FDA Approves Airpod Pro 2 & Software As OTC Hearing Aids

[RAMROD 117,011]

The U.S. Food and Drug Administration on Thursday authorized the first over-the-counter hearing aid software that is intended to be used with compatible versions of the Apple (AAPL.O), opens new tab AirPods Pro headphones.

Earlier this week, Apple said its AirPods Pro 2 could now be "transformed" into a personalized hearing aid via an upcoming software update that would boost specific sounds in real time, including parts of speech or elements within a user's environment.

New hearing health features will be available this fall for AirPods Pro 2 users in more than 100 countries and regions, Apple had said.

The FDA on Thursday authorized a piece of software called Hearing Aid Feature (HAF) that will allow Apple AirPods Pro 2 ear buds and other compatible Apple AirPods Pro devices to function as hearing aids when paired with an iOS 18-compatible iPhone or iPad. It's the first time the FDA has authorized an over-the-counter hearing aid software, the agency said.

iOS 18, the software through which HAF will be available is set to arrive by October, Apple previously said. 

Once installed and customized to the user's hearing needs, the software enables versions of the AirPods Pro to serve as an OTC hearing aid, that is intended to amplify sounds for 18 years or older people with perceived mild-to-moderate hearing impairment, the health regulator said.

"Hearing loss is a significant public health issue impacting millions of Americans," said Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health.

More than 30 million American adults report some degree of hearing loss, which can be caused by aging, exposure to loud noises, certain medical conditions, and other factors.

The authorization of an over-the-counter hearing aid software advances the availability, accessibility and acceptability of hearing support, Tarver added.

Apple AirPods Pro 2 retail for $249, which is far less than the thousands of dollars other models of OTC hearing aids can cost.

Otolaryngologists hope Apple's foray into the hearing aid market will compel more people who suffer from hearing loss to seek out assistance. The devices could also help reduce the stigma around hearing aids, given how ubiquitous ear buds including Apple AirPods are among all populations, including those who don't suffer from hearing loss.

https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software

 

https://www.reuters.com/business/healthcare-pharmaceuticals/fda-authorizes-first-otc-hearing-aid-software-be-used-airpods-pro-headphones-2024-09-12/

 

https://www.aol.com/fda-approves-apple-airpods-pro-132450617.html

[RAMROD 117,011]

This is groundbreaking news, especially for USA, cos often time, just like dental procedures, hearing aids are not included in health insurance package and it cost so much for people who needed it to actually afford it. But now people who already own airpods pro 2 doesn't need a new device anymore, and those who doesn't have one yet, can get them easily and also better than some other otc hearing aids that looks so dodgy.

[ActualPatient 2,512]

As someone who has had deteriorating hearing ability, I'm so happy because this massive update applies to already existing devices! I'm glad they're not locking out Airpods Pro 2 when the common practice is for them to just include new features on the 3rd gen device and call it a day... even if the old device can support it.