FDA.reportPublic FDA data

nuance audio

Primary DI
08056262819890
Brand
nuance audio
Company
LUXOTTICA GROUP SPA
Model
AAW0003EL
Device description
Remote control plus accessory
Published
2026-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056262819890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056262819890080562628198908056262819890

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid/implant system remote controlA battery-powered device designed to be operated by the wearer of a hearing aid or a hearing implant system to enable discreet wireless (remote) adjustments to the device (e.g., volume and program changes). It is designed to be conveniently portable (e.g., carried in a pocket, handbag, or attached to a key ring).

Regulatory Flags#

DUNS number
436825376
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056262844755nuance audioAW50053532026-07-31
08056262844762nuance audioAW50054532026-07-31
08056262844779nuance audioAW50055532026-07-31
08056262844786nuance audioAW50056532026-07-31
08056262844809nuance audioAW50059532026-07-31
08056262844816nuance audioAW500511532026-07-31
08056262844823nuance audioAW500512532026-07-31
08056262844830nuance audioAW500513532026-07-31
08056262844847nuance audioAW500514532026-07-31
08056262855942nuance audioAW500515532026-07-31
08056262856789nuance audioREB250054A02026-07-31
08056262859407nuance audioAW50063522026-07-31
08056262859414nuance audioAW50064522026-07-31
08056262859421nuance audioAW50065522026-07-31
08056262859438nuance audioAW50066522026-07-31
08056262859445nuance audioAW50069522026-07-31
08056262859452nuance audioAW500611522026-07-31
08056262859469nuance audioAW500612522026-07-31
08056262859476nuance audioAW500613522026-07-31
08056262859483nuance audioAW500614522026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056262856789nuance audioLUXOTTICA GROUP SPAQUG2026-07-31
06980305290013CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290020CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290037CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290044CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290068CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290082CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290099CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290105CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290112CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980305290129CEARVOLSHENZHEN CANNICE TECHNOLOGY CO.,LTDQUG2026-07-25
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820115n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09