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Which tinnitus devices received FDA clearance from 2020 to 2025?
Executive summary
From 2020–2025 the most clearly documented tinnitus device to receive U.S. FDA clearance is Neuromod Devices’ Lenire, which earned De Novo approval in March 2023 based on the TENT‑A3 pivotal trial and related evidence [1] [2] [3]. Available sources do not list any other new FDA clearances or approvals for tinnitus-specific devices in that 2020–2025 window; older maskers such as Neuromonics had prior 510(k) clearances but those predate 2020 in the cited materials [4].
1. The headline: Lenire is the documented 2023 De Novo winner
The strongest, consistent reporting across industry and clinical outlets identifies Lenire — a bimodal neuromodulation system combining sound with mild electrical tongue stimulation — as receiving FDA De Novo clearance in March 2023 after the company submitted clinical data from the TENT‑A3 trial and supporting studies [1] [2] [3]. News outlets (MedPage Today, Fierce Biotech, Healio) and peer‑reviewed publications explicitly link Lenire’s positive trial outcomes to the FDA decision [1] [2] [3].
2. What “De Novo” means and why it matters
De Novo is a regulatory pathway the FDA uses to create a classification for novel devices when there is no legally marketed predicate; it signals the agency found reasonable assurance of safety and effectiveness under specified controls [5]. Coverage emphasizes that Lenire’s approval established a new U.S. regulatory category for this class of bimodal neuromodulation tinnitus devices [6] [5].
3. The clinical evidence underpinning Lenire’s clearance
The De Novo clearance leaned heavily on the TENT‑A3 controlled pivotal study (reported in Nature Communications and company materials) that compared six weeks of sound‑only stimulation with six weeks of bimodal stimulation and found statistically meaningful benefit on tinnitus outcome measures, with no device‑related serious adverse events reported [3] [7]. Company and clinic press materials report high responder percentages in trials and real‑world series, which were part of the submission package cited in news pieces [8] [7].
4. Other tinnitus devices and prior clearances — limited mentions
Many longstanding tinnitus “maskers” and sound‑based devices (for example, Neuromonics) have historically been cleared through 510(k) pathways, but the policy file cited here notes such clearances predate the 2020–2025 interval and does not document new 2020–2025 510(k) clearances for other tinnitus devices in the provided results [4]. Summaries and clinic pages that list “FDA‑approved devices to treat tinnitus” do not, in these sources, identify additional new FDA clearances within 2020–2025 beyond Lenire [9].
5. Conflicting framings and commercial messaging to note
Company press materials, clinic outreach, and industry trade pieces characterise Lenire as “first and only” or “category‑defining” FDA‑cleared bimodal tinnitus therapy; independent coverage reproduces those claims while referencing the De Novo pathway [10] [7] [6]. At least one clinic review and some commentators highlight nuance about response rates and the proportion of benefit attributable to different trial stages, indicating that effectiveness interpretations vary and that some users report limited or mixed outcomes [11]. Those more critical voices appear in private clinic reviews rather than primary peer‑reviewed trial reports in the provided set [11].
6. What the sources do not say (limits of current reporting)
Available sources do not mention any other specific devices receiving new FDA clearances for tinnitus between 2020 and 2025 besides Lenire; they also do not provide exhaustive FDA device‑database pulls that would conclusively rule out other 510(k) actions in that period (not found in current reporting). If you want exhaustive, definitive FDA registry confirmation, that would require consulting the FDA’s device databases directly rather than the news, journal, and company materials cited here.
7. Practical takeaway for patients and clinicians
For patients and clinicians relying on available reporting, Lenire is the only clearly documented new FDA‑cleared tinnitus device in this set of sources for 2020–2025 — notable for its novel bimodal approach and backed by pivotal trial publications and the De Novo decision [1] [3]. Readers should weigh company and clinic promotional claims against trial data and independent commentary, and consult a licensed audiologist or ENT about suitability and alternatives; the sources show professional training, clinic rollouts, and VA access programs followed the clearance [12] [8].
Sources referenced in this piece: MedPage Today (Lenire De Novo report) [1]; Fierce Biotech (reporting on De Novo clearance) [2]; Nature Communications pivotal trial and article summary [3]; Healio coverage of the De Novo approval and trial basis [5]; company/clinic materials and press releases covering approval, rollout and claims [10] [8] [7] [12]; historical device policy noting prior 510(k) maskers [4]; critical clinic review with nuance about response rates [11].