FDA.reportPublic FDA data

Newsound

Primary DI
06945936704742
Brand
Newsound
Company
Xiamen New Sound Technology Co., Ltd.
Model
Primo RA
Published
2024-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

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
06945936704742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945936704742069459367047426945936704742

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528181200
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945936705688NewSoundPrimo DR64912026-06-02
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
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
06945936705688NewSoundXiamen New Sound Technology Co., Ltd.OSM2026-06-02
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07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
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