FDA.reportPublic FDA data

Hearing Test Feature

Primary DI
08806099222635
Brand
Hearing Test Feature
Company
Samsung Electronics Co., Ltd.
Model
V1.0
Device description
The Samsung Hearing Test is an over-the-counter (OTC) software-only, mobile medical application intended to be used as an air-conduction hearing screener for profiling hearing ability without the assistance of a hearing healthcare professional. The Samsung Hearing Test is intended for individuals who are at least 18 years old. The Hearing Test operates on compatible Samsung Galaxy mobile and earbud devices, both off-the-shelf commercial platforms.
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
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806099222635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806099222635088060992226358806099222635

GMDN Terms#

Term, Definition table
TermDefinition
Self-testing tone audiometerA battery-powered electroacoustic device that is designed for self-testing by the user to qualitatively evaluate hearing acuity by presenting a series of tones at a fixed level. It is placed over the user's ear and a microprocessor [central processing unit (CPU)] in the device automatically produces a range of tones at pre-set decibel (dB) levels. If the user cannot hear all of the tones then this may be an indication of diminished hearing acuity and the need for formal audiological assessment. This device is available [non-prescription] over-the-counter (OTC) and is typically used in the home or a general practitioner's office.

Regulatory Flags#

DUNS number
687967554
Device count
1
DM exempt
false
Premarket exempt
true
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
08806099221379Hearing Aid 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

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