Domain dossier
Shared background for a clinical problem, keyed by domain rather
than by candidate, so the second idea in an area starts from the first one's research.
A dossier carries no confidence tags. A line here has to be copied into a
candidate's claims as unverified before anything can check or score it.
Used by: idea-006
Research reports behind it: care-pathway · clinical-evidence · epidemiology · market-players · reference-products · reimbursement · technology · user-groups
Chronic subjective tinnitus has no cure and no single dominant standard of care; the FDA-created product code this domain centers on (QVN, 21 CFR 874.3410) exists because one company's De Novo grant defined an entirely new device category in 2023, three years before this file was built. Read the thinness up front: this dossier is strong on the founding device's own published pivotal-trial data (Section 5) and on the standard-of-care comparator literature (Section 4), because those are class-2 findings a literature connector reaches directly. It is weak-to-absent on US severity-stratified epidemiology (no NHANES-derived, severity-banded prevalence figure was located), on VA-specific figures (no connector in this repo reads VBA/VHA data, and the one primary VA document located could not be text-extracted in this environment — see Section 6 and Section 10), and on reimbursement (no HCPCS/payment/ coverage cache exists on this machine). A second candidate in this domain should expect to start from a well-populated Section 5 and a nearly empty Section 1 and Section 6.
This file carries no confidence tags. Every line below is context with a source attached. To affect a score, a line must be copied into a candidate's ## Claims as unverified and pass the Verifier or the Corroborator. See README.md in this directory.
as_of: 2026-08-27 · sources searched: connectors literature ("tinnitus prevalence United States adults", "chronic tinnitus prevalence severity United States NHANES"), literature-detail on PMID 27441392, WebSearch/WebFetch of the AAO-HNS guideline fact sheet · not searched: a severity-stratified (moderate-or-greater) prevalence estimate specific to the indicated population; incidence; demographic/geographic concentration; trend direction over time (a 2026 title, PMID 42089210, "Tinnitus Trends in Young Adults: Prevalence and Duration from 2008 to 2023," was located but not read past its title)
| Fact | Quantity (n, population, date) | Source |
|---|---|---|
| 12-month tinnitus prevalence, general US adult population | 9.6% (SE 0.3%) — 21.4 (SE 3.4) million of an estimated 222.1 (SE 3.4) million US adults ≥18, 2007 National Health Interview Survey, raw n=75,764 respondents, published 2016 | [1] |
| Subjective severity among those with tinnitus | 7.2% rated it "a big or a very big problem"; 41.6% rated it "a small problem"; 31% "not bothered" (2007 NHIS cross-section) | [1] |
| Duration / chronicity among those with tinnitus | 27% reported symptoms for longer than 15 years; 36% reported nearly-constant symptoms | [1] |
| Alternative prevalence estimate (secondary/promotional, not independently retrieved as primary) | "More than 50 million people in the United States have reported experiencing tinnitus, resulting in an estimated prevalence of 10% to 15% in adults" | [15] |
Verbatim, for anything load-bearing:
"Among an estimated (SE) 222.1 (3.4) million US adults, 21.4 (3.4) million (9.6% [0.3%]) experienced tinnitus in the past 12 months... In terms of subjective severity, 7.2% reported their tinnitus as a big or a very big problem compared with 41.6% who reported it as a small problem." — [1]
"Tinnitus affects up to 21% of the adult population with an estimated 1% to 3% experiencing severe problems." — [11] (Cochrane review background statement, itself citing other sources not independently traced here)
Gaps: No source located gives a severity-banded prevalence figure matching the candidate's actual indicated population ("moderate or greater severity," the validated-scale threshold the pivotal trials use — see Section 4/5 THI≥38 cutoff). [1]'s 7.2% "big or very big problem" figure is a self-report severity band from a different instrument (NHIS free-text severity, not THI/TFI) and should not be read as interchangeable with "moderate or greater" on a validated tinnitus-severity scale — that is an explicit gap, not a finding. This is a class-2 vs. proxy issue: the number exists, but it does not answer the population question the candidate's intended_use: poses. Not searched: any VA/veteran- specific chronic-tinnitus prevalence figure independent of the compensation-claims data in Section 6 (a compensation count is not a prevalence estimate, and Section 6 already carries that caveat).
as_of: 2026-08-27 — not researched this pass beyond what the guideline fact sheet and the candidate's own frontmatter establish.
