DEVICE: Tranquil I OTE (00089518000276)
Device Identifier (DI) Information
Tranquil I OTE
Tranquil I,OTE,10A,Digital,Black,Left
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Black,Left
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Behind-the-ear air-conduction tinnitus masker | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
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KLW | Masker, Tinnitus |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K061459 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3926e6b8-fcf4-4704-a6be-cb431f830170
July 06, 2018
3
September 28, 2016
July 06, 2018
3
September 28, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-824-3021
customercare@generalhearing.com
customercare@generalhearing.com