Apple’s hearing aid software could change how we deal with hearing loss forever

Did you hear the news? Apple’s AirPods Pro 2 line will transform into hearing aids with new software – here’s why it matters.

You're missing out! For the full version of DECODED Medical Devices, subscribe here.

"Prevention,”; “awareness”; “assistance” – that’s what Apple described as the three key tenets behind implementing hearing aid capabilities into its best-selling earphones.

Apple revealed an entry into the hearing loss space during a keynote presentation in September, unveiling software that will transform its Airpods into hearing aids for patients with mild forms of auditory impairment.

Just a few days after the presentation, the US Food and Drug Administration (FDA) approved Apple’s over-the-counter (OTC) hearing aid software – which the agency described as the first of its kind. The software, which is expected to ?roll out to compatible devices in late 2024 has been hailed as a gamechanger by many – but will it introduce a new paradigm to hearing impairment?

Software centricity

Cardiovascular parameters; medication management; sleep apnoea – Apple’s suite of medical capabilities is growing at great speed. Addressing hearing loss – which affects more than 30 million people in America to some degree – is the latest string the US technology giant is adding to its healthcare bow.

“We’re thrilled to provide breakthrough software features with AirPods Pro that put users’ hearing health front and center, bringing new ways to help test for and receive assistance for hearing loss,” Apple’s vice president of health Sumbul Desai said in a statement.

What separates Apple from many others designing hearing aids is that its therapeutic framework lies in software, as opposed to a dedicated device. Apple’s AirPods Pro 2 are used for listening to music and podcasts normally, but when coupled with the software – called Hearing Aid Feature – they transform into a hearing aid. The FDA says it is intended to amplify sounds for those aged 18 years and over with perceived mild to moderate hearing impairment.

The FDA based its decision on data from a trial involving 118 participants with this type of hearing loss. Results showed that patients who used the software received similar benefits to those using traditional devices.

The trial’s principal investigator Rick Neitzel said in a statement: “These tools will help people protect their ears from noise pollution, be aware of changes in their hearing over time, and have important conversations with their healthcare providers when they need additional support.”

The FDA stated the authorisation “exemplifies [its] continued commitment to provide safe and effective solutions for those with hearing loss.” The approval follows on from OTC hearing aid regulations established in October 2022 that opened regulatory avenues for mild to moderate hearing impairment technologies that do not require an audiologist appointment or a medical exam.

Select from over 20+ sectors, from Technology to Retail, by subscribing today.

The FDA’s Center for Devices and Radiological Health acting director Michelle Tarver said the approval “advances the availability, accessibility and acceptability of hearing support”.

Apple is by no means the only company to harness this regulation, though it is the first to use it for approval solely of software. Companies such as Jabra, Audien, and Eargo are popular options in the US – all FDA-approved as OTC devices. Sony has also developed its own device, a self-fitting hearing aid with a companion app on Apple and Android.

Apple’s unique selling point, though, is that its software can be loaded into its AirPod Pro headphones – an already well-established wearable with wide-reaching market penetration. ?Apple’s AirPod revenues in 2024 are estimated to generate around $22bn, according to Bloomberg.

GlobalData analyst Shabnam Pervez says Apple’s wealth of resources and market dominance will play a key role in potential swing in preference of devices from patients, along with resisting challenges posed by smaller companies.?

“Apple has a strong brand image and a loyal customer base, which can make it difficult for competitors to gain market share,” Pervez explains.

Accessibility and cost

Apple has the biggest smartphone market share in the US, and its headphone products also occupy large segments in the wearables sector. Implementing hearing aid capabilities into an already established and easily visible device will transform how hearing loss is treated, according to Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA).

“When a company like Apple comes out with this technology, it’s in the mainstream. It gets people thinking about hearing loss. Maybe people aren’t ready to wear a hearing aid seven days a week, eight hours a day, but they’re already wearing AirPods. This reduces stigma because everybody’s got devices in their ears nowadays.”

AirPods Pro 2 are currently listed on Apple’s website at $249. Whilst this does not take into account the added expense of the iPhone itself that is needed for the earbuds to function, it is still a lot cheaper than Sony’s hearing aids, which sets users back around $1300. However, compared to other OTC hearing aids, Apple’s technology still arguably represents a premium option.

Pervez says: “Apple’s tech products are generally priced higher than competitors in the same market segment. However, it’s important to note that Apple’s products often hold their value well over time, and many consumers are willing to pay a premium for the perceived benefit of owning an Apple device.”

The FDA has approved Apple’s hearing aid software – which will be a free update to operating systems – for mild to moderate hearing loss, so it cannot be compared to prescription hearing aids. These devices are fitted and maintained by a healthcare professional for patients with significant hearing loss. Prescription hearing aids are more expensive because of their greater auditory capabilities – with an average cost of around $2500.?

Whilst Pervez asserts that the AirPods Pro 2 are not a replacement for traditional hearing aids, she says “they do offer a valuable and accessible option for many people with slight hearing loss.”

Technology gap

One of the biggest challenges to Apple’s launch in the hearing loss market is the lack of penetration in the older population. A 2023 report by AARP shows that 28% of adults aged 50 and over own a wearable device. This does not consider the digital skills needed to conduct the hearing test feature included in Apple’s software. And whilst smartphone ownership is higher amongst this age group, it is still not uniformly high.

This could “create a hurdle and narrow the market opportunity as this limits the potential user base to individuals who already own an iPhone or are willing to purchase one,” according to Pervez.

For those who are invested in a different smartphone ecosystem, switching to an iPhone solely for the AirPods Pro 2 can be a “significant barrier,” she adds.

Data shows that most individuals with hearing loss in this age group, however, fall under the more severe form of hearing impairment. Thus, Apple’s target market – those with moderate hearing loss – is usually younger, where the company’s devices are widespread.

Apple’s senior director of Global Accessibility Policy and Initiatives, Sarah Herrlinger said the new features would “make an impact on so many people by driving more awareness around hearing health and empowering individuals with new customisable tools.”

And whilst Apple battles antitrust legal cases in the US centred around smartphone monopolisation, Kelley says ultimately the company’s entry into the hearing loss device arena is “exciting.”

“A lot of people with hearing loss are going to progress and end up in the good care of audiologists, with a prescription hearing aid. But if people take a step to treatment sooner rather than later, that’s important.”

For the future, Kelley says she hopes to see “an explosion of technology where people have a lot of choices.” Whether all those choices will come from Apple market domination remains to be seen.

Stay informed, stay ahead. Subscribe now to DECODED Medical Devices.

By Robert Barrie