FDA.reportPublic FDA data

ampli-mini I 5 5P CIC-10 TI NWL PH

Primary DI
07613389772852
Brand
ampli-mini I 5 5P CIC-10 TI NWL PH
Company
Sonova AG
Model
10 TI NWL PH
Catalog number
063-0534-0167
Published
2024-11-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air-Conduction, Prescription
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389772852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389772852076133897728527613389772852

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
480662550
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389540031Sonova Brand (multiple brand)051-5047-AB2022-12-12
07613389564228Sonova Brand (multiple brand)051-5046-AB2022-12-12
07613389619621Sonova Brand (multiple brand)051-5107-AB2022-12-12
07613389557930All-Day Clear 1.0 app088-5015088-50152023-02-16
07613389771831MEMINI E D 6P R-R PH (silver gray)050-1145-P6B12026-03-26
07613389771855MEMINI E D 6P R-R AI PH (silver gray)050-1147-P6B12026-03-26
07613389772012ampli-mini E 2 6P R-R PH (velvet black)050-1137-P8672026-03-26
07613389772401MEMINI E 2 6P R-R PH (silver gray)050-1137-P6B12026-03-26
07613389772418MEMINI E 2 6P R-R PH (velvet black)050-1137-P8B12026-03-26
07613389772548MEMINI E 5 6P R-R AI PH (sand beige)050-1141-P1B12026-03-26
07613389772555MEMINI E 5 6P R-R AI PH (sandalwood)050-1141-P3B12026-03-26
07613389772562MEMINI E 5 6P R-R AI PH (silver gray)050-1141-P6B12026-03-26
07613389772579MEMINI E 5 6P R-R AI PH (velvet black)050-1141-P8B12026-03-26
07613389772586MEMINI E 4 6P R-R AI PH (sand beige)050-1142-P1B12026-03-26
07613389772593MEMINI E 4 6P R-R AI PH (sandalwood)050-1142-P3B12026-03-26
07613389772609MEMINI E 4 6P R-R AI PH (silver gray)050-1142-P6B12026-03-26
07613389772616MEMINI E 4 6P R-R AI PH (velvet black)050-1142-P8B12026-03-26
07613389772623MEMINI E 3 6P R-R AI PH (sand beige)050-1143-P1B12026-03-26
07613389772630MEMINI E 3 6P R-R AI PH (sandalwood)050-1143-P3B12026-03-26
07613389772647MEMINI E 3 6P R-R AI PH (silver gray)050-1143-P6B12026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214567Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214574Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214581Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214598Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
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05714880219432Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219449Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219456Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219463Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219470Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219869Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219876Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219883Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219890Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219906Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219913Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219944Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880219951Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
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00858177007823PersonaINTRICON CORPORATIONESD2022-06-21