FDA.reportPublic FDA data

Siemens

Primary DI
04046355362826
Brand
Siemens
Company
Ws Audiology Usa, Inc.
Model
HA NITRO 301 SP LTBLU
Catalog number
10605308
Device description
Siemens HA NITRO 301 SP LTBLU Hearing Aid
Published
2016-05-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046355362826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046355362826040463553628264046355362826

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

Contacts#

Phone, Email table
PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags#

DUNS number
157412271
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880296440SIGNIAKIT Silk C&G 7IX RB210550502026-07-22
05714880296464SIGNIAKIT Silk C&G 7IX RB210550522026-07-22
05714880296488SIGNIAKIT Silk C&G 5IX RB210550542026-07-22
05714880296501SIGNIAKIT Silk C&G 5IX RB210550562026-07-22
05714880296525SIGNIAKIT Silk C&G 3IX RB210550582026-07-22
05714880296549SIGNIAKIT Silk C&G 3IX RB210550602026-07-22
05714880296563SIGNIAKIT Silk C&G 2IX RB210550622026-07-22
05714880296587SIGNIAKIT Silk C&G 2IX RB210550642026-07-22
05714880296600SIGNIAKIT Silk C&G 1IX RB210550662026-07-22
05714880296624SIGNIAKIT Silk C&G 1IX RB210550682026-07-22
05714880296648SIGNIAKIT Silk C&G sDemo DIX RB210550702026-07-22
05714880296679SIGNIAKIT Styletto sDemo DIX RB210551302026-07-22
05714880296709SIGNIAKIT Styletto 1IX RB210551272026-07-22
05714880296716SIGNIAKIT Styletto 1IX RB210551262026-07-22
05714880296747SIGNIAKIT Styletto 2IX RB210551222026-07-22
05714880296754SIGNIAKIT Styletto 2IX RB210551212026-07-22
05714880296853SIGNIAKIT Styletto 3IX RB210551112026-07-22
05714880296860SIGNIAKIT Styletto 3IX RB210551102026-07-22
05714880296877SIGNIAKIT Styletto 3IX RB210551092026-07-22
05714880296884SIGNIAKIT Styletto 3IX RB210551082026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126191373AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191380AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191397AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191403AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191410AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191427AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191434AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191441AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191458AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191465AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191472AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191489AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191496AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191502AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191519AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191526AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191533AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191540AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191557AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191564AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191571AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191588AudinaAudina Hearing Instruments, Inc.ESD2023-01-31
00810126191595AudinaAudina Hearing Instruments, Inc.ESD2023-01-31