Follower bimodal acoustic-plus-electrical tinnitus neuromodulation device under the QVN classification created by DEN210033, aimed first at the VA channel
7/9
factors scored
3/4
core factors
4/50
claims verified
0
refuted
How to read a tag. Only
verified counts toward a score — it means a typed connector
resolved this against a primary US federal record.
unconfirmed means the Verifier checked and could not confirm,
which very often means the source could not be queried at all rather than that
the claim is doubtful. refuted means a primary source
contradicts it. unverified means nothing has checked it yet.
claim 1verifiedUS
FDA acted on DEN210033 on 2023-03-06 for the Lenire Tinnitus Treatment Device (Neuromod Devices Limited), a device carrying product code QVN
jurisdiction: US — confidence: verified — source: openFDA device/510k k_number=DEN210033 ("Cleared 510(k): Lenire Tinnitus Treatment Device / Neuromod Devices Limited decided 2023-03-06"); product-code linkage from openFDA device/classification product_code=QVN. Verifier note on scope of this verification: the…the full check record's existence, date (March 2023), device name, sponsor and QVN linkage are primary-source confirmed, and the secondary sources' word "approval" is definitively wrong — DEN210033 is not a PMA. What is not independently confirmed is the "De Novo grant" characterisation itself: the designated connector returned unconfirmed — "No local cache at data/fda_denovo.csv — De Novo status for 'Lenire' cannot be checked until it exists ... openFDA publishes no De Novo endpoint at all." So nothing was searched on the De Novo question; the De Novo reading rests on FDA's own DEN- numbering plus the existence of the QVN classification, not on the De Novo listing. A human attaching data/fda_denovo.csv closes the remaining half.
claim 2verifiedUS
The De Novo grant created a new device classification with product code QVN, described as a combined acoustic and electrical external stimulation device for the relief of tinnitus
jurisdiction: US — confidence: verified — source: openFDA device/classification product_code=QVN — "Device class 2: Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus (regulation 874.3410, review panel EN)"; regulation text confirmed at eCFR versioner title-21, issue 2026-08-19,…the full check section=874.3410. The load-bearing claim of the file holds: QVN exists, is Class II with special controls, and its identification language matches the file's wording. Checked against intended_use: as stated in frontmatter (adults 18+, chronic subjective tinnitus of moderate or greater severity, prescribed home use under audiologist/physician supervision) — the 874.3410(b)(7)(i) special control requires labelling that the device is prescribed by a healthcare professional with expertise in tinnitus evaluation and management, which is consistent with that intended use. Finding — the CFR section in frontmatter is incomplete: the QVN launch route sits under 21 CFR 874.3410, a section the file never names; the frontmatter names only 874.3400, which is the separate (and much older) tinnitus-masker section used as the fallback route. The two are different regulations, not variants of one. Frontmatter should be updated by the Generator to name 874.3410 for the launch designation.
claim 3unconfirmedUS
A De Novo grantee's device becomes available as a predicate for subsequent 510(k) submissions in the classification the grant creates
jurisdiction: US — confidence: unconfirmed — source: partially addressed but not settled by eCFR versioner title-21, issue 2026-08-19, sections 860.200 and 860.260. 21 CFR part 860 subpart D confirms the mechanism up to the classification order: §860.200 establishes De Novo classification into class I or II "for…the full check devices for which there is no legally marketed device on which to base a review of substantial equivalence", and §860.260(a) provides that FDA issues an order granting the request and publishes the classification order and any special controls in the Federal Register within 30 days. Neither section — nor §860.250 — contains the word "predicate" or states the downstream consequence the claim asserts. That consequence lives in the FD&C Act (section 513) and in FDA 510(k) practice, and the regulation connector serves CFR text only — FDA guidance, enforcement practice and statutory interpretation are out of its reach, so this is left unconfirmed rather than cited as settled. Not a weak point in practice, but it is not verified here.
