FDA.reportPublic FDA data

SilentCloud Web App

Primary DI
07613389938531
Brand
SilentCloud Web App
Company
Sonova AG
Model
1.5.8
Catalog number
088-0037-00010
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
07613389938531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613389938531076133899385317613389938531

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
07613389927696Phonak CROS E-R(beige)050-1144-H0B32026-08-03
07613389927719Phonak CROS E-R(sand beige)050-1144-P1B32026-08-03
07613389927726Phonak CROS E-R(sandalwood)050-1144-P3B32026-08-03
07613389927733Phonak CROS E-R(chestnut)050-1144-P4B32026-08-03
07613389927740Phonak CROS E-R(champagne)050-1144-P5B32026-08-03
07613389927757Phonak CROS E-R(silver gray)050-1144-P6B32026-08-03
07613389927764Phonak CROS E-R(graphite gray)050-1144-P7B32026-08-03
07613389927771Phonak CROS E-R(velvet black)050-1144-P8B32026-08-03
07613389928181Phonak CROS E-R(sienna red)050-1144-8AB32026-08-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SKLW2026-10-05
05708296394036BeltoneGn Hearing A/SKLW2026-10-05
05708296394098BeltoneGn Hearing A/SKLW2026-10-05
05708296394104BeltoneGn Hearing A/SKLW2026-10-05
05708296394111BeltoneGn Hearing A/SKLW2026-10-05
05708296394128BeltoneGn Hearing A/SKLW2026-10-05
05708296394135BeltoneGn Hearing A/SKLW2026-10-05
05708296394197BeltoneGn Hearing A/SKLW2026-10-05
05708296394203BeltoneGn Hearing A/SKLW2026-10-05
05708296394210BeltoneGn Hearing A/SKLW2026-10-05
05708296394487BeltoneGn Hearing A/SKLW2026-10-05
05708296394494BeltoneGn Hearing A/SKLW2026-10-05
05708296394555BeltoneGn Hearing A/SKLW2026-10-05
05708296394562BeltoneGn Hearing A/SKLW2026-10-05
05708296394579BeltoneGn Hearing A/SKLW2026-10-05
05708296394586BeltoneGn Hearing A/SKLW2026-10-05
05708296394593BeltoneGn Hearing A/SKLW2026-10-05
05708296394654BeltoneGn Hearing A/SKLW2026-10-05
05708296394661BeltoneGn Hearing A/SKLW2026-10-05
05708296394678BeltoneGn Hearing A/SKLW2026-10-05
05708296397877BeltoneGn Hearing A/SKLW2026-10-05
05708296397884BeltoneGn Hearing A/SKLW2026-10-05
05708296397945BeltoneGn Hearing A/SKLW2026-10-05
05708296397952BeltoneGn Hearing A/SKLW2026-10-05
05708296397969BeltoneGn Hearing A/SKLW2026-10-05
05708296429455BeltoneGn Hearing A/SKLW2026-10-05
05708296429462BeltoneGn Hearing A/SKLW2026-10-05
05708296429523BeltoneGn Hearing A/SKLW2026-10-05
05708296429530BeltoneGn Hearing A/SKLW2026-10-05
05708296429547BeltoneGn Hearing A/SKLW2026-10-05