Hearing aids can finally be sold over the counter from Monday, after the U.S. Food and Drug Administration approved them for sale without a prescription in August.
Many people have no doubt been awaiting this day, with approximately 15 percent of adults in the U.S. having some trouble hearing. The FDA’s decision was aimed at making hearing aids accessible to more people who need them, with their wider availability intended to encourage competition and lower cost. The FDA has also laid out rules and regulations for over-the-counter hearing aids to ensure all devices sold are safe.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” FDA commissioner Dr. Robert M. Califf said at the time of the decision.
“Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
Sony is among the first tech manufacturers to offer prescription-free hearing aids under the new rules. Designed in partnership with WS Audiology, the company’s CRE-C10 and CRE-E10 hearing aids will set you back a pretty penny at $999.99 and $1,299.99 per pair respectively. This may sound like a lot, it’s still much more affordable than the average cost of hearing aids up until now, with a pair capable of costing anywhere from $4,000 to $6,000.
Prior to the FDA’s approval, anyone wanting to get a hearing aid had to undergo a medical and/or audiological examination to evaluate the type and amount of their hearing loss; obtain written medical clearance for a device (or sign a medical waiver); and make multiple visits to an audiologist to get evaluated, fitted, and for follow-up checks.
Now it may be as simple as ordering your hearing aids online and setting them up yourself at home.
