WSJ Article on Mead Killion's Fight for Affordable Hearing Aids

[Tony Miller <ajmiller@xxxxxxx>]

Debate over hearing aid prices heats up

By ANN ZIMMERMAN
The Wall Street Journal
3/24/04 8:55 AM

A set of hearing aids costs about $2,200 on average. Mead Killion thinks
that's crazy. He believes an effective aid for mild-to-moderate hearing
loss could be sold over the counter for around $100 -- using technology
that already exists.

But bringing inexpensive hearing aids to the masses won't be easy. Dr.
Killion, a hearing-aid pioneer, is battling a tight-knit group of
licensed specialists who by law are the only people allowed to dispense
hearing devices. The Food and Drug Administration, which regulates the
industry, so far has sided mostly with the specialists, who are trained
to calibrate and fit devices suited to each patient. If anyone could
sell a hearing aid, the FDA says, elderly people might be victimized by
shoddy merchandise and fail to get treatment for serious medical
conditions.

Dr. Killion's campaign has revived a debate among hearing-aid
specialists and manufacturers about how to improve access to help for
the 30 million Americans with hearing loss. "We do such a poor job as an
industry meeting the needs of masses of individuals," says Wayne Staab,
an audiologist and the executive director of the American Auditory
Society. "We develop instruments for people who have the most money and
leave the other individuals on the sidelines."

Bea Corbello put off buying hearing aids for years, because of the
price. A 75-year-old widow from Leakesville, Miss., she says she finally
broke down and bought a pair for $3,000 about a year ago. Her husband
was dying of cancer and he pleaded with her to do something about her
hearing loss. "We really couldn't afford it and if it was up to me I
wouldn't have paid the price, but I wanted to please him," says Mrs.
Corbello.

Hearing loss is the third-most-common chronic condition in older people
after arthritis and high blood pressure, according to a recent study
published in the Journal of the American Medical Association. Another
study in JAMA showed that elderly people who don't treat their hearing
loss are more likely to experience depression, anxiety and paranoia.
Medicare, the government health program for the elderly, and many
private insurers don't pay for hearing aids.

Only about one in five people who needs a hearing aid has one, according
to Sergei Kochkin, executive director of the Better Hearing Institute,
an education and advocacy group in Alexandria, Va. The proportion has
declined in the past two decades.

The web of regulations dates back to the mid-1970s. Evidence presented
at Senate hearings at that time showed that aggressive salespeople from
unregulated hearing-aid centers often sold elderly people products they
didn't need or that were defective. Audiologists testified that some
people bought hearing aids when their hearing loss actually required
medical treatment for infection, an acoustical nerve tumor or too much
ear wax.

Congress amended the Food, Drug and Cosmetic Act to give the FDA
regulatory power over all medical devices, and the FDA followed with the
Hearing Aid Rule of 1977. It required consumers to see a physician to
rule out a medical problem before getting a hearing aid. It also created
an exception: Adults could bypass a doctor if they signed a waiver
administered by a state-licensed hearing-aid dispenser. By signing,
customers would acknowledge that they understood the dangers of skipping
a full medical evaluation.

Today, two types of licensed specialists are the main vendors of hearing
aids. State-licensed hearing-aid specialists need only a high-school
education but have to pass tests proving their competence to administer
hearing exams, fit devices and recognize underlying physical problems.
Audiologists must have at least a master's degree, though they generally
aren't medical doctors. After the FDA rule went into effect,
audiologists changed their professional code of ethics and jumped into
the business of selling hearing aids.

Under standards set by professional bodies, the specialists require a
battery of tests and fitting sessions, driving up the cost. That results
in the $2,200 average cost for hearing aids, a figure cited in an
industry study sponsored by Knowles Electronics, an Illinois components
maker.

"The prices are obscene," says Aaron Thornton, the recently retired
director of the audiology program at the Massachusetts Eye and Ear
Infirmary, which is affiliated with Harvard Medical School. "The
technology can be made for hundreds of dollars; the rest is distribution."

Mead Killion agrees. In 1989, the bald-headed engineer with a handlebar
mustache developed a component that allowed hearing aids to amplify soft
sounds without simultaneously amplifying loud sounds to a painful level.
Today almost every manufacturer uses circuitry patterned after his
invention, called a K-amp. Last year the American Academy of Audiology
honored the 64-year-old inventor with an award, saying he "profoundly
influenced the path of hearing care."

Dr. Killion and his wife, Gail Gudmundsen, both of whom hold doctorates
in audiology, think there's a place for high-priced hearing aids and the
professionals who dispense them, but they say many people don't need
elaborate tests and fittings. "There are a lot of uncomplicated hearing
losses in the mild to moderate range that don't require a very
sophisticated instrument," Dr. Killion says. "At the worst, maybe it
won't work for someone, but it won't hurt them."

Dr. Killion says technology developed over the last two decades has made
it possible to create a high-quality hearing aid at a low cost. New
materials allow a better fit without a custom-made ear mold.

Most hearing loss in the elderly is caused by a gradual deterioration of
hair cells in the inner ear that makes it difficult to hear
high-frequency sounds. It is a natural part of aging, akin to the
deterioration of eyesight over time. But in some 5 percent of cases,
hearing loss is a symptom of a medical problem that needs a doctor's
attention.

