Hearing loss is a serious health problem and many people are reluctant or can’t afford to get conventional hearing aids. To offer perspective: Around 30 million Americans experience hearing loss, but only about one-fifth of them get help. Many have mild to moderate hearing loss, yet most people don’t look at hearing devices because of their looks or cost.

That is where Apple comes in. Last week, the US Food and Drug Administration said it had approved a piece of software that will transform Apple’s AirPods Pro 2 earbuds into over-the-counter hearing aids, meaning the company’s hearing aid feature will be pushed to eligible devices through a software update in the coming weeks (it is expected to reach over 100 countries ultimately).

Instead of introducing new hardware to tackle the issue, the Apple hardware from 2022 comes with an upgrade. Many may have one of these in the bag or drawer.

Apple unveiled the world’s first end-to-end hearing health experience at its annual event in Cupertino on September 9 and is the latest example of the company’s strategy to break into the health industry, a potential $15 trillion market by 2030, according to RBC Capital Markets. In 2019, CEO Tim Cook said: “We are taking what has been with the institution and empowering the individual to manage their health. And we’re just at the front end of this…. I do think, looking back, in the future, you will answer that question: Apple’s most important contribution to mankind has been in health.”

AirPods Pro 2 adds a clinical-grade, over-the-counter hearing aid capability for users with mild to moderate hearing loss

The Cupertino HQ-ed company’s strategy includes developing FDA-cleared features for its wearable products and offering alternatives to what are often more expensive purpose-built medical devices. For example, for years, Apple has added a notification service for irregular heartbeats, an atrial fibrillation reader and an electrocardiogram reader to its Apple Watch.

Three-pronged approach

The latest innovation could help hundreds of millions of people around the world to hear more clearly. It could help ease the stigma around traditional hearing devices.

There are three parts to the conversation around using AirPods Pro 2’s “clinical-grade” hearing aid feature.

First comes prevention. One in three people is regularly exposed to environmental noise levels that could impact their hearing. To put this into perspective, there are all kinds of sounds that can be concerning in daily life whether that’s commuting or when you’re headed to that next event. The more you’re exposed, the more it can impact your hearing.

Apple’s VP of Health, Dr Sumbul Desai, said during the keynote presentation: “To help our users minimise their exposure we’re adding hearing protection to AirPods Pro by default across listening modes. The ear tips help to provide passive noise reduction whether you’re attending a live show or playing at the show, machine learning on the H2 chip actively reduces louder, more intermittent noises.”

Next comes awareness because hearing loss often worsens gradually. It can be really hard to detect. Apple is offering a “clinically-validated hearing test” with your AirPods Pro and iPhone.

It’s a simple five-minute check you can take at home. All you need to do is tap the screen when you hear a series of tones at different volumes and frequencies. The hearing test builds on learnings from the Apple hearing study and was developed using large-scale real-world data and it was validated against the clinical gold standard of pure-tone audiometry.

Once you’re done you’ll see easy-to-understand results in a personalised hearing profile. The Apple Hearing Study revealed that 75 per cent of people diagnosed with hearing loss haven’t received the assistive support they need.

Next comes taking action. AirPods Pro is receiving a clinical-grade over-the-counter hearing aid feature for users with mild-to-moderate hearing loss. It is estimated that around 1.5 billion people around the world are living with hearing loss, according to the World Health Organisation. And there are links between hearing loss and its impact on a person’s overall wellbeing.

To help users minimise their exposure to unnecessary noises, Apple is adding Hearing Protection to AirPods Pro.

FDA approval

The software feature highlights the power of technology and how it can be implemented to bring about a positive impact. The FDA signed off on over-the-counter hearing aids in 2022, allowing people access to cheaper alternatives that don’t require them to see a doctor. Usually, visiting audiologists and then buying hearing aids can be expensive.

Since AirPods are almost everywhere, this rollout means a lot of people who already own the second-gen Pro buds will get instant access to Apple’s hearing aid solution. Instead of amping up the volume on the TV, people may start popping in the AirPods Pro they already own and turn on a few features after taking a test. It’s something existing over-the-counter hearing aid providers can’t easily offer.

The price of AirPods Pro 2 itself can shake up the market for such devices because it’s far cheaper than many high-end OTC hearing aids.

However, Apple’s AirPods won’t immediately make other hearing aids obsolete. The caveat is that users will still need an iPhone with iOS 18 and newer for this new feature to work. The other caveat can be battery life because a single charge of the AirPods can offer up to six hours of listening time on a single charge but many hearing aids offer more. But it hardly takes time to charge AirPods.

Earlier, all hearing aids required a prescription after testing from a licensed audiologist but in 2022, the FDA opened up the market to over-the-counter hearing aids that were significantly cheaper.

AirPods Pro 2 comes with active Hearing Protection, a clinically-validated Hearing Test feature, and an over-the-counter Hearing Aid feature

FDA said that Apple’s hearing test was evaluated in a study with 118 subjects in the US, with “comparable results” to professional fitting. Bridget Dobyan, executive director of the Hearing Industries Association, said that she welcomed Apple’s entrance into the market to increase awareness of hearing health.