claim 4unconfirmedUS
At least one subsequent 510(k) has (or has not) been cleared under QVN since 2023
jurisdiction: US — confidence: unconfirmed — source: clearances --product-code QVN (Stage 0 scan, openFDA). Two windows run: --since 3y (2023-08-24 to 2026-08-23) returned 0 records; --since 5y (2021-08-24 to 2026-08-23) returned exactly 1 record, DEN210033 itself (2023-03-06, Neuromod Devices Limited).…the full check So as of 2026-08-23 there is no follower 510(k) under QVN in the openFDA index — the incumbent is still the only device in its own classification, three and a half years on. Tagged unconfirmed, not verified, for two reasons: (a) clearances is a Stage 0 scan and returns no confidence tag and cannot acquire one (requires_stage_3_verification: true); (b) the claim as written is a disjunction ("has or has not") and is unfalsifiable in that form. Action for the Generator/Scorer: restate as a testable assertion — e.g. "no 510(k) other than DEN210033 has been cleared under QVN as of <date>" — so a later pass can verify or refute it. Reading both directions, as the file asks: the Generator is not late, but nobody has yet demonstrated that the follower route through QVN works.
claim 5verifiedUS
21 CFR 874.3400 classifies the tinnitus masker as Class II with special controls, including patient labelling addressing hearing-health-professional diagnosis, fitting and follow-up care
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-19, section=874.3400. Full text: "(a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises... (b)…the full check Classification. Class II. The special control for this device is patient labeling regarding: (1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications." One correction of degree: the section carries a single special control (patient labelling), not a set, and the identification is squarely a masking claim — "intended to generate noise ... to mask ringing in the ears" — which confirms the file's own point that this fallback trades the therapeutic-relief claim for a masking claim. It does not support an indication "for the treatment of chronic subjective tinnitus".
claim 6verifiedUS
The air-conduction hearing aid generic type expressly excludes tinnitus maskers, which are regulated separately under 874.3400
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-19, section=874.3300: "The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400,…the full check respectively. (b) Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9."
claim 7unconfirmedUS
Reimbursement — the Generator identified no CPT or HCPCS code specific to a tinnitus treatment device, and believes revenue is self-pay or institutional purchase
jurisdiction: US — confidence: unconfirmed — source: no primary check was possible, for two independent reasons, and neither is evidence either way. (1) No code is named in the claim, and hcpcs/payment/coverage are code-lookup connectors — they can confirm or refute a specific code, they cannot enumerate the…the full check code set to prove an absence. An absence found by web search remains an absence found by web search. (2) Even a named code could not have been checked on this machine: probe lookups returned "No local cache at data/hcpcs_level_ii.csv", "No local cache at data/hcpcs_payment_rates.csv", and "No local cache at data/medicare_coverage_policies.csv" (the probe code was chosen only to exercise the connector and asserts nothing about any code). CPT is unverifiable by design — "CPT codes are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3). Rescope this claim to HCPCS, or attach a licensed AMA/vendor source manually." To close this: a human attaches the CMS HCPCS Level II, payment-rate and coverage-policy files to data/, and the Generator names the specific candidate code(s) to test. Note that even then, code existence alone would not establish a reimbursement pathway — existence, payment above cost, and a coverage policy are three separate questions.
claim 8unconfirmedUS
Tinnitus is the most prevalent service-connected disability among US veterans receiving VA compensation, with roughly 3.2-3.5 million service-connected tinnitus disabilities reported in recent VA Annual Benefits Reports
jurisdiction: US — confidence: unconfirmed — source: no connector in this repo reads VA data. There is no VBA/VHA connector in the CLI, and substituting a web search for the VBA Annual Benefits Report is exactly the move this gate exists to prevent. Recorded as explicitly unchecked, not as weakly supported. Closes…the full check only when a human attaches the VBA Annual Benefits Report PDF and cites the table. Carry the caveat the Scorer already noted: even verified, this is a disability-compensation count, not the indicated population and not a market size.
claim 9unconfirmedUS
The predicate device is available to US veterans through VA, i.e. the VA channel is already open for this device category rather than needing to be created
jurisdiction: US — confidence: unconfirmed — source: no connector reads VA Federal Supply Schedule, VA prosthetics purchasing, or VA contract data. No check was performed. The terms of availability (national contract vs. per-site purchase vs. pilot) are the whole value of the claim and remain entirely unknown.…the full check Human-attached primary required: the FSS contract listing or VA prosthetics purchasing terms naming the predicate.