| Step in the pathway | Setting / site of service | Who performs it | What equipment is already there | Source |
|---|---|---|---|---|
| Initial evaluation, ruling out treatable/pulsatile causes | Audiology or otolaryngology clinic | Audiologist or physician | Audiometric booth, tympanometry | [15] (guideline recommends against imaging for typical, non-pulsatile, non-asymmetric cases) |
| Device fitting (candidate's proposed model: remote) | Predicate's model: in-clinic; candidate proposes remote fitting as its own product change | Audiologist/physician (predicate); remote per candidate's design | Fitting software, headphones, electrode component | Candidate frontmatter (mechanism:); not independently verified against the predicate's actual fitting protocol in this pass |
| Home daily treatment | Patient's home | Patient, unsupervised between visits | Headphones + electrical-stimulation unit | Candidate frontmatter |
| Follow-up / outcome assessment | Audiology clinic (pivotal trials) or virtual visit (NCT05518682 protocol) | Audiologist | THI/TFI questionnaires | [16], [18] |
Gaps: Not researched: staffing model and time-per-patient for fitting/follow-up, whether audiology clinics that dispense the predicate already have spare capacity or would need to add staff, and whether "remote fitting" as the candidate proposes has been done for any device in this classification (NCT05518682, [18], is a University of Minnesota protocol that explicitly tests self-adjustment via virtual visits, but it has posted no results — hasResults=false — so this is a registered intention, not a finding, on exactly the question the candidate's design rests on).
as_of: 2026-08-27 — not researched this pass; entries below are read off frontmatter and Section 5/6 findings, not independently sourced.
| Role | Who they are | What they gain | What they lose / what it costs them | Whose budget | Source |
|---|---|---|---|---|---|
| Prescriber / decider | Licensed audiologist or physician (per candidate intended_use:) | A second device line to offer, per unverified deck assumption | Time to learn a new fitting workflow | N/A | Candidate frontmatter (not independently sourced here) |
| Operator / daily user | Patient | Potential symptom reduction (see Section 4/5 effect sizes) | Daily adherence burden; no cure — tinnitus is not eliminated in any trial reviewed | Patient (self-pay, per Section 6) | [2], [3], [1] |
| Purchaser | Patient, or VA formulary (channel-dependent) | — | Device cost ($3,500-$4,750 self-pay range per secondary/blog sources, not independently confirmed against a primary price list — see Section 6) | Patient out-of-pocket, or VA budget if VA-dispensed | Secondary sources only, flagged as such in Section 6 |
| Payer | Commercial insurers reportedly do not cover Lenire (secondary-source claim, not independently verified) | — | — | — | Not independently retrieved as primary; recorded as unconfirmed pending a payer policy document |
| Patient | Same as operator above |
Gaps: This section was not researched independently in this pass; every row rests on material already gathered for Sections 5/6 rather than a dedicated incentive-mapping exercise. Not searched at all: audiologist compensation/incentive structure for dispensing a device family, VA clinician workload/formulary-decision process.
