DEVICE: Tranquil I OTE (00089518000283)
Device Identifier (DI) Information
Tranquil I OTE
Tranquil I,OTE,10A,Digital,Black,Right
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
Tranquil I,OTE,10A,Digital,Black,Right
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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43018 | Air-conduction tinnitus masker, out-of-ear |
A battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask tinnitus (a ringing sound in the ear or internal head noises) by neutralizing a patient’s perception of the symptoms for temporary relief. It typically consists of a miniature generator/microphone or speaker, which may be contained in a case worn behind-the-ear (BTE) or worn on the body (e.g., on a neck pendant, clipped to clothing), that delivers white noise to the eardrum through air; its digital design allows for the introduction of new tinnitus-masking software programs.
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Active | false |
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
3303e0fe-8469-49e9-b543-36c62b4d8c64
August 05, 2022
4
September 28, 2016
August 05, 2022
4
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
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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