FDA.reportPublic FDA data

Newsound

Primary DI
06945936703288
Brand
Newsound
Company
Xiamen New Sound Technology Co., Ltd.
Model
POCO ZA401
Published
2022-09-05
Public version status
New
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
16945936703285PrimaryGS10
06945936703288Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694593670328516945936703285
06945936703288069459367032886945936703288

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
528181200
Device count
2
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
06945936705626RETEKESSTE1032025-12-16
16945936705623RETEKESSTE1032025-12-16
06945936705602IFLYTEKVAN 610 Pro2025-12-02
06945936705619IFLYTEKVAN 203 Pro2025-12-02
16945936705609IFLYTEKVAN 610 Pro2025-12-02
16945936705616IFLYTEKVAN 203 Pro2025-12-02
06945936705299METIKOelclear 91062025-09-02
16945936705296METIKOelclear 91062025-09-02
06945936704889AHA TechnologiesPureEQ2025-02-12
16945936704886AHA TechnologiesPureEQ2025-02-12
06945936704834PowerLixPoco M4012024-12-11
16945936704831PowerLixPoco M4012024-12-11
06945936704742NewsoundPrimo RA2024-11-28
06945936704759NewsoundRealtone2024-11-28
06945936704766Newsound Puretone2024-11-28
06945936704773NewsoundSupertone2024-11-28
06945936704780NewsoundWing2024-11-28
06945936704797NewsoundClass D2024-11-28
06945936704063NanoFirst Ear Plus ITE2024-05-21
06945936704070NanoFirst Ear Plus BTE2024-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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