The US Food and Drug Administration said Tuesday that hearing aids will be available over the counter and without a prescription as soon as mid-October.
The new FDA rule means adult patients with mild or moderate hearing loss will no longer need to go to a doctor or audiologist before they’ll be able to get a hearing aid, and instead will be able to buy one at a drug store, traditional retailer or online.
About 30 million adults in the US could benefit from a hearing aid, according to the FDA, and making them available without requiring a doctor’s visit or other health care hurdle (and shadowing medical bill) is expected to lower the cost. Medicare doesn’t cover the cost of hearing aids, or doctor’s visits to get fitted for one.
The FDA’s action follows the Biden administration’s executive order to promote availability of low-cost hearing aids, and bipartisan legislation from 2017.
“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 Robert M. Califf said in a news release.
“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,” Califf said.
The over-the-counter rule will apply to certain air-conduction hearing aids for adults with mild or moderate hearing loss. Hearing aids for children and teens younger than 18 will still require a prescription, as will aids for people with severe hearing loss or impairment, the FDA said.
The FDA’s revised ruling considered public comments from health care providers, consumers and other members of the public, and the agency said it’s taking into account measures that will lower the risk of over-amplification of hearing aids, require that all over-the-counter hearing aids have user volume control and more.
Hearing loss happens to many people, especially as we age. Older adults may be likely to have some form of hearing impairment, and as many as half of adults older than 75 have difficulty hearing. Not being able to hear, however — a pillar of our communication as human beings — can increase the risk of mental health issues, like anxiety and depression.
Read more: Hearing Aids Are Getting Smarter: Think AI, Health Tracking
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
