FDA.reportPublic FDA data

nuance audio

Primary DI
08056262487013
Brand
nuance audio
Company
LUXOTTICA GROUP SPA
Model
REB0080A0
Device description
Remote control accessory sold as spare part
Published
2025-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08056262487013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056262487013080562624870138056262487013

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436825376
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056262233191nuance audioAW50017542025-09-29
08056262234266nuance audioAW50047562025-09-29
08056262234655nuance audioAW50027482025-09-29
08056262316665nuance audioAW50019542025-09-29
08056262666319nuance audioAW50029482025-09-29
08056262666326nuance audioAW50049562025-09-29
08056262846506nuance audioREL0063A02025-05-13
00777797633444nuance audioREL0063A02025-05-13
08056262282434nuance audioAAW0001EL2025-05-13
08056262282489nuance audioAAW0002EL2025-05-13
08059820279648nuance audioAW50013542025-02-06
08059820279662nuance audioAW50015542025-02-06
08059820279679nuance audioAW50016542025-02-06
08056262013229nuance audioWAW0000012025-02-05
08059820279655nuance audioAW50014542025-02-05
08059820279761nuance audioAW50023482025-02-05
08059820279778nuance audioAW50024482025-02-05
08059820279785nuance audioAW50025482025-02-05
08059820279792nuance audioAW50026482025-02-05
08059820279860nuance audioAW50043562025-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01
06973967150351Audien HearingXiamen Vienatone Medical Technology Co., Ltd.QUG2026-04-28
00860015094803LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094810LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094827LegatoLEGATO AUDIO, INC.QUG2026-03-25
00860015094834LegatoLEGATO AUDIO, INC.QUG2026-03-25
00850080488249flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-03-06
16974308960209Retone, NebrooXiamen Retone Hearing Technology Co., LtdQUG2026-02-05
00850080488140flysoundShenzhen Flysounds Medical Technology Co.,Ltd.QUG2026-01-16
05714880290325hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290332hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290349hear.comWs Audiology Usa, Inc.QUG2026-01-12
05714880290356hear.comWs Audiology Usa, Inc.QUG2026-01-12
16974308960193Retone Xiamen Retone Hearing Technology Co., LtdQUG2026-01-08
06977352080438ELEHEARELEHEAR Inc.QUG2025-12-31
06943786079911AUSTARAustar Hearing Science & Technology (Xiamen) Co., Ltd men) Co., Ltd.QUG2025-12-03
06975958551277MirasingXiamen Mirasing Technology Co.,Ltd.QUG2025-11-03
00810153660828Lexie H1 OTC Hearing BudsHEARX GROUP (PTY) LTDQUG2025-10-01
06971094538486H-earrings Huizhou Jinghao Medical Technology Co., LtdQUG2025-10-01
05708296386239GN HearingGn Hearing A/SQUG2025-09-21
05708296386246GN HearingGn Hearing A/SQUG2025-09-21
05708296391240GN HearingGn Hearing A/SQUG2025-09-21
05708296386253GN HearingGn Hearing A/SQUG2025-09-19
05708296386260GN HearingGn Hearing A/SQUG2025-09-19
05708296386277GN HearingGn Hearing A/SQUG2025-09-19
05708296386284GN HearingGn Hearing A/SQUG2025-09-19
05708296386291GN HearingGn Hearing A/SQUG2025-09-19
05708296386307GN HearingGn Hearing A/SQUG2025-09-19
05708296386314GN HearingGn Hearing A/SQUG2025-09-19