The FDA’s new hearing aid won’t solve the market’s biggest problems



On August 16, the Food and Drug Administration released a final rule creating a new category of over-the-counter (OTC) hearing aids, which will go into effect as early as mid-October.

Under this rule, adults with mild to moderate hearing loss can purchase hearing aids without a prescription from any vendor for around $600 to $800 a pair. This will save millions of Americans thousands of dollars. Traditional hearing aids average between $5,000 and over $14,000 a pair, including professional fitting and aftercare services. FDA guidelines also ensure patient safety – such as ensuring hearing aids are not so loud that they cause further damage to the ears – and other technical specifications to ensure good performance of the device.

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

Still, they won’t benefit all hearing-impaired Americans. Without proper examinations and individualized fitting, OTC hearing aids will not target a person’s specific hearing loss, requiring evaluation and calibration for maximum sound benefits. Indeed, experts advise consumers to consider having their hearing evaluated by a certified audiologist before purchasing a device. Also, since hearing aids are considered consumer products rather than essential medical devices, they are not covered by insurance.

In short, while these new devices hold great promise, they leave in place issues that have plagued Americans with hearing loss for more than half a century. While Congress has grappled with how to manage the medical-consumer divide of hearing loss and high costs since the 1960s, lawmakers have taken no action. However, in the absence of fundamental legal changes, these flaws are likely to persist.

Beginning in the 1920s, five companies controlled the hearing aid market. Industry vendors, not medical professionals, have guided consumers’ device choices with few safeguards to ensure quality. Doctors routinely accused vendors of encroaching on their turf, but the truth was that vendors monopolized this space because most medical experts found fitting hearing aids 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 established the Committee on the Conservation of Hearing. This committee played a major role in setting standards for hearing acuity and defining the principles of audiometry that would later improve hearing aid design. He also touched on the technical specifications of hearing aids, evaluating manufacturers’ boastfulness in advertisements to determine whether the claims met AMA standards.

Thanks to the committee’s work and wartime technological innovations such as the circuit board and the transistor, post-war hearing aids were more powerful and reliable than their early counterparts. Yet, although costs have barely increased for manufacturers, prices paid by consumers have skyrocketed. Rising prices have sparked fierce competition between major hearing aid manufacturers, prompting the AMA, in conjunction with the Federal Trade Commission and the Better Business Bureau, to define fair trade practices for the industry in an effort to regulate prices and ensure consumer choice.

But despite these guidelines, a 1962 public health survey reported that at least 54% of millions of hearing aid users had not received proper audiometric or medical examinations before purchase.

The Byzantine market for hearing aids was particularly difficult for the elderly. There were over 300 models available, ranging in cost from $100 to $400 (about $980 to $3,900 in today’s dollars). Older Americans were the most vulnerable to unscrupulous salespeople, who pressured them to buy devices that weren’t suitable for their hearing loss. This has led customers to reject their hearing aids and to despise the industry for victimizing people who have been deafened.

The problem wasn’t a misdiagnosis. Instead, customers were being sold devices that were not suitable for their range of hearing loss. Industry leaders and healthcare professionals have 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 subject to 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 hearing aid industry business practices and insufficient medical involvement. Dr. Eldon L. Eagles of the University of Pennsylvania Graduate School of Health, for his part, testified that the lack of proper medical care was a major reason for consumer dissatisfaction and eventual dropout. hearing aids. He pointed out: “Just as we no longer buy glasses and try on a few pairs until we feel we see an improvement”, neither was deafness “just a mechanical situation”, with a solution. unique. . In short, people needed the right hearing aid — not just any listening device for the hearing impaired.

But lawmakers also heard from industry experts who said it takes an average of five years for consumers to seek out tech assistance for hearing loss. When they sought help, they were faced with a confusing market filled with both medical professionals and salespeople offering potential options. Some experts have even testified that the solution is to educate consumers to understand that hearing aids are essential medical devices that require a good fit, not stigmatized products to conceal hearing loss.

Because of this confused picture, Congress took no action, although lawmakers encouraged the medical professions to become more involved in hearing assessments, eventually allowing the audiology profession to dominate.

In 1973, the Retired Professional Action Group, a subsidiary of the consumer group Public Citizen, published a 300-page report, “Paying Through the Ear”, which denounced the monopolistic nature of the hearing aid industry, of which four companies represented half . of all sales and the FTC has 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 cut costs and mandatory hearing tests for all hearing aid prescriptions.

The Senate Subcommittee on Consumer Interests of Senior Citizens responded with another hearing. This time, senators learned that although it costs about $15 to $35 to make a hearing aid ($100 to $233 today), manufacturers have marked up the devices by $200 to $600 ( $1,335 to $4,000) – a gap that only grew in the years that followed. half century.

Again, however, conflicting testimony made lawmakers reluctant to act. Instead, the FTC recommended that potential buyers refrain from purchasing hearing aids without a prescription, or at least waive their right to have one in writing. Congress held further hearings in the 1980s, but they also failed to produce legislation to alleviate the plight of consumers, as the FTC argued that the evidence compiled over the previous decade was outdated. and that further investigation was necessary.

But without categorizing hearing aids as essential medical devices, reducing prices has proven difficult without increased competition. In the 1980s and 1990s, inexpensive alternatives to traditional hearing aids appeared on the market, but they were fundamentally different – called “personal sound amplification products” (PSAPs). These unregulated devices were a poor, albeit cost-effective, alternative to prescription hearing aids. Variants of “self-adjusting hearing aids” – or “hearing aids” – such as Bose’s SoundControl hearing aids, which cost $850 a pair, have also hit the market, as have direct to ear hearing aids. consumers, the cost of which ranges from $150 to $3,000 a pair.

But none of these market innovations addressed the most fundamental problems that plagues Americans with hearing loss – the difficulty of getting a high-quality hearing aid suited to someone’s needs at 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 hearing aids. Industry experts suggest that over-the-counter hearing aids could drive down the costs of traditional hearing aids, or at least force manufacturers to offer inexpensive alternatives to their pricey models.

Even so, the gap between the sale of hearing aids and the medical evaluation required to fit them properly will remain, and the government will still classify hearing aids as consumer goods, not medical devices, which means that insurers will not pay them. As long as these defects persist, it will be difficult for consumers to receive appropriate hearing care at reasonable prices.


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