FDA.reportPublic FDA data

Tinearity

Primary DI
07350136210099
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

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.

Regulatory Flags#

DUNS number
353427191
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350136210020Tinearity AdaptersG160422023-07-28
07350136210051Tinearity AdaptersG160422023-07-28
07350136210075TinearityG161032023-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840388220580Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220597Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220757Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220764Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220771Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220788Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220795Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220801Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220818Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220825Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220863Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220917Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220955Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388220993Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221006Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221013Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221020Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221037Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221044Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221051Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221068Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221075Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221136Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221181Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221228Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221266Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221280Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221297Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221303Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04
00840388221327Starkey G Series AIStarkey Laboratories, Inc.KLW2026-09-04