By Ann Zimmerman, the Wall Street Journal
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
Bea Corbello put off
buying hearing aids for years, because of the price. A 75-year-old widow
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
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
Web of Regulations
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
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
"The prices are
obscene," says Aaron Thornton, the recently retired director of the
audiology program at the Massachusetts Eye and Ear Infirmary, which is
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
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% 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
Some colleagues accused
Drs. Killion and Gudmundsen of proposing the rule changes so that their
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.
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
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
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
Richard Goode, a professor
Some consumers are buying
devices over the Internet or via mail order, bypassing doctors and
specialists. Those sales have grown 83% since 1997, to 3.5% 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.