FDA Approves the Sale of Hearing Aids over the Counter

Recently, the FDA approved the sale of some over-the-counter (OTC) hearing aids, widening access to those who need them. According to the National Institute on Deafness and Other Communication Disorders, approximately 13% of people over 12 in the United States have hearing loss in both ears. Additionally, 28.8 million American adults should be using hearing aids.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions. 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,” stated the FDA Commissioner, Robert M. Califf, MD, in the press release.

Risk factors for hearing loss include genetics, age, regular exposure to loud noises, medications, and disease. According to the Mayo Clinic, hearing loss can impair quality of life. The inability to communicate can lead to isolation and depression.

Data from the Center for Audiology suggests that hearing loss is associated with feelings of irritability, fatigue, withdrawal, and loneliness. Additionally, untreated hearing loss can correlate with cognitive decline.

The Center for Audiology also states that many people struggle with access to hearing loss treatments. It takes approximately seven years for people experiencing hearing loss to seek care.

According to the FDA press release, this new approval will allow the sale of air-conduction hearing aids for adults over 18 with mild or moderate hearing loss. Not only will this proposal allow for widened access to hearing aids, but it will also reduce the financial burden of hearing loss.

Data from a JAMA Otolaryngology-Head & Neck Surgery study shows that untreated hearing loss costs approximately $22,434 in healthcare expenses.

“The rule is expected to lower the cost of hearing aids, furthering the Biden–Harris Administration’s goal of expanding access to high-quality healthcare and lowering healthcare costs for the American public. It is designed to assure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearing aid technology marketplace,” stated the FDA press release.