Last August, after he got the award, Dr. Killion and his wife petitioned
the FDA to permit the sale of hearing aids over the counter and do away
with the requirement for a physician's screening or waiver. They argued
that the potential harm was negligible and called the present FDA policy
"discriminatory against the low-income population." They said
hearing-aid packages should list warning signs of a serious medical
problem such as bleeding from the ear and chronic dizziness.

The petitions rattled many in the profession. At a workshop at
Northwestern University, in Evanston, Ill., Dr. Killion says audiology
graduate students asked him why he wanted to take away their future
jobs. Audiologists say the complaints about prices fail to recognize the
work they do. Hearing professionals figure out how much amplification
patients need at various frequencies and use a computer to program the
aids accordingly.

Some colleagues accused Drs. Killion and Gudmundsen of proposing the
rule changes so that their Elk Grove Village, Ill., company, Etymotic
Research, could market an over-the-counter aid. The company currently
sells hearing-aid circuits, earphones for hearing testing and
high-fidelity ear plugs for professional musicians. Wrote one
audiologist on an industry Internet site: "They are business people
first and foremost. And the pocketbook is a highly motivating factor for
people. Obviously Mead and Gail are not exempt." Another called for a
"big effort" to stop the couple from their "money hungry folly."

Dr. Killion confirms that he'd like to sell an over-the-counter device
but insists his main motivation is to make hearing help more affordable
and easier to obtain.

The American Academy of Audiology and the International Hearing Society,
which represents mostly state-licensed hearing-aid dispensers, opposed
the petitions. The academy said granting the petitions "could lead to
widespread confusion and abuse." The society's executive director, Robin
Clowers, says over-the-counter aids could bring a return to the bad old
days, when fly-by-night operators took advantage of the elderly by
selling useless devices.

In February of this year, the FDA rejected the main petitions from Dr.
Killion and his wife. "FDA is concerned that if prospective purchasers
of hearing aids are not examined by a physician prior to using the
hearing aid, 'red flag' ear conditions will go undiagnosed and
unevaluated ... and lead to irreparable damage," the rejection notice
said. Eric Mann, head of the FDA's division of ear, nose and throat
devices, says the agency is also worried that defective over-the-counter
products would deter people from getting further help.

The decision was a "kick in the head," says Dr. Killion. He thinks
consumers would be smart enough to distinguish legitimate products from
junk. "A lot of manufacturers have a high-quality product waiting in the
wings," he says. "They tell me they would have it ready for market if it
was legal. They sell it now in India and other markets."

Several years ago, Dr. Thornton of Massachusetts Eye and Ear Infirmary
purchased hearing aids lacking custom ear pieces and programming
capabilities that were made by Siemens AG of Germany for less-regulated
European markets. He says he paid $60 apiece for the devices, which
Siemens was closing out at the time, and sold them at his clinic for
$200. "My patients were very satisfied with them," he says. "In fact,
they were mad when the time came for new ones and I couldn't get them
again."

Richard Goode, a professor at Stanford University and the former
president of the American Academy of Otolaryngology-Head and Neck
Surgeons, thinks the FDA is inconsistent. "If the FDA does not require
the public to see a doctor to rule out glaucoma or other diseases before
getting reading glasses, why does it do so for hearing aids?" he asks.

Some consumers are buying devices over the Internet or via mail order,
bypassing doctors and specialists. Those sales have grown 83 percent
since 1997, to 3.5 percent of all hearing-aid sales, according to the
Knowles Electronics study. However, the quality of those devices varies
greatly, and some of the purveyors operate in a legally gray area, since
some states prohibit mail-order sales. Most, but not all, include a
waiver and the warning signs on their Internet site or mail-order forms.

Dr. Killion still holds out hope for another petition he has submitted
to the FDA, which hasn't been ruled on yet. It calls for the agency to
create a new "one size fits most" classification for hearing aids that
would be subject to fewer restrictions than the hearing aids on the
market now. In effect, it is another stab at getting the FDA's approval
for over-the-counter sales.

Dr. Killion says many stores already sell "listening devices" for people
with normal hearing that differ little from hearing aids. For example,
sporting-goods stores sell ear devices for hunters that muffle the sound
of gun shots but also amplify quiet sounds, such as animals rustling in
vegetation. Dr. Killion says the hunters' device is actually quite
effective for people who have trouble hearing and illustrates his point
that there's no technological barrier to an inexpensive over-the-counter
hearing aid.

To prove his point, he recently played two recordings before an audience
of 50 audiologists. One was of a person speaking in cafeteria noise,
amplified by a $149 sporting-goods device. The other was of the same
speech amplified through a popular $2,000 digital hearing aid. The
audience rated the $149 device as having clearer sound. "The point is,
there are reasonably good OTC aids out there now," Dr. Killion said.


--
Tony Miller
Eaton-Peabody Laboratory, Massachusetts Eye and Ear Infirmary
243 Charles St, Boston, MA 02114
ajmiller@mit.edu | (617) 510-3629 | http://tonymiller.info