I know, I know, you are tired of me beating on the FDA. Too bad. The beatings will continue until mortality improves.
Today’s beating, however, concerns hearing aids rather than than vaccines. The current system, much like the optometry racket, requires that hearing aids be purchased through an audiologist:
WEBMD: A pair of hearing aids runs $5,600 on average — a cost that health insurance doesn’t typically pick up. In order to get the devices, people with hearing loss must have a medical exam to rule out the slim chance of a serious medical problem that is causing the hearing loss, or they must sign a waiver opting out of the exam. You can only buy hearing aids through an audiologist or a licensed hearing aid dispenser, who is authorized to test hearing and sell hearing aids.
…choosing a hearing professional limits a person’s hearing aid choices, and changing audiologists as a result of location or personal preference could require a person to change hearing aids, too.
Due in part to these hurdles, once a person starts to lose their hearing, they wait an average of 7 years before they seek help.
The NYTimes continues the story:
By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration….in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.
Of course, the FDA is likely to miss the deadline. But even I am willing to cut them some slack, given other more pressing concerns. The real issue, however, is one that the NYTimes doesn’t confront and that is why does the FDA regulate hearing aids at all?
Headphones and earbuds are not regulated as medical devices and hearing aid technology is similar to hearings buds with a sophisticated equalizer. Indeed, you can even buy “personal sound amplification products” that are not FDA regulated or approved. It’s only the somewhat arbitrary declaration that these products are “medical devices” that brought them under FDA regulation to the detriment of consumers. The National Academy of Sciences report agrees writing:
FDA has established regulations for hearing aids, including quality system regulation requirements, mandatory labeling, and pre-purchase medical evaluation (or a documented waiver). These regulations, along with a number of state regulations, have largely restricted the availability of hearing aids to being mainly dispensed through medical, audiology, or hearing instrument specialist venues.
…In examining the Food and Drug Administration’s (FDA’s) requirements for physician evaluation prior to obtaining hearing aids, the committee finds no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit.
Addendum: In some positive news the FDA lifted its ban on the first non-prescription, at-home SARS-COV test and also on a prescription, paper-strip test. Now all we need is a non-prescription paper-strip test! Come on guys.