereabouts,'' her son said recently.

The eBay model sits behind her ear and "works just as well,'' he said. "And if she loses it, I don't cry.''

But deVlaming later learned that selling hearing aids by mail is a second-degree misdemeanor in Florida, which left him aghast.

"This isn't contraband, this isn't marijuana, this is a hearing aid,'' he said. "And somebody could go to jail.''

Internet sales are notoriously difficult to regulate. Given how child pornography and addictive painkillers get through the mail it's hard to imagine that a $7.92 "Power Tone" from Hong Kong would create much stir.

But the law — passed decades ago — illustrates how thoroughly the digital age has transformed the hearing aid market.

People once preferred inside-the-ear models that hid signs of aging. Those hearing aids often require individual molding and multiple visits to audiologists.

Now, ear hardware is hip. Earbuds tie teens to iPhones. Entrepreneurs cut business deals via Bluetooth devices readily evident in their ears. So cheap amplification devices that tuck behind the ear fit right in. Just as eyeglasses, medicine and other health products now sell online, the $7.92 hearing device has found its niche.

Aid vs. amplification

By age 75, half of Americans suffer some hearing loss, according to the National Institutes of Health. High frequency sounds and some consonants become harder to pick up, said Pam Mason, director of audiology practices for the American Speech-Language-Hearing Association.

"It's like the rheostat in a dining room dimming imperceptibly day by day," Mason said. It sounds like "other people are mumbling.''

Personalized treatment from licensed professionals holds several advantages, she said.

Some hearing loss stems from disease, like brain tumors or perforated ear drums. No Hong Kong seller will spot that.

Like much digital technology, hearing aids are becoming more sophisticated, requiring programming and calibration for maximum effect. Professionals can tailor them to individual ear shapes. Fitted and used correctly, a good aid can actually help the brain rewire and regain functionality, Mason said.

"You say that hearing aids cost $3,000 and it gives the impression that it is all about the device,'' Mason said. "But the audiologist connects the human being to the technology.''

Both the U.S. Food and Drug Administration, which regulates medical devices, and Florida law require professional testing and fitting before any sale. Some Internet sellers skirt that with semantics — calling their product a "personal amplification device" instead of a hearing aid.

The difference, according to the FDA, mainly relates to purpose, not technology. Hearing aids are for hearing loss. Amplification devices supposedly are for people with normal hearing who just want better sound — like a conventioneer in a noisy lecture hall.

The Internet is full of amplification devices. Cheaper ones may do nothing more than boost sound. Others advertise that they clarify sound — just like high-end hearing aids.

"I don't need a hearing aid. I just need people to stop mumbling,'' says a gray-haired businessman on the Sound World Solutions website.

The company's $300 "amplification device" is Bluetooth-enabled to stream from a TV or cellphone. A smartphone programs it remotely. It filters ambient noise and looks trendy.

"A lot of people don't want to admit to the world that they need a hearing aid,'' said company spokesman Shawn Stahmer. "Our approach is to design it like a Bluetooth headset so they are not forced to admit that.''

Federal vs. state

Only 20 percent of American adults with hearing loss use hearing aids, according to the National Institutes of Health. Denis deVlaming thinks price is a big reason. Medicare usually does not cover hearing aids, "so it's even more important that the elderly have a chance to buy a cheaper one,'' he said.

Internet deals abound. Amazon sells hearing aids or amplifiers, as does Walmart.com. Models can range up to $1,000, including some of the same devices that can cost twice as much from a store-based retailer.

Walmart.com follows federal law and is comfortable that it supersedes state law, said spokeswoman Dianna Gee.

The FDA allows hearing aid sales without professional testing and fitting if consumers first sign a waiver. But Florida law offers no such waiver opportunity. It simply requires professional fittings and forbids sales by mail. Missouri once had a similar law, but a U.S. appellate court threw it out in 2009 because the state did not offer a waiver similar to the FDA's.

Officials at the Florida Department of Health could not confirm any cases in which an Internet seller was prosecuted for selling to a Floridian.

Last year, the state did send a threatening letter to Best Buy for offering a $300 Focus Ear "personal sound amplifier'' online. The device had enough sophisticated features that the state contended it was, in fact, a hearing aid.

After the complaint, Best Buy stopped selling the Focus Ear in Florida, DOH spokeswoman Courtney Gager said. But as of last week, bestbuy.com still offered the Focus Ear for sale.

Best Buy spokesman Jeremy Baier said the company "fully complies with the law,'' but declined to say whether or not Floridians could buy the device online.

DeVlaming notes that online shoppers can protect their health by getting a medical exam first. He speculates that the mail sale ban mainly protects an established, store-based industry.

"For the life of me,'' he said. "I don't understand why people that could use the $7.92 device are deprived of at least trying it.''

Contact Stephen Nohlgren at [email protected] Times researchers Carolyn Edds and Caryn Baird contributed to this report.

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