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.

• Ask your pharmacist or doctor for advice before using or taking the product (e.g. if pregnant or breastfeeding)

  Nuance Audio™ Plus and the Nuance Audio™ 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 Nuance Audio™ Plus and the Nuance Audio™ Charging Pad.

• Consider hazards from magnetic fields

  Don’t go 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.

• Refer to instruction manual/booklet
• Consult healthcare professional before use

  If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT). • 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 in the past 6 months. • Your ear feels painful or uncomfortable. • You have a lot of ear wax, or you think something could be in your ear. • You get really 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

• Do not store near magnets or magnetic devices

  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.

• Single patient multiple use
• MR UNSAFE

Primary placement in Italy; available across 32 countries total.

Trade name

Nuance Audio Plus

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08059820535607

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

8056597000000Y214506CB0CN

Reference / catalog number

AW50051453

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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

• 53 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

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

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.