Are there any new devices or apps FDA-cleared for tinnitus since 2020?

1. The breakthrough repeatedly cited: Lenire, a bimodal neuromodulation device

Reporting across industry, academic and patient‑facing outlets identifies Neuromod Devices’ Lenire as the regulatory milestone since 2020: the FDA issued De Novo clearance/approval in 2023 for a device that pairs auditory stimulation with mild electrical pulses to the tongue, and that approval is presented as the first of its kind for tinnitus in the U.S. ^{[1] [2] [4]}. Lenire’s clinical program—TENT‑A3 and supporting real‑world evidence—was central to the FDA action, and peer‑reviewed clinical trial results appear in Nature Communications ^{[5] [6]}.

2. What the clinical evidence and regulatory record say

The Nature Communications pivotal trial (TENT‑A3) used a within‑subject design comparing sound‑only stimulation to bimodal treatment and reported statistically and clinically meaningful improvements for bimodal therapy; the paper and subsequent FDA De Novo grant are explicitly linked in reporting ^{[5] [2]}. Neuromod’s published materials and independent outlets note no device‑related serious adverse events in trials and cite responder rates and sustained benefit in follow‑up and real‑world cohorts ^{[7] [8] [5]}.

3. Market uptake and availability reported in the U.S.

Multiple clinic and university announcements show Lenire being adopted into clinical offerings across the U.S. after the FDA action, with clinics, VA options and university speech/hearing centers listing assessment appointments and treatment availability ^{[9] [10] [11]}. Industry and consumer pieces emphasize that Lenire is provided under clinician supervision—not sold as an over‑the‑counter consumer gadget—and that initiation requires a qualified professional ^{[7] [12]}.

4. Are there other FDA‑cleared devices or apps since 2020?

Within the provided set of sources, no other distinct new FDA‑cleared tinnitus devices or mobile apps are named after 2020. Older clearances (e.g., a 2019 tinnitus add‑on feature for HyperSound Clear 500P) predate 2020 and are cited as historical context, but the search results do not show additional novel FDA clearances or approvals for tinnitus devices/apps between 2020 and the present reporting besides Lenire ^{[13] [14] [15]}. Therefore, available sources do not mention other post‑2020 FDA‑cleared tinnitus devices or standalone apps (not found in current reporting).

5. How reporters and manufacturers frame limitations and claims

Manufacturer and clinic statements position Lenire as an evidence‑backed, noninvasive treatment option that is “not a cure” but can deliver clinically meaningful symptom reduction for many patients; patient and clinic reports highlight high responder and recommendation rates but also note treatment is clinician‑prescribed and follow‑up dependent ^{[7] [3] [8]}. Independent peer‑reviewed results supporting efficacy are cited (Nature Communications), but outlets also acknowledge that tinnitus remains heterogeneous and that what helps one patient may not help another ^{[5] [3]}.

6. Competing perspectives and uncertainties to watch

Industry and manufacturer sources characterize Lenire as the first and only FDA‑approved bimodal device and emphasize positive trial and real‑world outcomes ^{[6] [7]}. Independent reportage in clinical outlets (PracticalNeurology, Nature Communications) corroborates trial data but also imply broader questions remain about long‑term effectiveness across diverse patient subgroups and about comparative performance versus other therapies ^{[4] [5]}. Available sources do not report competing FDA‑cleared devices or apps since 2020 to contest Neuromod’s positioning; if you are tracking alternatives (wristbands, neck/face stimulation, apps), those appear in clinical discussion but not in the provided FDA‑clearance reporting ^{[15] [16]}.

7. Practical takeaway for patients and clinicians

If you are asking “any new FDA‑cleared tinnitus devices/apps since 2020?” — the record in these sources identifies Lenire as the prominent FDA‑cleared device (De Novo 2023) and no other new FDA‑cleared tinnitus devices or apps are named in the provided reporting ^{[1] [2]}. Patients should consult qualified audiologists/ENTs for suitability assessment and note that sources stress clinician‑supervision, trial‑backed protocols, and that Lenire is intended as a treatment option—not a guaranteed cure ^{[12] [3]}.

Limitations: this analysis uses only the supplied search results; claims about other FDA actions, apps, or later approvals are outside these sources and therefore "not found in current reporting" here.