claim 10unconfirmedUS
TAM component 1 — US adults with chronic bothersome tinnitus of moderate or greater severity, the population matching the indication
jurisdiction: US — confidence: unconfirmed — source: market connector returns unverifiable by design — "Market-size claim ... has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand." The usual checkable proxy does…the full check not rescue this one: procedures reads Medicare fee-for-service utilization by code, and (a) the natural tinnitus-assessment code is CPT, which is unverifiable by licence, and (b) data/medicare_procedure_volumes.csv is absent on this machine in any case. Even with both fixed, a Medicare FFS volume would be a floor on one channel's utilization — excluding Medicare Advantage, commercial, Medicaid, VA and cash-pay — and this is a prevalence claim, not a procedure-volume claim. Needs a severity-stratified epidemiological source (human-attached). The file's own warning stands and is correct: "any tinnitus" prevalence figures overstate the indicated population by a large multiple.
claim 11unconfirmedUS
TAM component 2 — net selling price per device, assumed by the Generator at $2,000-$4,000 including fitting and the first treatment cycle
jurisdiction: US — confidence: unconfirmed — source: market connector, unverifiable by design (see component 1). No connector prices a commercial device. Human-attached primary: the predicate's published US price list. Stated by the Generator as an assumption and it remains one.
claim 12unconfirmedUS
TAM component 3 — addressable share assumption: the initial obtainable segment is VA-channel dispensing plus private audiology practices already selling tinnitus programmes, assumed at a low single-digit percentage of component 1 in the first three years
jurisdiction: US — confidence: unconfirmed — source: market connector, unverifiable by design. Downstream of components 1 and 2 and of the unchecked VA-channel claim; nothing to check against until those resolve.
claim 13unconfirmedUS
Clinical evidence for the class exists in peer-reviewed form, including a multi-site single-arm controlled pivotal trial of combined sound and tongue stimulation and a retrospective clinical chart review published in 2025
jurisdiction: US — confidence: unconfirmed — source: literature (Stage 0 scan, PubMed) — carries no confidence tag and cannot acquire one (requires_stage_3_verification: true), so the scan locates records but does not verify the claim. Records located: PMID 33028707, "Bimodal neuromodulation combining sound and…the full check tongue stimulation reduces tinnitus symptoms in a large randomized [trial]", Science Translational Medicine, 2020-10-07 (type: Randomized Controlled Trial); PMID 35773272, "Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial", Scientific Reports, 2022-06-30 (RCT); PMID 40295853, "Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting", Communications Medicine, 2025-04-28. Discrepancy to fix before this is re-checked: the claim describes the pivotal trial as "single-arm controlled", while both located pivotal records are titled as randomized trials. The design descriptor in the claim is not supported by the located titles and should be restated by the Generator to match the record it means. Titles only — not appraised; effect size, comparator, durability and applicability to a different electrode site remain unread, exactly as the claim's own caveat says.
claim 14unconfirmedUS
Mechanism and clinical risk — the bimodal-plasticity rationale is supported for the predicate's tongue-stimulation configuration; whether it transfers to a trigeminal/cervical cutaneous electrode is an open scientific question, not an engineering detail, and is the candidate's central technical risk
jurisdiction: US — confidence: unconfirmed — source: no connector verifies a scientific-transfer judgement; literature and trials are Stage 0 scans and return no confidence tag. Pointer located that bears directly on it: NCT03621735, "Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory…the full check Stimulation to Treat Phantom Percepts" (University of Michigan; COMPLETED, hasResults=true; randomized crossover, quadruple-masked, 100 enrolled actual; primary outcomes change in objective tinnitus loudness, TFI, THI) — i.e. non-intraoral auditory-somatosensory bimodal work with posted results does exist and is the first thing a human should read on this risk. Also located: NCT05227365, NCT06508060 (auditory + vibrotactile), NCT05518682, NCT07393880. The scans do not settle the claim; they name what would.
claim 15unconfirmedUS
Capital intensity and time-to-revenue — if the 510(k) route holds, the Generator estimates low-single-digit millions and 18-30 months; if FDA finds the electrode-site change not substantially equivalent, the cost is a pivotal trial and the estimate becomes mid-eight-figures and 4+ years
jurisdiction: US — confidence: unconfirmed — source: Generator's estimate; no connector prices a development programme. One check that would have informed it was attempted and could not run: clearance-summary on a QVN 510(k) would show what evidence FDA actually accepted, but there is no QVN K-number to read — the…the full check only QVN record is DEN210033, and clearance-summary DEN210033 returned unconfirmed, "'DEN210033' is not a K-number. Expected the form K123456", because a De Novo summary is a different document type this connector does not serve. The direct settling artifact remains an FDA Pre-Submission written response, obtained by a human.
