Unitron TrueFit 5.9 088-5019-00058

GUDID 07613389837827

Sonova AG

Audiometric/hearing device software
Primary Device ID07613389837827
NIH Device Record Keyb365c794-7777-4385-b1a5-018e9adfc946
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnitron TrueFit 5.9
Version Model Numbern/a
Catalog Number088-5019-00058
Company DUNS480662550
Company NameSonova AG
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107613389837827 [Primary]

FDA Product Code

OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-07
Device Publish Date2025-12-30

Devices Manufactured by Sonova AG

07613389837810 - TrueFit 5.9 USB2026-01-07
07613389837827 - Unitron TrueFit 5.92026-01-07
07613389837827 - Unitron TrueFit 5.92026-01-07
07613389837841 - Aura:fit AudioNova 5.92026-01-07
07613389837858 - Aura:fit Relate 5.92026-01-07
07613389812190 - Insera S1-R2025-12-29
07613389812206 - Insera S3-R2025-12-29
07613389813814 - Insera S5-R2025-12-29
07613389813821 - Insera S7-R2025-12-29

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