By mid-October, the hearing aid industry will be in the throes of a revolution, a revolution that is long in coming. And it could open up a lucrative new realm for tech companies and be a boon for consumers, too.
On Tuesday, the Food and Drug Administration (FDA) announcement this would allow some hearing aids to be sold over-the-counter for the first time, a move that will make assistive devices much more widely available and, in all likelihood, significantly cheaper.
This is an increasingly important decision, as hearing loss is expected to increase dramatically in the coming decades. The World Health Organization (WHO) warns that by 2030, nearly 630 million people worldwide will have hearing loss. By 2050, that figure could rise to 900 million, in part because of regular exposure to loud sounds at work and in people’s personal lives (like listening to music through headphones).
Currently, 15% of American adults (37.5 million) aged 18 and over report hearing problems.
The law has certain limitations. Devices for severe hearing loss and those intended for children under 18 will still require a prescription. But for the millions of people with mild to moderate hearing loss, buying a hearing aid could be as simple as buying a pair of reading glasses from the drug store.
They won’t be as cheap, of course, but they’ll likely be cheaper than today’s hearing aids, which can cost up to $5,000 and often aren’t covered by insurance. The FDA has estimated that the price of these devices could be cut in half once the rule takes effect.
“I am confident that we will see a significant price reduction for consumers with mild to moderate hearing loss,” said Blake Cadwell, Founder and CEO of Soundlya site that allows people to compare and buy hearing aids online. “Expect simple products like the Bose B1 hearing aid to go on sale for $899 and more expensive devices to go on sale for $1,500. In the long term, we could see even lower prices as consumers become familiar with more self-service. For now, OTC players will need to invest heavily in education and customer service, which will keep prices above other consumer electronics.
It is estimated that the hearing aid market reach $19.5 billion by 2030. And among the winners could be startups and other companies that have worked on “augmented hearing aids” over the past few years. Nuheara, for example, offers the IQbuds, which claim to automatically calibrate to your hearing profile. These are currently selling for $499. And ZVOX’s VoiceBuds, an FDA-registered Class 1 hearing aid, currently sell for less than $300.
Don’t expect the big players in the consumer tech space to sit on the sidelines, either.
“Established companies like Phonak and ReSound have prepared for these guidelines and will almost certainly launch their own products within a year or two,” Cadwell said. “In the short term, I expect brands like Lexie, which distributes a Bose hearing aid, and Eargo, which offers an innovative invisible design, to benefit. Expect tech leaders like Apple and Jabra to watch this space in the months and years to come. »
Hearing aids have been a hot MedTech article at CES for years. In 2021, Oticon More won an innovation award for being the world’s first hearing aid to include Deep Neural Network technology, which it claims can deliver more refined sound that supports natural brain function. In 2022Bose won an innovation award for its SoundControl hearing aids. Signia was also recognized for its Bluetooth-enabled in-ear hearing aid, the Insio Charge & Go AX.
Venture capitalists are also waiting for the FDA to make this decision. In 2020, Whisper emerged from stealth with a $35 million Series B investment round, led by Quiet Capital, bringing its total funding to $53 million. The company’s product uses artificial intelligence to adapt to different situations, such as a crowded bar or a dinner party with friends.
Last year, hearing society Olive Union landed $7 million in its own Series B round. And Eargo, in 2020, announced $71 million Series E funding round after throwing his hearing aid, which is largely invisible because it sits in the ear canal.
The FDA’s decision comes after a multi-year surge by legislators and hearing aid companies to expand the category. As with corrective eyewear, over-the-counter hearing aids won’t wipe out the existing audiology industry, but they should expand availability and, ideally, begin to erase the stigma that many people feel when it comes to problems. of hearing.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to communicate effectively in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD. in a report. “The creation of this new regulatory category will allow people with mild to moderate hearing loss to have convenient access to a range of safe, effective and affordable hearing aids at their neighborhood store or online.”