FDA Finally Improves Access to Hearing Aids for SOME People

Jeffrey A. SingerToday the Food and Drug Administration issued a final rule which will give millions of Americans over ‐​the‐​counter access to hearing aids that heretofore required a prescription. The new rule, scheduled to take effect in mid ‐​October, will benefit as many as30 million people who suffer from hearing loss.In 2017 Congress passed, and President Trump signed, theOver ‐​the‐​Counter Hearing Aid Act as a rider on the FDA Reauthorization Act of 2017. The Act created a new category of OTC hearing aids as devices using air conduction to improve hearing among adults with mild to moderate hearing impairment. It differentiates these devices from devices that amplify sound for people with normal hearing, such as noise ‐​cancelling headphones. The latter are not considered to be hearing aids. Regulations for the new class of OTC hearing aids were originally supposed to be released in 2020 but were delayed due to the COVID-19 pandemic. President Biden issued anexecutive order on July 9, 2021 that, among other things, prodded the FDA to speed up the rule ‐​making process for OTC hearing aids.The new rule applies only to persons over age 18 with mild ‐​to‐​moderate hearing loss. Hearing aids intended for children and for people with severe hearing loss will still require a prescription.This is welcome news. But it doesn ’t go far enough. AsMichael Cannon and I explain inDrug Reformation, the FDA has, since...
Source: Cato-at-liberty - Category: American Health Authors: Source Type: blogs