Tranquil I OTE

GUDID 00089518000276

The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integrated into a cosmetically appealing mini OTE case design. Designed for patients that suffer from Tinnitus

GENERAL HEARING INSTRUMENT, INC.

Behind-the-ear air-conduction tinnitus masker

• Primary Device ID: 00089518000276
• NIH Device Record Key: 3926e6b8-fcf4-4704-a6be-cb431f830170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tranquil I OTE
• Version Model Number: Tranquil I,OTE,10A,Digital,Black,Left
• 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	00089518000276 [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: 2016-09-28

On-Brand Devices [Tranquil I OTE]

• 00089518000320: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000313: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000306: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000290: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000283: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000276: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000269: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000252: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000245: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000238: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000221: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr
• 00089518000214: The Tranquil I OTE utilizes advanced digital signal processing with broadband white noise integr