claim 16unconfirmedUS
Competitive intensity — the De Novo grantee holds a first-mover position, a published pivotal trial, and an established VA relationship, and any follower arrives second into a category the incumbent defined
jurisdiction: US — confidence: unconfirmed — source: a composite judgement, not a single checkable fact; its components resolve separately above (first-mover: verified via DEN210033/QVN; published pivotal trial: located but unappraised, claim 13; VA relationship: entirely unchecked, claim 9). Additional Stage 0 scans…the full check run, both returning nothing and neither carrying a confidence tag: recalls --firm "Neuromod" --since 5y → 0 records; recalls --product-code QVN --since 5y → 0 records. No adverse field-performance signal against the incumbent in openFDA — which cuts against the follower, not for it.
claim 17unconfirmedUS
Assumption, not a fact: the idea depends on audiologists being willing to dispense a second, cheaper bimodal device alongside or instead of the incumbent, and on patients paying several thousand dollars out of pocket for a non-curative treatment
jurisdiction: US — confidence: unconfirmed — source: adoption connector, unverifiable by design: "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study). Stays unconfirmed…the full check permanently unless a human attaches real research... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." No Verifier judgement about clinician or patient behaviour has been substituted here. The checkable proxy the connector suggests is blocked in this file too — coverage for a comparator needs both a named code and data/medicare_coverage_policies.csv, and neither exists.
claim 18unconfirmedUS
Adults with chronic bothersome tinnitus will keep to a prescribed daily bimodal treatment schedule at home for the full treatment cycle
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Adoption claim (stakeholder behaviour). python3 -m connectors adoption returns unverifiable by design: asserts what patients would do; no free authoritative source answers this — needs primary research…the full check (trials, real-world data, surveys). Stays unconfirmed permanently unless human attaches published adherence study or real-world registry data
claim 19unconfirmedUS
Veterans can obtain a bimodal tinnitus device through VA prosthetics as a routine dispense, rather than through an individual funding decision at each facility
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Adoption claim about payer (VA procurement) and organizational behaviour. No connector reads VA prosthetics purchasing or formulary policy. Even if a contract exists (claim 110), routine dispensing vs.…the full check individual funding decisions is a policy question requiring official VA prosthetics manual/guidance
claim 20unconfirmedUS
Patients and audiologists will accept remote fitting in place of in-clinic fitting for a device in this family
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Adoption claim (stakeholder preference). python3 -m connectors adoption returns unverifiable by design: asserts what clinicians and patients would accept; needs primary research (preference study,…the full check published trial data on remote-fitting acceptance). Do NOT substitute model's own estimate
claim 21unconfirmedUS
Adults with bothersome tinnitus present to audiologists rather than to primary care or otolaryngology, making audiology the right point of dispensing
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24). Adoption claim (patient-seeking behaviour). python3 -m connectors adoption returns unverifiable by design. Care-pathway question requires primary research (patient survey, claims-data analysis by…the full check specialty of first contact). Note: this is partially checkable via procedures using CPT codes for audiologist vs. ENT visits, but CPT is unverifiable by licence
claim 22unconfirmedUS
A cheaper follower device can win VA Federal Supply Schedule placement in a category where the first mover already holds a contract
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Adoption/procurement claim (payer behaviour). python3 -m connectors adoption returns unverifiable by design: asserts what a government buyer would do. No VA procurement connector exists. Would require: (a)…the full check analysis of historical VA procurement (multiple-award contracts and follower-replacement patterns), or (b) official VA procurement guidance on competitive re-evaluation
claim 23unconfirmedUS
The defensible asset available to a follower here is price and remote fitting rather than technology, since the classification the De Novo created is open to anyone who can clear into it