as_of: 2026-08-27 · sources searched: connectors literature on TRT/CBT/sound-therapy RCTs and Cochrane reviews, literature-detail on four PMIDs, WebSearch/WebFetch of the AAO-HNS 2014 guideline fact sheet · not searched: any post-2014 AAO-HNS guideline update (none was found to exist as of this search; not confirmed absent, just not located)
| Item | What it establishes | Evidence quality (design, n, endpoint) | Source |
|---|---|---|---|
| Guideline position — hearing aids | "Clinicians should recommend hearing aid testing for patients with hearing loss and persistent, bothersome tinnitus" | AAO-HNSF 2014 multidisciplinary guideline, 13 recommendations | [15] |
| Guideline position — CBT | "Clinicians should recommend cognitive behavior therapy to patients with persistent, bothersome tinnitus" | Same guideline | [15] |
| Guideline position — sound therapy | "Clinicians may offer sound therapy to patients with persistent, bothersome tinnitus" (weaker verb — "may offer," not "should recommend") | Same guideline | [15] |
| Guideline position — electrical/neuromodulation | "Clinicians should NOT recommend transcranial magnetic stimulation for treating patients with persistent, bothersome tinnitus." No guideline statement located on bimodal acoustic-electrical neuromodulation specifically — the QVN classification postdates this 2014 guideline by nine years | Same guideline; TMS is a different modality from the candidate's, noted for completeness, not read as directly on-point | [15] |
| Pivotal trial(s) — predicate's own configuration (tongue stimulation) | TENT-A2: RCT, n=326 adults with chronic subjective tinnitus, 3 arms, 12-week treatment + 12-month follow-up. THI Cohen's d -0.87 to -0.92 (P<.001); TFI -0.77 to -0.87 (P<.001). "High compliance and satisfaction rates with no treatment-related serious adverse events." | Randomized, double-blinded, exploratory, industry-sponsored (Neuromod) | [2] |
| Pivotal trial(s) — predicate, settings-optimization follow-on | Second large RCT testing whether background noise was necessary and whether re-adjusting settings at 6 weeks overcomes habituation. Cohen's d -0.7 to -1.4 across arms/measures over the full period. "High compliance rate (83.8%) with 70.3% of participants indicating benefit." | Randomized, double-blinded | [3] |
| Effect size vs. comparator — standard of care (TRT), independent of the predicate | Multicenter phase 3 RCT, 151 active-duty/retired military and dependents, moderate-to-severe subjective tinnitus, TRT vs partial-TRT vs standard of care, 18-month follow-up. "There were few differences between treatment groups" on the primary Tinnitus Questionnaire endpoint; "About half of participants showed clinically meaningful reductions" — but this held across all three arms including standard of care, not preferentially for TRT | Randomized, placebo-controlled, phase 3, NCT01177137, 6 US military hospitals | [10] |
| Effect size vs. comparator — CBT | Cochrane review, 28 studies, n=2,733. CBT vs audiological care: THI mean difference -5.65 points (95% CI -9.79 to -1.50), moderate certainty, MCID=7 points — i.e. the pooled effect falls short of the study's own minimal-clinically-important-difference threshold. CBT vs no intervention: SMD -0.56, low certainty | Cochrane systematic review/meta-analysis, GRADE-rated | [11] |
| Effect size vs. comparator — sound therapy (hearing aids / sound generators) | Cochrane review, 8 studies, n=590. "There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device." Quality of evidence "low" throughout | Cochrane systematic review, GRADE-rated | [12] |
| Known negative / equivocal findings | The single largest, most rigorous RCT located for the standard-of-care comparator (TRT, [10]) found no meaningful separation from standard of care at 18 months; the Cochrane sound-therapy review ([12]) found no evidence of superiority over no treatment at all | See rows above | [10], [12] |
Verbatim:
"Longitudinal analyses showed no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT, on TQ, TFI, or THI total scores... There were few differences between treatment groups." — [10]
"There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device... The quality of evidence for the reported outcomes, assessed using GRADE, was low." — [12]
Gaps: No head-to-head trial of bimodal acoustic-electrical neuromodulation against TRT, CBT, or sound therapy was located — [2] and [3] are single/parallel-arm comparisons of the predicate's own settings against each other, not against another standard-of-care modality. Read at abstract depth only; risk-of-bias tables, full CONSORT flow, and funding/COI disclosures were not read for any trial in this table. No post-2014 AAO-HNS guideline update was located (not confirmed to be absent — simply not found by this search).
