Hearing Aid Rules are for ‘Socialists’

By SAM URETSKY

In decades past, Eleanor Roosevelt often spoke to groups of high school students. The talks always began with Mrs. Roosevelt putting on her glasses and saying “I only wear these when I want to hear.” That was a joke. There was, and is, something of a stigma to any sort of physical disability, but eyeglasses were more acceptable than hearing aids. Mrs. Roosevelt’s glasses had the electronics in the ear pieces, so that the hearing aid could be worn, and disguised (somewhat). Her comment was a variation on people who said “I only wear glasses for reading”.

The electronic hearing aid was developed in the early 20th century. The electronics relied on vacuum tubes and were the size of a cigar box, or the portable radios of the period. Technological advances came with the transistor, and digital data processing so that a modern hearing aid can be worn inside the ear, almost invisibly. Even so, the hearing aid has its drawbacks – not the least of which is the price, and the fact that they can’t be purchased without a prescription from a physician and sold by a licensed audiologist or hearing aid dispenser. The regulations governing sale of hearing aids are controlled by the Food and Drug Administration and regulations may limit the availability and affordability of hearing aids.

Last August the FDA announced that it was changing the enforcement of the rules, so that some hearing aids could be sold over-the-counter, whether on-line or in retail stores. According to the FDA website, “The FDA has issued guidance communicating that we do not intend to enforce the requirement for a medical evaluation or waiver prior to the sale of certain hearing aids for users 18 years of age or older.

While the FDA believes a medical evaluation may not be necessary for people 18 years of age or older before buying hearing aids, if you experience any of the following conditions, you should consult a medical professional:

• Visible deformities of the ear since birth or from injury;

• Fluid, pus, or blood coming out of the ear within the previous three months;

• Sudden, quickly worsening, or fluctuating hearing loss within the previous three months;

• Dizziness;

• Hearing loss in only one ear or a large difference in hearing between ears

• Ear wax build up or feeling that something is in the ear canal

• Pain or discomfort in the ear

• Tinnitus or ringing in one or both of your ears”

Rules will remain on the books, but will not be enforced. Before the new decision sound amplification devices (they weren’t allowed to call them “hearing aids”) were readily available, but have significant limitations. They increase all sounds, rather like the volume dial on a radio. All sounds become louder or softer, while with modern digital hearing aids an audiologist can adjust which frequencies should be emphasized. The latest wrinkle uses AI so that the hearing aid can make adjustments itself, depending on the environment.

The New York Times reported, “The agency cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 or more.” Personal sound amplification devices are relatively inexpensive. One brand was on sale for $300/pair, while others were priced close to entry level hearing aids.

The goal is to encourage competition which may lower prices while encouraging more innovative technology, making hearing improvement available to more people. It might work. The White House Blog (07/09/2021) said, “Healthy market competition is fundamental to a well-functioning US economy. Basic economic theory demonstrates that when firms have to compete for customers, it leads to lower prices, higher quality goods and services, greater variety, and more innovation.” On the other hand, how trustworthy is a hearing test conducted over a made-in-China laptop?

One alternative might be to change Medicare to cover hearing aids, but that would be condemned as socialism. It’s easier to push the rules aside.

Sam Uretsky is a writer and pharmacist living in Louisville, Ky. Email sdu01@outlook.com.

From The Progressive Populist, November 1, 2022


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