The hearing aid market is ripe for disruption thanks to the US Food and Drug Administration’s recent decision to allow over-the-counter hearing aid sales.
The FDA last week issued a final rule expanding access to over-the-counter hearing aids for people with perceived mild to moderate hearing loss who are 18 and older. In mid-October, this group can go to retail outlets and pharmacies to buy a pair of hearing aids without a medical exam, prescription or visit to the audiologist.
The measure has been in the works for years after Congress passed bipartisan legislation in 2017 to push the FDA to create a category of over-the-counter hearing aids. The FDA’s decision should reduce the high cost of hearing aids, but also marks an opportunity for entrepreneurs to improve a technology that has long been dominated by a select group of manufacturers such as ReSound, Sonova and Demant. The valuation of the global hearing aid market reached $10.1 billion last year, according to information from Grand View Research, a market research and business consulting firm in San Francisco.
By setting new standards, big brands like Apple, Samsung and more can now adapt their current hearing aids to become hearing aids, says Frank Lin, director of the Cochlear Center for Hearing and Public Health at Johns Hopkins Bloomberg School of Public. Health. “This, in one fell swoop, opens the market to an incredible amount of innovation,” Lin says. “Once that happens, it automatically increases access, dramatically reduces costs, and enables a whole new world of innovation and competition in this space compared to previous conditions, which is not just a matter of ageing, but a real public health problem.”
A set of hearing aids costs consumers $2,500 to $7,000 and lasts three to seven years. Most insurers, including Medicare, don’t cover hearing aids, let alone batteries, wax guards, and other accessories. The average hearing aid battery lasts between three and 22 days, according to Starkey, a hearing technology company based in Eden Prairie, Minnesota. There are also rechargeable options.
But cost isn’t the only barrier to getting a set of hearing aids right now. Lin explains that access is another issue, since patients seeking help must work with an audiologist or otolaryngologist like him. Still, it is probably in the consumer’s best interest to visit the audiologist for fitting and to be evaluated by a professional to determine the level of hearing loss. This can help consumers avoid purchasing a hearing aid that may not work for them.
The FDA rule is seen as a huge win for consumers, as millions of Americans are living with hearing loss and many are forgoing treatment, Lin said. Hearing loss isn’t just for the elderly – Johns Hopkins estimates that about 14.3 percent of Americans ages 12 and older, or about 38.2 million people, have hearing loss in both ears. Congenital hearing loss affects between 1.2 and 1.7 per 1,000 live births in the United States, according to an April 2019 reading from the University of Iowa Carver College of Medicine.
Not everyone will qualify for over-the-counter hearing aids, as the new rule applies to people with mild to moderate hearing loss. There are different measures of hearing loss that look at frequency, ranging from mild and mild on one side of the spectrum to severe and profound on the other.
Companies are already seizing the opportunity. Best Buy announced on August 17 the launch of a new experience for people with hearing loss, which includes an online hearing assessment tool and the expansion of its hearing aid portfolio. For example, Best Buy will include products from Perth, Australia-based Nuheara, a company looking to enter the space with its smart headphones designed for hearing enhancement. Nuheara’s self-adjusting hearing aid is currently awaiting FDA clearance. Domestic companies will certainly follow.
Unlike a pair of glasses which can restore most people’s vision to a baseline of 20/20, hearing aids have yet to reach that standard. Some users report that the hearing aids have not yet fully captured the timbre of a musical instrument, making the music sound more “flat” as it would, for example, a recording.
Protecting hearing aids from moisture is another hurdle. Some have a high ingress protection rating (IP ratings measure hearing aids’ ability to repel debris, water, and other substances), but there are still opportunities to make hearing aids more resistant to the elements.
What makes the innovation angle particularly exciting, Lin points out, is that the market was historically dominated by five manufacturers, whereas now smaller players have access to create out-of-the-box approaches as they are attacking a less restricted market.
“You now have a market where companies are making products directly for consumers, and that’s changing the amount of innovation and the product lifecycle to react quickly to what the consumer wants,” Lin said. “Whereas right now it’s not like that.”