FDA.reportPublic FDA data

Triad Combonation Unit

Primary DI
00089518000511
Brand
Triad Combonation Unit
Company
GENERAL HEARING INSTRUMENT, INC.
Model
Triad Combo,OTE,10A,Digital,RIC,Beige,Left
Device description
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
Published
2016-09-28
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
K974751000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974751000TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CICGeneral Hearing Instruments, Inc.1998-03-06ESD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00089518000511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089518000511000895180005110895180005110089518000511

GMDN Terms#

Term, Definition table
TermDefinition
Behind-the-ear air-conduction tinnitus maskerA 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 generator/microphone, contained in a case worn behind-the-ear (BTE), that delivers the noise to the eardrum through air; its digital design 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
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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