ORLANDO, Fla.—Following the recent U.S. FDA approval of EssilorLuxottica's  (Euronext: EL) over-the-counter Nuance Audio Glasses, the company has wasted little time in ensuring product is available to meet demands. On Wedneday, the company told VMAIL that it shipped its first 25,000 units of Nuance Audio overnight to the U.S. once the approval came in, with additional shipments on the way. This news was also shared with audience members at the company's recent Transitions Academy, held this week in Orlando, Florida.

 
 Fabrizio Uguzzoni.
With the FDA approval, Nuance Audio Hearing Aid Software has become the first FDA-cleared, preset software as medical device (SaMD) in the U.S., the company has advised, delivering open-ear hearing that is integrated into a pair of smart glasses.

“With Nuance Audio, we are building an entirely new category, and true category innovation benefits the entire industry,” said Fabrizio Uguzzoni, president of Professional Solutions Americas, EssilorLuxottica. "Trusted ECPs will gain a new way to serve their patients more holistically. And patients will now have access to advanced hearing technology that is invisible, comfortable and affordable. We are full steam ahead, working hard to get Nuance Audio onto the faces of consumers in what has long been an underserved market.”


The group also announced Monday that it had simultaneously achieved CE marking under the medical devices regulation in the European Union, alongside the development of an ISO Quality Management System certification dedicated to hearing aids, which will allow Nuance Audio to launch in Europe.

With this in mind, EssilorLuxottica advised VMAIL that it is planning its launch of Nuance Audio in phases. The company intends to have the product available in the U.S. at 1,400 storefronts by February 16, at 2,300 storefronts by February 24, and at LensCrafters, Target Optical and Pearle Vision by mid-March, with plans to roll out to remaining U.S. wholesale customers in April. At Transitions Academy, the company further advised that the product's European pilot would encompass retail and wholesale customers in Italy and coincide with the second wave of U.S. launches on February 24, with availability in other EU countries planned for April.

The global audience for this product is 300,000 wholesale customers and 80,000 audiologists, the company told VMAIL. Looking ahead, the company also noted potential long-term initiatives for Nuance Audio, advising the audience at Transitions Academy that these may include incorporating new health sensors, an expansion of the product collection (including new colors and styles), a hearing test feature and AI-powered noise reduction technologies.