FDA.reportPublic FDA data

Phonak Audéo E30-Sphere

Primary DI
07613389861433
Brand
Phonak Audéo E30-Sphere
Company
Sonova AG
Model
(velvet black)
Catalog number
050-1211-P8
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
07613389861433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389861433076133898614337613389861433

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
07613389915006SilentCloud Mobile App1.5.8088-0033-000102026-06-24
07613389938531SilentCloud Web App1.5.8088-0037-000102026-06-24
07613389860436Phonak Audéo E30-Sphere(Copper)050-1211-1A2026-03-17
07613389860443Phonak Audéo E30-Sphere(sienna red)050-1211-8A2026-03-17
07613389860450Phonak Audéo E30-Sphere(atlantic green)050-1211-9A2026-03-17
07613389860467Phonak Audéo E30-Sphere(beige)050-1211-H02026-03-17
07613389860474Phonak Audéo E30-Sphere(sand beige)050-1211-P12026-03-17
07613389860481Phonak Audéo E30-Sphere(sandalwood)050-1211-P32026-03-17
07613389860498Phonak Audéo E30-Sphere(chestnut)050-1211-P42026-03-17
07613389860504Phonak Audéo E30-Sphere(champagne)050-1211-P52026-03-17
07613389861419Phonak Audéo E30-Sphere(silver gray)050-1211-P62026-03-17
07613389861426Phonak Audéo E30-Sphere(graphite gray)050-1211-P72026-03-17
07613389891461Phonak Audéo E30-Sphere(Caribbean Blue)050-1211-3C2026-03-17
07613389891478Phonak Audéo E30-Sphere(blue ocean)050-1211-M72026-03-17
07613389891485Phonak Audéo E30-Sphere(precious pink)050-1211-T32026-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389915006SilentCloud Mobile AppSonova AGKLW2026-06-24
07613389938531SilentCloud Web AppSonova AGKLW2026-06-24
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295719SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.KLW2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.KLW2026-06-08