FDA.reportPublic FDA data

nuance audio

Primary DI
08056262859414
Brand
nuance audio
Company
LUXOTTICA GROUP SPA
Model
AW5006452
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
SCRAir-Conduction Hearing Aid Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCRAir-Conduction Hearing Aid SoftwareEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243150000Nuance Audio Hearing Aid SoftwareLuxottica Group S.P.A.2025-01-31SCR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056262859414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056262859414080562628594148056262859414

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, spectacleA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case built into the arm(s) of spectacles. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
436825376
Device count
1
DM exempt
false
Premarket exempt
false
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
08056262819890nuance audioAAW0003EL2026-07-31
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
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
08056262844755nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844762nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844779nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844786nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844809nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844816nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844823nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844830nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262844847nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262855942nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859407nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859421nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859438nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859445nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859452nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859469nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859476nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859483nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262859490nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866412nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866436nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866443nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866450nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866467nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866474nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866481nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866498nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866504nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262866511nuance audioLUXOTTICA GROUP SPASCR2026-07-31
08056262233191nuance audioLUXOTTICA GROUP SPASCR2025-09-29