FDA, Nuance and EssilorLuxottica

The FDA and EU clear Nuance Audio, smart glasses with built-in hearing aids, for sale
Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially ready to sell in the US and Europe.
EssilorLuxottica receives FDA clearance for its Nuance audio glasses
EssilorLuxottica said on Monday it received a green light from the U.S. Food and Drug Administration (FDA) for its over-the-counter Nuance audio glasses.
EssilorLuxottica wins FDA clearance and EU approval for OTC audio glasses
EssilorLuxottica has received approval in the US and EU to market its Nuance audio glasses, a device that combines hearing solutions with prescription lenses. According to a 3 February press release,
These smart glasses just got FDA clearance as OTC hearing aids.
I got to try out EssilorLuxottica’s Nuance Audio glasses last month at CES 2025. They look like normal glasses, but can amplify the voice of whoever you’re speaking to while also dampening noisy environments.
Essilux: Nuance Audio Hearing Glasses Arrive in the United States and Italy. Here's When and Price
EssilorLuxottica has obtained FDA clearance for Nuance Audio Glasses, glasses that combine vision correction and hearing support. They will be on sale in the United States and Italy by March. Shares f
OTC hearing aid eyeglasses available soon in US following FDA approval
Nuance Audio showcased its glasses with built-in hearing aids at CES 2025. Now that the product is FDA-approved, it will be available in the US in the coming months.
EssilorLuxottica receives FDA clearance and EU certifications for Nuance Audio, making it available to consumers in the U.S. and Europe
EssilorLuxottica receives FDA clearance and EU certifications for Nuance Audio, making it available to consumers in the U.S. and Europe Paris, France (3 February 2025) – EssilorLuxottica announced today that it has received clearance from the Food and Drug Administration (FDA) for its OTC Nuance Audio Glasses.
Essilorluxottica receives US, EU, green light for OTC Audio Glasses
Essilorluxottica SA received U.S. FDA clearance for its over-the-counter Nuance Audio Glasses, which combines sight and sound technologies, to help people improve their vision and hearing. The device also received a CE mark certification under the Medical Devices Regulation from the EU authorities.
I tried smart glasses with built-in hearing aids - and they worked surprisingly well at CES
EssilorLuxottica, the holding company behind eyewear brands like Ray-Ban, Oakley, and Foster Grant, is entering the over-the-counter hearing aid industry with Nuance Audio.
US FDA approves first-ever smart glasses with hearing aid for mild to moderate loss
In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses have gained clearance from the Food and Drug Administration (FDA) for over-the-counter sales in the United States.
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