FDA.reportPublic FDA data

audifon

Primary DI
EADF0231749046315917201
Brand
audifon
Company
audifon GmbH & Co. KG
Model
rega P
Catalog number
023174-9046-3159-1720
Device description
BTE-TRT
Published
2017-05-02
Public version status
Update
Distribution status
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
EADF0231749046315917201PrimaryHIBCC0

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

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Primary DI, Brand, Company table
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