FDA Approves Nuheara Smart Hearing Aids for US Sales
The FDA has officially registered the IQbuds² Pro from Australian hearables developer Nuheara as a medical device. That means Nuheara can sell the smart hearing aids in the U.S. without the need for further clinical trials, a huge saving in time and resources for the company as it looks to expand its share of this increasingly competitive market.
Nuheara’s IQbuds² Pro hearing aid is a brand new addition to the company’s portfolio, joining the IQbuds² Max earbuds that debuted at CES in 2020. The Pro is designed explicitly for people with significant hearing loss. The Max can still be used as a limited hearing aid but is more suitable for cases of relatively minor hearing loss. Both rely on the same IQbuds² hardware platform that Nuheara built in a partnership with Hewlett Packard, which invested $2 million to develop IQbuds2 hardware. The companies have a three-year manufacturing agreement they signed at the end of last year. Approval to sell the IQbuds² Pro in the U.S. gives Nuheara access to an enormous slice of the estimated $9 billion annual global hearing aid market, according to the company. North America as a whole makes up more than a third of those sales, $3.37 billion every year. Nuheara has been growing quickly, reporting a 406% rise in invoiced revenue for the first six months of 2021. The FDA approval could accelerate that growth even more.
“This is a significant development in Nuheara’s mission to make hearing health more accessible and affordable for all,” Nuheara CEO Justin Miller said in a statement. “Over many years the business has invested tens of millions of dollars in our proprietary hearing technology platform. The IQbuds² Pro as a hearing aid device represents further opportunities to expand Nuheara’s leadership position in both hardware and software of hearing health devices. This registration effectively enables Nuheara to meet the varied hearing needs of a growing base of underserved customers with a wider spectrum of hearing loss.”
Nuheara’s smart hearing aids are a growing facet of the hearables market as it expands. The Olive Pro earbuds offer hearing tests and adjustments that allow them to work as hearing aids and are also registered as medical devices by the FDA. Google’s parent company Alphabet is designing its own hearables capable of distinguishing individual voices in a crowd and improving people’s hearing. The project is named Wolverine in reference to the X-men character’s heightened senses. Voicebot’s research has found a major jump in hearables ownership, 23% over the last two years among U.S. adults. Hearing aids that double as standard earbuds could make up a notable element of the space.