as_of: 2026-08-27 · sources searched: connectors literature/literature-detail, connectors trials/trial-detail, connectors clearances/recalls/classification, WebSearch/WebFetch of company and press materials · not searched: MAUDE adverse-event narratives specific to Lenire (no MAUDE connector run this pass), post-market surveillance reports, any formal withdrawal-reason table from the pivotal trials (none of the abstracts read report a per-arm dropout/attrition count — see gap below)
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Discontinuation / dropout rate, pivotal RCT (TENT-A2) | Not reported in the abstract read; "no treatment-related serious adverse events" and "high compliance and satisfaction rates" stated in aggregate, no per-arm attrition count given | [2] |
| Discontinuation / dropout rate, settings RCT | Not reported as a discontinuation figure; compliance reported as 83.8% (i.e. an adherence rate, not a dropout count) with 70.3% reporting benefit | [3] |
| Discontinuation / dropout rate, real-world US retrospective chart review | 220 patients identified; 212 had available outcome data at ~12 weeks (8 of 220, 3.6%, had no outcome recorded — the paper does not state whether this is loss-to-follow-up/discontinuation or a data-completeness artifact; not the same claim as a discontinuation rate, flagged as a gap, not a finding) | [1a] |
| Adherence over time | 83.8% compliance rate reported in [3]; no adherence curve over the full recommended treatment duration was located | [3] |
| Stated reasons for discontinuation | Not found. No trial or chart review read in this pass reports a withdrawal-reason table | — |
| Recurring complaint or failure mode | Not found. No MAUDE search run this pass; no adverse-event narrative source retrieved | — |
| Recalls / enforcement | 0 records. recalls --product-code QVN --since 5y → 0; recalls --firm "Neuromod" --since 5y → 0. A Stage-0 scan result, carries no confidence tag — absence of a recall record is not the same as absence of a field-performance problem | openFDA recalls scan |
| Withdrawn from commercial distribution | Not found; no indication located that Lenire has been withdrawn |
"out of 212 patients with available data, there was a high responder rate of 91.5% (95% CI: 86.9%, 94.5%) with a mean improvement of 27.8 ± 1.3 (SEM) points, and no device-related serious adverse events." — [1a]
Gaps: The single most decision-relevant number this section is missing — a stated, per-arm discontinuation/dropout rate with reasons, of the kind docs/research-lane-spec.md §3.1 asks for — was not found in any of the three predicate-specific publications read at abstract depth. This may be a "not searched at full-text depth" problem rather than a "does not exist" problem: full-text methods/results sections (not retrieved in this pass) commonly report CONSORT flow diagrams with exact per-arm dropout counts that an abstract omits. Recorded as not found at abstract depth, not searched at full-text depth.
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Effect vs. standard of care | No statistically meaningful separation from standard of care at 18 months on the primary endpoint, across TRT, partial-TRT, and SoC arms alike | [10] |
| Responder rate, TRT arm vs. others | "About half of participants showed clinically meaningful reductions in the effect of tinnitus" — reported in aggregate, not broken out as a TRT-specific advantage over SoC | [10] |
| Meta-analytic support | A 2021 meta-analysis of 13 RCTs (n=1,345) found TRT-plus-drugs outperformed drugs alone, but rated the underlying evidence "low-quality... with a high risk of bias" | [13] |
"Analysis of limited studies low-quality evidence with a high risk of bias showed that the TRT was an effective treatment for tinnitus... However, more multicenter RCTs with a large sample number and high quality should verify the conclusion." — [13]
| Signal | Quantity (n, population, date) | Source |
|---|---|---|
| Effect vs. audiological care | THI mean difference -5.65 points (95% CI -9.79 to -1.50), moderate certainty — below the review's own 7-point MCID | [11] |
| Trial attrition, internet-delivered CBT for acute tinnitus | 34.48% dropout attrition; 64.4% "training attrition" (non-usage) in the internet-delivered arm of a 337-participant RCT (87 in the internet-training condition) | [14] |
"There was a 34.48% dropout from the Internet-based training (dropout attrition). The training attrition from the Internet-based training was even higher at 64.4%." — [14]
Note this is acute tinnitus and an internet-delivery format, not the candidate's chronic/home-device population — carried here as the closest attrition figure located for a psychological-counseling comparator, with that scope difference flagged explicitly.
"There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options... over each other." — [12]
No discontinuation-rate table was located within this review; "insufficient evidence" is the review's own limitation statement, not a dropout figure.
Section 5 overall gaps: No product in this section has a sourced, quantified discontinuation/dropout-with-reasons table at the standard this section's template asks for. The closest approaches are [14]'s attrition figures (wrong population/modality) and [1a]'s 212-of-220 completion figure (real-world, right device, but not stated by the authors as a discontinuation rate). This is the section's single biggest open item and the first place a Corroborator or a later Researcher pass should look at full-text depth.
