Cover Image for The FDA and the EU approve Nuance Audio's smart headphones, which include glasses with integrated earbuds, for commercialization.
Mon Feb 03 2025

The FDA and the EU approve Nuance Audio's smart headphones, which include glasses with integrated earbuds, for commercialization.

Nuance Audio's smart glasses with headphones have received FDA approval and CE marking in the EU, allowing for their launch in the first quarter.

Nuance Audio, the new "hearing glasses" from EssilorLuxottica, have received FDA approval and CE marking under medical device regulations in the European Union, meaning they are ready to be marketed in both the United States and Europe. These smart glasses essentially function as prescription optical frames that incorporate an over-the-counter hearing aid. Using open-ear speakers and an array of directional microphones, Nuance Audio can amplify the volume of the person being conversed with while attempting to suppress background noise.

Control of the glasses can be done through a companion app or a dedicated remote control. However, they are only available in two shapes, two colors, and three sizes, which limits options compared to traditional eyewear brands from EssilorLuxottica and the Ray-Ban Meta smart glasses. Despite this limitation, the technology has the potential to be applied to new designs in the future.

During CES 2025, Cherlynn Low, deputy editor of Engadget, had the opportunity to try Nuance Audio and found them very comfortable and lightweight, although she couldn't fully assess their capabilities as a hearing device. Nuance Audio joins a growing trend of similar devices to hearing aids that have emerged since the FDA implemented its over-the-counter hearing aid regulations in 2022. Like Nuance Audio, Apple's AirPods Pro 2 now offer hearing aid functionalities enabled by software, along with an integrated hearing test and a hearing protection feature in noisy environments. While transforming each pair of AirPods Pro 2 into hearing aids may be a cost-effective option, having a pair of Nuance Audio glasses that also serve as prescription eyewear could be even more practical.

EssilorLuxottica has announced that Nuance Audio will be available in the United States in the first quarter, and that "certain European countries" will receive these glasses in the first half of 2025, starting with Italy in the first quarter, followed by France, Germany, and the United Kingdom. No official information has been provided regarding the price of Nuance Audio.