HQ Team
February 3, 2025: Franco-Italian EssilorLuxottica SA got approval from the Food and Drug Administration to market its over-the-counter audio glasses in the US for people with hearing loss.
The Nuance Audio Glasses also received a nod from the CE marking under the Medical Devices Regulation in the EU, to sell in Europe, according to a company statement.
Nuance Audio Hearing Aid Software is the first FDA-cleared preset Software as a Medical Device (SaMD) in the US. The open-ear hearing solution is seamlessly integrated into a pair of smart glasses.Â
The device will be available in the US and Italy at the beginning of the first quarter. In the first half of 2025, it will be available in certain European countries, including France, Germany and UK.
âSee and hearâ
EssilorLuxottica will leverage its extensive retail network while also engaging both traditional audiology practices and optical wholesale customers to make the product accessible to consumers wherever possible.Â
âTwo years ago, we set out to create a first-of-its-kind product that would change the way people see and hear. We didnât just aim to combine two medical devices â 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,â said Francesco Milleri, Chairman and CEO of EssilorLuxottica.
The global hearing solutions market remains underserved, much like the vision market decades ago, where consumers were often hesitant to wear corrective devices due to factors such as stigma, discomfort, cost, and limited accessibility.
Mild to moderate hearing loss
Nuance Audio seeks to overcome these barriers, which have hindered the widespread adoption of traditional hearing aids.Â
The company aims to serve about 1.25 billion people worldwide who experience mild to moderate hearing loss.
The global eyewear market size was valued at $183.36 billion in 2023 and is expected to grow at a CAGR of 8.3% from 2024 to 2030, according to Grand View Research.
The market growth is attributed to several factors, such as the increasing prevalence of eye conditions such as myopia, hyperopia and astigmatism, which is driving demand for corrective eyewear. Rising disposable incomes and the growing acceptance of eyewear as a fashion accessory have further fuelled market growth.
EssilorLuxottica markets ophthalmic lenses, equipment and instruments, precision glasses and sunglasses. It is headquartered in Paris.
Pulse Audition acquisition
Essilor and Luxottica merged in October 2018 and named the new entity as EssorLuxottica.Â
EssilorLuxottica acquired Pulse Audition, a French startup delivering AI-based noise reduction and voice enhancement in January this year.Â
In December last year, EssilorLuxottica announced that it would buy Espansione Group, an Italy-based company specialised in the design and manufacturing of non-invasive medical devices for the diagnosis and treatment of dry-eye, ocular surface and retinal diseases.
In July 2024, EssilorLuxottica agreed to buy US streetwear brand Supreme for $1.5 billion, expanding its brand portfolio beyond eyewear and lenses for the first time.
In the same month, EssilorLuxottica acquired an 80% shareholding in Heidelberg Engineering.
