Entrants, exits, funding, launches, recalls — chronic subjective tinnitus neuromodulation

1. Summary

The domain dossier's §7 already establishes that product code QVN has exactly one clearance — Neuromod's founding De Novo grant — and zero followers in the 3.5 years since. This report looks past that single code at what else is moving in the surrounding FDA registry: an adjacent, older tinnitus-device classification (KLW, tinnitus masker/sound generator) that has kept clearing new entrants every year or two, including two in 2026 alone; a single product line (Levo) whose FDA applicant of record has changed name three times across twelve years; and one neuromodulation mechanism — vagus-nerve stimulation paired with tones — that was registered for a tinnitus proof-of-concept a decade ago, enrolled ten patients, posted no results, and resurfaced as an FDA-approved product for a different indication entirely. No recall has been recorded under either product code in the last five years. Company financing activity was located but could not be carried forward as a finding — see §5.

2. What Changed

_Baseline (v1). No prior version; this establishes the starting point for future diffs._

3. Details

The bimodal classification (QVN): one entrant, still

FDA's De Novo grant DEN210033, decided 2023-03-06, created product code QVN — "Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus," Class II, 21 CFR 874.3410 — for Neuromod Devices Limited's Lenire [1][2]. Re-running the same scan the domain dossier ran, as of this report's run date no 510(k) has cleared under QVN in either the trailing three years or the trailing five years; the only record the product code has ever produced is the founding De Novo itself [1]. Neuromod remains the sole cleared entrant in this specific device category.

The adjacent classification (KLW) is where the entrant activity actually is

A broader FDA device-name search for "tinnitus" clearances over the last ten years returns ten records, and nine of the ten sit under a different, older product code: KLW, "Masker, Tinnitus," Class II, 21 CFR 874.3400 [3][4] — sound-generator devices, not bimodal acoustic-electrical neuromodulation, and therefore adjacent to rather than inside this domain's own definition. That code has cleared new applicants steadily: Sound Options Tinnitus Treatments, Inc. (K161562, 2016-09-28), Jiangsu Betterlife Medical Co. (K163094, 2017-05-17), Audiofon USA (K171243, 2017-10-19), GN Hearing A/S three times (K181586 2018-07-13, K180495 2018-11-30, K193303 2020-02-20), Starkey Laboratories (K201370, 2020-06-19), Sivantos GmbH (K260614, 2026-06-10), and Levo Medical Corporation (K260413, 2026-08-13) [3]. The two most recent clearances both fall within four months of this report's run date, which is the closest this scan comes to a "launch" signal in the conventional sense: two new tinnitus-labeled devices reaching market in 2026 — both under the older masker classification, neither a bimodal-neuromodulation competitor to Lenire under QVN.

One product line, three FDA applicant names across twelve years

The Levo Gen 2 clearance above is the newest entry in a corporate lineage traceable directly in FDA's own 510(k) records. The original device — "Levo Tinnitus Masking Software Device" — was cleared to Otoharmonics Corp on 2014-07-18 (K140845) [5]. A follow-on clearance for "Levo Max" went to a different applicant of record, Levo AG, on 2015-01-21 (K140706) [6]. The most recent generation, "Levo Gen 2 Tinnitus Therapy System," is now held by Levo Medical Corporation, cleared 2026-08-13 (K260413) [3]. FDA's registry does not state a reason for the applicant changing name three times, and no acquisition, licensing, or corporate-restructuring record was independently retrieved in this pass to explain it — this is recorded as what the registry shows, not as a confirmed acquisition history.

