FDA.reportPublic FDA data

nuance audio

Primary DI
08059820279648
Brand
nuance audio
Company
LUXOTTICA GROUP SPA
Model
AW5001354
Published
2025-02-06
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08059820279648PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059820279648080598202796488059820279648

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436825376
Device count
1
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
08056262487013nuance audioREB0080A02025-05-13
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
08056262233191nuance audioLUXOTTICA GROUP SPASCR2025-09-29
08056262234266nuance audioLUXOTTICA GROUP SPASCR2025-09-29
08056262234655nuance audioLUXOTTICA GROUP SPASCR2025-09-29
08056262316665nuance audioLUXOTTICA GROUP SPASCR2025-09-29
08056262666319nuance audioLUXOTTICA GROUP SPASCR2025-09-29
08056262666326nuance audioLUXOTTICA GROUP SPASCR2025-09-29
00195950732382Hearing Aid Feature 2.0 (HAF 2.0)APPLE INC.SCR2025-09-09
00195950732399Hearing Aid Feature 2.0 (HAF 2.0)APPLE INC.SCR2025-09-09
00195950732405Hearing Aid Feature 2.0 (HAF 2.0)APPLE INC.SCR2025-09-09
00195950732412Hearing Aid Feature 2.0 (HAF 2.0)APPLE INC.SCR2025-09-09
08059820279662nuance audioLUXOTTICA GROUP SPASCR2025-02-06
08059820279679nuance audioLUXOTTICA GROUP SPASCR2025-02-06
08056262013229nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279655nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279761nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279778nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279785nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279792nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279860nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279907nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279914nuance audioLUXOTTICA GROUP SPASCR2025-02-05
08059820279921nuance audioLUXOTTICA GROUP SPASCR2025-02-05
00195949149924Hearing Aid Feature (HAF)APPLE INC.SCR2024-10-21
00195949149931Hearing Aid Feature (HAF)APPLE INC.SCR2024-10-21
00195950095067Hearing Aid Feature (HAF)APPLE INC.SCR2024-10-21
00195950095074Hearing Aid Feature (HAF)APPLE INC.SCR2024-10-21