FDA Approves Nuance Audio Glasses: A New Era for Hearing Aids

The concept of hearing aid glasses is not a new one. They have been around since the 1960’s with several companies attempting to produce them. Recently EssilorLuxottica has announced it received FDA clearance for the Nuance Audio glasses. They are set to launch commercially in the US in early 2025.

According to IEEE Pulse  the first eyeglass hearing aids originated in the 1950s by Otarion Electronics. Their device was called the Otarion Listener 10 and the electronics were embedded in the temple pieces of eyeglasses. Several other companies then introduced their version of eyeglass hearing aids.

Eyeglass hearing aids fell out of popularity fairly quickly and by the early 2000’s hearing aids advanced to become digital. They became much smaller so they could easily be hidden behind the ear.

EssilorLuxottia is reintroducing hearing aid eyeglasses to the US and EU market. On Feb 3, 2025 they announced they received FDA clearance for their OTC Nuance Audio Glasses. The press release states: “Paving the way for a disruptive new category in the med-tech space, Nuance Audio Hearing Aid Software is the first FDA cleared, preset Software as Medical Device (SaMD) in the U.S. It delivers a groundbreaking open-ear hearing solution seamlessly integrated into a pair of stylish smart glasses. 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. Nuance Audio will be available for purchase in the U.S. beginning in Q1. In the first half of 2025, it will be available in certain European countries, including France, Germany and UK, starting progressively from Italy in Q1, in parallel with U.S. market.”

Read the Press Release

Nuance Audio

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