FDA.reportPublic FDA data

Neosonic

Primary DI
16945936703445
Brand
Neosonic
Company
Xiamen New Sound Technology Co., Ltd.
Model
Neosonic BT-Omni
Published
2022-09-09
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

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
16945936703445PrimaryGS10
06945936703448Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694593670344516945936703445
06945936703448069459367034486945936703448

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.

Regulatory Flags#

DUNS number
528181200
Device count
2
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
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
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214611Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214628Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219425Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219432Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880279566SigniaWs Audiology Usa, Inc.OSM2026-05-27