4/27/2016 Hearing Aid Prices Under Pressure From Consumer Electronics The
New York Times
By ANDREW POLLACK APRIL 20, 2016
PHOENIX — At the Audiology Now! convention here last week, visitors stood next to lowing electric fans to experience how a new hearing aid could screen out wind noise. They donned goggles to attend a virtual reality dinner party to learn how new technology made it easier to hear conversations around them. But the elephant in the room, as it were, was what was happening outside the convention hall.
The consumer electronics industry is encroaching on the hearing aid business, offering products that are far less expensive and available without the involvement of audiologists r other professionals. That is forcing a reexamination of the entire system for providing hearing aids, which critics say is too costly and cumbersome, hindering access to devices vital for the growing legions of older Americans.
“The audiology profession is obviously scared, for good reason, right now,” said Abram Bailey, an audiologist and chief executive of Hearing Tracker, a consumer website.
Whether regulations on hearing aids should be relaxed in an effort to lower costs will be the topic of a daylong public workshop being held Thursday by the Food and Drug Administration. A White House advisory group has already recommended that they should be. The National Academies of Science, Engineering and Medicine is expected to issue its own report in June.
“We are willing to evolve and change, if that is appropriate,” Dr. William H. Maisel, acting director of the Office of Device Evaluation at the F.D.A., said in an interview.
Hearing aid manufacturers say that diagnosing and treating hearing loss are too complex for consumers to do using consumer devices, without the aid of a professional.
Hearing is just one realm in which new technology is clashing with traditional medical practice and regulations. There have been debates over genetic tests ordered by consumers rather than doctors, and over medical diagnoses using smartphone apps.
Just this month, the American Optometric Association complained to the F.D.A. about Opternative, a startup that offers eyeglass prescriptions based on a selfadministered
online test, without the need to visit an eye doctor.
But the opportunity in hearing aids appears particularly striking. Nearly 30 million Americans, including twothirds of those over 70, are said to have hearing loss. But only 15 to 30 percent of those who could benefit from hearing aids use them.
“The archaic service delivery is one of the reasons the adoption rate hasn’t increased,” said Amyn M. Amlani, associate professor of audiology at the University of North Texas.
Hearing aids are regulated as medical devices by the F.D.A. Under federal and state rules they generally must be provided by an audiologist, a licensed dispenser or a doctor.
Consumers are supposed to get a medical evaluation first, to make sure they do not have a serious ear disease, though most Hearing aids cost an average of nearly $2,400 each, or close to $5,000 a pair, according to the White House advisory group. Medicare does not pay for them, nor do most insurers. By contrast, the consumer devices are not regulated and sell for a few hundred dollars apiece, at most.
About 3.1 million hearing aids were sold in the United States in 2014, with a wholesale value of $1.7 billion and a retail value of $5.2 billion, according to estimates by Lisa Bedell Clive, an analyst at Sanford C. Bernstein & Company.
More than 90 percent of the business is controlled by six large manufacturers: Sonova, Sivantos, William Demant, GN Store Nord, Widex and the lone American company, Starkey Hearing Technologies.
Pressures are already lowering costs. Costco sells hearing aids at a far lower price than most audiologists charge. Hearing aids are being sold online or through the mail, despite efforts by some states to block that. The Academy of Doctors of Audiology, a trade association, has contracted with a manufacturer for basic hearing aids that its members can sell for only a few hundred dollars apiece.
Still, the White House advisory group, the President’s Council of Advisors on Science and Technology, said in a blistering report last October that industry concentration and overregulation meant that hearing aids had “not experienced the dramatic reductions in price and increases in features that have been routinely seen across consumer electronics.”
“When compared in complexity to today’s smartphones costing a few hundred dollars each,” the report said, “even premiummodel hearing aids are simple devices but can cost several thousand dollars.”
It recommended that some hearing aids for mild to moderate agerelated hearing loss be available over the counter, just as reading glasses are.
That is where the consumer products are trying to step in. Some sound amplifiers have been around for years but they are growing in sophistication, taking advantage of signal processing chips developed for phones, Bluetooth headsets and computers.
The devices include the Smart Listening System from Soundhawk, which sells at $400 for a single ear; the Bean from Etymotic Research, at $300; the CS50+ from Sound World Solutions at $350; and the Crystal Ear from NeutronicEar, at $545.
Others, like the phone giant Samsung, are rumored to be entering the field. In some cases hearing assistance will be added to multipurpose products, sometimes called “hearables,” that consumers already wear on their ears to listen to music, talk on the phone and even track physical activity. The consumer devices are not regulated because they are not, strictlyspeaking, hearing aids but instead are personal sound amplification products,
or PSAPs (pronounced PEEsaps).
What sets them apart legally is their intended use. They cannot be marketed for hearing loss, a medical condition. Rather, according to draft guidance issued by the F.D.A. in 2013, PSAPs are for people with normal hearing who need an extra boost in certain situations, like birdwatching, hunting or listening to a lecture from a distant speaker.
But it is almost farcical to pretend that PSAPs are being used only by birdwatchers. The F.D.A. is now reevaluating the guidance. Ira Dolich, 81, said that when he started having trouble hearing students in the college marketing classes he taught, he did not consider the problem serious enough to spend several thousand dollars for hearing aids, especially after hearing unfavorable reviews from friends and relatives who had done so.
So Mr. Dolich, who has since retired and lives in Georgetown, Tex.,
“To me it was a reasonable investment to experiment with,” he said, adding that he used the device only occasionally, such as to hear his wife better when they are in their car.
“I’ve been pretty pleased with it,” he said. Hearing aid manufacturers and many audiologists say consumers lack the ability to diagnose and treat hearing loss themselves, and might miss serious diseases. They say that hearing aids are tailored for an individual, amplifying different frequencies by different amounts, a precision not typically available
“Amplifying sound is not correcting hearing loss,” said Jeffrey Geigel, president of the American division of Widex. Mr. Geigel, whose father and grandfather had profound hearing loss, said of PSAPs, “Don’t call yourself a hearing aid and trick the consumer.”
Scott Davis, chairman of the Hearing Industries Association, which represents hearing aid manufacturers, said that twothirds of the price of hearing aids was for service, including hearing evaluation, counseling and adjustments over the life of the product. Dr. Frank Lin, associate professor of otolaryngology at Johns Hopkins University, who has evaluated some PSAPs, said some cheaper ones can veramplify sound. “Some can be frankly dangerous,” he said. But some, he said, are being created by people from the hearing aid industry and are “very good.”
A committee of consumer electronics companies is now trying to develop minimum standards for PSAPs. And some audiologists, like Lynn Firestone in Farmington, Conn., are starting to offer PSAPs to customers who do not want “I think we have to change and be willing to have additional options for patients,” she said.
A version of this article appears in print on April 21, 2016, on page B1 of the New York edition with the headline: Consumer Devices Move In on the Hearing Aid Trade.
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