FDA Proposes Rule for OTC Hearing Aids

Hearing loss, while common among older adults, if left untreated can increase the risk of becoming socially isolated and of developing dementia.  The U.S. Food and Drug Administration wants to make hearing aids more accessible and affordable and is taking action to bring hearing aids to more people with over-the-counter (OTC) devices for mild to moderate hearing loss. 

According to a recent NPR Your Health report, the FDA estimates that 37.5 million American adults have hearing problems.  The new proposed rule was announced Tuesday and will be up for 90 days of public comment.   Affordable, FDA-approved OTC hearing aids will give consumers a lower-cost option, helping to improve the quality of life for many older adults. 

Although there is no specific timeline for when OTC hearing aids will be made widely available, the move brings the possibility of affordable, non-prescription devices one step closer.  In the meanwhile, sound boosting “personal sound amplification products” (PSAPs) can be sold directly to consumers without the need for a hearing test, or an audiologist appointment to dial in a traditional hearing aid.  PSAPs are also a much cheaper option than hearing aids that can cost thousands of dollars. 

Hearing loss can not only make people feel isolated, but it can also contribute to cognitive decline and memory loss over time.  Untreated hearing loss can also influence a person’s safety and sense of security.  According to a recent study published in The Hearing Journal, approximately 30 percent of adults over the age of 65 have some degree of hearing loss.  By the age of 80, 55 percent of seniors have hearing loss.   The risk of developing dementia doubles for older adults with mild hearing loss and triples for those with moderate hearing loss. 

Untreated hearing loss can also be misdiagnosed as dementia when it causes confusion during conversations and difficulty communicating or completing everyday tasks.  Hearing problems can also increase stress and feeling of fatigue because it becomes so difficult to follow conversations, especially in noisy settings.  This frustration often leads people with untreated hearing loss to withdraw from social activities which can contribute to greater isolation and depression.