Triad Combonation Unit

Basic Information

• Brand Name: Triad Combonation Unit
• Primary DI: 00089518000511
• Version / Model: Triad Combo,OTE,10A,Digital,RIC,Beige,Left
• Company Name: GENERAL HEARING INSTRUMENT, INC.
• Labeler DUNS: 131229197
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 20fd3c95-07b4-4f6a-8827-a8a03c48ff4e

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLW	Masker, Tinnitus	Ear, Nose, Throat	874.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00089518000511	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K974751	000