as_of: 2026-08-27 · sources searched: connectors hcpcs/payment/coverage (probed on speculative codes V5299, L8679), WebFetch of VA National Acquisition Center Schedule 65 II A page and its redirect target, WebFetch of two company press releases, WebFetch attempt on the VBA Annual Benefits Report FY2025 compensation PDF · not searched: the VA National Acquisition Center's own contract-catalog search tool for the actual FSS contract number
| Item | Detail | Source |
|---|---|---|
| Codes in use (HCPCS; CPT only if licensed) | None confirmed. hcpcs/payment/coverage connectors return unconfirmed for lack of a local CMS cache (data/hcpcs_level_ii.csv, data/hcpcs_payment_rates.csv, data/medicare_coverage_policies.csv all absent on this machine) — this is a missing-cache gap, not a confirmed absence of any code | Connector probes, this pass |
| Payment rate / fee schedule | Not established; no code confirmed to check a rate against | — |
| Coverage policy (NCD/LCD, commercial) | Not established via connector. Secondary/consumer sources state Lenire is "not covered by insurance" and is self-pay — not independently verified against a payer policy document, recorded as an unconfirmed secondary claim, not a finding | Secondary web sources only |
| Site-of-service differential | Not researched | — |
| Whose budget it comes out of — private channel | Patient, self-pay (per unconfirmed secondary sources above) | — |
| Whose budget it comes out of — VA channel | Reported by the manufacturer to be available via a VA Federal Supply Schedule 65 II A Medical Equipment and Supply Contract to "Neuromod USA Inc.," effective per the press release 2024-06-17, also extending to DoD, Bureau of Prisons, Indian Health Services, Public Health Service | [20], [21] |
| VA procurement mechanism, general (not Lenire-specific) | The VA National Acquisition Center's Schedule 65 II A covers "worldwide distribution of hearing aids, hearing aid accessories, auditory implants, assistive devices, batteries... Telehealth messaging devices and peripherals." Contracts are "indefinite delivery/indefinite quantity type contracts awarded to pre-approved vendors using full and open competition," requiring "a proposal and undergo a thorough review process that considers ... commercial sales practices, capabilities, financials, and past performance." | [19] |
| VA disability-compensation context (not a market-size or coverage figure) | Company press materials state, citing "US VA Benefits Report Fiscal Year 2023": "More than 2.9 million veterans received more than $5 billion in compensation in 2023" for tinnitus and "Sixty-three percent of all auditory Veteran Compensation Claims were for tinnitus." This is sourced to a company press release quoting a federal document, not to the federal document's own text — see the attempted primary retrieval below | [21] |
Verbatim:
"Neuromod USA Inc. has been awarded a Federal Supply Schedule 65 II Medical Equipment and Supply Contract from the US Government" — [20], dated in the release to 2024-06-17
"Contracts are awarded to pre-approved vendors using full and open competition. To obtain a VA Schedule Contract a company must submit a proposal and undergo a thorough review process that considers factors including commercial sales practices, capabilities, financials, and past performance." — [19]
CPT descriptors are AMA-licensed and must not be reproduced here. No candidate HCPCS code was named or tested in this pass beyond exploratory probes on V5299/L8679, both of which returned unconfirmed for a missing cache, not for the code being wrong or right.
Gaps — primary-document attempt and its outcome, stated plainly: The VA Benefits Administration's own Annual Benefits Report (located at https://www.benefits.va.gov/REPORTS/abr/docs/2025-compensation.pdf, a real, retrievable federal PDF) was fetched, but this environment has no PDF text-extraction tool (pdftoppm/poppler-utils absent, pypdf/PyPDF2/fitz unusable) and the fetched document could not be read for its table content. This is "not retrieved," not "not found": the primary document exists and its URL is recorded, but its text was not confirmed to say what the press release says it says. The 2.9-million/63%/"#1 disability since 1955" figures therefore remain sourced only to a company press release quoting the report, not to the report's own text, and should not be treated as independently confirmed. Also not searched: the VA National Acquisition Center's contract-catalog tool for the actual FSS contract number, which would let a later pass confirm the contract's existence and terms independently of company messaging.
