Beware of 'miracle' hearing aids Health: Products sold through the mail may not deliver what their advertisements promise.

June 07, 1998|By Audra D.S. Burch | Audra D.S. Burch,SPECIAL TO THE SUN

As the last of the baby boomers scale the half-century mountain and settle into middle age, they are reminiscing about the good old days: the days when they could hear the birds chirp, buses roar, televisions blare.

The generation that partied at Rolling Stones concerts and listened to transistor radios is gradually losing its hearing, joining 28 million Americans who suffer from some form of hearing loss. Even President Clinton admitted last year that his hearing had grown rusty.

"Gradual hearing loss comes from noisy lifestyles ` from rock concerts to personal stereos," says Glenn Peacock, marketing director of the International Hearing Society, a trade organization based in Livonia, Mich. "The big problem with hearing loss is that it is so gradual. You simply forget sounds ` you forget that a bird once chirped outside your window ` which makes it hard to detect."

It's not just adults either ` a recent federal study found that 7 million children age 6 to 19 have hearing loss and called for more testing in elementary, middle and high school.

With the final acceptance of hearing loss comes another challenge: choosing a hearing aid in a market that 25 years ago offered five types and now offers 600. Models range from $500 to $1,500, for one ear, from behind-the-ear models to in-the-ear digital computer chips controlled by wireless remote.

Consumer officials warn that the field is crowded with cheap "miracle" products.

One company, Crystal Ear, is currently under state and federal scru-tiny and could provide a cautionary tale for consumers. Crystal Ear is a mail-order product advertised nationally in USA Today, Newsweek, infomercials and the Internet. It's billed as a revolutionary new sound solution smaller than a fingertip, a one-size-fits-all contact for the ear. The company claims dramatic hearing improvement for almost 90 percent of people with mild hearing loss. All for three easy payments of $99.95.

Thousands liked what they heard. The company has sold at least $11 million worth since October. But federal and state consumer investigators say Crystal Ear is "an unapproved medical device." Particularly troubling is that the pitchman, Dr. Dale Glen Massad, lost his medical license six years ago, according to Florida state records.

Crystal Ear is now the subject of a 14-state investigation, including Virginia (but not Maryland) over what state officials call unlicensed sales and advertising practices. The U.S. Food and Drug Administration is conducting a separate probe.

Among the allegations lodged by state officials: The company is selling a hearing aid by mail in violation of several state laws; the company is making performance claims without FDA clearance; and the company's marketing fails to disclose that the hearing device is the subject of a federal warning.

Crystal Care, which markets Crystal Ear, is based in Lutz, Fla.; its parent company is Comtrad Industries, in Midlothian, Va. Crystal Care president Michael W. Nehr declined comment, saying he didn't want to be part of a "negative article."

But in papers submitted to state and federal officials, the company says Crystal Ear is an "amplification" or "assisted listening"device - much like infrared TV amplifiers and phones - and not subject to certain hearing-aid sales regulations.

Whether the product actually lives up to the claims is unclear. State and federal officials make no statements about its performance. There are few, if any, consumer complaints; Maryland consumer officials report none. But one New York consumer, in a letter to federal officials, says he bought the device for his right ear and didn't like it.

"I wrote the company it was no good but I said I would wait for the left-ear equipment before deciding," says Albert Donohue, of Bronxville, N.Y. "It was also terrible, so I wrote and asked for a refund. None was made."

The International Hearing Society says the product presents a safety hazard, especially since it circumvents the fitting process.

"The bottom line is people who use hearing aids need an evaluation, and you can't get one through the mail," says Peacock. "And, if, in fact, they are an amplifier, then that's problem, too, because in many cases they am-plify sounds and shoot it against the eardrum. It can make the problem worse."

FDA officials also accused the company of failing to advise consumers that before purchasing the product, they must either get a medical evaluation or sign a waiver.

The claims against Crystal Ear are similar to a 1996 case, the Whisper 2000 case, in which 17 state consumer officials, including Maryland's, said Telebrands, a Roanoke, Va., company, wasn't delivering on its promise that its Whisper XL and Whisper 2000 hearing devices would allow users to hear a whisper up to 100 feet away. The settlement provided for consumer refunds.

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