DEVICE: Triad Combonation Unit (00089518000559)

Device Identifier (DI) Information

Triad Combonation Unit
Triad Combo,OTE,10A,Digital,RIC,Brown,Right
In Commercial Distribution

GENERAL HEARING INSTRUMENT, INC.
00089518000559
GS1

1
131229197 *Terms of Use
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KLW Masker, Tinnitus
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K974751 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

fe2e9294-24cb-41db-b743-76c5d5d5f570
July 06, 2018
3
September 29, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
1-800-824-3021
customercare@generalhearing.com
CLOSE