What changed in ten years and what is newly possible or cheap — chronic subjective tinnitus neuromodulation

1. Summary

Over the ten years to 2026-09-01, FDA created exactly one new device category for chronic subjective tinnitus — product code QVN (21 CFR 874.3410), via a single De Novo grant to Lenire in 2023 — and a repeated registry query across that window still returns exactly one record under it: no follower device has cleared [1]. Over the same window, the pre-existing tinnitus-masker category, product code KLW (21 CFR 874.3400, dating to 1986), kept clearing new 510(k)s on a steady annual cadence across four different manufacturers, most recently in 2026 [2][3][4][5][6]. A full ten-year search of the FDA device database by device name "tinnitus" returns entries only under these two codes — none for an implanted or transcutaneous vagus-nerve-stimulation device, nor for any transcranial electrical or magnetic stimulation device [1]-[6]. A 2022 FDA final rule created an over-the-counter hearing-aid category for adults with "perceived mild to moderate hearing loss," a general acoustic-hardware rule that sits underneath, but is not itself, the tinnitus-specific claim either code above carries [14].

2. What Changed

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

3. Details

The De Novo-created bimodal category has one member; the pre-existing masker category keeps clearing

Lenire's De Novo grant, decided 2023-03-06, established product code QVN and its own regulation, 21 CFR 874.3410 [1]. A registry query spanning the full ten years to 2026-09-01 returns exactly one record under that code — DEN210033 itself — confirming no follower device has cleared in this window [1]. Alongside it, the older tinnitus-masker code, KLW under 21 CFR 874.3400 ("an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises," Class II, dating to a 1986 rule last amended in 2000) [6], cleared nine 510(k)s between 2016-09-28 and 2026-08-13, spanning at least four applicants: Sound Options Tinnitus Treatments (2016) [2], Starkey Laboratories (2020) [3], Sivantos GmbH (2026) [4], and Levo Medical Corporation (2026) [5]. The most recently read Indications for Use, for Sivantos's 2026-06-10 clearance, states the device is "intended to output noise of sufficient intensity and bandwidth to be used for tinnitus habituation therapy and is also suitable for tinnitus masking therapy," fit "by a qualified audiologist or other hearing healthcare professional," for the "adult population over 18 years of age" and "children 5 years of age or older" [4] — language close to the 1986 regulation's own [6]. A device-name="tinnitus" search of the full FDA 510(k)/De Novo database across the same ten years returns records only under QVN and KLW; it names no vagus-nerve-stimulation, transcranial-magnetic, or transcranial-electrical device [1]-[5].

An implanted vagus-nerve-stimulation route reached human trials and did not proceed to a clearance

MicroTransponder Inc. ran a triple-masked, sham-controlled, surgically-implanted trial (n=30) pairing vagus-nerve stimulation with tones for chronic tinnitus; the published pilot results (2017) report the paired-VNS group improved on the Tinnitus Handicap Inventory within-group (P=.0012) but the between-group difference over sham was 10.3% and did not reach significance (P=.3393), with roughly half of the paired-VNS group showing a clinically meaningful response at 6 weeks and at one year [single-source · sponsor-reported][7]. The same sponsor's registered trial record (NCT01962558) confirms the 30-participant, industry-sponsored, randomized/triple-masked design and posts results [sponsor-reported][8]. No 510(k) or De Novo record for a vagus-nerve-stimulation tinnitus device appears in the ten-year device-name search above [1]-[5]. A separate, academically-sponsored implanted-VNS tinnitus study (University of Texas at Dallas, NCT03143842) was withdrawn before enrolling any participant, with the reason recorded verbatim in the registry as "Not enough participants" [sponsor-reported][9]. An independent 2021 scoping review of the same modality describes transcutaneous (skin-surface) vagus-nerve stimulation as "a non-invasive alternative approach" that "has received increasing attention," distinct from the implanted route the 2017 pilot used [10].

Non-invasive brain stimulation: published evidence grew; no matching clearance followed

Two independent meta-analyses read at abstract depth report measurable effect sizes for non-invasive brain-stimulation modalities — outside the modality set (hearing aids, CBT, sound therapy, TMS) the 2014 AAO-HNS guideline evaluated. A 2020 JAMA Otolaryngology–Head & Neck Surgery network meta-analysis (32 RCTs, n=1,458) found cathodal transcranial direct current stimulation over the left dorsolateral prefrontal cortex combined with transcranial random noise stimulation over bilateral auditory cortex produced the largest reduction in tinnitus severity versus control (standardized mean difference −1.89, 95% CI −3.00 to −0.78) [single-source][11]. A 2024 Otolaryngology–Head and Neck Surgery meta-analysis (19 RCTs, n=1,186) reported short-term Tinnitus Handicap Inventory improvements of −16.2 points for transcutaneous electrical nerve stimulation and −19 points for transcranial direct current stimulation, and a long-term −8.6-point effect for repetitive transcranial magnetic stimulation [single-source][12]. Neither publication corresponds to an FDA-cleared device carrying a tinnitus indication in the ten-year clearance search above [1]-[5].