as_of: 2026-08-27 · sources searched: connectors clearances --product-code QVN (3y and 5y windows) · not searched: a longer historical view of tinnitus-device clearance activity generally (only the QVN-specific window was run), FDA guidance on tinnitus devices
| Change | When | What it enabled | Source |
|---|---|---|---|
| De Novo grant creates product code QVN | 2023-03-06 | A 510(k) pathway into a "combined acoustic and electrical" tinnitus-relief claim that did not exist before; this is the entire regulatory premise of idea-006 | [4], [5] |
| Follower 510(k) activity under QVN | As of 2026-08-27 | clearances --product-code QVN --since 3y → 0 records; --since 5y → exactly 1 record (DEN210033 itself). No follower has cleared under this code in the 3.5 years the classification has existed | openFDA clearances scan |
| Non-intraoral (auditory-somatosensory) bimodal research activity outside the predicate | Ongoing — NCT03621735 (completed, results posted, University of Michigan, trigeminal/somatosensory-adjacent, n=100), NCT07092033, NCT07158034, NCT06508060, NCT07393880 (various non-intraoral electrode/modality approaches, mostly academic-sponsored, mostly no results posted yet) | Establishes that non-intraoral bimodal stimulation is an active academic research area, separate from the predicate's own intraoral configuration — directly relevant to the candidate's central technical risk (Claim 14 in idea-006) | [16] and trial registry scan |
Gaps: No count of tinnitus-device clearances outside QVN (e.g., under 874.3400 or 874.3300) over time was run, so "the clearance rate over time" for the broader category (rather than just QVN) is unestablished.
as_of: 2026-08-27 — largely unresearched this pass beyond what Sections 5-7 already surface.
| Player | Position | Entered / exited | Recent activity (funding, launch, recall) | Source |
|---|---|---|---|---|
| Neuromod Devices Limited / Neuromod USA Inc. | Sole holder of the QVN-founding De Novo grant; sole occupant of the classification as of this search | Entered 2023 (US De Novo grant) | VA/DoD Federal Supply Schedule contract award, reported 2024-06-17; ongoing academic/industry trial activity ([17], [18], both hasResults=false) | [4], [20], [21] |
| University-sponsored non-intraoral bimodal researchers (Michigan, Minnesota, Trinity College Dublin) | Academic research groups, not commercial entrants | Various, ongoing | Multiple registered trials, mostly no posted results | Trial registry scan, [16] |
Gaps: No funding-round, company-financial, or competitor-intent data was researched. This section should not be read as a market map — it is a byproduct of the regulatory and clinical-evidence searches above, not an independent market scan.
| Question | Class (1 registry / 2 published / 3 stakeholder-future) | What would settle it | Reachable by? |
|---|---|---|---|
| What fraction of Lenire/TENT-A2/TENT-A3 pivotal-trial participants discontinued treatment before the primary endpoint, and for what stated reason? | 2 — published finding | Full-text CONSORT flow diagrams / results sections of [2] and [3], not just their abstracts | Yes — full-text retrieval, not yet done this pass |
| Does the VA's own National Acquisition Center contract-catalog record confirm the Federal Supply Schedule award to Neuromod USA Inc. independently of company press materials, and what are its actual terms (national vs. per-facility, exclusivity, price)? | 1 — registry fact (VA contract record) | vendorportal.ecms.va.gov/nac contract search, or a human-obtained copy of the contract itself | Not reachable by any connector in this repo; a human/manual lookup |
| What is the severity-stratified (moderate-or-greater, THI/TFI-equivalent) prevalence of chronic subjective tinnitus among US adults? | 2 — published finding, if a NHANES/THI-stratified analysis exists | A dedicated literature search for a severity-banded prevalence analysis (not yet located) | Possibly, via literature, not yet run to exhaustion |
| Would VA audiologists prescribe a cheaper follower device over the incumbent Lenire? | 3 — stakeholder future | Not answerable. Revealed-behaviour twin: the incumbent's own real-world US chart-review outcome data ([1a]) and its documented VA/DoD Federal Supply Schedule contract terms are the closest observable analogue to "the VA channel accepted this device family at all" — researched above in Sections 5-6. What remains genuinely unanswerable is whether a second device would be added, which is the class-3 core of the question and is recorded, not answered, here | Twin researched; original left class 3 |