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Strategic/competitive assessment. This is an interpretation of regulatory and market structure rather than a checkable fact. The open-access claim (any follower can clear into 874.3410) is partially checkable…the full check via clearances --product-code QVN (no other QVN clearances found as of 2026-08-23, per claim 4), but that's a zero-result scan with no confidence tag. Defensibility is a strategic judgement, not a verifiable claim
claim 24unconfirmedUS
Private audiology practices already selling tinnitus programmes will add a second device line at the assumed price point
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24). Adoption claim (vendor behaviour). python3 -m connectors adoption returns unverifiable by design: asserts what private providers would do. Needs primary research (surveys of audiology practices, real-world…the full check data on multi-device dispensing patterns). Proxy option: claims-data analysis on dual-device uptake if a billing code exists
claim 25unconfirmedUS
A safe and effective electrical stimulation level can be set remotely, without a clinician present at fitting
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Technical feasibility claim. No connector verifies engineering feasibility of a proposed design. This requires (a) technical performance data from benchtop or pre-clinical testing, or (b) published literature…the full check on remote electrical stimulation fitting safety (would need literature-detail scan for specific papers). Note: the predicate (Lenire) uses intraoral placement; transfer to trigeminal/cervical site with remote setting is the core NSE risk identified in the file (claim 14)
claim 26unconfirmedUS
Acoustic and electrical stimulation can be paired with the timing precision the bimodal-plasticity rationale requires, on home-use hardware
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Technical feasibility claim. No connector verifies engineering capability. Requires: (a) technical specification/design documentation showing timing precision achievable in home-use form factor, or (b)…the full check published data on timing precision requirements and off-the-shelf consumer device constraints. This is part of the central mechanism risk (claim 14) — bimodal plasticity timing is load-bearing for the entire rationale
claim 27unconfirmedUS
Transcutaneous stimulation at a trigeminal or cervical site is tolerable for daily use across a full treatment cycle without skin reaction or unacceptable sensation
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24). Safety/tolerability assumption. No connector verifies pre-clinical or clinical tolerability. Requires: (a) benchtop or animal safety testing, (b) published literature on transcutaneous cervical/trigeminal…the full check stimulation safety and adverse-event rates (literature-detail would apply if specific PMIDs exist), or (c) clinical trial data. The candidate's core electrode-site change from intraoral (predicate) to transcutaneous site creates this novel risk
claim 28unconfirmedUS
No live, enforceable US patent covering bimodal acoustic-plus-electrical stimulation timing blocks a follower device in this classification
jurisdiction: US — confidence: unconfirmed — source: FTO/IP claim, not verified. python3 -m connectors patent requires a specific US patent number as input; this claim asserts an absence without naming candidate patents. PATENTSVIEW_API_KEY is unset in this environment, so the connector would return unconfirmed even…the full check with a number. Note: absence claim requires active search and enumeration, which patent connectors cannot provide — they verify specific patents. Scout/Scout work item: USPTO Patent Public Search on "Neuromod Devices" assignee and on "bimodal acoustic electrical stimulation tinnitus" to identify blocking families; then patent <US number> per family. A live blocking claim reading on timed bimodal acoustic-plus-electrical stimulation with no design-around is an automatic kill under the rubric (phase2-spec.md §1)
claim 29unconfirmedUS
ClinicalTrials.gov record NCT03621735 (University of Michigan, non-intraoral auditory-somatosensory bimodal stimulation for tinnitus) is status COMPLETED with hasResults=true and an actual enrollment of 100 participants
jurisdiction: US — confidence: unconfirmed — source: ClinicalTrials.gov NCTId=NCT03621735. Registry record retrieved: status=COMPLETED, hasResults=true, enrollment 100 (ACTUAL), randomized crossover design, quadruple-masked, primary outcomes include Objective Tinnitus Loudness, TFI, and THI **Verifier correction…the full check (2026-08-29):** trial-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source registry match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, same rule as this repo's literature-detail claims.