A mechanism that entered tinnitus research and did not return with a tinnitus filing

MicroTransponder Inc. registered a proof-of-concept trial pairing vagus nerve stimulation (VNS) with tones for severe subjective tinnitus, NCT01253616, enrolling 10 patients (actual) under a single-group, unmasked design; the record was last updated 2017-02-17, status COMPLETED, and no results have ever been posted to the registry [7]. The sponsor's own registered purpose was "to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus" [sponsor-reported] [7] — a stated intention, not a finding, and one that was never followed by a results posting or, so far as this pass located, a US marketing filing for a tinnitus indication under any product code. The same VNS-pairing platform did reach FDA approval, but for a different condition: PMA P210007, "Vivistim® System" (applicant of record "Mobia Medical, Inc." per the current FDA record), decided 2021-08-27, is indicated for chronic ischemic stroke patients with moderate-to-severe upper-extremity motor deficits [8] — not tinnitus. Read together, a registered tinnitus proof-of-concept with no posted results and a since-renamed applicant's only approved VNS-pairing product being indicated for stroke is the closest this pass comes to a market exit signal for a neuromodulation mechanism distinct from Lenire's bimodal (sound-plus-tongue) design [inference — see §5].

Recalls: none recorded under either product code

FDA's device-recall database returns zero records for product code QVN over the five years ending on this report's run date, and zero records for product code KLW over the same window [9][10]. Absence of a recall record is not the same as absence of a field-performance problem — no MAUDE adverse-event narrative search was run in this pass — but as a matter of the recall registry specifically, neither device category shows one.

Continued real-world evidence generation for the founding device

A 2026 single-site, single-arm US chart review of 140 patients treated with Lenire between 2023-05-01 and 2024-01-19 found that, among patients with moderate-or-worse baseline tinnitus, 81.8% (95% CI 70.9%-89.3%) achieved a Tinnitus Handicap Inventory improvement of at least 7 points (the study's minimal-clinically-important-difference threshold) after roughly 12 weeks, with a mean reduction of 23.8 ± 2.3 points; patients with slight/mild baseline severity showed "nearly zero change in score, on average" [11]. This is a distinct chart review from the 220-patient one already in the domain dossier's §5 — different n, different date range, same device — and its existence in 2026 indicates the founding device's US real-world-evidence program is still active three years after clearance, independent of any specific commercial announcement [single-source].

4. Sources

[1] 510(k) DEN210033 — Lenire Tinnitus Treatment Device, Neuromod Devices Limited — FDA openFDA device/510k (decision 2023-03-06; accessed 2026-09-01; re-queried for 3y and 5y follower windows, both zero records). DEN210033 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210033 [federal-registry] [2] openFDA device/classification, product_code=QVN — FDA (queried 2026-09-01; accessed 2026-09-01). Device class 2, "Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus," 21 CFR 874.3410, review panel EN — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=QVN [federal-registry] [3] openFDA device/510k scan, device_name="tinnitus", window 2016-09-03 to 2026-09-01 — FDA (queried 2026-09-01; accessed 2026-09-01). 10 records; K-numbers cited inline: K260413 (Levo Medical Corporation, dec. 2026-08-13), K260614 (Sivantos GmbH, dec. 2026-06-10), K201370 (Starkey Laboratories, dec. 2020-06-19), K193303, K180495, K181586 (GN Hearing A/S, dec. 2020-02-20 / 2018-11-30 / 2018-07-13), K171243 (Audiofon USA, dec. 2017-10-19), K163094 (Jiangsu Betterlife Medical Co., dec. 2017-05-17), K161562 (Sound Options Tinnitus Treatments, Inc., dec. 2016-09-28), plus DEN210033 (cited above as source 1) — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm [federal-registry] [4] openFDA device/classification, product_code=KLW — FDA (queried 2026-09-01; accessed 2026-09-01). Device class 2, "Masker, Tinnitus," 21 CFR 874.3400, review panel EN — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KLW [federal-registry] [5] 510(k) K140845 — Levo Tinnitus Masking Software Device, Otoharmonics Corp — FDA openFDA device/510k (decision 2014-07-18; accessed 2026-09-01). K140845 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140845 [federal-registry] [6] 510(k) K140706 — LEVO MAX, Levo AG — FDA openFDA device/510k (decision 2015-01-21; accessed 2026-09-01). K140706 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140706 [federal-registry] [7] ClinicalTrials.gov NCT01253616 — "Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus," MicroTransponder Inc., sponsor (record last updated 2017-02-17; accessed 2026-09-01). Status COMPLETED, enrollment 10 (ACTUAL), hasResults=false. NCT01253616 — https://clinicaltrials.gov/study/NCT01253616 [trial-registry] [8] FDA PMA P210007 — "Vivistim® System," applicant of record Mobia Medical, Inc. — openFDA device/pma, queried directly via the openFDA API (no PMA connector exists in this repo; decision 2021-08-27; accessed 2026-09-01). Indication: chronic ischemic stroke, moderate-to-severe upper-extremity motor deficits. P210007 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=P210007 [federal-registry] [9] openFDA device/recall scan, product_code=QVN, window 2021-09-02 to 2026-09-01 — FDA (queried 2026-09-01; accessed 2026-09-01). Zero records matched. Cf. DEN210033, 21 CFR 874.3410 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [10] openFDA device/recall scan, product_code=KLW, window 2021-09-02 to 2026-09-01 — FDA (queried 2026-09-01; accessed 2026-09-01). Zero records matched. Cf. 21 CFR 874.3400 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [11] "Bimodal Neuromodulation for Tinnitus in a Clinical Practice Setting: Clinically Significant Benefit for Patients With Moderate or Worse Symptoms" — American Journal of Audiology (published 2026-03-05; accessed 2026-09-01). PMID 41528257 — https://pubmed.ncbi.nlm.nih.gov/41528257/ [peer-reviewed]

