FDA.reportPublic FDA data

SilentCloud Mobile App

Primary DI
07613389915006
Brand
SilentCloud Mobile App
Company
Sonova AG
Model
1.5.8
Catalog number
088-0033-00010
Published
2026-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221125000SilentCloudAureliym GmbH2023-01-04KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613389915006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389915006076133899150067613389915006

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus masking application softwareAn individual software application program or group of programs, routines or algorithms designed for use in, or together with, other devices such as a computer, a digital hearing aid, or formated into a compact disc read-only memory (CD-ROM) or an MP3 format to enable it to provide generated noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). The basic set of applications programs and routines can be upgraded to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Regulatory Flags#

DUNS number
480662550
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
07613389840599Moxi S9-RXSonova AGKLW2026-07-26
07613389840605Moxi S9-RXSonova AGKLW2026-07-26
07613389842012Moxi S7-RXSonova AGKLW2026-07-26
07613389842029Moxi S7-RXSonova AGKLW2026-07-26
07613389842036Moxi S7-RXSonova AGKLW2026-07-26
07613389842043Moxi S7-RXSonova AGKLW2026-07-26
07613389842050Moxi S7-RXSonova AGKLW2026-07-26
07613389842067Moxi S7-RXSonova AGKLW2026-07-26
07613389842074Moxi S9-RXSonova AGKLW2026-07-26
07613389842081Moxi S9-RXSonova AGKLW2026-07-26
07613389842098Moxi S9-RXSonova AGKLW2026-07-26
07613389842104Moxi S9-RXSonova AGKLW2026-07-26
07613389842111Moxi S-RX FLEX:TRIALSonova AGKLW2026-07-26
07613389843682Relate5.0 Platinum RIC RXSonova AGKLW2026-07-26
07613389843699Relate5.0 RIC RX DEMOSonova AGKLW2026-07-26
07613389844627Relate5.0 Gold RIC RXSonova AGKLW2026-07-26
07613389844634Relate5.0 Gold RIC RXSonova AGKLW2026-07-26
07613389844641Relate5.0 Gold RIC RXSonova AGKLW2026-07-26
07613389844658Relate5.0 Platinum RIC RXSonova AGKLW2026-07-26
07613389844665Relate5.0 Platinum RIC RXSonova AGKLW2026-07-26
05714880296440SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296464SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296488SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296501SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296525SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296549SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22