Triad Combonation Unit

Basic Information

• Brand Name: Triad Combonation Unit
• Primary DI: 00089518000757
• Version / Model: Triad Combo,Custom,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: 2016-09-29
• Public Version: 4
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 3d9e4fe6-7054-492d-ab62-3ff4f3fc11e1

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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00089518000757	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974751	000