On Thursday, September 12th, the FDA approved a new software called the Hearing Aid Feature (HAF), which allows Apple’s AirPods Pro 2 and other compatible models to function as hearing aids when paired with iOS 18-compatible iPhones or iPads. This marks the first time the FDA has authorized an over-the-counter hearing aid software.

Apple is expected to release iOS 18, the operating system that supports the HAF, by October. The HAF software is designed for the estimated 30 million Americans who experience mild to moderate hearing loss due to aging, loud noise exposure, medical conditions, and other factors. The application will also feature a hearing test, allowing users to customize volume, tone, and balance settings for their specific needs.

“Hearing loss is a major public health concern affecting millions of Americans,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health. “This new authorization for over-the-counter hearing aid software in a widely-used consumer audio product represents an important step in making hearing support more accessible and acceptable for adults with mild to moderate hearing loss.”

The FDA previously introduced over-the-counter hearing aid regulations in October 2022, allowing consumers to purchase hearing aids directly from stores without needing a physician’s visit. This move has made it easier for people to access hearing assistance.

Apple’s AirPods Pro 2, priced at $249, are significantly more affordable than many traditional hearing aids, which can cost thousands of dollars. Otolaryngologists believe Apple’s entry into the hearing aid market will encourage more individuals with hearing loss to seek assistance. Additionally, they hope the widespread use of AirPods will help reduce the stigma associated with wearing hearing aids, as earbuds have become common among all age groups.

Barbara Kelley, executive director of the Hearing Loss Association of America, praised Apple’s move, telling CBS: “The price point is much lower than other OTC hearing aids, and the fact that it’s such a mainstream product means it can really help people with hearing loss. Apple’s involvement brings much-needed attention to hearing health, which is an important aspect of overall wellness.”