Nuance Audio

Organization name

Luxottica Group S.p.A

SRN

IT-MF-000041132

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW275

  The Nuance Audio ™ Glasses and the Charging Pad contain magnetic material and components that emit radio waves, which could affect the operation of medical devices such as but not limited to pacemakers or insulin pumps, or other implantable devices, consult your doctor or the medical device manufacturer before using the Nuance Audio ™ Glasses and the Charging Pad.
• CW023

  Don’t near active HF surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of EM disturbances is high.
• CW018

  EUDAMED did not publish a description for this code.
• CW030

  If you have any of the problems listed below, please see a healthcare professional. • Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident. • You saw blood, pus or fluid coming out of your ear within the past 6 months. • Your ear feels painful or uncomfortable • You have a lot of earwax or you think something could be in your ear • You get dizzy or have a feeling of spinning or swaying (called vertigo) • Your hearing changed suddenly in the past 6 months • Your hearing changes: it gets worse then gets better again • You have worse hearing in one ear • You hear ringing or buzzing in only one ear
• CW024

  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
• CW027

  EUDAMED did not publish a description for this code.
• CW262

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

Nuance Audio

UDI-DI code

08059820279686

Basic UDI-DI

8056597000000Y214506CB0CN

Reference / catalog number

AW5001754

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 54 MU50

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y2145060101BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)