Apple AirPods Pro Become FDA-Cleared Hearing Aids, Expanding Tech Company’s Healthcare Reach
Soon, people with AirPods in their ears might not be drowning you out – they may be using them to hear you better. Apple recently announced that its AirPods Pro 2 headphones will become FDA-cleared hearing aids in the coming weeks through a software update. This means that adults with mild or moderate hearing loss – an estimated 30 million Americans – will be able to use Apple earphones to amplify specific sounds they want to hear better.
Key Takeaways:
- Apple is officially entering the hearing aid market by adding an FDA-cleared hearing aid feature to its AirPods Pro 2.
- This feature is a free software update for some AirPods models and will be included with the $249 AirPods Pro 2.
- The Apple hearing aid experience uses a built-in hearing test to create a personalized profile for each user.
- According to Apple, this new development is a prime example of its strategy to break into the health industry, a market anticipated to reach $15 trillion by 2030.
How Apple AirPods Pro Function as Hearing Aids
Apple’s hearing health experience requires both a pair of Apple’s AirPods Pro headphones and an iPhone. The company has integrated a hearing test into its devices inside the Settings app. After the headphones are properly fitted, a series of tones are played for about five minutes. Users are instructed to tap the screen when or if they hear a tone.
This process creates a profile of different frequencies and volume settings that users may have difficulty hearing, which is then stored within the Health app. This profile can then be used to personalize the AirPods Pro and transform them into hearing aids.
Apple has stated that their hearing test is scientifically validated and based on data garnered from their noise detection apps and a 2019 study involving 160,000 participants.
Over-the-Counter Hearing Aids and the Role of FDA Regulation
Apple’s launch has been facilitated by a significant regulatory change. In the past, all hearing aids required a prescription after testing by a licensed audiologist. However, in 2022, the FDA opened the over-the-counter hearing aid market, allowing for cheaper devices due to the use of audio testing software and at-home fittings.
While Apple’s move is significant, it won’t make other hearing aids obsolete. The AirPods Pro’s six-hour battery life, for instance, isn’t sufficient for the all-day wear that some OTC hearing aids enable.
Furthermore, the AirPods Pro are only designed for those with mild or moderate hearing loss, meaning they are primarily for individuals with difficulty hearing speech in noisy environments. Those with severe or profound hearing loss still need to see a licensed audiologist, experts have emphasized.
It is important to also note that Apple’s hearing aid features, despite their ease of use, still require FDA clearance. Devices that use customized hearing aid fit and settings require premarket clearance from the agency, an FDA spokesperson stated. Apple is currently awaiting FDA clearance as well as clearance from regulatory bodies worldwide.
Apple’s Growing Presence in the Healthcare Sector
This latest development underscores Apple’s commitment to branching into the healthcare sector. Over the past few years, Apple has incorporated a series of FDA-cleared features into its wearable devices, often offering alternatives to more expensive medical devices.
Since 2020, Apple has added a notification service for irregular heartbeats, an atrial fibrillation reader, and an electrocardiogram reader to its Apple Watch.
Bridging the gap between technology and healthcare, Apple is aiming to improve accessibility to hearing aids for a broader audience. Apple’s move is likely to increase awareness of hearing health, potentially leading to earlier detection and intervention for individuals with hearing loss.
While some see this as a revolution in hearing aid accessibility, others, including healthcare professionals, caution against seeing Apple’s innovation as a complete replacement for traditional medical devices.
There is a growing sentiment that Apple’s health features, while convenient and user-friendly, are best used as complementary tools rather than outright substitutes for specialist care. The market for hearing aids is complex, with varying degrees of hearing loss and individual needs.
