FDA.reportPublic FDA data

ClearWaves

Primary DI
00810113578170
Brand
ClearWaves
Company
VIVE HEALTH LLC
Model
LVA3071BLK
Device description
Hearing Aids (Advanced)
Published
2024-09-13
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
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUGHearing Aid, Air-Conduction With Wireless Technology, Over The CounterEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810113578177PackageGS150In Commercial Distribution
00810113578170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011357817710810113578177
00810113578170008101135781708101135781700810113578170

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-the-earA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone or microphones and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the outer ear [receiver-in-the-ear (RITE)]. The microphone(s) 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 profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810226440104ViveLVA3167BLK2026-06-04
00810226440111ViveLVA3167BLKPAK22026-06-04
00810178889969ViveLVA3166WHT2026-06-03
00810178889976ViveLVA3164BBB2026-06-03
00810178889983ViveLVA3164BBP2026-06-03
00810178889990ViveLVA3164BGN2026-06-03
00810226440005ViveLVA3165BB2026-06-03
00810226440012ViveLVA3165BP2026-06-03
00810226440029ViveLVA3165GN2026-06-03
00810226440036ViveSUP3008BLU2026-06-03
00810226440043ViveSUP3008PNK2026-06-03
00810178889624Vive BreatheLVA31612026-06-01
00810178889921ViveCareRHB3079S100CT2026-05-29
00810178889938ViveCareRHB3079M100CT2026-05-29
00810178889945ViveCareRHB3079L50CT2026-05-29
00810178889723ViveSUP3158BLKXS2026-05-27
00810178889730ViveSUP3158BLKS2026-05-27
00810178889747ViveSUP3158BLKM2026-05-27
00810178889754ViveSUP3158BLKL2026-05-27
00810178889761ViveSUP3158BLKXL2026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06980134820016n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820023n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820030n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820047n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820054n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820061n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820078n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820085n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820092n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820108n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820115n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820122n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820139n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820146n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820153n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820160n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820177n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820184n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820191n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820207n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820214n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820221n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820238n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820245n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820252n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820269n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820276n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06980134820283n/aBlue Deer Medical Equipment (guangdong) Co., Ltd.QUG2026-06-09
06973967150658EaraXiamen Vienatone Medical Technology Co., Ltd.QUG2026-05-19
06971094538677AntOkayHuizhou Jinghao Medical Technology Co., LtdQUG2026-05-01