Millions of Americans soon may be able to buy much cheaper devices to help them with their mild to moderate hearing loss and avoid costly hearing aids prescribed by specialists.

It took far too long for this big step to occur, and consumers won’t see its full benefits for a bit still.

But the Food and Drug Administration, by issuing a new, draft hearing device regulation, took a major step in helping ordinary folks, as Congress intended with bipartisan legislation passed in 2017.

Years ago, lawmakers recognized that technology had evolved quickly and made nonsensical the grip that a few manufacturers had on the market for aids that could help the 38 million patients who report hearing impairment.

High-tech firms like Apple, Bose, and Skullcandy, in the meantime, have made ear buds, earphones, and headphones ubiquitous with lower cost, higher fidelity, and ease and convenience with long-battery lives and connection via wi-fi and Bluetooth technologies. Bose already has won special clearance for an $850-a-pair hearing device (see above).

In contrast, federal regulators exercised oversight on hearing aids costing on average $5,000 a pair — an expense that insurers and traditional Medicare did not cover, forcing individuals to bear the unaffordable prices out of pocket.

Further, hearing aids — as a regulated medical device — required prescription by audiologists, specialists whose added expertise was not always needed and added to patient costs. To be sure, specialists can help patients with serious hearing impairment. They can, for example, determine patients’ losses in frequency ranges and adjust devices for this, and help those with more severe impairment, as well as consumers who may need screening for sounds in certain ranges (the hum of noisy conversational spaces).

The harms of inaction

But few of those who said they had hearing loss ran the gantlet to use hearing aids, which consumers complained needed frequent adjustment and had weak battery performance. Patients, experts said, typically take seven years to fess up to themselves that their hearing has declined — and their inaction, combined with the inaccessibility of hearing aids, was detrimental to their well-being, NPR reported:

“Hearing loss has been linked to cognitive decline and other health problems in older people and can bring a sense of insecurity and isolation to someone experiencing it. ‘The greater the hearing loss, the greater the risk of loss of thinking and memory abilities over time,” Dr. Frank Lin, a researcher at the Johns Hopkins University School of Medicine, told NPR in 2017. It’s not just the elderly who are having trouble hearing. One in 5 teenagers experiences hearing loss to some degree, according to the Hearing Loss Association of America.”

The New York Times reported that the FDA hearing aid rule, which replace guidelines that have existed for four decades, will be open for public comment for several months and still must be finalized. But the newspaper reported of the FDA directive, also quoting Dr. Lin, an otolaryngologist and director of the Cochlear Center for Hearing and Public Health at Johns Hopkins University:

“The proposed rule would allow adults who have mild to moderate hearing impairments to purchase certain kinds of hearing aids in stores or online without a prescription. Children and people with severe or profound hearing loss would still be required to visit an audiologist or licensed provider. The rule also establishes performance, design, and safety standards, and outlines labeling requirements for the devices. The rule is likely to encourage more companies to enter the hearing aid market, which could encourage competition, allow manufacturing at scale, and ultimately drive prices down, Dr. Lin said. Although it is hard to predict how the market will develop, Dr. Lin said that over-the-counter hearing aids might eventually be available for a few hundred dollars. (Although that is substantially lower than the current average, that price may still be out of reach for many Americans.)”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous products, notably of the medical variety. Lawmakers and regulators, as well as patients and experts in the field, will need to keep a watch on the FDA’s new hearing aid rule to see that it functions as hoped and does not allow loopholes that work to the detriment of those with hearing loss.

Still, this reform — proposed as far back as 2015 by a blue-chip scientific panel — illustrates the hodge-podge of regulatory functions the FDA exercises, and how, as critics assert, the agency can get so bogged down in its own red tape that it serves medical device makers ahead of patients and the public.

Important FDA recalls snagged by 1950s approaches

MedTechDive, an industry newsletter focused on medical technology, is scrutinizing the risky, outdated way that the FDA recognizes problematic medical devices and stumbles to protecting the public from them with recalls. The site, as other news organizations have found, says the agency relies in excess on manufactures to collect crucial data and effective to self-report and self-police problems with devices affecting tens of millions of patients. Further, the FDA processes slog along with 1950s-era tech, including too many important documents shared on fax machines or in snail-mail filings. Really?

We have much work to do to increase the affordability, access, safety, and quality of medical devices, including ensuring that we’re not wrapping up in red tape important tools on which technology has raced ahead, Jetson style, even as we ignore flawed and risky items by plodding along with Flintstone’s type information sharing.