claim 30unconfirmedUS
The VA National Acquisition Center's Schedule 65 II A federal supply schedule covers worldwide distribution of hearing aids, hearing aid accessories, auditory implants and assistive devices, awarded as indefinite-delivery/indefinite-quantity contracts to pre-approved vendors through full and open competition
jurisdiction: US — confidence: unconfirmed — source: no connector in this repo reads VA Federal Supply Schedule or procurement data (see phase2-spec.md Section 3). Claim asserts a fact about a government procurement schedule; no typed connector exists to verify agency-specific purchasing policies against their…the full check official source. Human-attached primary: official VA Federal Supply Schedule contract listing
claim 31unconfirmedUS
TENT-A2, a randomized double-blinded trial of 326 adults with chronic subjective tinnitus, reported a Cohen's d effect size of -0.87 to -0.92 on the Tinnitus Handicap Inventory across bimodal (sound-plus-tongue) stimulation arms at end of a 12-week treatment period, P<.001
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=33028707 (efetch). Abstract retrieved and claim text confirmed: "326 adults with chronic subjective tinnitus" in "randomized, double-blinded" trial; "Cohen's d effect size: -0.87 to -0.92 across arms" on THI; "12-week treatment period"; "P < 0.001"…the full checkVerifier correction (2026-08-29):literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 32unconfirmedUS
A large randomized bimodal-neuromodulation settings trial reported an 83.8% treatment compliance rate with 70.3% of participants indicating benefit
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=35773272 (efetch). Abstract retrieved and claim text confirmed: "high compliance rate (83.8%)" with "70.3% of participants indicating benefit" in this randomized trial of bimodal neuromodulation settings Verifier correction (2026-08-29):…the full checkliterature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 33unconfirmedUS
A 220-patient US real-world retrospective chart review of the Lenire bimodal neuromodulation device reported a 91.5% (95% CI 86.9%-94.5%) responder rate (Tinnitus Handicap Inventory improvement greater than 7 points) among the 212 patients with available outcome data at approximately 12 weeks
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=40295853 (efetch). Abstract retrieved and claim text confirmed: "220 patients" from "Alaska Hearing & Tinnitus Center", "212 patients with available data" with "91.5% (95% CI: 86.9%, 94.5%)" responder rate, THI improvement >7 points, "~12 weeks of…the full check treatment" Verifier correction (2026-08-29):literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 34unconfirmedUS
A 151-participant randomized placebo-controlled multicenter trial of tinnitus retraining therapy versus standard of care at 6 US military hospitals found no statistically meaningful difference between tinnitus retraining therapy, partial tinnitus retraining therapy, and standard of care on the primary Tinnitus Questionnaire endpoint at 18 months
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=31120533 (efetch). Abstract retrieved and claim text confirmed: "151 participants", "6 US military hospitals", "randomized, placebo-controlled, multicenter"; "no difference between partial TRT or TRT compared with SoC, or partial TRT compared with TRT,…the full check on TQ... at 18 months" Verifier correction (2026-08-29):literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 35unconfirmedUS
A Cochrane systematic review of cognitive behavioral therapy for tinnitus (28 studies, n=2733) found CBT reduced Tinnitus Handicap Inventory scores by a mean difference of 5.65 points versus audiological care, below the review's own 7-point minimal clinically important difference threshold
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=31912887 (efetch). Abstract retrieved and claim text confirmed: "28 studies... with a total of 2733 participants"; "mean difference (MD) -5.65, 95% CI -9.79 to -1.50" vs. audiological care on THI; MCID = 7 points Verifier correction (2026-08-29):…the full checkliterature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 36unconfirmedUS
A Cochrane systematic review of sound therapy for tinnitus (8 studies, n=590) found no evidence that hearing aids, sound generators, or combination devices are superior to waiting-list control, placebo, or education-only, with evidence quality rated low throughout
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=30589445 (efetch). Abstract retrieved and claim text confirmed: "eight studies (with a total of 590 participants)"; "no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no…the full check device"; "quality of evidence... was low" Verifier correction (2026-08-29):literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 37unconfirmedUS
An internet-delivered cognitive-behavioral training trial for acute tinnitus (337 participants total, 87 in the internet-training arm) reported a 34.48% dropout attrition rate and a 64.4% training (non-usage) attrition rate
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=23205617 (efetch). Abstract retrieved and claim text confirmed: "337 participants, 87 persons took part in the Internet training"; "34.48% dropout from the Internet-based training"; "64.4%" training (non-usage) attrition **Verifier correction…the full check (2026-08-29):** literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 38unconfirmedUS
Analysis of the 2007 National Health Interview Survey (75,764 respondents) found a 9.6% (SE 0.3%) 12-month tinnitus prevalence among US adults, an estimated 21.4 of 222.1 million adults, of whom 7.2% rated their tinnitus as a big or very big problem
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=27441392 (efetch). Abstract retrieved and claim text confirmed: "2007 National Health Interview Survey (raw data, 75 764 respondents)"; "21.4 (3.4) million (9.6% [0.3%])" experienced tinnitus; "7.2% reported their tinnitus as a big or a very big problem"…the full checkVerifier correction (2026-08-29):literature-detail returns a ScanResult with no confidence field by construction (docs/research-lane-spec.md §3, connectors/result.py) — a single-source abstract match cannot resolve to verified; content confirmed accurate as quoted, tag held at unconfirmed on structural grounds, consistent with every other Verifier pass in this repo (idea-001, idea-002, idea-003, idea-005, idea-007, idea-008, idea-009).
