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

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

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

Just a few days after the presentation, the U.S. 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, is being hailed by many as a game changer, but will it introduce a new paradigm for hearing loss?

Software centricity

Cardiovascular parameters; medication management; sleep apnea – Apple’s suite of medical capabilities is growing at a rapid pace. Tackling hearing loss – which affects more than 30 million people in America to some degree – is the latest chord the US tech giant is adding to its healthcare business.

“We’re excited to deliver groundbreaking software features with AirPods Pro that put users’ hearing health first and provide new ways to test for hearing loss and get help,” said Sumbul Desai, Apple’s vice president of healthcare, in a statement. declaration.

What sets Apple apart from many others who design hearing aids is that the therapeutic framework lies in software, as opposed to a special device. Apple’s AirPods Pro 2 are normally used to listen to music and podcasts, but when combined with the software – called Hearing Aid Feature – they transform into a hearing aid. The FDA says it is intended to amplify sounds for people 18 years and older with perceived mild to moderate hearing impairment.

The FDA based its decision on data from a study involving 118 participants with this type of hearing loss. The results showed that patients using the software received similar benefits as those using traditional devices.

Study lead researcher 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 need support.”

The FDA stated that the authorization “exemplifies (its) continued commitment to providing safe and effective solutions for people with hearing loss.” The approval follows the OTC hearing aid regulations adopted in October 2022, which opened up regulatory opportunities for technologies for mild to moderate hearing impairment that do not require an appointment with an audiologist or a medical examination.

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

Apple is certainly not the only company to use this regulation, although it is the first to use it exclusively for software approval. Companies like 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-adaptive hearing aid with an accompanying app on Apple and Android.

However, Apple’s unique selling point is that its software can be loaded into the AirPod Pro headphones – an already established wearable with wide market penetration. Apple’s AirPod revenue is estimated to reach around $22 billion by 2024 Bloomberg.

GlobalData analyst Shabnam Pervez says Apple’s wealth of resources and market dominance will play a key role in the potential shift in patient device preferences, along with withstanding challenges from 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 costs

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

“When a company like Apple comes to market with this technology, it is mainstream. It makes people think about hearing loss. Maybe people aren’t ready to wear hearing aids seven days a week, eight hours a day, but they already wear AirPods. This reduces the stigma because everyone has devices in their ears these days.”

AirPods Pro 2 are currently listed on Apple’s website for $249. While this doesn’t take into account the additional cost of the iPhone itself required for the earbuds to function, they are still a lot cheaper than the hearing aids from Sony, which will set users back about $1300. However, compared to other OTC hearing aids, Apple’s technology is still a premium option.

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

The FDA has approved Apple’s hearing aid software – a free operating system update – 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 due to their greater auditory capabilities – with an average cost of approximately $2,500.

While Pervez claims the AirPods Pro 2 are not a replacement for traditional hearing aids, she says they “do provide a valuable and accessible option for many people with mild hearing loss.”

Technology gap

One of the biggest challenges in Apple’s entry into the hearing loss market is the lack of penetration among the older population. A 2023 report from AARP shows that 28% of adults age 50 and older own a wearable device. This does not take into account the digital skills required to perform the hearing test function included in Apple’s software. And while smartphone ownership is higher among this age group, it is still not uniformly high.

This could “create a hurdle and reduce market opportunity as it limits the potential user base to individuals who already own an iPhone or are willing to buy one,” Pervez said.

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

However, data shows that most people with hearing loss in this age group fall under the more severe form of hearing loss. So Apple’s target audience – people with moderate hearing loss – tends to be 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 “impact so many people by raising awareness around hearing health and providing individuals with new, customizable tools.”

And as Apple battles antitrust lawsuits over smartphone monopolization in the U.S., Kelley says the company’s entry into hearing loss devices is ultimately “exciting.”

“Many people with hearing loss progress and end up receiving good care from audiologists, with a prescription hearing aid. But if people sooner or later take the step towards treatment, that is important.”

Looking ahead, Kelley says she hopes for “an explosion of technology where people have a lot of choices.” Whether all these choices stem from Apple’s market dominance remains to be seen.

“Apple’s hearing aid software could forever change the way we manage hearing loss” was originally created and published by Medical Device Network, a brand owned by GlobalData.

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