| Would patients pay several thousand dollars out of pocket for a non-curative device when TRT/CBT/hearing aids (cheaper, often covered) show similarly modest effect sizes? | 3 — stakeholder future, with a revealed-behaviour twin | Not answerable directly. Twin: what fraction of TRT/CBT/hearing-aid users discontinue those cheaper standard-of-care options, and why (Section 5) — researched above, and the honest finding is that none of the three standard-of-care abandonment tables were fully populated either (dropout figures found for CBT's internet-delivery format only, [14], in the wrong population) | Twin partially researched; gap recorded |
| What does the CFR §874.3410 special-controls set (seven controls per idea-006's own Verifier note) require for clinical performance testing, and does it constrain the candidate's electrode-site change? | 1 — registry fact | connectors regulation 874.3410 (already run by idea-006's own Verifier pass, per its Claims section) | Yes, and already done at the candidate level — recorded here for domain reuse |
| Section | as_of | How it was gathered | Never checked |
|---|---|---|---|
| 1 Epidemiology | 2026-08-27 | connectors literature + literature-detail (PMID 27441392), WebSearch/WebFetch of AAO-HNS fact sheet | Severity-banded (moderate-or-greater) prevalence specific to the indicated population; incidence; trend over time |
| 2 Care pathway | 2026-08-27 | Read off candidate frontmatter and trial protocols located for other sections; no dedicated search run | Staffing/capacity model at existing audiology practices; any completed remote-fitting study (only a no-results-posted protocol, [18], was found) |
| 3 User groups | 2026-08-27 | Inferred from Sections 5-6, not independently researched | Audiologist incentive structure; payer decision process |
| 4 Clinical evidence | 2026-08-27 | connectors literature/literature-detail on TRT/CBT/sound-therapy RCTs and Cochrane reviews; WebSearch/WebFetch of AAO-HNS guideline fact sheet | Post-2014 guideline update (not located, not confirmed absent); full-text risk-of-bias/COI review of any trial |
| 5 Reference products | 2026-08-27 | connectors literature/literature-detail/trials/trial-detail/clearances/recalls; WebFetch of company FAQ/press pages | Per-arm discontinuation/dropout-with-reasons table at full-text depth for the predicate's own pivotal trials; MAUDE adverse-event narratives; any formal withdrawal-reason table |
| 6 Reimbursement | 2026-08-27 | connectors hcpcs/payment/coverage probes (unconfirmed, missing cache); WebFetch of VA NAC page and two company press releases; WebFetch attempt on VBA ABR FY2025 PDF (retrieved but not text-readable in this environment) | The VBA Annual Benefits Report's own table text (fetched, not machine-readable here); the VA NAC contract-catalog record for the actual FSS contract number; any commercial payer coverage policy document |
| 7 Technology | 2026-08-27 | connectors clearances --product-code QVN (3y, 5y); trial registry scan for non-intraoral bimodal research | Clearance-rate history for the broader tinnitus-device category outside QVN |
| 8 Market players | 2026-08-27 | Byproduct of Sections 5-7 | Funding rounds, competitor financials, any company besides Neuromod with a stated commercial intent |
What this dossier has never looked at: MAUDE adverse-event narratives for Lenire or any tinnitus device; any FDA guidance document on tinnitus devices (fda.gov intermittently gates automated requests, per this repo's standing caveat, and none was attempted here); CPT coding (licensed, out of scope by design); veterinary tinnitus data (does not apply — no US federal dataset exists for veterinary anything, noted for completeness); the VA's own contract-catalog system, as opposed to company press materials describing a VA contract; patent/FTO landscape for bimodal stimulation (out of scope for a domain dossier — this is a per-candidate FTO question, already flagged as idea-006's own most conspicuous gap in its Claims section, not duplicated here).
[1] PMID 27441392 — Bhatt SS, Nagler J, Bhattacharyya N. "Prevalence, Severity, Exposures, and Treatment Patterns of Tinnitus in the United States." JAMA Otolaryngology–Head & Neck Surgery, 2016 Oct 1. https://pubmed.ncbi.nlm.nih.gov/27441392/
[1a] PMID 40295853 — "Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting." Communications Medicine, 2025 Apr 28. https://pubmed.ncbi.nlm.nih.gov/40295853/
[2] PMID 33028707 — "Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study." Science Translational Medicine, 2020 Oct 7. https://pubmed.ncbi.nlm.nih.gov/33028707/
[3] PMID 35773272 — "Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial." Scientific Reports, 2022 Jun 30. https://pubmed.ncbi.nlm.nih.gov/35773272/
[4] openFDA device/510k, k_number=DEN210033 — "Lenire Tinnitus Treatment Device" / Neuromod Devices Limited, decided 2023-03-06. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN210033
[5] openFDA device/classification, product_code=QVN — "Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus," Class 2, regulation 874.3410, review panel EN.
[6] eCFR, Title 21, section 874.3410 (issue 2026-08-19).
[7] eCFR, Title 21, section 874.3400 — "tinnitus masker" (issue 2026-08-19).
