United States Food and Drug Administration FDAtook the expected step today and released AirPods Pro 2 “hearing aid” approval gave.
Thanks to FDA approval, the model can now be marketed as a non-prescription hearing aid. Apple previously shared the following about this useful infrastructure of the product: “This fall, the world’s first end-to-end hearing care experience will debut with AirPods Pro 2, featuring Active Hearing Protection, scientifically validated Hearing Testing, and clinical-grade Hearing Aids.” Apple, which made a statement, gave the following details about the new infrastructure: “According to the World Health Organization, approximately 1.5 billion people worldwide have hearing loss. Apple has been working on hearing health for years, including the Noise app on Apple Watch, headphone volume levels on iPhone, hearing accessibility features, and the Apple Hearing Study, and offers an end-to-end experience focused on preventing, detecting, and helping with hearing loss.
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According to the Apple Hearing Study, one in three people are regularly exposed to loud sounds in their environment that can affect their hearing health. Examples include taking the subway to work, mowing the lawn, attending a sporting event, and many other common scenarios. Hearing Protection is being added to AirPods Pro to help users protect themselves from being exposed to loud sounds in their environment while preserving the authenticity of the content they listen to.
The ear tips passively reduce noise, while the H2 chip helps actively reduce louder, intermittent sounds 48,000 times per second. Hearing Protection, which is on by default in all listening modes, benefits a variety of noisy environments. In addition, thanks to the brand-new multi-band high dynamic range algorithm, sounds sound natural and vibrant in live performances such as concerts, so users don’t miss a sound.
Apple is also introducing the scientifically validated Hearing Test feature, available with AirPods Pro and a compatible iPhone or iPad. This feature lets users check their hearing health in just a few minutes from home. The test is easy to complete and interactive, using a standard clinical approach called pure-tone audiometry and advanced acoustic science.
Once users complete the test, they can see an easy-to-understand summary of their results in their personalized AirPods Pro hearing profile. These results are stored securely in the Health app and are not shared with anyone else. Users can also share these results with their healthcare professionals to have more informed conversations.
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AirPods Pro also features an innovative over-the-counter hearing aid feature for users with mild to moderate hearing loss. Using the personalized hearing profile from the Hearing Test, this new feature transforms AirPods Pro into a clinical-grade hearing aid. Once set up, the feature provides personalized dynamic settings, amplifying the sounds around users in real time.
This allows users to better participate in conversations and connect with people and everything else around them. The user’s personalized hearing profile is automatically applied to music, movies, games and phone calls across all their devices, with incredible sound quality on AirPods Pro without any adjustments.
This first-of-its-kind software-based Hearing Aid feature gives users the ability to make changes to their experience at any time and access hearing assistance more easily than ever at an affordable price. They can also calibrate their Hearing Aid with an audiogram created by a hearing care professional.
Both the Hearing Test and Hearing Aid features were developed with scientific foundations and have been validated through rigorous scientific studies. Marketing authorization for the Hearing Test and Hearing Aid features is expected to be received from global health authorities soon. These features will be available in more than 100 countries and regions, including the United States, Germany, and Japan, by next fall.
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“In addition, users who complete the Hearing Test can personalize their listening experience with AirPods Pro using their hearing profiles. More people, including those with mild hearing loss, can benefit from this feature and make individual adjustments to frequencies. Created to provide the best listening experience, the new Ambient Assist feature benefits an even wider audience by increasing the volume of certain parts of conversations in phone calls or instruments in music.”
“Hearing health is an important part of our overall health, yet it can often be overlooked. According to the Apple Hearing Study, 75 percent of people diagnosed with hearing loss do not receive treatment.” Dr. Sumbul Desai, Apple’s Vice President of Health, continues: “With AirPods Pro, we’re excited to deliver groundbreaking software features that put users’ hearing health at the core and create new ways to test for and get help with hearing loss.”