Photo source: Apple
During the recent “Glowtime“ event, while many Apple enthusiasts were focused on the forthcoming iPhone 16 Pro, attention was drawn to an innovative software update that enables Apple AirPods Pro 2 to function as hearing aids.
This feature is specifically designed for individuals experiencing mild to moderate hearing loss, although it required approval from the FDA at the time of the announcement.
On Thursday, the FDA confirmed that it had authorised this software-based hearing aid technology. Traditional hearing aids can often be prohibitively expensive, sometimes exceeding $2,000, whereas the AirPods Pro 2 are priced at $249. The new feature allows the AirPods to automatically adjust the sound based on a user’s personalised hearing profile.
This approval is noteworthy as it represents the first instance of the FDA sanctioning over-the-counter software for hearing loss, following its earlier approval of over-the-counter hearing aids in October 2022.
“Today’s marketing authorization of an over-the-counter hearing aid software on a widely used consumer audio product is another step that advances the availability, accessibility, and acceptability of hearing support for adults with perceived mild to moderate hearing loss,” said Michelle Tarver, the acting director of the FDA’s Center for Devices and Radiological Health.
Hearing loss is a significant issue in New Zealand, affecting about 28% of older adults and 32% of Māori communities, as reported in the New Zealand TRAK Report 2022. Despite this prevalence, many individuals do not use hearing aids. A study found that among 15,480 participants, only 683 were hearing aid users while 633 had hearing loss.
Additionally, a report by the New Zealand Hearing Industry Association states that one in six Kiwis currently experience hearing loss, with projections suggesting this could rise to one in four (around 1.2 million people) by 2050.
In response, Apple aims to provide direct solutions to consumers. The company will incorporate a pure-tone audiometry hearing test into iPhones and iPads. This method, commonly used in medical settings, involves playing various tones at different pitches and frequencies, prompting users to indicate when they hear a sound. The results from this test, or an audiogram from a healthcare professional, will be used to customise the AirPods for the user.
The efficacy of this technology is supported by a clinical study involving 118 participants, which demonstrated that fitting hearing aids using Apple’s app was as effective as professional fittings.
“Results also showed comparable performance for tests measuring levels of amplification in the ear canal, as well as a measure of speech understanding in noise. No adverse events related to the device were observed in this study,” the FDA noted.
Apple has not yet provided a comment on this development, but it plans to roll out the hearing aid feature for the AirPods Pro 2 this autumn in over 100 markets.
