FDA.reportPublic FDA data

audifon

Primary DI
EADF030239980831317201
Brand
audifon
Company
audifon GmbH & Co. KG
Model
risa S
Catalog number
030239-9808-313-1720
Device description
audifon risa S -- beigeBTE
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
EADF030239980831317201PrimaryHIBCC0

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
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26
07613389842104Moxi S9-RXSonova AGOSM2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGOSM2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGOSM2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844641Relate5.0 Gold RIC RXSonova AGOSM2026-07-26
07613389844658Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844665Relate5.0 Platinum RIC RXSonova AGOSM2026-07-26
07613389844955Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844962Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844979Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844986Unitron ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389844993Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389845006Easy Line ChargerGo RIC S-RXSonova AGOSM2026-07-26
07613389867022Unitron TrueFit 5.10Sonova AGOSM2026-07-26
07613389867039Aura:fit AudioNova 5.10Sonova AGOSM2026-07-26
07613389867046Aura:fit 5.10Sonova AGOSM2026-07-26
07613389867053HANSATON scout 5.10Sonova AGOSM2026-07-26