Lenire

Basic Information

• Brand Name: Lenire
• Primary DI: 05391540580028
• Version / Model: CR-201
• Company Name: NEUROMOD DEVICES LIMITED
• Labeler DUNS: 985051113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-19
• Public Version: 1
• Public Version Date: 2023-05-29
• Public Version Status: New
• Public Device Record Key: 193286b2-8ee4-4045-9d41-1e02a070e98c

Device Description

Lenire Tinnitus Treatment Device

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: Yes
• 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
QVN	Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus	Ear, Nose, Throat	874.3410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65707	Tinnitus therapy auditory/translingual electrical stimulation system	An electrically-powered assembly of devices designed to treat tinnitus through bimodal neuromodulation of the brain, involving simultaneous application of electrical pulses to the tongue and delivery of specific sounds to the auditory system. It includes a system generator and a tongue applicator with integrated electrodes; it is intended to be used with headphones which might be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391540580028	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN210033	000