FDA.reportPublic FDA data

SOUNDWEAR

Primary DI
06945936700492
Brand
SOUNDWEAR
Company
Xiamen New Sound Technology Co., Ltd.
Model
SOUNDWEAR BW20
Published
2020-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06945936700492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945936700492069459367004926945936700492

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, wearable caseA 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 on the body (e.g., in a pocket or on a belt). 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 connected to the case by a cord. Because it's relatively large size permits high amplification, this device has been used for profound hearing loss; it has largely been replaced with behind-the-ear (BTE) devices.

Regulatory Flags#

DUNS number
528181200
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
06945936701420NanoNano Sigma Beige2020-02-26
06945936701567OtofonixOtofonix Sona Beige2020-09-03
06945936703462VivtoneXpure2022-09-15
06945936703479VivtoneSmart2022-09-15
06945936703493NewSoundPrimo RA8012022-09-15
06945936703721NewsoundTactEar 8012023-11-17
06945936704063NanoFirst Ear Plus ITE2024-05-21
06945936704070NanoFirst Ear Plus BTE2024-05-21
06945936704087NanoFirst Ear Pro BTE2024-05-21
06945936703776NewsoundPrimo S2012024-01-19
06945936703714NewsoundPrimo SA4012023-11-17
06945936703394MDMDHearingAid VOLT2022-09-09
06945936703400NeosonicNeosonic MX-Smart2022-09-09
06945936703448NeosonicNeosonic BT-Omni2022-09-09
06945936703349NewSoundPoco XA6012022-09-08
06945936703363WENKEYWE-6012022-09-08
06945936703288NewsoundPOCO ZA4012022-09-05
06945936799106NewsoundHearIQ ITC2021-07-31
06945936799038OtofonixHelix2021-04-01
06945936799045OtofonixGroove2021-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880299359AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299403AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299410AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299427AudioServiceWs Audiology Usa, Inc.OSM2026-10-28
05714880299564REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299571REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299588REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299595REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299601REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299618REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299625REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299632REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299649REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299656REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299663REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299670REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299687REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299694REXTONWs Audiology Usa, Inc.OSM2026-10-28
05714880299991MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300000MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300017MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300024MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300031MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300048MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300055MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300062MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300079MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300086MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300093MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27
05714880300109MIRACLE EARWs Audiology Usa, Inc.OSM2026-10-27