FDA Gives Authorization for First Over-the-Counter Hearing Aid Software Device

The US Food and Drug Administration (FDA) announced its authorization of the Hearing Aid Feature, described as the first available over-the-counter hearing aid software device.¹

The announcement noted that the Hearing Aid Feature can also be customized to patients’ needs, with the aim being the amplification of sounds for those aged 18 years or older with mild to moderate hearing impairment. A notable aspect of the device is that it is intended for compatibility with certain versions of the Apple AirPods Pro headphones after installation.

“Hearing loss is a significant public health issue impacting millions of Americans,” Michelle Tarver, MD, PhD, acting director of the FDA's Center for Devices and Radiological Health, said in a statement. “Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”¹

In a related release by Apple, it was announced that the AirPods Pro 2 will allow for an introduction of the first available ‘end-to-end hearing health experience’ this fall.² The release highlighted the clinical-grade Hearing Aid feature as an element of this, and the FDA has granted marketing authorization for the Hearing Aid Feature to Apple Inc.

Loss of hearing is known to negatively impact relationships, human communication, performance in education or career, and emotional well-being. In fact, around 30 million adults in the US are known to experience some measure of hearing loss, though hearing aids may allow for a reduction in frequency or severity of hearing loss.

The FDA introduced over-the-counter regulations on hearing aids aimed at access to safe and effective hearing aids for adults with mild to moderate loss of hearing. The October 2022 regulations specifically allowed individuals to buy hearing aids directly from online sources or stores without requiring a prescription, medical exam, or an audiologist meeting.¹

The recent rule highlighted FDA officials’ ongoing aims to allow patients to access solutions for hearing loss as well as promote convenience.

A previous clinical study involved 118 participants that reported perceived mild to moderate hearing loss, and the results indicated that those implementing the Hearing Aid Feature’s self-fitting method had similar benefits to those who had the same device fitted professionally. Comparable levels of amplification and speech understanding within louder environments were also noted, and there were no adverse events reported by subjects.¹

The Hearing Aid Feature includes a mobile medical application on iOS which is designed with a self-fitting approach, giving its users the ability to customize the device to their needs without the help of a hearing professional. Patients use an iPhone or iPad, with the Hearing Aid Feature adjusting based on one’s hearing levels drawn from the iOS HealthKit.

This device’s application was assessed by FDA officials through their De Novo premarket review pathway, a regulatory process which evaluates devices which are low- to moderate-risk, novel, and have no previous legally marketed equivalents.

References

1. ^{FDA Authorizes First Over-the-Counter Hearing Aid Software. FDA. September 12, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software. Date accessed: September 12, 2024.}
2. ^{Apple introduces AirPods 4 and the world’s first all-in-one hearing health experience with AirPods Pro 2. Apple. September 9, 2024. https://www.apple.com/newsroom/2024/09/apple-introduces-airpods-4-and-a-hearing-health-experience-with-airpods-pro-2/. Date accessed: September 12, 2024.}