FDA.reportPublic FDA data

Hearing Aid Feature

Primary DI
08806099221379
Brand
Hearing Aid Feature
Company
Samsung Electronics Co., Ltd.
Model
V1.0
Device description
The Samsung Hearing Aid is an over-the-counter (OTC) software-only, mobile medical application intended to amplify sound for users 18 years or older with perceived mild-to moderate hearing impairment. The device operates on compatible Samsung Galaxy mobile and earbud wearable devices, both off-the-shelf commercial platforms. The user is intended to self-fit the device, including adjusting it to suit their own hearing needs, without assistance from a hearing healthcare professional.
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K261187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K261187000Hearing Aid FeatureSamsung Electronics Co., Ltd.2026-07-31SCR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806099221379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806099221379088060992213798806099221379

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.

Regulatory Flags#

DUNS number
687967554
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
08806099221355Hearing Aid FeatureV1.02026-10-19
08806099222635Hearing Test FeatureV1.02026-10-19
08806099223052Sleep Apnea Feature v2.0v2.X2026-10-19
08806099223069Sleep Apnea Feature v2.0v2.X2026-10-19
08806099236564Sleep Apnea Feature v2.0v2.X2026-10-19
08806092938823ECG Monitor Appv1.12021-08-25
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094948233Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806090792021ECG Monitor Appv1.12020-09-24
08806090792045ECG Monitor Appv1.12020-09-24
08801643467098NAAuto Lung Nodule Detection2026-03-17
08806088565231NAGC85A2016-09-24
08806088582412NAGM852016-11-26
08806088773797NAGR40CW2019-06-19
08806094936872Samsung Sleep Apnea Feature (Wear OS)1.X2025-02-24
08806094936889Samsung Sleep Apnea Feature (Android OS)1.X2025-02-24
08806092938854Samsung Health Body Composition1.x2021-09-07
08806095896144NAF4343-AW2024-11-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806099221355Hearing Aid FeatureSamsung Electronics Co., Ltd.SCR2026-10-19
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
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