Subject: WSJ Article on Mead Killion's Fight for Affordable Hearing Aids From: Tony Miller <ajmiller(at)MIT.EDU> Date: Wed, 24 Mar 2004 18:00:39 -0500Debate 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(at)mit.edu | (617) 510-3629 | http://tonymiller.info