5. Sourcing & Gaps

Well established: nothing in this report rests on two independent, non-affiliated primary sources agreeing on the same fact — every line is a single federal registry record, a single trial-registry record, or a single peer-reviewed publication. This is disclosed rather than smoothed over: a federal registry record is authoritative about its own contents, but "one record says so" is still one source.

Thin: every fact in §3 is [single-source] by construction. The connective claim linking NCT01253616 to PMA P210007 (that the same underlying VNS-pairing technology moved from a tinnitus proof-of-concept to a stroke-indicated approval, and did not return to tinnitus) is this report's own synthesis of two registry facts, not a statement either registry record makes directly, and is marked [inference] accordingly. The applicant-name lineage for the Levo product (Otoharmonics Corp → Levo AG → Levo Medical Corporation) is reported exactly as the registry shows it; whether it reflects an acquisition, a licensing arrangement, or a distributor change was not established and is not asserted.

Rescoped from class 3: "which companies would enter the bimodal-neuromodulation tinnitus market" is unanswerable and was not asked. This report answers its revealed-behaviour twin — which companies have filed a 510(k) or De Novo under the relevant product codes, and which registered a tinnitus trial and did not carry it to a US filing — per docs/research-lane-spec.md §3.1.

Out of scope: company funding-round amounts (Neuromod's disclosed 2023 and 2025 financings), retail/clinic-network partnership announcements, and international (Canada/Australia) launch news were all located via manufacturer press releases and trade-press coverage during this pass. None of them carries a resolvable registry identifier (PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX number, or FR Doc number) as this report's format requires, so per the sourcing rule they are not carried forward as findings rather than cited without one. MAUDE adverse-event narratives, the VA Federal Supply Schedule contract's own procurement record (as opposed to the manufacturer's description of it, already flagged as unconfirmed in the domain dossier §6), and any non-US, non-EU jurisdiction are also out of scope for this report.

Not searched vs. not found: the product codes and applicants of the two 2014-2015 Levo clearances [5][6] were not independently re-confirmed against the KLW code specifically in this pass (not searched, not asserted). A full MAUDE query for either QVN or KLW device names was not searched at all in this pass, so the "recalls: none recorded" finding in §3 should not be read as "no field-performance problem has ever been reported" — that is a materially different, wider claim that was not searched.

[inference] The reading that MicroTransponder's VNS-pairing mechanism "exited" the tinnitus indication (§3, fourth subsection) is this report's synthesis of two registry facts that do not themselves state a causal or sequential relationship; no primary source asserts that the company abandoned tinnitus in favor of stroke, only that one trial with no posted results and one stroke-indicated PMA both exist in the registry under related sponsor/technology names.

6. Claim Candidates