EssilorLuxottica Gains FDA Clearance for Nuance Audio Glasses; Prepares for US and European Launches

Nuance Audio Glasses, the world’s first over-the-counter (OTC) hearing aids integrated into a pair of stylish smart glasses, have received clearance from the U.S. Food and Drug Administration (FDA). At the same time, Nuance Audio’s parent company, EssilorLuxottica—the largest vision-wear company in the world—has obtained the CE mark under the EU’s Medical Devices Regulation and established an ISO-certified Quality Management System specifically for hearing aids, paving the way for Nuance Audio’s debut in European markets.

Nuance Audio Glasses are an OTC hearing solution that reportedly combines cutting-edge speech-enhancing software with stylish eyewear, with the goal of improving communication for the 1.25 billion people worldwide who have mild to moderate hearing loss. Unlike traditional hearing aids, Nuance Audio Glasses use hidden speakers and directional microphones to amplify speech while leaving the ears open, eliminating the comfort and stigma issues of conventional devices. The advanced beamforming technology is designed to provide a blend of vision and sound without earpieces, wires, or tubes—offering a natural hearing experience in a sleek, rechargeable accessory.

HearingTracker Founder and Audiologist Abram Bailey, AuD, and Audiologist Matthew Allsop have favorably reviewed Nuance Audio glasses (see YouTube video below), along with several other experts in the field.

Nuance Audio Glasses will be available for purchase in the U.S. starting in the first quarter of this year. In a review of products showcased at the 2025 Consumer Electronics Show (CES), Nuance’s Global Marketing Director Davide D’Alena told HearingTracker that the new hearing glasses will be offered for around $1,100. Its European rollout will begin in Italy during the first quarter, with availability expanding to select markets, including France, Germany, and the UK, in the first half of 2025.

With 18,000 stores globally and with access to over 300,000 third-party stores, Italy-based EssilorLuxottica owns major vision care outlets including LensCrafters, Target Optical, Pearle Vision, Sunglass Hut, Ray-Ban, and Oakley. As part of its open business model, the company plans to utilize its large retail network to make Nuance Audio Glasses widely accessible, including collaboration with traditional audiology practices and optical wholesale partners so the product reaches as many consumers as possible.

“Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear,” said EssilorLuxottica Chairman and CEO Francesco Milleri in a press statement. “We didn’t just aim to combine two medical devices— we created an entirely new smart glasses form factor to support the two human senses we depend on the most. It is not only groundbreaking, but also incredibly accessible. We’re pleased now to turn our focus to getting this life-changing technology into the hands of people around the world who truly need it.”

According to EssilorLuxottica, the hearing industry today faces similar challenges that the vision industry faced years ago when many consumers were reluctant to use corrective devices due to stigma, discomfort, cost, and accessibility issues. Nuance Audio seeks to break down these barriers, making amplification more appealing and widely accepted compared to traditional hearing aids.

As reported by HearingTracker in January, EssilorLuxottica has also recently purchased Pulse Audition, the French manufacturer of Pulse Frames and its AI-driven software for hearing glasses. Pulse Audition’s proprietary technologies, expertise in AI software development, embedded AI, audio signal processing, and team of skilled professionals are expected to further enhance EssilorLuxottica's future offerings.