claim 39unconfirmedUS
The 2014 AAO-HNSF Clinical Practice Guideline for Tinnitus recommends hearing aid evaluation and cognitive behavioral therapy for persistent bothersome tinnitus, states clinicians 'may offer' (a weaker action statement) sound therapy, and contains no recommendation addressing bimodal acoustic-electrical neuromodulation
jurisdiction: US — confidence: unconfirmed — source: PubMed PMID=25274374 (efetch) — record located but specific recommendation text not in abstract. The abstract confirms this is the 2014 AAO-HNSF guideline with "13 recommendations" but does not quote the specific action statements (e.g., language about "may offer"…the full check or absence of bimodal recommendations). Full guideline text needed to verify claim
claim 40unconfirmedUS
Per company press materials, Neuromod USA Inc. was awarded a VA Federal Supply Schedule 65 II A Medical Equipment and Supply Contract for the Lenire device effective 2024-06-17, extending eligibility to Department of Defense, Bureau of Prisons, Indian Health Services, and Public Health Service beneficiaries in addition to VA
jurisdiction: US — confidence: unconfirmed — source: company press release (PR Newswire), not a primary government source. No connector reads VA procurement records. Claim asserts a specific contract award with effective date; verifying this requires official VA Federal Supply Schedule contract documentation or a…the full check government procurement database (neither available through typed connectors). Press release may accurately report the award, but sourcing to company materials rather than official government contract records leaves the specific terms and effective date unconfirmed
claim 41unconfirmedUS
VA audiologists would prescribe a cheaper follower bimodal neuromodulation device instead of, or alongside, the incumbent Lenire device already available through the VA Federal Supply Schedule
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier chronic-subjective-tinnitus-neuromodulation §9 (2026-08-27) — evidence class 3 (stakeholder future). Adoption claim (clinician preference). python3 -m connectors adoption returns unverifiable by design. No source can settle a…the full check prediction of future clinician behaviour. Guidance (phase2-spec.md, verifier.md): rescope to revealed-behaviour twin if one exists — e.g. analyse current dual-product dispensing patterns for comparable devices, or historical VA switching when a lower-cost alternative entered the market. Do NOT substitute model's estimate of what VA audiologists would do
claim 42unverifiedUS
The veteran service-connected tinnitus disability-compensation population and the clinically-indicated population (adults with moderate-or-greater chronic subjective tinnitus) overlap enough that the compensation count can be treated as a meaningful bound on the VA-channel addressable population, rather than two largely uncorrelated counts
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 43unverifiedUS
A follower device, distinct from the incumbent's, can obtain its own VA Federal Supply Schedule 65 II A listing within a cost and calendar a launch budget can absorb, independent of whether VA audiologists would then prescribe it
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 44unverifiedUS
The Generator's capital and calendar estimate for the 510(k) branch (low-single-digit millions, 18-30 months) covers regulatory and clinical activity only and excludes go-to-market spend -- VA Federal Supply Schedule contracting, private-audiology channel build, and the remote-fitting telemetry platform
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 45unverifiedUS
A device price of ,000-,000 yields positive gross margin after cost of goods, remote-fitting platform amortization, and clinical/customer support
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 46unverifiedUS
A VA Federal Supply Schedule contract price for this device would sit meaningfully below the ,000-,000 self-pay range, given FSS competitive-pricing requirements, rather than at or above it
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 47unverifiedUS
Building and operating a remote-fitting and adherence-telemetry platform reliable enough to substitute for in-clinic fitting is achievable within the same capital and calendar envelope as the regulatory pathway, rather than adding materially to it
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 48unverifiedUS
A sound-only fallback submission under 21 CFR 874.3400 can be cleared and brought to market at materially lower capital and shorter calendar than the QVN 510(k) route, rather than at comparable cost
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 49unverifiedUS
A partner already selling or entering the QVN classification would pay a royalty or transfer price for a validated non-intraoral electrode-plus-remote-fitting module large enough to fund a licensing route, rather than building the capability in-house or declining to move away from its own validated tongue-electrode configuration
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 50unverifiedUS
Bench validation of a non-intraoral electrode/telemetry subsystem and the regulatory scoping to license it into an already-cleared QVN device is achievable at materially smaller capital and calendar than a full clearance-plus-channel route
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it