FDA.reportPublic FDA data

Phonak Audéo E30-Sphere

Primary DI
07613389860467
Brand
Phonak Audéo E30-Sphere
Company
Sonova AG
Model
(beige)
Catalog number
050-1211-H0
Published
2026-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
07613389860467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389860467076133898604677613389860467

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.

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613389840599Moxi S9-RX(velvet black)050-6927-P82026-07-26
07613389840605Moxi S9-RX(sand)050-6927-R82026-07-26
07613389842012Moxi S7-RX(amber beige)050-6926-P22026-07-26
07613389842029Moxi S7-RX(chestnut)050-6926-P42026-07-26
07613389842036Moxi S7-RX(silver gray)050-6926-P62026-07-26
07613389842043Moxi S7-RX(graphite gray)050-6926-P72026-07-26
07613389842050Moxi S7-RX(velvet black)050-6926-P82026-07-26
07613389842067Moxi S7-RX(sand)050-6926-R82026-07-26
07613389842074Moxi S9-RX(amber beige)050-6927-P22026-07-26
07613389842081Moxi S9-RX(chestnut)050-6927-P42026-07-26
07613389842098Moxi S9-RX(silver gray)050-6927-P62026-07-26
07613389842104Moxi S9-RX(graphite gray)050-6927-P72026-07-26
07613389842111Moxi S-RX FLEX:TRIAL(silver gray)050-6928-P62026-07-26
07613389843682Relate5.0 Platinum RIC RX(sand)050-6927-R8762026-07-26
07613389843699Relate5.0 RIC RX DEMO(silver gray)050-6928-P6762026-07-26
07613389844627Relate5.0 Gold RIC RX(chestnut)050-6926-P4762026-07-26
07613389844634Relate5.0 Gold RIC RX050-6926-P676050-6926-P6762026-07-26
07613389844641Relate5.0 Gold RIC RX(sand)050-6926-R8762026-07-26
07613389844658Relate5.0 Platinum RIC RX(chestnut)050-6927-P4762026-07-26
07613389844665Relate5.0 Platinum RIC RX(silver gray)050-6927-P6762026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714878800291MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
07613389840599Moxi S9-RXSonova AGOSM2026-07-26
07613389840599Moxi S9-RXSonova AGKLW2026-07-26
07613389840605Moxi S9-RXSonova AGOSM2026-07-26
07613389840605Moxi S9-RXSonova AGKLW2026-07-26
07613389842012Moxi S7-RXSonova AGOSM2026-07-26
07613389842012Moxi S7-RXSonova AGKLW2026-07-26
07613389842029Moxi S7-RXSonova AGOSM2026-07-26
07613389842029Moxi S7-RXSonova AGKLW2026-07-26
07613389842036Moxi S7-RXSonova AGOSM2026-07-26
07613389842036Moxi S7-RXSonova AGKLW2026-07-26
07613389842043Moxi S7-RXSonova AGOSM2026-07-26
07613389842043Moxi S7-RXSonova AGKLW2026-07-26
07613389842050Moxi S7-RXSonova AGKLW2026-07-26
07613389842050Moxi S7-RXSonova AGOSM2026-07-26
07613389842067Moxi S7-RXSonova AGKLW2026-07-26
07613389842067Moxi S7-RXSonova AGOSM2026-07-26
07613389842074Moxi S9-RXSonova AGKLW2026-07-26
07613389842074Moxi S9-RXSonova AGOSM2026-07-26
07613389842081Moxi S9-RXSonova AGKLW2026-07-26
07613389842081Moxi S9-RXSonova AGOSM2026-07-26
07613389842098Moxi S9-RXSonova AGKLW2026-07-26
07613389842098Moxi S9-RXSonova AGOSM2026-07-26