A software-only delivery channel reached a sham-controlled randomized trial

A 2026 JAMA Otolaryngology–Head & Neck Surgery double-blind, sham-app-controlled randomized trial (n=60; Japan jRCT identifier 032230359) tested a smartphone application delivering education and cognitive-behavioral-therapy elements for chronic tinnitus over 16 weeks. The therapeutic-app group improved on the Tinnitus Handicap Inventory versus the sham-app group by a between-group difference of −20.4 points (95% CI −28.2 to −12.6) at week 16, sustained at −18.3 points at week 24; no serious adverse events or device malfunctions were reported [single-source][13]. No FDA clearance record for this or a comparable tinnitus app appears in the searches run for this report.

What got cheaper on the acoustic side, and its stated limit

FDA's 2022 final rule establishing an over-the-counter hearing-aid category (21 CFR 800.30) states the OTC category is "intended to address perceived mild to moderate hearing loss in people aged 18 or older" [14] — a general hearing-aid rule, not a tinnitus rule. The same rule's preamble records that "a few comments requested that OTC hearing aid labeling include a warning that people should not use OTC hearing aids if they have tinnitus" because "tinnitus can be an indicator of serious medical conditions requiring proper management from a hearing healthcare professional" [14]. This report did not retrieve FDA's specific response to that comment; the rule change lowers the cost and prescription-gatekeeping of the hearing-aid hardware platform that the KLW tinnitus-masking feature and the standard-of-care hearing-aid pathway both run on, without itself being a tinnitus clearance.

4. Sources

[1] 510(k) DEN210033 — "Lenire Tinnitus Treatment Device" (Neuromod Devices Limited), De Novo grant establishing product code QVN — FDA CDRH (decided 2023-03-06; accessed 2026-09-01). DEN210033 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210033 [federal-registry] [2] 510(k) K161562 — "Sound Options Tinnitus Treatment" (Sound Options Tinnitus Treatments, Inc.), product code KLW — FDA CDRH (decided 2016-09-28; accessed 2026-09-01). K161562 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K161562 [federal-registry] [3] 510(k) K201370 — "Multiflex Tinnitus Technology" (Starkey Laboratories, Inc.), product code KLW — FDA CDRH (decided 2020-06-19; accessed 2026-09-01). K201370 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201370 [federal-registry] [4] 510(k) K260614 — "Tinnitus Therapy" (Sivantos GmbH), product code KLW, Indications for Use — FDA CDRH (decided 2026-06-10; accessed 2026-09-01). K260614 — https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260614.pdf [federal-registry] [5] 510(k) K260413 — "Levo Gen 2 Tinnitus Therapy System" (Levo Medical Corporation), product code KLW — FDA CDRH (decided 2026-08-13; accessed 2026-09-01). K260413 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260413 [federal-registry] [6] eCFR, Title 21, section 874.3400, "Tinnitus masker" (product code KLW, Class II) — Office of the Federal Register (issue 2026-08-27; accessed 2026-09-01). 21 CFR 874.3400 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=KLW [federal-registry] [7] PMID 28931943 — Engineer ND, et al. "Vagus Nerve Stimulation Paired with Tones for the Treatment of Tinnitus: A Prospective Randomized Double-blind Controlled Pilot Study in Humans." Scientific Reports (published 2017-09-20; accessed 2026-09-01). PMID 28931943 — https://pubmed.ncbi.nlm.nih.gov/28931943/ [peer-reviewed] [8] ClinicalTrials.gov NCT01962558 — "Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus," MicroTransponder Inc., COMPLETED, hasResults=true, n=30 actual (last updated 2018-04-06; accessed 2026-09-01). NCT01962558 — https://clinicaltrials.gov/study/NCT01962558 [trial-registry] [9] ClinicalTrials.gov NCT03143842 — "Investigating Accelerated Learning in Tinnitus Participants Implanted With Vagus Nerve Stimulation," University of Texas at Dallas, WITHDRAWN, enrollment 0 actual (last updated 2022-01-28; accessed 2026-09-01). NCT03143842 — https://clinicaltrials.gov/study/NCT03143842 [trial-registry] [10] PMID 34122002 — "Direct and Transcutaneous Vagus Nerve Stimulation for Treatment of Tinnitus: A Scoping Review." Frontiers in Neuroscience (published 2021, month not given in the PubMed record; accessed 2026-09-01). PMID 34122002 — https://pubmed.ncbi.nlm.nih.gov/34122002/ [peer-reviewed] [11] PMID 32644131 — "Association of Central Noninvasive Brain Stimulation Interventions With Efficacy and Safety in Tinnitus Management: A Meta-analysis." JAMA Otolaryngology–Head & Neck Surgery (published 2020-09-01; accessed 2026-09-01). PMID 32644131 — https://pubmed.ncbi.nlm.nih.gov/32644131/ [peer-reviewed] [12] PMID 38353342 — "Neuromodulation for Treatment of Tinnitus: A Systematic Review and Meta-Analysis." Otolaryngology–Head and Neck Surgery (published 2024-05, day not given in the PubMed record; accessed 2026-09-01). PMID 38353342 — https://pubmed.ncbi.nlm.nih.gov/38353342/ [peer-reviewed] [13] PMID 42096236 — "Mobile Application as a Digital Therapeutic for Chronic Tinnitus: A Randomized Clinical Trial." JAMA Otolaryngology–Head & Neck Surgery (published 2026-07-01; accessed 2026-09-01). PMID 42096236 — https://pubmed.ncbi.nlm.nih.gov/42096236/ [peer-reviewed] [14] Federal Register, "Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids," Final Rule, 87 FR 50698 (published 2022-08-17; accessed 2026-09-01). FR Doc No. 2022-17230 — https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids [federal-registry]

