AirPods Pro will gain a new “hearing aid mode” with the release of iOS 18 later this year, according to the latest report by Bloomberg‘s Mark Gurman.
Writing in the subscriber edition of his regular Power On newsletter, Gurman claims that the “big news” for AirPods Pro in the near term will be support for a hearing aid-style function when iOS 18 drops in the fall.
To be clear, this isn’t the first time we have heard a potential hearing aid feature for AirPods Pro. The first rumor appeared in a 2021 Wall Street Journal report, but it was previously framed as a feature that would be exclusive to a next-generation model of AirPods Pro. However, Apple in September 2022 released the second-generation AirPods Pro, while the company more recently released a refreshed model with a USB-C port.
AirPods Pro already offer a Conversation Boost feature, which boosts the volume and clarity of people directly in front of the wearer, but Apple has not advertised the earbuds as a hearing aid device, because this would require FDA regulatory approval.
As per the FDA, a hearing aid is defined as “any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” This definition encompasses both air-conduction and bone-conduction devices in a variety of styles (for example, behind-the-ear, in-the-canal, or body worn).
Notably, in August 2022 the FDA approved a new category of over-the-counter hearing aids that do not have to adhere to the same strict legal requirements. The new category is called Personal sound amplification products (PSAPs). PSAPs are defined as any “electronic product that is intended for non-hearing impaired consumers to amplify sounds in certain environments, such as for hunting or other recreational activities, and is not intended to aid persons with or compensate for impaired hearing.”
Unlike hearing aid devices, PSAPs are “not intended to treat, cure, mitigate, or prevent disease, and are not intended to affect the structure or function of the body.” As such, there is no regulatory classification or product code for these products, and there are no requirements for legal registration by manufacturers or listing of these products with the FDA.
It is not yet clear whether Apple will need FDA clearance in order to make explicit or implicit claims about the rumored “hearing aid mode,” which may not even adopt this exact name. If, for example, Apple subsequently suggests that AirPods Pro are for users with certain types or severity of hearing loss/impaired hearing, or for use as an alternative to a hearing aid, then they will require FDA regulatory approval to be marketed as such.
Apple is set to preview iOS 18 in June at its annual Worldwide Developers Conference, and will inevitably release the major software update when the iPhone 16 series is launched, which is likely to be sometime in September.
