By Chris Welch
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.
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.”
Disclaimer
The information contained in South Florida Reporter is for general information purposes only.
The South Florida Reporter assumes no responsibility for errors or omissions in the contents of the Service.
In no event shall the South Florida Reporter be liable for any special, direct, indirect, consequential, or incidental damages or any damages whatsoever, whether in an action of contract, negligence or other tort, arising out of or in connection with the use of the Service or the contents of the Service. The Company reserves the right to make additions, deletions, or modifications to the contents of the Service at any time without prior notice.
The Company does not warrant that the Service is free of viruses or other harmful components
This article originally appeared here and was republished with permission.