5. Sourcing & Gaps

Well established: The clearance counts, decision dates, product codes and CFR/Federal-Register text in the "De Novo-created bimodal category" and "what got cheaper" subsections rest directly on federal registry queries (openFDA 510(k)/De Novo, eCFR, Federal Register) run for this report and carry no marker, consistent with this repo's convention that a direct registry lookup is its own source of record rather than a claim needing corroboration.

Thin: The MicroTransponder VNS pilot result (10.3% between-group difference, P=.3393) rests on one industry-sponsored publication and its own registry entry [single-source · sponsor-reported][7][8]. The UT Dallas withdrawal reason rests on the registry's own account of itself [sponsor-reported][9]. Both non-invasive-brain-stimulation effect sizes rest on one meta-analysis each, read at abstract depth only — no risk-of-bias tables, no funding disclosures, no assessment of whether the two meta-analyses' included-trial lists overlap [single-source][11][12]. The digital-therapeutic app finding rests on one trial [single-source][13]. None of the class-2 findings in this report were corroborated against a second independent source.

Rescoped from class 3: None in this report — every question addressed here is a registry fact or a published measured finding, not a question about what a person would do.

Out of scope: CPT descriptors, veterinary datasets, fda.gov guidance documents and case law, and any PatentsView-backed patent search (patent connector returned unconfirmed for a missing EPO_OPS_KEY/EPO_OPS_SECRET, and this domain's own dossier already flags PatentsView as unavailable). Non-US/non-EU jurisdictions were not queried. Two 2026 FDA Breakthrough Device Designations located by WebSearch (Serenity Medical's "Serenity Shepherd Stent" and Sonorous Neurovascular's "BosSTENT") were excluded from this report on population grounds, not sourcing grounds: both target pulsatile (objective, vascular) tinnitus from venous sinus stenosis, a different condition from the chronic subjective tinnitus this domain and dossier address, and neither was independently verified against a primary FDA record for this report.

Not searched vs. not found: FDA's specific response to the tinnitus-warning comment in the OTC hearing-aid rulemaking was found to have been raised but its resolution was not searched. Full-text methods and risk-of-bias assessment for every trial and meta-analysis cited here was not searched — all class-2 findings were read at abstract depth only, per this report's word budget. A 510(k)/De Novo search restricted to device-name="tinnitus" would not surface a differently-named device that treats tinnitus without the word appearing in its device name (e.g., a general neurostimulator cleared for a different primary indication and used off-label); that broader possibility was not searched. Whether the Sivantos, Starkey, GN Hearing or Levo KLW-coded features are sold at a lower unit cost than a standalone tinnitus device was not searched — no HCPCS/payment cache exists on this machine, consistent with the domain dossier's own Section 6 gap.

[inference] The clustering of all nine KLW clearances inside existing hearing-aid product lines from four different manufacturers, against QVN's single De Novo entrant with zero followers in 3.5 years, is read here as consistent with the acoustic/masking claim continuing to iterate through the ordinary 510(k) pathway inside a mature hardware category, while the combined-modality and brain/nerve-stimulation approaches have not yet found an equivalent 510(k) route to a tinnitus-specific indication — a reading the registry counts support but do not themselves state.

6. Claim Candidates