Apple gets FDA authorization to turn the AirPods Pro into hearing aids

Just days after Apple announced a new hearing aid feature for the second-generation AirPods Pro, the US Food and Drug Administration (FDA) has authorized the software that powers this functionality. In a press release, the FDA describes Apple’s solution as “the first over-the-counter (OTC) hearing aid software device.”

The feature “was evaluated in a clinical study with 118 subjects with perceived mild to moderate hearing loss,” according to the FDA, and “the results demonstrated that subjects who used the HAF self-fitting strategy achieved similar perceived benefit as subjects who received professional fitting of the same device.”

Enabling the AirPods Pro to double as clinical-grade hearing aids is one of several new features that Apple is bringing to the second-gen AirPods Pro this fall as part of the company’s continued focus on hearing health. The earbuds will also gain a Hearing Protection mode that allows them to safeguard your ears in loud environments like concerts. Hearing Protection will be enabled by default and preserve “natural and vibrant” sound at live performances.

Additionally, AirPods Pro owners will be able to access a new Hearing Test that asks them to tap the screen when they hear a variety of tones played through the earbuds. Test results will appear in Apple’s Health app and will be used to create a personalized audio profile for the hearing aid feature.

Bringing hearing aid functionality to the AirPods Pro is a significant development that could help to reduce stigma and lessen costs for consumers looking to protect their hearing. Approximately 1.5 billion people globally are living with some level of hearing loss, according to the World Health Organization.

Apple’s various platforms already have a number of software features that can warn customers when they’re in dangerously loud conditions or listening to audio at levels that could put them at risk of permanent hearing damage. It’s a fitting initiative from the company that gave us the iPod and later the iPhone.

The FDA notes that Apple’s application was reviewed under De Novo classification, which is intended for “low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.”