FDA.reportPublic FDA data

Tinearity

Primary DI
07350136210075
Brand
Tinearity
Company
Duearity AB
Model
G1
Catalog number
6103
Published
2023-07-28
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223694000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223694000Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB2023-06-30KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350136210075Direct MarkingGS10
07350136210099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350136210075073501362100757350136210075
07350136210099073501362100997350136210099

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction tinnitus maskerA battery-powered acoustic device designed to provide ultrasonic broadband noise and/or sweep-frequency stimuli noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It consists of an out-of-ear miniature generator/amplifier with a piezoelectric element which conducts the noise to the inner ear across the skin and via the mastoid bone; it may be contained in a case worn behind-the-ear (BTE), attached to a headband, or hand-held by the user against the skin over the mastoid bone.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
353427191
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
false
Expiration date on label
true
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
07350136210020Tinearity AdaptersG160422023-07-28
07350136210099TinearityG161032023-07-28
07350136210051Tinearity AdaptersG160422023-07-28

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