At Apple’s latest event, it announced its plans to enter the hearing aid market, and the FDA has also approved the software to be used in the new AirPods Pro 2. This means that the headphones are suitable for both consumers with hearing problems and those without.
When discussing the product, Apple said: “The Hearing Test and Hearing Aid features are expected to be available fall 2024. The Hearing Aid feature is pending marketing authorization from global health authorities.
The Hearing Test and Hearing Aid features will be supported on AirPods Pro 2 with the latest firmware paired with a compatible iPhone or iPad with iOS 18 or iPadOS 18 and later, and are intended for people 18 years or older. The Hearing Aid feature is intended for people with perceived mild to moderate hearing loss.”
The FDA has classified Apple’s new Hearing Aid Feature (HAF) as a “mobile medical application.” Like over-the-counter (OTC) hearing aids, this feature uses a self-fitting approach, allowing users to adjust it on their own without needing help from a hearing professional.
Apple’s HAF underwent clinical trials with 118 individuals experiencing mild to moderate hearing loss, where participants who self-adjusted their AirPods Pro experienced similar benefits to those whose devices were professionally fitted.
According to the FDA, the study showed comparable performance in terms of amplification levels within the ear canal and speech clarity in noisy environments. No device-related adverse events were reported during the study.
Over the past two years, since OTC hearing aids hit the market, the FDA’s involvement in regulating self-fitting devices has sparked tension between major electronics brands and hearing professionals.
While companies argue that hearing aids should be affordable, hearing specialists maintain that hearing care is as crucial as eye care and should be handled with the same precision.
When the FDA opened the door to OTC hearing aids, it led to a wave of consumer complaints. Issues ranged from difficulties with self-fitting to trouble accessing service, and some overseas manufacturers exploited the situation by selling questionable products on platforms like Amazon, marketing them as legitimate hearing aids.
Apple seems to have learned from these missteps and is confidently launching its new product. Inspired by the marketing strategies of OTC hearing aid manufacturers, Apple has branded the AirPods 2 as the “world’s first end-to-end hearing health experience.”
This includes features like active Hearing Protection, a scientifically validated Hearing Test, and a clinical-grade Hearing Aid function.
For current Apple users, the AirPods Pro are likely to integrate seamlessly with other Apple devices, such as iPhones, iPads, or Macs running the latest operating system.
The cost of the AirPods 2 ranges from $129 to $549, depending on the features you choose, like USB-C charging. This pricing is often more competitive than many OTC hearing aids, making them a good option for budget-conscious consumers, particularly seniors aiming to stay within a fixed income.
