FDA.reportPublic FDA data

Phonak CROS E-R

Primary DI
07613389761870
Brand
Phonak CROS E-R
Company
Sonova AG
Model
(Copper)
Catalog number
050-1144-1A
Published
2026-03-16
Public version status
New
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
07613389761870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389761870076133897618707613389761870

GMDN Terms#

Term, Definition table
TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

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
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
07613389861433Phonak Audéo E30-Sphere(velvet black)050-1211-P82026-03-17
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945936705701QuietlyBoldXiamen New Sound Technology Co., Ltd.OSM2026-06-09
05714880295719SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295726SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295733SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295740SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295788SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295795SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295849SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295856SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295900SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295917SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880295986SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296013SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296044SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296075SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
05714880296105SIGNIAWs Audiology Usa, Inc.OSM2026-06-08
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