WASHINGTON, SEPT 13 – The United States (US) Food and Drug Administration (FDA) has approved software that allows the latest version of Apple’s AirPods Pro earphones to act as a hearing aid, reports United Press International (UPI).
Yesterday’s announcement by the federal agency comes just four days after the US tech giant on Monday launched a redesigned line of AirPods, including AirPods Pro 2 with clinical-grade hearing aids that can be purchased without a prescription and a clinical hearing test that can be accessed via iPhone. users.
According to Apple, users will be able to use their iPhone in conjunction with the new AirPods Pro to create a personalized listening profile that ‘seamlessly transforms AirPods Pro into a clinical-grade hearing aid.’
The FDA yesterday said the product’s marketing approval is the first for a hearing aid software device that can be purchased without a prescription.
“Today’s marketing authorization of over-the-counter hearing aid software on widely used consumer audio products is another step that increases the availability, accessibility and acceptance of hearing support for adults with mild to moderate hearing loss,” said the Center’s executive director FDA for Devices and Radiological Health, Michelle Tarver, in a statement.
According to the FDA, the AirPods Pro hearing aid feature is designed for people 18 years of age or older with mild to moderate hearing loss.
This software-activated hearing aid feature uses a self-adjustment strategy that allows users to adapt AirPods Pro to their hearing needs without professional help, with adjustments made via iPhone or iPad and hearing levels accessed by the device’s operating system HealthKit app.
A clinical study involving 118 people across the US found that self-adjustment strategies on AirPods Pro achieved similar results to devices fitted by professionals, according to a statement from federal authorities.
“Results also show comparable performance for tests measuring amplification levels in the ear canal, as well as measures of speech understanding in noise,” said the FDA.
“No device-related adverse events were observed in the study.” – Named
