FDA authorizes first OTC hearing aid software to be used in Apple's
AirPods Pro

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 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.

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.

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

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On Thu, 12 Sep 2024 22:27:55 -0500, JAB <here@is.invalid> wrote:

FDA authorizes first OTC hearing aid software to be used in Apple's
AirPods Pro

The most impressive health initiative coming this year is the
company's new set of hearing features. As I reported several months
ago, https://www.bloomberg.com/news/newsletters/2023-07-02/apple-airpods-plans-hearing-test-body-temperature-cheaper-models-usb-c-ljlfwffu

this involves turning AirPods into a clinical-grade hearing test
machine as well as -- most impressively -- an over-the-counter hearing
aid. Shortly after the announcement, the technology got approval from
the US Food and Drug Administration.

A conventional hearing aid can cost anywhere from $300 to upwards of
$2,000. Apple's option will bring that price point to $249 --- the
cost of the AirPods Pro. That's critical given that most US insurance
companies don't reimburse over-the-counter hearing-aid purchases. It
also will integrate more seamlessly with the iPhone, giving it a
better interface than most existing hearing devices.

https://www.bloomberg.com/news/newsletters/2024-09-15/apple-s-hearing-aid-sleep-apnea-saved-iphone-16-event-m4-mac-launch-details-m13kkabb

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