FDA.reportPublic FDA data

RCA

Primary DI
00044476153280
Brand
RCA
Company
Voxx Accessories Corp.
Model
RSH052BK
Device description
OTC hearing aids, behind-the-ear design, one pair
Published
2023-11-29
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

Related Records

Product Codes

CodeName
QUFHearing Aid, Air-Conduction, Over The Counter

Product Code Classifications

CodeDeviceSpecialtyClass
QUFHearing Aid, Air-Conduction, Over The CounterEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00044476153280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00044476153280000444761532800444761532800044476153280

GMDN Terms

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

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature3 Degrees Celsius46 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
800466695
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DIBrandModelCatalogPublished
00044476158483RCARSH072GY2024-07-26
00044476158605RCARSH082GM2024-04-08
00044476153143RCARSH05BG2023-11-29
00044476153150RCARSH05GY2023-11-29
00044476153167RCARSH05BK2023-11-29
00044476153266RCARSH052BG2023-11-29
00044476153273RCARSH052GY2023-11-29
00044476153198RCARSH20WH2023-11-22
00044476153174RCARSH20BGW2023-10-02
00044476153181RCARSH20GYW2023-10-02
00044476158049RCARSH053BG2023-10-02
00044476158056RCARSH053SL2023-10-02
00044476157417RCARSH062BG2023-09-01
00044476157424RCARSH062SL2023-09-01
00044476157523RCARSH30BG2023-09-01

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06975958550386MirasingXiamen Mirasing Technology Co.,Ltd.QUF2025-12-09