Tinnitus Masker

GUDID 00089518000801

The Tinnitus custom device utilizes advanced digital signal processing with broadband white or pink noise integrated into a cosmetically appealing design. Designed for patients that suffer from Tinnitus to ease ringing in the ear.

GENERAL HEARING INSTRUMENT, INC.

In-the-ear air-conduction tinnitus masker, digital

• Primary Device ID: 00089518000801
• NIH Device Record Key: aed0c8ca-adfe-4a5f-9b94-83a43ec6d8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tinnitus Masker
• Version Model Number: Tinnitus,Custom,Pair
• Company DUNS: 131229197
• Company Name: GENERAL HEARING INSTRUMENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com
• Phone: 1-800-824-3021
• Email: customercare@generalhearing.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00089518000801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061459

FDA Product Code

• KLW: Masker, Tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-29

On-Brand Devices [Tinnitus Masker]

• 00089518000801: The Tinnitus custom device utilizes advanced digital signal processing with broadband white or p
• 00089518000795: The Tinnitus custom device utilizes advanced digital signal processing with broadband white or p
• 00089518000788: The Tinnitus custom device utilizes advanced digital signal processing with broadband white or p