De Novo · Granted
GrantedLenire Tinnitus Treatment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromod Devices Limited · QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Granted on Mar 6, 2023 as a new device type through De Novo after a 565-day review.
- Decided
- Mar 6, 2023
- Review
- 565 days
- Class
- Class II
- Product code
- QVN
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QVN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All QVN devicesQVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVN
Too few QVN 510(k)s in any year since 2007 to give a median.
Recalls per year · QVN
No recall names QVN since 2007.
Adverse event reports per year · QVN
7in 2024
MAUDE reports naming product code QVN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Lenire is intended to provide bimodal (sound and transmucosal electrical tongue) stimulation to temporarily relieve the symptoms of tinnitus in patients 18 years of age and older suffering from at least moderate (as defined by the Tinnitus Handicap Inventory) tinnitus. The treatment is intended to be self-administered by the patient following prescription by a healthcare professional who is experienced in the evaluation and management of tinnitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN210033 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN210033: Lenire Tinnitus Treatment Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN210033
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026