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If you are under 18 years of age, do not use this product.
It is recommended that you consult a physician, preferably an ear, nose, and throat specialist (ENT), as your condition may require professional medical care.
This medical device is intended only for users aged 18 and older. It is designed for adults with signs of mild to moderate hearing loss.

System Requirements:

An iPhone with iOS (iOS 16.6.1 or later) or an Android smartphone (Android 12 or later).
Detailed system requirements, software license terms, and service conditions are available at www.nuanceaudio.com.
Warranty information is provided in the product packaging and on www.nuanceaudio.com.

Nuance Audio™ Glasses use Bluetooth® technology to exchange data with a paired mobile device.
Android® is a registered trademark of Google LLC.
iPhone® is a trademark of Apple Inc., registered in the U.S. and other countries. The iPhone® trademark is used under license from Apple.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc., and any use of such marks by Nuance Audio™ is under license.
Nuance Audio™ is a trademark of Essilor International SAS.

FCC Compliance Statement
The medical device and the Nuance Audio™ Charging Pad comply with Part 15 of the FCC Rules.
Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) This device must accept any interference received, including interference that may cause undesired operation.

Relevant data for all parameters measured in accordance with ANSI S3.22-2014 / CTA2051:2017 can be found in the Instructions for Use.

Technical Specifications of Nuance Audio™ Glasses:

  • Standard-band device

  • Frequency response bandwidth: 200 Hz – 5000 Hz

  • Maximum output limit (OSPL90): 110.5 dB

Operating Conditions:

  • Temperature: –10°C to +45°C

  • Atmospheric pressure: 101.3 kPa to 61.9 kPa

  • Humidity: 20% to 60% below +35°C for 1,000 hours

  • Maximum altitude: 3,900 meters for 1 hour at 0°C and +35°C

Transport and Storage Conditions:
Products must remain functional after exposure to:

  • Minimum storage temperature of –30°C and maximum of +75°C

  • High humidity (90%) at +45°C for 288 hours

  • Altitude of 12,000 meters (18.8 kPa) for 12 hours at both –10°C and +45°C

Luxottica Group Registry Numbers:

  • A.E.E. Register Number: IT21090000013299

  • P&A Register Number: IT21090P00007288

 

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