In a landmark move, the U.S. Food and Drug Administration (FDA) has approved the Hearing Aid Feature (HAF), an over-the-counter (OTC) software that allows Apple AirPods Pro to function as hearing aids for individuals with mild to moderate hearing loss. This is the first FDA-authorized OTC hearing aid software, making hearing support more accessible for millions of Americans.
The HAF enables users to personalize their hearing experience directly from an iOS device, adjusting settings such as volume and tone to meet their specific needs. This approval builds on the FDA’s 2022 initiative to simplify access to hearing aids, removing the need for a prescription.
According to a statement released on Thursday, September 12, the software was tested in a study involving 118 participants and demonstrated performance comparable to that of professionally fitted hearing aids. An FDA spokesperson spoke about the rationale behind the approval of the HAF software for AirPods Pro.
Improving Access to Hearing Support
“The FDA authorized the Hearing Aid Feature as the sponsor demonstrated the device met the applicable criteria to market this product to consumers,” said the spokesperson. “This technology will enhance the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”
The HAF was evaluated in a clinical study conducted at multiple sites across the U.S. The study found that participants who used the HAF’s self-fitting strategy reported similar benefits to those who had their devices professionally fitted. The study also showed comparable performance in tests that measured amplification levels in the ear canal and speech understanding in noisy environments. Importantly, no adverse events related to the device were observed.
“This OTC hearing aid software is available on a widely used consumer audio product, thereby expanding the potential reach of hearing support for adults with perceived mild to moderate hearing loss,” the spokesperson added.
Addressing OTC Hearing Aid Limitations
While the HAF software offers significant benefits, the FDA has addressed the limitations of OTC hearing aids. The agency recommends that adults aged 18 or older with perceived mild to moderate hearing loss can purchase OTC hearing aids without needing to consult a doctor or audiologist. However, individuals with more severe hearing loss should consult a licensed professional, as OTC devices may not provide sufficient support.
The FDA spokesperson emphasized, “OTC hearing aids are limited in their maximum output and may not adequately treat more severe hearing losses.”
No Doctor Required
One of the key features of the HAF software is its self-fitting strategy, allowing users to adjust their hearing settings independently, without the need for professional assistance. The setup process is carried out using an iOS device such as an iPhone or iPad, and the user’s hearing data can be accessed through the iOS HealthKit to personalize the HAF.
“Users can further refine volume, tone, and balance settings after the initial setup,” said the spokesperson.
With over 30 million American adults reporting some degree of hearing loss, this development marks a significant step forward. The use of hearing aids has been linked to reducing cognitive decline, depression, and other health issues in older adults. The FDA’s approval of this innovative software could dramatically improve the quality of life for millions of people by making hearing aids more accessible and affordable.
