DEVICE: Simply Tranquil II (00089518000498)
Device Identifier (DI) Information
Simply Tranquil II
Simply Tranquil II,10A,Digital,Right
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
Simply Tranquil II,10A,Digital,Right
In Commercial Distribution
GENERAL HEARING INSTRUMENT, INC.
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.
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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In-the-ear air-conduction tinnitus masker, digital | 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 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. |
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
dfafbb18-f40e-4320-981a-ba90fd1fbdda
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
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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