Details checkedStrong evidenceCheckedregulatory

Lenire Tinnitus Treatment Device

Also known as: Lenire, Neuromod Lenire, Tonguetip, bimodal neuromodulation

Neuromod Devices

Primary source

Company

Neuromod Devices

Program Type

Device

Modality

Neuromodulation

Stage

Marketed

Status

Marketed

Target Gene

—

Route / Mode

External wearable controller, headphones, and tongue stimulation device

Confidence

97%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-05-31

Geography

United States, Europe

Population

adult, tinnitus

Trial IDs

Mechanism

A bimodal tinnitus therapy that pairs acoustic stimulation with mild electrical stimulation of the tongue to relieve tinnitus symptoms.

Indications

Tinnitus

Notes

The most commercially visible regulated tinnitus neuromodulation device and the clearest benchmark for the tinnitus-device field in the U.S.

Evidence & Sources

2 structured sources

regulatory

Supports: canonicalName, company, modality, stage, status, notes, keyEvents

IDs: DEN210033

Open

company

Supports: aliases, mechanism, indications, route, geography

Open

Key Events

2023-03-06

FDA granted De Novo classification to Lenire

Related Programs

Auricle Tinnitus Device

Company: Auricle Inc. · Neuromodulation · Phase 2

Neuromonics Tinnitus Treatment System

Company: Neuromonics · Neuromodulation · Marketed

Tinearity G1 Tinnitus System

Company: Duearity · Neuromodulation · Marketed

Beltone Serene Hearing Aids

Company: Beltone · Hearing Aid/Software · Marketed

Signia Notch Therapy

Company: Signia · Neuromodulation · Marketed

ELEHEAR Beyond Pro OTC Hearing Aids

Company: ELEHEAR · Hearing Aid/Software · Marketed