FDA.reportPublic FDA data

Tinnitus Masker

Primary DI
00089518000788
Brand
Tinnitus Masker
Company
GENERAL HEARING INSTRUMENT, INC.
Model
Tinnitus,Custom,Left
Device description
The Tinnitus custom device utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing design. Designed for patients that suffer from Tinnitus to ease ringing in the ear.
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K061459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061459000TRANQUIL TRI-BTEGeneral Hearing Instruments, Inc.2006-06-30KLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089518000788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089518000788000895180007880895180007880089518000788

GMDN Terms#

Term, Definition table
TermDefinition
In-the-ear air-conduction tinnitus masker, digitalA battery-powered digital acoustic device designed to provide 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). It typically consists of a miniature sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device allows for the introduction of new tinnitus masking software programs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-824-3021customercare@generalhearing.com

Regulatory Flags#

DUNS number
131229197
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089518000351Tranquil II OTETranquil II,OTE,10A,Digital,Beige,Pair2016-09-28
00089518000504Simply Tranquil IISimply Tranquil II,10A,Digital,Pair2016-09-28
00089518000214Tranquil I OTETranquil I,OTE,10A,Digital,Beige,Left2016-09-28
00089518000221Tranquil I OTETranquil I,OTE,10A,Digital,Beige,Right2016-09-28
00089518000238Tranquil I OTETranquil I,OTE,10A,Digital,Beige,Pair2016-09-28
00089518000245Tranquil I OTETranquil I,OTE,10A,Digital,Brown,Left2016-09-28
00089518000252Tranquil I OTETranquil I,OTE,10A,Digital,Brown,Right2016-09-28
00089518000269Tranquil I OTETranquil I,OTE,10A,Digital,Brown,Pair2016-09-28
00089518000276Tranquil I OTETranquil I,OTE,10A,Digital,Black,Left2016-09-28
00089518000283Tranquil I OTETranquil I,OTE,10A,Digital,Black,Right2016-09-28
00089518000290Tranquil I OTETranquil I,OTE,10A,Digital,Black,Pair2016-09-28
00089518000306Tranquil I OTETranquil I,OTE,10A,Digital,Grey,Left2016-09-28
00089518000313Tranquil I OTETranquil I,OTE,10A,Digital,Grey,Right2016-09-28
00089518000320Tranquil I OTETranquil I,OTE,10A,Digital,Grey,Pair2016-09-28
00089518000337Tranquil II OTETranquil II,OTE,10A,Digital,Beige,Left2016-09-28
00089518000344Tranquil II OTETranquil II,OTE,10A,Digital,Beige,Right2016-09-28
00089518000368Tranquil II OTETranquil II,OTE,10A,Digital,Brown,Left2016-09-28
00089518000375Tranquil II OTETranquil II,OTE,10A,Digital,Brown,Right2016-09-28
00089518000382Tranquil II OTETranquil II,OTE,10A,Digital,Brown,Pair2016-09-28
00089518000399Tranquil II OTETranquil II,OTE,10A,Digital,Black,Left2016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05714880296563SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296587SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296648SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296679SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296747SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296754SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296853SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296860SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296877SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296884SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296891SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296907SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880296914SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297010SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297027SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297034SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297041SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297058SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297065SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297072SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297188SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297195SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297201SIGNIAWs Audiology Usa, Inc.KLW2026-07-22
05714880297218SIGNIAWs Audiology Usa, Inc.KLW2026-07-22