FDA.reportPublic FDA data

SilentCloud - Android

Primary DI
04260768760202
Brand
SilentCloud - Android
Company
Aureliym GmbH
Model
1
Catalog number
020
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04260768760202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260768760202042607687602024260768760202

GMDN Terms#

Term, Definition table
TermDefinition
Tinnitus masking application software"An 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
315093599
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260768760103SilentCloud - iOS10102026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714878800291MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800307MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800314MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
05714878800352MIRACLE EARWs Audiology Usa, Inc.KLW2026-07-29
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