UPDATE: Apple already received FDA OTC Certification, only three days after the announcement. Here is the FDA press release: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software
With the recent announcements of updates to its AirPods lineup, Apple is challenging us once again to (re)consider this product segment as an evolving platform. The possibility to use AirPods Pro earbuds as an all-in-one hearing health solution has been discussed for nearly two years, and some “accessibility” features have even been introduced very discreetly.
It’s important to remember that Apple announced the updated AirPods Pro 2nd generation in September 2022, delivering 2x better Active Noise Cancellation (ANC), longer battery life, better drivers and a new improved charging case. Precisely a year later, Apple announced its AirPods Pro 2 with USB-C charging capabilities and some minor hardware updates, including a better radio module to support lossless audio over 5GHz. In this September 2024 event, Apple simply confirmed its vision for hearing enhancement with a new software update for the AirPods Pro 2. The form factor as remained the same. Completely new for 2024, Apple also introduced a new industry-defining design for AirPods 4 - the first open-ears in the industry to feature a complete ANC/transparency implementation.
Everyone was expecting a decisive update for Apple’s AirPods lineup but no one predicted that Apple would opt to simply activate a software update which expands considerably what is possible to do with all the many features that the company has been developing. On top of its highly effective Active Noise Cancellation, and existing Adaptive Audio, Transparency mode, Conversation Awareness, Voice Isolation, Personalized Volume, Loud Sound Reduction for hearing protection, Personalized Spatial Audio with dynamic head tracking, and Adaptive EQ features (also available to all users of the original AirPods Pro which Apple continues to update), the latest model now expands its Hearing Health features to become a fully-featured hearing aid solution for mild and moderate hearing loss.
Many in the industry reacted to this announcement as though Apple needed to do this to expand sales. One thing that should be clear to all, is that the volumes of AirPods Pro 2 earbuds sold to consumers far outpace any volumes that might result from potential buyers looking for the new hearing aid features. It all adds up in the end, but Apple knows that it’s all about increasing the value and benefits of its products to more people. And that many users who have no interest today in hearing aids will discover the potential benefits of the product as is today, and will grow with it in the future. Because essentially, these are the very first hearables.
Starting this year, AirPods Pro 2 will introduce a complete end-to-end hearing health experience, delivering active Hearing Protection, a scientifically validated Hearing Test, and a clinical-grade Hearing Aid feature. All on a free software update. “And with a revolutionary update to the world’s best-selling headphones, AirPods Pro will deliver groundbreaking new capabilities — including Hearing Test and Hearing Aid features — to help more than a billion people affected by hearing loss,” says John Ternus, Apple’s senior vice president of Hardware Engineering.
In reality, this is a very complex proposition, that should be seen purely from a consumer perspective. And that’s why the announcement that Apple is seeking FDA certification is puzzling. What explains it is the fact that, during the company’s significant testing and implementation efforts, the product design and technology was effectively validated by the leading audiology entities around the world. As audioXpress learned from the reactions to the announcement, the extensive research involved some of the most respected audiology institutions and members of the medical and scientific community.
Also, the new features are only possible because of the progress that Apple has made with its own silicon (far more advanced than anything used in hearing aids) in combination with its software, operating systems, and overall services ecosystem. As the Apple event revealed, the newly announced iPhone 16 didn’t change much from the outside, but inside, all four new models are now fully optimized for artificial intelligence - or Apple Intelligence. The biggest perceived benefit for anyone thinking about upgrading to iPhone 16, are AI and services. Basically, turning complex technology into a simple user experience that rewards users way more than folding screens. And these integrated capabilities are decisive to lock users into the Apple ecosystem.
The concept is exactly the same regarding the new Apple Watch and AirPods. Apple didn’t promote the features. It promotes a vision of benefits related to health and fitness. The release of hearing health features for AirPods Pro 2 is part of a vision that will resonate globally - not only in the US, where the FDA certification is relevant. This certification will imply that users will be able to perform self-tests, determine their level of hearing, and adjust the hearing compensation features according to their unique profile - all assisted by AI.
The technology and the implementation also allows all users to use their AirPods for hearing protection and augmentation, such as maintaining comfortable conversations even in noisy environments. Apple knows that the hearing aid feature will create awareness for the important topics of hearing health, inviting those who require medical help to seek it. But for the vast majority of users with mild hearing loss - estimated to be the large majority in the approximately 1.5 billion with some form of hearing loss, according to the World Health Organization - those same features will be a lifesaver they didn’t know existed. As the hearing aid companies know from multiple studies, those users would never even consider hearing aids for all sorts of different reasons.
