FDA.reportPublic FDA data

RCA

Primary DI
00044476158049
Brand
RCA
Company
Voxx Accessories Corp.
Model
RSH053BG
Device description
OTC hearing aids, behind-the-ear design
Published
2023-10-02
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
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00044476158049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00044476158049000444761580490444761580490044476158049

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, behind-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 microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). 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 through an earmould that fits inside the outer ear or a tube in the ear canal. 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800466695
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00044476158483RCARSH072GY2024-07-26
00044476158605RCARSH082GM2024-04-08
00044476153143RCARSH05BG2023-11-29
00044476153150RCARSH05GY2023-11-29
00044476153167RCARSH05BK2023-11-29
00044476153266RCARSH052BG2023-11-29
00044476153273RCARSH052GY2023-11-29
00044476153280RCARSH052BK2023-11-29
00044476153198RCARSH20WH2023-11-22
00044476153174RCARSH20BGW2023-10-02
00044476153181RCARSH20GYW2023-10-02
00044476158056RCARSH053SL2023-10-02
00044476157417RCARSH062BG2023-09-01
00044476157424RCARSH062SL2023-09-01
00044476157523RCARSH30BG2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977171530008TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530015TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530022TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06977171530039TECHMITechmi (HongKong) Co., LimitedQUF2026-06-03
06971094538721KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538738KLARIQHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-26
06971094538707XQYMHuizhou Jinghao Medical Technology Co., LtdQUF2026-05-08
06971094538691OricleHuizhou Jinghao Medical Technology Co., LtdQUF2026-04-30
06973967150276WuveeXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150283NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150313VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150320VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150368NebrooXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06973967150573VienatoneXiamen Vienatone Medical Technology Co., Ltd.QUF2026-04-28
06971094538622Savvy SmartHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-25
06971094538639Spade & CoHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-24
06971094538615GIATATHAHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-20
06971094538592LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2026-03-18
06950715563090CofoeCofoe Medical Technology Co.,LtdQUF2026-02-24
06971094538585Bachgold Huizhou Jinghao Medical Technology Co., LtdQUF2026-02-05
06979053570034UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06979053570041UltrotingShenzhen Magnet Technology Co., LtdQUF2026-01-21
06971094538530LITOULFHuizhou Jinghao Medical Technology Co., LtdQUF2025-12-19
06978898058011Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058028Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058035Viva HearShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058042Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058059Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06978898058066Xpect VisionShenzhen Cresendo Technology Co.,Ltd.QUF2025-12-12
06975958550010MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09