EssilorLuxottica Expands Med-Tech Frontiers with FDA Clearance and EU Certification for Nuance Audio Glasses

EssilorLuxottica has announced a major milestone in its mission to enhance both vision and hearing accessibility. The company has received clearance from the U.S. Food and Drug Administration (FDA) for its over-the-counter (OTC) Nuance Audio Glasses. Simultaneously, it has achieved the CE marking under the European Union’s Medical Devices Regulation and developed an ISO Quality Management System certification dedicated to Hearing Aids. This positions Nuance Audio Glasses as a groundbreaking solution in both the U.S. and Europe.

A Disruptive Innovation in Smart Glasses
Nuance Audio introduces a pioneering category in the med-tech space by integrating prescription eyewear with a cutting-edge hearing aid. Unlike traditional hearing aids, which many individuals avoid due to stigma, discomfort, or high costs, Nuance Audio presents an attractive and functional alternative. The software powering Nuance Audio is the first FDA-cleared, preset Software as a Medical Device (SaMD) in the U.S., offering users an open-ear hearing solution within a sleek, stylish frame.

This advancement aims to bridge the accessibility gap in hearing solutions, much like the company’s historical efforts in vision correction. Approximately 1.25 billion people worldwide experience mild to moderate hearing loss, yet adoption of traditional hearing aids remains low. Nuance Audio Glasses seek to remove barriers by providing a seamless experience for both vision and hearing, eliminating the need for separate medical devices.

Availability and Market Expansion
EssilorLuxottica plans to launch Nuance Audio in the U.S. market in the first quarter of 2025. The rollout in Europe will begin in select countries, including France, Germany, and the U.K., following an initial launch in Italy. The company aims to leverage its extensive retail network while collaborating with optical wholesale customers and audiology professionals to ensure broad accessibility for consumers.

“Two years ago, we set out to create a first-of-its-kind product that would change the way people see and hear,” said Francesco Milleri, Chairman and CEO of EssilorLuxottica. “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.”

Hearing and Balance: Addressing a Growing Health Concern
The launch of Nuance Audio Glasses comes at a crucial time, as the hearing and balance industry continues to face significant challenges. A recent study from the American Institute of Balance (AIB) highlights the growing need for integrated hearing solutions. The study investigated the incidence of benign paroxysmal positional vertigo (BPPV), a common vestibular disorder often linked to aging, osteoporosis, and vitamin D deficiency. Researchers found that BPPV is most prevalent among individuals aged 60-70 and can significantly impact quality of life, increasing the risk of falls, fractures, and even cognitive decline.

The study further noted that the incidence of BPPV peaks in winter months, potentially due to seasonal variations in vitamin D levels. Such findings underscore the importance of early intervention and accessible hearing solutions to mitigate balance disorders and their associated risks. Nuance Audio Glasses’ ability to enhance both hearing and situational awareness could provide a meaningful benefit to those with vestibular conditions, complementing traditional balance therapies and interventions.

The Future of Vision and Hearing Care
As the global population continues to age, the demand for innovative solutions addressing both vision and hearing impairment is expected to grow. EssilorLuxottica’s approach — integrating two essential sensory aids into a single wearable — represents a step forward in making assistive technology more appealing, accessible, and functional. With the upcoming rollout of Nuance Audio Glasses, eye care professionals and audiologists will play a key role in introducing this technology to patients seeking an all-in-one solution.

Nuance Audio Glasses are not just a product; they represent a paradigm shift in health care technology. By addressing long-standing barriers to hearing aid adoption while maintaining its commitment to vision excellence, EssilorLuxottica is setting the stage for a new era of sensory enhancement.

U.S.-based ECPs are invited to complete an interest form or contact their EssilorLuxottica representatives directly to get first access to offer in their practice.