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IT-MF-000041132Nuance Audio is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Luxottica Group S.p.A. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 19, 2024
8056597000000Y214506CB0CNPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08059820279907
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
7 warnings recorded — scroll inside the panel to see all entries.
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.
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.
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
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.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Italy; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08059820279907Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
8056597000000Y214506CB0CNAW5004456UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Y2145060101BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE)No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.