FDA.reportPublic FDA data

audifon

Primary DI
EADF0207157682315917201
Brand
audifon
Company
audifon GmbH & Co. KG
Model
elia XS TRT
Catalog number
020715-7682-3159-1720
Device description
BTE-TRT
Published
2016-11-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130514000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130514000AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRTAudifon-USA, Inc.2013-11-21KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EADF0207157682315917201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction hearing aidA 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
344064407
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EADF039943B42731117201SyncLyncAscend+039943-B427-311-17202025-07-11
EADF039943B427312017201SyncLyncAscend+039943-B427-3120-17202025-07-11
EADF039943B427312717201SyncLyncAscend+039943-B427-3127-17202025-07-11
EADF039943B42731317201SyncLyncAscend+039943-B427-313-17202025-07-11
EADF039943B427315917201SyncLyncAscend+039943-B427-3159-17202025-07-11
EADF039943B42732517201SyncLyncAscend+039943-B427-325-17202025-07-11
EADF039943B427338117201SyncLyncAscend+039943-B427-3381-17202025-07-11
EADF039943B427338217201SyncLyncAscend+039943-B427-3382-17202025-07-11
EADF039943B427981717201SyncLyncAscend+039943-B427-9817-17202025-07-11
EADF039945B42831117201SyncLyncAscend 039945-B428-311-17202025-07-11
EADF039945B428312017201SyncLyncAscend 039945-B428-3120-17202025-07-11
EADF039945B428312717201SyncLyncAscend 039945-B428-3127-17202025-07-11
EADF039945B42831317201SyncLyncAscend 039945-B428-313-17202025-07-11
EADF039945B428315917201SyncLyncAscend 039945-B428-3159-17202025-07-11
EADF039945B42832517201SyncLyncAscend 039945-B428-325-17202025-07-11
EADF039945B428338117201SyncLyncAscend 039945-B428-3381-17202025-07-11
EADF039945B428338217201SyncLyncAscend 039945-B428-3382-17202025-07-11
EADF039945B428981717201SyncLyncAscend 039945-B428-9817-17202025-07-11
EADF03410600217207189audifonaudifon APP 1.4.3034106002172071892023-03-31
EADF034106002172068681audifonaudifon APP 1.4.2034106002172068682022-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297188SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297195SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297201SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297218SIGNIAWs Audiology Usa, Inc.KLW2026-07-22