Last month, the U.S. Food and Drug Administration (FDA) greenlit an intriguing over-the-counter hearing aid offering from Apple that could encourage millions of people to address their mild to moderate hearing loss. With a software update later this fall for iOS 18-compatible iPhones and iPads, Apple’s AirPods Pro 2 earbuds will offer hearing support for $249, making them one of the more affordable over-the-counter hearing aids on the market (not including the cost from the phone or tablet).
The hope is that Apple’s offering will be an improvement over the current crop of over-the-counter (OTC) hearing aids. Since FDA approval two years ago, OTC hearing aids have generated excitement, optimism and disappointment. “They are basic amplifiers that amplify all sound,” said Dr. Linnea Fechtner The shipping. Fechtner, an otologist in Grand Junction, Colorado, said quality and customer support for OTC hearing aids vary widely by device, and customer return rates are higher than expected.
The cheaper the device, the more the burden falls on the consumer to test, try and adjust the devices – something they are not necessarily skilled at. This may be the main reason why the adoption rate of OTC hearing aids is only 2 percent of the adult market. “The good ones aren’t as cheap as I thought they would be,” Fechtner said. “It’s not a cheap experiment.”
That wasn’t exactly what Sens. Elizabeth Warren of Massachusetts and Chuck Grassley of Iowa had in mind when they teamed up in 2016 to try to lower the costs of certain consumer products. Hearing aids were a worthy first target: hearing loss is a major public health problem whose solution was effectively blocked by the high cost of prescription hearing aids – in part because the five largest hearing aid manufacturers had a market share of more than 90 percent.
Approximately 38 million American adults and 1.5 billion people worldwide suffer from some degree of hearing loss. And yet, unlike vision loss, hearing loss has proven more resistant to helping. Although 75 percent of people over the age of 45 used glasses, contact lenses or other vision correction in 2019, only 7 percent used hearing aids.
The result is worse than having to say or hear “what?” all day. Hearing loss can lead to social isolation, depression and cognitive decline. In her 2021 book Of Sound Mind: how our brain constructs meaning in a sonic worldwrites neuroscientist Nina Kraus that controlling for other factors, “Hearing loss is strongly and independently associated with cognitive impairment.” And the self-imposed isolation of many people suffering from hearing loss, she writes, can lead to social disconnection and is “linked to dementia.”
At an average cost of $2,680, and often many times more expensive, prescription hearing aids are the third largest expense for Americans who buy them, after a house and a car, according to the National Council on Aging. Then there is the stigma of being seen with a hearing aid. Grassley and Warren couldn’t do much about that, but could they at least convince the FDA to open the market to cheaper hearing aids?
In 2017, Congress passed the Over-the-Counter Hearing Aid Act, legislation, co-sponsored by Grassley and Warren, that changed regulations to allow consumers to purchase certain types of hearing aids without a prescription. President Donald Trump signed the legislation into law, but the FDA did not take the required next steps to issue regulations on OTC hearing aids.
Meanwhile, Apple, known for taking a long-term strategy in developing its healthcare offerings, had been working toward such a possibility. Since 2014, the company has added relevant hardware features to its earbuds: speech-detecting accelerometers, which recognize when you speak; optical in-ear sensors, which detect when you are wearing earplugs; dual microphones that pick up sound in a targeted manner and help distinguish ambient noise from a person speaking in front of you; and inward-facing microphones, which help reduce noise; and other sensors, as well as headset chips that perform the works.
These hardware (and software) improvements left Apple ready to submit its OTC offering to the FDA for de novo approval (the FDA’s marketing process for classifying new medical devices) in the fall of 2023.
By then, President Joe Biden had issued an executive order that reinstated FDA approval. Despite efforts by the dominant prescription hearing aid manufacturers to weaken the FDA’s proposed rule for the devices, the agency approved OTC hearing aids in August 2022.
Today, these over-the-counter hearing aids range from $299 to $2,500 per pair. Opening the market to over-the-counter products has not so much made hearing aids cheaper, but it has exposed the market economy: a large part of the value of a hearing aid appears to lie in the human input: correct hearing testing and correct fitting and adjusting the devices. Apart from any quality issues, manufacturers of cheaper devices either don’t offer customer support or don’t provide enough support to meet demand. “The complaint I hear is, ‘I can’t get a hold of anyone!’” Fechtner said.
Apple’s product is clearly different from the rest of the field. Instead of developing a new device, it has brought an easy-to-install software update to its latest generation of wireless earbuds. It turns one of the more expensive earbuds on the market into one of the most affordable OTC hearing aids, says Wiredwith more “advanced audio processing chops.”
Perhaps most crucially, Apple will deliver its hearing support in the simple and intuitive technology package that has made its products so successful. As Steve Jobs said at least once, according to biographer Walter Isaacson, “The most important thing in our design is to make things intuitively clear.” This usability can help AirPods owners make the critical DIY adjustments needed to achieve an effective hearing aid fitting.
Apple’s hearing software will be included in a routine software update sometime this fall. Using the software seems quite simple: you first take a self-administered hearing test, where you listen to a series of tones at different frequencies and volumes in each ear. An audiogram will appear, similar to the audiogram you would receive from an audiologist, showing your hearing sensitivity at different frequencies and volumes (you can also upload an audiogram from a hearing care professional).
After completing a few more programming steps, a user can begin using Apple’s hearing features. These include amplifying sounds in real time depending on your audiogram. They also include Live Listen, which lets you use your device as a directional microphone to better hear speech instead of noise, and Conversation Boost, which lets you point the microphone at the person in front of you. Fechtner finds Apple’s new hearing loss “prevention” features “extremely exciting.” And unlike most OTC hearing aids, Apple’s offering automatically works with streaming media: phone calls, music, movies and games.
The limited battery life means that, unlike many OTC wireless hearing aids, the AirPods won’t last all day. The AirPods Pro 2’s batteries last up to six hours, but five minutes in the charging case adds about an hour of listening or talk time. According to Apple, all health data (including hearing data) is as secure as any other health information you access from your device. Health insurance plans, including Medicare, generally do not currently cover over-the-counter hearing aids, but some private insurers have formed partnerships with individual device manufacturers. Uninsured buyers can apply for other financial assistance.
Fechtner advises patients to visit an audiologist, get tested, and try different devices to determine exactly what they need. And with those requirements in hand, to shop for an over-the-counter device that suits them best. At the very least, Fechtner said, an OTC hearing aid “can provide relief at a lower cost until you get a prescription device.”
Read more at De Uitzending
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