FDA.reportPublic FDA data

Olive Smart Hearing aid

Primary DI
08800034600038
Brand
Olive Smart Hearing aid
Company
Olive Union inc
Model
OLV-01W
Published
2018-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800034600038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800034600038088000346000388800034600038

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
694767953
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809637100419Olive Air OTCOU0P0303032024-07-30
08809637100426Olive Air OTCOU0P0302032024-07-30
08800034600069Olive MaxOU1P01022023-04-10
08800034600076Olive PlusOSE300M2023-04-11
08800034600106Olive PlusOSE3002023-04-11
88000346000762Olive PlusOSE300M2023-04-11
88000346001066Olive PlusOSE3002023-04-11
88000346000694Olive MaxOU1P01022023-04-10
08800034600007Olive Smart Hearing AidOLV-012018-07-02

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