Hearing Aid Newbies Tuned, Eargo Says OTC Is a Game Changer

The hearing aid industry makes its voice heard.

Starting Monday morning, retailers like Walgreens, Best Buy and Walmart will sell hearing aids without a prescription thanks to an August ruling by the U.S. Food and Drug Administration. The regulation was finally passed under the OTC Hearing Aids Act of 2017. In July, the Biden administration ordered the full implementation of the law after a COVID-related delay.

The move has made companies in both the consumer electronics and digital health industries excited about the potential of using the technology to treat moderate to mild hearing loss. But while innovation is on the minds of many, some industry stakeholders are weighing more heavily on the impact of the FDA’s decision.

“Innovation is already happening regularly,” said Kate Carr, president of the Hearing Aid Association, an industry group representing many of the industry’s largest companies. “Technology is constantly improving. Will other companies go into space? We’ve already seen it.”

Carr said that while five companies — Sonova, GN ReSound, Starkey, Demant and WS Audiology — control most of the market, about 80 of them have registered hearing aids with the FDA. She added that it is a misconception that hearing aids are a universal device.

However, executives at some upstart companies say the decision is a game-changer for device innovation and value.

“It’s comparable to how streaming completely revolutionized the recording industry, or with the release of the iPhone in 2007,” said Danny Aronson, CEO of Tuned, a New York-based digital hearing aid company. “This is a fundamental game-changer in an industry that has been completely dominated by an oligopoly of five hearing aid manufacturers for decades.”

While technology in hearing aids has caught up, Aronson said it has been a slow process. For example, he said that it took too long for these large companies to add Bluetooth capabilities. Technology in wireless headphones from consumer electronics companies has helped drive innovation, he says.

Femtosense, a San Bruno, California-based company, is developing chips that could provide artificial intelligence capabilities to small, battery-powered devices such as hearing aids. Sam Fok, CEO of the company, said that the latest hearing aid revolution in terms of technology took place in the 1990s when sound switched from analog to digital. Since then, there have been gradual changes, he said.

Fok said that the OTC market will lead to increased competition and better device development, such as the introduction of AI.

“I think that with artificial intelligence, you can be more selective about the sounds that pass – or don’t pass – through the hearing aid,” Fock said. “Two trends are converging: technology is advancing, and the market is forcibly opening up. This should lead to potentially better outcomes for consumers.”

Aronson said companies like Tuned have begun working with software makers to tailor and personalize hearing aids to the needs of users.

Well-known hearing aid companies are not ignoring the OTC hearing aid movement. Some even work with major consumer electronics companies to launch new products. WS Audiology, the multi-billion dollar Danish hearing aid manufacturer, is partnering with Sony to launch devices to be sold through Amazon and Best Buy. Swiss company Sonova bought the hearing aid division of consumer electronics company Sennheiser for $241 million in May 2021.