EssilorLuxottica has received clearance from the U.S. Food and Drug Administration (FDA) for its over-the-counter Nuance Audio Glasses, alongside achieving CE marking under the EU’s Medical Devices Regulation. The company also developed an ISO Quality Management System certification for hearing aids, enabling the product’s launch in Europe.
Courtesy of Nuance Audio.
Nuance Audio Hearing Aid Software is the first FDA-cleared, preset software-as-a-medical device (SaMD) in the U.S., marking a new category in medical technology. The product integrates an open-ear hearing solution into smart glasses, offering a dual-purpose vision and hearing correction device. The glasses address long-standing barriers to hearing aid adoption, such as comfort, visibility, and stigma.
The glasses will be available in the U.S. starting in Q1 2025. A phased rollout in Europe will begin in Italy, followed by France, Germany, and the U.K. EssilorLuxottica plans to make the product widely accessible by leveraging its retail network and collaborating with audiology practices and optical wholesalers.
“Two years ago, we set out to create a first-of-its-kind product that would change how people see and hear. 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.”
The global hearing solutions market remains underserved, with many consumers hesitant to use traditional hearing aids due to stigma, discomfort, cost, and accessibility issues. Nuance Audio Glasses aim to address these challenges, targeting the estimated 1.25 billion people worldwide with mild to moderate hearing loss.
The Consumer Technology Association (CES) named EssilorLuxottica a CES 2025 Honoree in Digital Health, saying “Nuance Audio OTC Hearing Aid Glasses combine revolutionary technology with premium eyewear design to transform people’s quality of life and ability to hear sounds for perceived mild to moderate hearing loss combined with vision needs in one unique product at the intersection of sight and hearing.”
