FDA.reportPublic FDA data

Desyncra For Tinnitus Therapy System

Primary DI
EDSYTI1001EU01
Brand
Desyncra For Tinnitus Therapy System
Company
DESYNCRA TINNITUS LIMITED
Model
Size S
Catalog number
TI10.01EU_01
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDSYTI1001EU01PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
220194467
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
EDSYTI1002EU01Desyncra For Tinnitus Therapy SystemSize MTI10.02EU_012017-06-12
EDSYTI1003EU01Desyncra For Tinnitus Therapy SystemSize LTI10.03EU_012017-06-12
EDSYTI1004EU01Desyncra For Tinnitus Therapy SystemSize XLTI10.04EU_012017-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880295054SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295061SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295078SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295689SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295764SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295771SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295825SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295832SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295887SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295894SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295948SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295955SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295962SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880295979SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296006SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296037SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296068SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
05714880296099SIGNIAWs Audiology Usa, Inc.KLW2026-05-22
07613389834147Phonak Audéo E90-Sphere Sonova AGKLW2026-03-17
07613389860498Phonak Audéo E30-Sphere Sonova AGKLW2026-03-17
07613389891171Phonak Audéo E90-RSonova AGKLW2026-03-16
05714464175529BernafonSbo Hearing A/SKLW2026-02-25
05714464175567NeutralSbo Hearing A/SKLW2026-02-25
05714464175598PhilipsSbo Hearing A/SKLW2026-02-25
05714464175628OticonSbo Hearing A/SKLW2026-02-25
05714464176151PhilipsSbo Hearing A/SKLW2026-02-25
05714464176168PhilipsSbo Hearing A/SKLW2026-02-25
05714464176335OticonSbo Hearing A/SKLW2026-02-25
05714464176359OticonSbo Hearing A/SKLW2026-02-25
05714464182848OticonSbo Hearing A/SKLW2026-02-25