FDA.reportPublic FDA data

egger

Primary DI
EGOL208181
Brand
egger
Company
Egger Otoplastik + Labortechnik GmbH
Model
flex/AB 40 shore, transparent
Published
2022-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
EGOL208181PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328465042
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EGOL206041eggerA/ITE2022-08-31
EGOL206171eggerA/soft S 502022-08-31
EGOL840851PHONAKC&C Wipe2023-01-01
EGOL840940PHONAKC&C Wipe2023-01-01
EGOL206001eggerA/soft2022-08-31
EGOL207001eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL207021eggerflex/AB 40 shore, beige2022-08-31
EGOL207031eggerflex/AB 40 shore, red2022-08-31
EGOL207041eggerflex/AB 40 shore, blue2022-08-31
EGOL207071eggerflex/AB 40 shore, white2022-08-31
EGOL207081eggerflex/AB 40 shore, green2022-08-31
EGOL207091eggerflex/AB 40 shore, yellow2022-08-31
EGOL207161eggerflex/AB 40 shore, black2022-08-31
EGOL207181eggerflex/AB 40 shore, transparent2022-08-31
EGOL207191eggerflex/AB 40 shore, orange2022-08-31
EGOL207351eggerflex/AB 25 shore, transparent2022-08-31
EGOL208101eggerflex/AB 40 shore, reddish-transparent2022-08-31
EGOL208351eggerflex/AB 40 shore, pink2022-08-31
EGOL208361eggerflex/AB 40 shore, purple2022-08-31
EGOL208401eggerflex/AB 60 shore, S 50, colorless-transparent2022-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388201145STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201541STARKEYStarkey Laboratories, Inc.ESD2025-06-25
00840388201640AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201657AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201664AUDIBELStarkey Laboratories, Inc.ESD2025-06-25
00840388201695NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201701NUEARStarkey Laboratories, Inc.ESD2025-06-25
00840388201725MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201732MICROTECHStarkey Laboratories, Inc.ESD2025-06-25
00840388201763AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201770AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201787AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201794AUDIGYStarkey Laboratories, Inc.ESD2025-06-25
00840388201886AMPLIFONStarkey Laboratories, Inc.ESD2025-06-25
00840388201909AMPLIFONStarkey 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
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