FDA.reportPublic FDA data

Hearing Aid Feature 2.0 (HAF 2.0)

Primary DI
00195950732412
Brand
Hearing Aid Feature 2.0 (HAF 2.0)
Company
APPLE INC.
Model
Feature version 2.X
Device description
Hearing Aid Feature macOS (2.X)
Published
2025-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
DEN230081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230081000Hearing Aid Feature (HAF)Apple, Inc.2024-09-12SCR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195950732412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195950732412001959507324121959507324120195950732412

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, in-the-earA 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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe 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
060704780
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195950591545Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00195950591552Medical Imaging Calibration Feature (MICF)Feature version 1.X2026-04-23
00190199649286ECG 2.0 AppFeature Version 2.x2020-12-15
00190199649293ECG 2.0 AppFeature Version 2.x2020-12-15
00190198909534ECG AppFeature Version 1.x2019-01-14
00190198909541ECG AppFeature Version 1.x2019-01-14
00195949001789Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949001796Hypertension Notification Feature (HTNF)Feature version 1.X2025-09-18
00195949948411Digital Prism Correction Feature (DPCF)Feature version 1.X2025-09-11
00195950732382Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732399Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195950732405Hearing Aid Feature 2.0 (HAF 2.0)Feature version 2.X2025-09-09
00195949149931Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00194253312512Cycle Tracking 4.0Feature Version 4.x2024-11-01
00194253312529Cycle Tracking 4.0Feature Version 4.x2024-11-01
00195949149924Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195949149948Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195949149955Hearing Test Feature (HTF)Feature version 1.X2024-10-21
00195950095067Hearing Aid Feature (HAF)Feature version 1.X2024-10-21
00195950095074Hearing Aid Feature (HAF)Feature version 1.X2024-10-21

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
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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
08056262859414nuance 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