By mid-October, the hearing aid industry will be completely in the throes of a revolution – one that has been underway for a long time. And it could open up a new, lucrative area for tech companies and also be a real boon for consumers.
On Tuesday, the Food and Drug Administration (FDA) announced this could 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 likely significantly cheaper.
It is a step that has become increasingly important 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 a hearing impairment. By 2050, that could rise to 900 million, in part from regular exposure to loud noises at work and in personal life (such as listening to music through earphones).
Currently, 15% of US adults (37.5 million) aged 18 and older report hearing problems.
The legislation has some limitations. Devices for severe hearing loss and devices intended for use on children under the age of 18 still require a prescription. But for the millions who suffer from mild to moderate hearing loss, buying a hearing aid can be about as easy as buying reading glasses at the drugstore.
They won’t be that cheap, of course, but they’ll likely be cheaper than current hearing aids, which can cost as much as $5,000 — and often aren’t covered by insurance. The FDA estimated that the price of those devices could be halved once the rule goes into effect.
“I am confident we will see a significant price reduction for consumers with mild to moderate hearing loss,” said Blake Cadwell, founder and CEO of solida 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 for $1,500. In the long run, we may see even lower prices as consumers become more comfortable with more self-service. For now, OTC players will 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 grow to $19.5 billion by 2030. And among the winners could be startups and other companies that have been working on “augmented hear devices” in recent years. For example, Nuheara offers the IQbuds, which claim to automatically calibrate to your hearing profile. Those currently sell for $499. And ZVOX’s VoiceBuds, an FDA-registered Class One hearing aid, currently sells for less than $300.
Also, don’t expect major consumer technology players to sit on the sidelines.
“Established companies such as Phonak and ReSound have prepared for these guidelines and will almost certainly launch their own products within the next two years,” Cadwell said. “In the short term, I expect brands like Lexie, which distributes a Bose hearing aid, and Eargo, which makes an innovative invisible design, will benefit. Expect tech leaders like Apple and Jabra to watch this space in the months and years to come.”
Hearing aids are a hot MedTech item been at CES for years. In 2021 Oticon More won an Innovation Award for being the world’s first hearing aid with Deep Neural Network technology, which it claims can deliver a more refined sound that supports the natural functioning of the brain. in 2022Bose won an Innovation Award for its SoundControl hearing aids. Signia was also honored for its Bluetooth-enabled, in-the-ear hearing aid, the Insio Charge & Go AX.
Venture capitalists have been waiting for the FDA to make this ruling as well. in 2020, To whisper emerged from stealth with a $35 million Series B investment round led by Quiet Capital, bringing total funding to $53 million. The company’s product uses artificial intelligence to adapt to different situations, such as a crowded bar or dinner with friends.
Last year, hearing company Olive Union landed $7 million in his own Series B round. And Eargo, in 2020, announced a $71 million Series E financing round after introducing his hearing aid, which is largely invisible because it sits in the ear canal.
The FDA decision comes after a perennial push by legislators and hearing aid companies to broaden the category. As with corrective glasses, over-the-counter hearing aids won’t take away the existing audiology industry, but it should increase availability and, ideally, remove the stigma many people feel when it comes to hearing problems.
“Hearing loss is a critical public health problem affecting the ability of millions of Americans to communicate effectively in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD in a statement. “By introducing this new regulatory category, people with perceived mild to moderate hearing loss will be able to easily access a range of safe, effective and affordable hearing aids at their convenience store or online.”