[8] eCFR, Title 21, section 874.3300 — air-conduction hearing aid, excludes tinnitus masker (issue 2026-08-19).
[10] PMID 31120533 — Henry JA, et al. "Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial." JAMA Otolaryngology–Head & Neck Surgery, 2019 Jul 1. ClinicalTrials.gov NCT01177137. https://pubmed.ncbi.nlm.nih.gov/31120533/
[11] PMID 31912887 — "Cognitive behavioural therapy for tinnitus." Cochrane Database of Systematic Reviews, 2020 Jan 8. https://pubmed.ncbi.nlm.nih.gov/31912887/
[12] PMID 30589445 — "Sound therapy (using amplification devices and/or sound generators) for tinnitus." Cochrane Database of Systematic Reviews, 2018 Dec 27. https://pubmed.ncbi.nlm.nih.gov/30589445/
[13] PMID 34303210 — "Efficacy of tinnitus retraining therapy in the treatment of tinnitus: A meta-analysis and systematic review." American Journal of Otolaryngology, 2021 Nov-Dec. https://pubmed.ncbi.nlm.nih.gov/34303210/
[14] PMID 23205617 — "An internet-based cognitive-behavioural training for acute tinnitus: secondary analysis of acceptance in terms of satisfaction, trial attrition and non-usage attrition." Cognitive Behaviour Therapy, 2013. https://pubmed.ncbi.nlm.nih.gov/23205617/
[15] PMID 25274374 — Tunkel DE, et al. "Clinical practice guideline: tinnitus executive summary." Otolaryngology–Head and Neck Surgery, 2014. AAO-HNSF fact sheet: https://www.entnet.org/resource/aao-hnsf-cpg-tinnitus-press-release-fact-sheet/
[16] ClinicalTrials.gov NCT03621735 — "Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts," University of Michigan, COMPLETED, hasResults=true, n=100 actual. https://clinicaltrials.gov/study/NCT03621735
[17] ClinicalTrials.gov NCT05227365 — "Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3" (TENT-A3 protocol), Neuromod Devices Ltd., COMPLETED, hasResults=false, n=112 actual. https://clinicaltrials.gov/study/NCT05227365
[18] ClinicalTrials.gov NCT05518682 — "Assessment of Bimodal Stimulation Device Compliance and Satisfaction in Individuals With Tinnitus," University of Minnesota, COMPLETED, hasResults=false, n=26 actual. https://clinicaltrials.gov/study/NCT05518682
[19] VA Office of Procurement, Acquisition and Logistics, National Acquisition Center, "Schedule 65 II A Medical Equipment & Supplies" (redirects to https://department.va.gov/procurement-acquisition-and-logistics/national-acquisition-center/federal-supply-schedule-service/), retrieved 2026-08-27.
[19b] Neuromod, "How much does Lenire cost?" (company FAQ page), https://www.lenire.com/faqs/how-much-does-the-lenire-cost/, retrieved 2026-08-27. Not a source of record for a price figure — cited only for its own hedge language.
[20] PR Newswire UK, "Neuromod's FDA-Approved Lenire Device Now a Treatment Option for 2.9 Million US Veterans with Tinnitus," dated in-release to 2024-06-17. https://www.prnewswire.co.uk/news-releases/neuromods-fda-approved-lenire-device-now-a-treatment-option-for-2-9-million-us-veterans-with-tinnitus-302173371.html
[21] Neuromod newsroom, "Lenire Now a Treatment Option Through Veterans Affairs." https://neuromod.com/neuromod-newsroom/lenire-tinnitus-treatment-option-us-veterans/ — both [20] and [21] cite, but are not, the "US VA Benefits Report Fiscal Year 2023."
[22] US Department of Veterans Affairs, Veterans Benefits Administration, Annual Benefits Report FY2025, Compensation section (PDF). https://www.benefits.va.gov/REPORTS/abr/docs/2025-compensation.pdf — located and fetched, 2026-08-27; text not extractable in this environment (no PDF text-extraction tool available); table content not confirmed. Recorded as "not retrieved," not "not found."
Not independently retrieved as a source of record in this dossier (used only to describe the search landscape, not cited for any factual line above): thepricer.org, soundly.com, earpros.com, hearingaidcostguide.com, neuromedcare.com, tinnitusaz.com — consumer/blog pricing pages located by WebSearch and explicitly excluded per the rule that a search result is never a source of record.