FDA.reportPublic FDA data

audifon

Primary DI
EADF0302399808312017201
Brand
audifon
Company
audifon GmbH & Co. KG
Model
risa S
Catalog number
030239-9808-3120-1720
Device description
audifon risa S -- bronzeBTE
Published
2024-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EADF0302399808312017201PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
344064407
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
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.OSM2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296600SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296624SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296709SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296716SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.OSM2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.OSM2026-07-22