The hearing aid industry is making its voice heard.
As of Monday morning, retailers like Walgreens, Best Buy and Walmart will sell hearing aids over the counter thanks to an August ruling from the U.S. Food and Drug Administration. The ruling was finalized as part of the Over-the-Counter Hearing Aid Act of 2017. In July, the Biden administration ordered the law to be fully implemented after a COVID-related delay.
The move has companies in both consumer electronics and digital health excited about the potential of using technology to aid moderate to mild hearing loss. But while innovation is on the minds of many, some industry stakeholders are more measured about the effect of the FDA ruling.
“There is already innovation that happens on a regular basis,” said Kate Carr, president of the Hearing Aid Association, an industry group that represents many of the biggest companies in the industry. “The technology is constantly improving. Will there be more companies that are coming into the space? We've already seen that.”
Carr said that while five companies—Sonova, GN ReSound, Starkey, Demant and WS Audiology —control the majority of market share, around 80 have registered hearing devices with the FDA. She added that it’s a misconception that hearing aids are a one-sized-fits all device.
Still, executives at some of the upstart companies say the ruling is a game changer for innovation and the cost of devices.
“It’s comparable to how streaming completely upended the recording industry or to the iPhone coming out in 2007,” said Danny Aronson, CEO of Tuned, a digital hearing company based in New York City. “It’s a fundamental game changing shift in an industry that for decades has been completely dominated by an oligopoly of five hearing aid manufacturers.”
While technology within hearing devices has caught up, Aronson said it’s been a slow process. For instance, he said it took those bigger companies too long to add Bluetooth capabilities. The technology in wireless headphone devices from consumer electronics companies has helped push along innovation, he said.
Femtosense, a San Bruno, California-based company, develops chips that can bring AI capabilities to small-state battery-powered devices such as hearing aids. Sam Fok, the company’s CEO, said the last hearing aid revolution in terms of technology was in the 1990s when audio switched from analog to digital. Since then, it’s been incremental change, he said.
Fok said that an over-the-counter market will lead to more competition and better advancements in devices, such as the implementation of AI.
“With AI, I think you can be more selective about the sounds that come through—or don’t come through—the hearing aid,” Fok said. “There are two trends converging—the technology is developing and the market is being forced open. This should lead to potentially better outcomes for consumers.”
Aronson said companies like Tuned have begun working with software companies to adapt and personalize hearing aids for users’ needs.
The established hearing aid companies are not ignoring the over-the-counter hearing aid movement. Some are even working with large consumer electronics companies to launch products. WS Audiology, a multi-billion-dollar Danish hearing aid manufacturer, is partnering with Sony to launch devices that will be sold through Amazon and Best Buy. Switzerland-based Sonova bought the hearing aid division of consumer electronics company Sennheiser for $241 million in May 2021.