FDA.reportPublic FDA data

Phonak Audéo E50-Sphere

Primary DI
07613389762280
Brand
Phonak Audéo E50-Sphere
Company
Sonova AG
Model
(sienna red)
Published
2026-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389762280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389762280076133897622807613389762280

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. 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. 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
480662550
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
07613389836325DVD Phonak Target 12.012.0 DVD058-0125-1202026-06-01
07613389836332USB Phonak Target 12.0 USB12.0 USB058-0325-1202026-06-01
07613389836349Phonak Target 12.012.0088-0125-001202026-06-01
07613389842388Phonak ChargerGo ITEBULK075-01012026-06-01
07613389842395Phonak ChargerGo ITEno EPS075-0101-102026-06-01
07613389842401Phonak ChargerGo ITEUS EPS075-0101-112026-06-01
07613389843026Phonak ChargerGo ITEB3075-0101-030B32026-06-01
07613389917024Phonak ChargerGo RIC I ENO EPS075-0108-102026-06-01
07613389917116Phonak ChargerGo RIC I EUS EPS075-0108-112026-06-01
07613389917123Phonak ChargerGo RIC I EUS EPS VA075-0108-110902026-06-01
07613389540031Sonova Brand (multiple brand)051-5047-AB2022-12-12
07613389564228Sonova Brand (multiple brand)051-5046-AB2022-12-12
07613389619621Sonova Brand (multiple brand)051-5107-AB2022-12-12
07613389557930All-Day Clear 1.0 app088-5015088-50152023-02-16
07613389771831MEMINI E D 6P R-R PH (silver gray)050-1145-P6B12026-03-26
07613389771855MEMINI E D 6P R-R AI PH (silver gray)050-1147-P6B12026-03-26
07613389772012ampli-mini E 2 6P R-R PH (velvet black)050-1137-P8672026-03-26
07613389772401MEMINI E 2 6P R-R PH (silver gray)050-1137-P6B12026-03-26
07613389772418MEMINI E 2 6P R-R PH (velvet black)050-1137-P8B12026-03-26
07613389772548MEMINI E 5 6P R-R AI PH (sand beige)050-1141-P1B12026-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880293531SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
05714880297898SIGNIAWs Audiology Usa, Inc.OSM2026-06-04
06945936705688NewSoundXiamen New Sound Technology Co., Ltd.OSM2026-06-02
07613389836325DVD Phonak Target 12.0Sonova AGOSM2026-06-01
07613389836332USB Phonak Target 12.0 USBSonova AGOSM2026-06-01
07613389836349Phonak Target 12.0Sonova AGOSM2026-06-01
07613389842388Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842395Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389842401Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389843026Phonak ChargerGo ITESonova AGOSM2026-06-01
07613389917024Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917116Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
07613389917123Phonak ChargerGo RIC I ESonova AGOSM2026-06-01
05714880113778CONNEXXWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214345Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214369Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214376Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214383Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214390Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214413Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28
05714880214420Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
05714880214543Audio ServiceWs Audiology Usa, Inc.OSM2026-05-28