FDA.reportPublic FDA data

TrueFit Software v5.4

Primary DI
07613389644579
Brand
TrueFit Software v5.4
Company
Sonova AG
Model
058-5178-054
Catalog number
058-5178-054
Device description
TrueFit Software v5.4
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

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
07613389644579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389644579076133896445797613389644579

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41589280101info@sonova.com

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
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