The Apple Hearing Study revealed that 75 percent of people diagnosed with hearing loss haven’t received the assistive support that they need. The research was conducted in collaboration with the University of Michigan School of Public Health and the World Health Organization. “Hearing health is a cornerstone of overall wellbeing. Protecting and preserving our hearing enhances our quality of life both in the short-term and long-term,” says Rick Neitzel, University of Michigan School of Public Health’s professor of Environmental Health Sciences and principal investigator of the Apple Hearing Study. “I’m thrilled Apple is introducing important tools to support people’s hearing health. These tools will help people protect their ears from noise pollution, be aware of changes in their hearing over time, and have important conversations with their healthcare providers when they need additional support.”
This is possible after Apple invested years of work in hearing health — including resulting in the development of the Noise app on Apple Watch, headphone audio levels with iPhone, hearing accessibility features, and the Apple Hearing Study. This creates an end-to-end experience focused on prevention, awareness, and assistance. Apple will promote AirPods Pro as a device that can protect our health (Hearing Protection), assess our health (Hearing Test), and assist us in hearing the world around us (Hearing Aid). And all enabled with one software update. Truly remarkable.
Hearing Protection
According to the Apple Hearing Study, one in three people are regularly exposed to loud environmental noise levels that can impact their hearing. That can include common scenarios like taking the subway while commuting, mowing the lawn at home, attending a sporting event, and many more. In order to help users prevent exposure to loud environmental noise while preserving the sound signature of what they’re listening to, Apple introduced Hearing Protection to the AirPods Pro 2. The ear tips help to provide passive noise reduction, while the H2 chip helps to actively reduce louder, more intermittent noise at 48,000 times per second. On by default across all listening modes, Hearing Protection is helpful in a variety of loud settings. Plus, with an all-new multiband high dynamic range algorithm, sounds at live events like concerts remain natural and vibrant so users don’t miss a beat.
Hearing Test
Apple is also introducing a scientifically validated Hearing Test feature with AirPods Pro and a compatible iPhone or iPad, expanding the ability for users to quickly check their hearing from the comfort of their home in minutes. The test is simple to take, utilizes a standard clinical approach called pure-tone audiometry, leverages advanced acoustic science, and provides users with an interactive experience. When a user completes the test, they will see an easy-to-understand summary of their results in a personalized hearing profile for AirPods Pro, which is stored privately and securely in their Health app. Users can also share these results with their healthcare providers for more informed conversations.
“Hearing health is an essential part of our overall wellbeing, yet it can often be overlooked — in fact, according to the Apple Hearing Study, a staggering 75 percent of people diagnosed with hearing loss go untreated,” says Sumbul Desai, M.D., Apple’s vice president of Health. “We’re thrilled to provide breakthrough software features with AirPods Pro that put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss.”
Hearing Aid
Apple also confirmed that the AirPods Pro will add a clinical-grade, over-the-counter Hearing Aid capability for users with mild to moderate hearing loss. Using the personalized hearing profile from the Hearing Test, this new feature seamlessly transforms AirPods Pro into a clinical-grade hearing aid. After setup, the feature enables personalized dynamic adjustments so users have the sounds around them boosted in real time. This helps users better engage in conversation and keeps them connected to the people and environment around them.
Leveraging the audio quality of AirPods Pro, the user’s personalized hearing profile is automatically applied to music, movies, games, and phone calls across their devices without needing to adjust any settings. “This first-of-its-kind software-based Hearing Aid feature brings users the ability to fine-tune their experience at any time, making access to hearing assistance easier than ever at an approachable price point,” Apple states.
Users can fine-tune their experience at any time with the Hearing Aid feature, making access to hearing assistance easier than ever. After taking the Hearing Test, users can also use their hearing profile to personalize the AirPods Pro listening experience. This benefits even more people, including those with little to no hearing loss, who can take advantage of specific adjustments at individual frequencies. To help provide the best listening experience, Media Assist is an all-new feature that helps boost certain parts of speech on a phone call or instruments within a soundtrack to help an even broader population. And users can also set up the Hearing Aid feature with an audiogram created by a hearing health professional.
According to the announcement, the Hearing Test and Hearing Aid features are expected to receive marketing authorization from global health authorities soon, and will be available in Fall 2024 in more than 100 countries and regions, including the United States, Germany, and Japan.
The new hearing health features will be available for AirPods Pro 2 customers in a free software update when paired with iPhone or iPad running iOS 18 or iPadOS 18. AirPods Pro 2 are available for USD $249. There’s a lot of additional information that Apple made available here.
www.apple.com
