EssilorLuxottica’s Nuance Audio Glasses Approved by FDA

EssilorLuxottica has received FDA medical device approval for its Nuance Audio Glasses, a groundbreaking innovation that combines vision correction with an integrated open-ear hearing aid. The device has also secured CE marking under the Medical Devices Regulation in the EU and an ISO Quality Management System certification for Hearing Aids, enabling a simultaneous U.S. and European launch.

This approval marks a significant step in smart eyewear innovation, reinforcing EssilorLuxottica’s leadership in ophthalmic technology and expanding the role of eyeglasses beyond vision correction.

Bridging Vision and Hearing: The Role of Nuance Audio Glasses

Unlike traditional eyewear, Nuance Audio Glasses incorporate open-ear hearing aid technology, eliminating ear crowding—a common issue for individuals who wear both hearing aids and glasses. By integrating prescription lenses into a medical-grade smart device, this innovation addresses a long-standing barrier to dual sensory correction.

Francesco Milleri, Chairman and CEO of EssilorLuxottica, emphasized the transformative potential of this technology:

“Two years ago, we set out to create a first-of-its-kind product that would change the way 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.”

Smart Eyewear Meets Ophthalmic Innovation

With the FDA clearance, Nuance Audio Hearing Aid Software becomes the first Software as a Medical Device (SaMD) to receive approval for hearing aids in the U.S. This innovation highlights a new era of multi-functional eyewear, aligning with ongoing advancements in ophthalmic smart technology.

EssilorLuxottica’s press release underscores the importance of this innovation:

“After decades of adoption barriers ranging from comfort to visibility, consumers will finally be able to see clearly and hear clearly with a single product that is both beautiful and highly functional.”

Market Availability and Expansion

Following FDA and CE approvals, Nuance Audio Glasses will be available over the counter in the U.S. starting Q1 2025. The European rollout will begin in Italy, followed by France, Germany, the UK, and additional European markets throughout the first half of 2025.

Redefining Accessibility in Vision and Hearing Care

EssilorLuxottica developed Nuance Audio to overcome barriers to hearing aid adoption, such as:

• Stigma associated with traditional hearing aids.

• Discomfort of wearing both hearing aids and glasses simultaneously.

• High costs and limited accessibility of hearing care.

According to the World Health Organization’s 2021 World Report on Hearing, approximately 1.25 billion people worldwide experience mild to moderate hearing loss. With Nuance Audio, EssilorLuxottica aims to encourage wider adoption of hearing aids without compromising visual correction.

Implications for the Future of Smart Ophthalmic Devices

This approval signals a growing trend in ophthalmic technology, where smart eyewear goes beyond traditional vision correction. As ophthalmology intersects with wearable health technology, innovations like Nuance Audio Glasses could pave the way for future developments, such as:

• Eyewear with AI-driven visual enhancement features.

• Integrated vision and hearing diagnostics in smart glasses.

• Expanded applications of medical-grade smart lenses.

Conclusion

The FDA and CE approvals of Nuance Audio Glasses mark a milestone in smart eyewear innovation, combining vision correction with hearing assistance in a seamless, accessible design. By integrating ophthalmic expertise with wearable technology, EssilorLuxottica is leading the way toward a future where eyewear plays a larger role in holistic sensory health.