FDA.reportPublic FDA data

Tranquil II OTE

Primary DI
00089518000399
Brand
Tranquil II OTE
Company
GENERAL HEARING INSTRUMENT, INC.
Model
Tranquil II,OTE,10A,Digital,Black,Left
Device description
The Tranquil II OTE utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from 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
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
00089518000399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089518000399000895180003990895180003990089518000399

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
00089518000405Tranquil II OTETranquil II,OTE,10A,Digital,Black,Right2016-09-28

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