DEVICE: Simply Tranquil I (00089518000467)
Device Identifier (DI) Information
Simply Tranquil I
Simply Tranquil I,10A,Digital,Right
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil I,10A,Digital,Right
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
The Simply Tranquil I utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing in the canal 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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43826 | Air-conduction tinnitus masker, in-the-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 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.
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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
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No Device Sizes |
Device Record Status
673a450b-70ff-46cf-a483-6601d2b94bcf
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
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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