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FDA clears EssilorLuxottica's NuanceAudio for US market

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7 min read

After an anticipated multi-year buildup, the FDA has granted clearance to EssilorLuxottica’s over-the-counter (OTC) Nuance Audio Glasses, designed to provide advanced hearing assistance.

On a global scale: The glasses were also granted CE marking in the European Union (EU).

Let’s start with some background on hearing and vision loss.

This double threat—referred to as “dual sensory loss” or "deafblindness" when occurring together—impacts over 1.5 million individuals in the United States and roughly 0.2 to 2% of the global population.

Looking at hearing alone: In the U.S., over 50% of all people over the age of 75 are reported to have some form of age-related hearing loss.

Now bring in Essilor’s involvement in this.

The international eyecare and eyewear product company entered the global hearing aid market after acquiring the Israeli startup Nuance Hearing in 2022.

  • In announcing this purchase, Essilor reported the hearing solutions market had an 83% global service gap for those in need and that the company was working on its first product to shift that paradigm for the roughly 1.25 billion consumers with mild-to-moderate hearing loss.

How: Via Nuance’s “breakthrough hearing technology" featuring proprietary hardware and software.

Gotcha. Now let’s get a rundown on these glasses.

Nuance Audio is a pair of OTC smart glasses with a smartphone mobile application integrated into a general computing platform.

  • The basics: Hearing aids are paired with prescription-based glasses for a two-in-one option.

Its target users: Individuals (aged 18+) with mild-to-moderate hearing loss in both ears or who have difficulty understanding speech in noisy environments.

  • A special note: These glasses are also reported to provide “significant benefits for people without hearing loss,” as they amplify sounds coming from the direction a listener is facing.

Next: Talk about the frame design.

The Nuance Hearing technology is embedded into each eyeglass frame with a design featuring Essilor’s luxury eyewear theme—available in one of three style options and colors (see them here).

And this embedded hearing technology?

Designed to be “completely invisible” when embedded, the tech consists of microphones designed to capture and amplify sounds a user wants to hear based on their direction and focus in various environments.

More about this directional technology: This is tailored to amplify sounds a user wants to focus on via directional speakers on the frames, which include a novel open-ear technology for increased user comfort and sound amplification—ensuring any sound remains private to the wearer.

Hone in on the tech for a moment.

Dubbed “Nuance Audio Hearing Aid Software,” this is not just the first in a new category of the med-tech space—it’s also the first FDA-cleared, preset Software as Medical Device (SaMD) in the United States, according to Essilor.

SaMD refresh: This is standalone software intended to be used for medical purposes but is not part of a hardware medical device.

Amazing! So how is the volume controlled?

This is where the mobile application component comes into play.

Specifically: A companion app and pocket-sized remote control (for those users not as tech-savvy) give individuals volume control of the audio they’re hearing through the glasses.

  • The companion app can be used to adjust the glasses’ settings to a user’s selected preferences and adapt to any environment—including 360º amplification.
  • The remote control turns hearing assistance on/off and switches between audio modes based on what setting an individual is in (such as a crowded restaurant or speaking in a conversation, one-on-one).

Check out more how-to videos and information on the frames.

Circle back to that “prescription” component.

This is a major bonus! All Nuance Audio glasses are equipped with plano Transitions lenses (GenS), available in either a gray tint (with a shiny black frame) or an emerald tint (on a shiny burgundy frame).

About the GenS lenses: Manufactured by Transitions Optical (a joint venture of Essilor and PPG Industries), the Transitions lenses:

  • Provide light-responsive treatment
  • Feature darkening capabilities (in seconds) to block 100% of ultraviolet A and B rays
  • Fade back to clear in under 2 minutes

Could another lens type be fitted into the frame?

Yes! Essilor noted that prescription optical lenses (tailored to a user’s prescription and preferences) are also available as an optional upgrade to replace the Transitions GenS lenses.

And speaking of fitting …

Nope, a user doesn’t need to be fitted for these frames.

Since they’re OTC, there’s no pre-programming or hearing test needed before they can be purchased.

Got it. So what else comes with the glasses?

Did we mention they’re battery-powered? They are—and come with a magnetic, light-emitting diode(LED) wireless charging pad and glasses case.

The charging time: Roughly 3 hours.

  • And once charged: The battery should for—at a minimum—8 hours of continuous use in “average conditions” (moderate surrounding noise and typical amplification settings).

Usage hack: To extend the glasses’ performance, Essilor recommends turning off the frames when amplification is not needed “or when the surrounding environment requires less amplification and / or noise reduction."

And the major question: How much do these cost?

As we previously reported, Essilor clocked the expected price at $1,100 for just the frames (the addition of prescription optical lenses is extra).

Lastly, when and where can I purchase them?

Essilor stated NuanceAudio will be available in the U.S. beginning in Q1 2025 (so any day now).

  • To become a retailer as an eyecare practice, click here.

Outside the U.S: Plans are in motion for it to be distributed across certain European countries (including France, Germany, and the UK) starting in Q1 and extended throughout the first half (H1) of 2025.

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