Lenire Tinnitus Treatment Device
by Neuromod Devices Limited United States EUDAMED510(k)
510(k) DEN210033 Product code QVN
Overview
The Lenire Tinnitus Treatment Device is a Combined Acoustic and Electrical External Stimulation Device designed for the relief of tinnitus. It integrates auditory and electrical stimulation to modulate neural activity associated with chronic ringing or noise perception in the ears, targeting symptomatic management rather than underlying pathology.
This device is supplied as a reusable medical instrument, intended for use in clinical settings under professional supervision. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. No specific sterility requirements are noted, but proper cleaning and maintenance protocols must be followed to ensure safe, repeated use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG 510(k) | NumberDEN210033 | Date6 Mar 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- QVN
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3410
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- DENG De Novo granted
Other devices from Neuromod Devices Limited
Questions
Is the Lenire Tinnitus Treatment Device intended for home use or must it be used in a clinical setting?
The Lenire Tinnitus Treatment Device is designed for clinical use only under professional supervision. While it is classified as a reusable medical instrument, its intended use—combined acoustic and electrical stimulation for tinnitus relief—requires oversight by trained healthcare providers to ensure proper application and patient safety.
How is the Lenire device cleaned and maintained since it is reusable?
Since the Lenire is reusable, it must be cleaned and maintained according to manufacturer-provided protocols to prevent cross-contamination and ensure functionality. The device does not specify sterility requirements, but proper hygiene practices—such as disinfection between uses—are critical to comply with medical device safety standards.
What types of tinnitus symptoms does the Lenire device target, and how does it work?
The Lenire device targets chronic ringing or noise perception (tinnitus) by combining auditory and electrical stimulation to modulate neural activity. It is designed for symptomatic management, meaning it aims to reduce the perception of tinnitus rather than treat its underlying cause. The dual-stimulation approach helps retrain auditory pathways.
Are there different models or sizes available for the Lenire device, or is it a single-unit system?
The provided data does not specify multiple models or sizes for the Lenire device. It is described as a single, reusable system for combined acoustic and electrical stimulation, intended for consistent use across patients under clinical supervision.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) DEN210033
- EUDAMED