FDA.reportPublic FDA data

Simply Tranquil II

Primary DI
00089518000504
Brand
Simply Tranquil II
Company
GENERAL HEARING INSTRUMENT, INC.
Model
Simply Tranquil II,10A,Digital,Pair
Device description
The Simply Tranquil II utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing in the canal design. Designed for Tinnitus assistance. Excellent to sleep with while wearing the device.
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
00089518000504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089518000504000895180005040895180005040089518000504

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
5044424999rjuneau@softtouchlabs.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
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
00089518000405Tranquil II OTETranquil II,OTE,10A,Digital,Black,Right2016-09-28

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