Comment: Over-counter hearing aids won’t serve all consumers

By Jaipreet Virdi / Special To The Washington Post

On Aug. 16, the Food and Drug Administration issued a final rule creating a new category of over-the-counter (OTC) hearing aids, which will take effect as soon as mid-October.

Under this rule, adults with mild to moderate hearing loss can buy hearing aids without a prescription from any seller for approximately $600 to $800 a pair. That will save millions of Americans thousands of dollars. Traditional hearing aids average between $5,000 to upward of $14,000 a pair, including fitting and follow-up professional services. The FDA guidelines also ensure patient safety — like ensuring hearing aids aren’t so loud they cause further damage to the ears — and other technical specifications to ensure good device performance.

Once OTC hearing aids hit the market, they will offer consumers affordable, accessible and technologically sophisticated options for improving hearing.

Yet, they won’t benefit all Americans with hearing loss. Without proper exams and individualized fitting, OTC hearing aids won’t target someone’s specific hearing loss, which requires an evaluation and calibration for maximum sound benefits. Indeed, experts are advising consumers to consider getting a hearing assessment by a certified audiologist before purchasing a device. Moreover, since hearing aids are considered consumer products rather than essential medical devices, they are not covered by insurance.

In short, while these new devices offer great promise, they leave in place problems that have plagued Americans with hearing loss for over a half-century. While Congress has grappled with how to deal with the gap between the medical and consumer sides of hearing loss and high costs since the 1960s, legislators have taken no action. Absent fundamental legal changes, however, these flaws probably will linger.

Beginning in the 1920s, five companies controlled the market for hearing aids. Industry salesmen, not medical professionals, guided consumers’ selections of devices with few guardrails to guarantee quality. Doctors regularly accused salesmen of encroaching on their territory, but the truth was that salesmen monopolized this space because most medical experts found the fitting of hearing aids to be time-consuming — and often unnecessary — for their practice.

This structure began to change in 1943, when the American Medical Association and the American Academy of Ophthalmology and Otolaryngology created the Committee on the Conservation of Hearing. This committee played a major role in establishing standards for hearing acuity and defining the principles of audiometry that would later improve hearing aid designs. It also addressed the technical specifications of hearing aids, evaluating the boasting of manufacturers in advertisements to determine whether claims met AMA standards.

As a result of the committee’s work and wartime technological innovations such as the printed circuit and transistor, postwar hearing aids were more powerful and reliable than their early counterparts. Yet, although costs barely rose for manufacturers, the prices consumers paid skyrocketed. Rising prices ignited bitter competition between the top hearing aid manufactures, prompting the AMA, in conjunction with the Federal Trade Commission and the Better Business Bureau, to outline fair trade practices for the industry in an attempt to regulate prices and ensure consumer choice.

But despite these guidelines, a 1962 Public Health Survey reported that at least 54 percent of the millions of hearing aid users did not receive proper audiometric or medical examinations before purchase.

The byzantine market for hearing aids was especially difficult for seniors. There were more than 300 models available, which varied in cost from $100 to $400 (approximately $980 to $3,900 in today’s dollars). Elderly Americans were most vulnerable to unscrupulous salesmen, who pressured them to purchase devices that weren’t suitable for their hearing loss. This led customers to reject their hearing aids and scorn the industry for victimizing deafened people.

The problem wasn’t misdiagnosis. Instead, customers were being sold devices that weren’t fitted to their range of hearing loss. Industry leaders and medical professionals alike insisted that no hearing aid should be prescribed or purchased without a proper hearing test.

Despite these concerns, the classification of hearing aids as consumer goods — as opposed to medical devices with strict standards — meant that when Congress enacted Medicare in 1965, the devices were excluded.

Three years later, in July 1968, the Senate held hearings on the sales practices of the hearing aid industry and the inadequate involvement of the medical profession. Dr. Eldon L. Eagles of the University of Pennsylvania Graduate School of Health, for one, testified that the lack of proper medical attention was a major reason for consumer dissatisfaction and eventual abandonment of hearing aids. He emphasized: “Just as we no longer buy spectacles on the basis of trying on a few pairs until we feel that we notice some improvement,” neither was deafness “a simple mechanical situation,” with a one-size-fits-all solution. In short, people needed the right hearing aid; not just any hearing aid.

But legislators also heard from industry experts who claimed it took consumers, on average, five years to seek out technological assistance for hearing loss. When they did look for help, they confronted a confusing marketplace full of both medical professionals and salesmen offering potential options. Some experts even testified that the solution was educating consumers to understand that hearing aids were essential medical devices that needed proper fitting, not stigmatized products for concealing deafness.

Due to this muddied picture, Congress took no action, though legislators did encourage medical professions to become more involved in hearing assessments; eventually enabling the profession of audiology to dominate.

In 1973, the Retired Professional Action Group, a subsidiary of the consumer group Public Citizen, released a 300-page report, “Paying Through the Ear,” which denounced the monopolistic character of the hearing aid industry, in which four companies accounted for half of all sales and the FTC cited nearly every major manufacturer for anticompetitive practices. The report also criticized medical experts for not working hard enough to protect their patients, and it recommended greater regulation to reduce costs and mandatory hearing tests for all hearing aid prescriptions.

The Senate Subcommittee on Consumer Interests of the Elderly responded with another hearing. This time, senators heard that while it cost approximately $15 to $35 to manufacture a hearing aid ($100 to $233 today), manufacturers marked up the devices a whopping $200 to $600 ($1,335 to $4,000), a gap that has only increased in the ensuing half century.

Again, however, conflicting testimony made legislators reticent to act. Instead, the FTC recommended that prospective buyers refrain from purchasing hearing aids without a prescription, or at least waiving their right to one in writing. Congress held further hearings in the 1980s, but they too produced no legislative action to ease the plight of consumers, as the FTC argued the evidence compiled in the previous decade was outdated and a new survey was required.

But without categorizing hearing aids as essential medical devices, reducing prices proved difficult without increased competition. In the 1980s and 1990s, inexpensive alternatives to traditional hearing aids hit the market, but they were fundamentally different; branded as “personal sound amplification products” (PSAPs). These unregulated devices were a poor — albeit cost effective — stand-in for prescription hearing aids. Variations of “self-fitting hearing aids” — or “hearables” — such as Bose’s SoundControl Hearing Aids, which cost $850 per pair, have also hit the market, as have direct-to-consumer hearing aids, ranging in costs from $150 to $3,000 per pair.

But none of these market innovations addressed the most fundamental problems plaguing Americans with hearing loss: the difficulty of getting a high-quality hearing aid matched to someone’s needs for an affordable price. The hope is that the OTC hearing aids that emerge from the new FDA rule will be better-regulated alternatives to PSAPs and hearables. Industry experts suggest that OTC hearing aids might drive down the costs of traditional hearing aids, or at least force manufactures to offer low-cost alternatives to their expensive models.

Even so, the gap between the sale of hearing aids and the medical evaluation required to properly fit them will remain, and the government will still classify hearings aids as consumer goods, not medical devices, meaning insurers won’t pay for them. So long as those flaws persist, it will be hard for consumers to receive proper hearing health care at reasonable prices.

Jaipreet Virdi is a historian of medicine, technology and disability at the University of Delaware, and author of “Hearing Happiness: Deafness Cures in History.”