idea-006 · feasibility deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the engineers who have to pair sound and electrical stimulation with the timing the therapy depends on — at a different electrode site from the one the evidence was generated on.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-006.md — the number is the claim's position in its ## Claims list, the tag is copied from it and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. See docs/deck-spec.md.
What changed since the 2026-08-24 build: the class's clinical evidence is now specified rather than gestured at claim 31unconfirmed through claim 33unconfirmed, the comparators are characterised claim 35unconfirmed, claim 36unconfirmed, and — most usefully for this chair — a completed 100-participant randomized crossover trial of non-intraoral bimodal stimulation with posted results is now on record claim 29unconfirmed. That is the nearest existing evidence to this deck's load-bearing condition. Rebuilt from the file, not patched.
Would have to be true: Headphones and a transcutaneous stimulator would have to deliver timed acoustic and electrical stimulation together, on a fixed daily schedule, fitted remotely, with adherence telemetry back to the clinician.
Where it stands: No stimulation-parameter specification is stated as a claim [no claim], so this deck states none. The regulatory container is verified — FDA (US Food and Drug Administration) acted on the De Novo (De Novo classification request) in March 2023 claim 1verified, creating product code QVN for a combined acoustic and electrical stimulation device claim 2verified — and the special controls attached to that classification are the specification nobody has read. The class's pivotal evidence is now identified and can supply the stimulation parameters: a 326-adult randomized double-blinded trial claim 31unconfirmed, claim 13unconfirmed.
What would settle it: The QVN special controls and the De Novo decision summary, read directly for the performance requirements FDA attached; the pivotal trial's published stimulation parameters claim 31unconfirmed.
If it's false: There is no spec for the one parameter the therapy depends on, and the device is headphones plus a stimulator running independently.
Would have to be true: Bimodal plasticity would have to transfer from the predicate's tongue-stimulation configuration to a trigeminal or cervical cutaneous electrode.
Where it stands: Still the candidate's own central technical risk and still unbacked claim 14unconfirmed — but the evidence around it is now well mapped, and it splits cleanly. The tongue configuration works: Cohen's d of -0.87 to -0.92 on the Tinnitus Handicap Inventory across bimodal arms at 12 weeks, P<.001, in 326 adults claim 31unconfirmed, with a 91.5% real-world responder rate in a 220-patient US series claim 33unconfirmed and 83.8% compliance in a settings trial claim 32unconfirmed. None of that is evidence about a non-tongue electrode. What is: a University of Michigan randomized crossover trial of non-intraoral auditory-somatosensory bimodal stimulation, NCT03621735 (a ClinicalTrials.gov registration number), status COMPLETED, 100 participants actual, with results posted claim 29unconfirmed. That record exists, has results, and has not been read. It is the single most relevant unread document on this candidate.
What would settle it: Read NCT03621735's posted results claim 29unconfirmed — a registry record, free, with outcome data already public. Then the mechanistic literature on trigeminal versus lingual afferent pairing; then a single-arm study at the proposed site.
If it's false: The device is a differently-wired copy that does not work, and every regulatory and commercial advantage of being second evaporates — this is also precisely the finding that would push FDA toward not-substantially-equivalent claim 15unconfirmed.
Would have to be true: The follower route into QVN would have to exist, and its special controls would have to be satisfiable without a new pivotal trial.
Where it stands: Unchanged and unread. Whether a De Novo grantee's device becomes available as a predicate is unsettled on this file's own reading claim 3unconfirmed, and whether any subsequent 510(k) (premarket notification) has cleared under QVN since 2023 is unchecked claim 4unconfirmed — three years of silence in a classification created in March 2023 claim 1verified, claim 2verified. The adjacent tinnitus-masker regulation is verified and instructive about how FDA thinks about this device family, including a patient-labelling special control claim 5verified and the express exclusion of tinnitus maskers from the hearing-aid generic type claim 6verified.
What would settle it: The De Novo decision summary and QVN special controls read directly; an FDA pre-submission on the electrode-site change.
If it's false: A pivotal trial enters the critical path and the capital estimate moves from low single-digit millions to mid-eight figures claim 15unconfirmed.
Would have to be true: A safe and effective stimulation level would have to be set remotely, without a clinician present — because remote fitting is the candidate's stated differentiator, and setting an electrical dose is not a software preference.
Where it stands: Unbacked claim 25unconfirmed, and the adjacent regulation's professional-fitting special control claim 5verified is the nearest indication of how FDA treats fitting in this family. The commercial case for taking the risk is weaker than it looked at the last build: the incumbent is reported to hold the VA contract already claim 40unconfirmed, so remote fitting is not a way into an empty channel, it is a way to undercut an occupied one claim 23unconfirmed.
What would settle it: The QVN special controls on fitting; a human-factors and risk analysis for remote dose-setting; a tolerability study at the proposed electrode site claim 27unconfirmed.
If it's false: Either the differentiator goes — and the candidate is a price-only follower claim 23unconfirmed — or it stays and becomes the hardest part of the submission.
Would have to be true: Timing precision, current density and skin tolerability would all have to be characterised before any clinical work at the new electrode site.
Where it stands: All three are this deck's own write-back and all came back unconfirmed claim 26unconfirmed, claim 27unconfirmed, claim 25unconfirmed — engineering claims about unbuilt hardware that no connector here reaches. The ordering has improved since the last build: reading NCT03621735's posted results claim 29unconfirmed costs nothing and bears on whether the bench work is worth commissioning at all.
What would settle it: A bench rig measuring acoustic-electrical timing jitter end to end on home-use hardware; current-density and skin-response testing at the trigeminal/cervical site; and, first, the registry read and the mechanistic literature review, which cost only time.
If it's false: The trial that follows is testing a device whose pairing precision was never demonstrated, which risks a null result that means nothing.
Would have to be true: Consumer-grade headphones, a wearable stimulator, an app and a telemetry pipeline would all have to hold synchronisation and adherence data in a patient's home for weeks.
Where it stands: Timing on home hardware is unbacked claim 26unconfirmed. The adherence half of the requirement now has a class benchmark to design against: 83.8% compliance in a randomized settings trial claim 32unconfirmed, against which a telemetry pipeline's job is to detect the other 16%. Consumables, battery and telemetry use remain absent from the file [no claim].
What would settle it: A synchronisation budget across the full signal chain; the incumbent's own consumable and fitting model as a commercial benchmark.
If it's false: Real-world dose diverges from the prescribed schedule claim 18unconfirmed, which is indistinguishable from the therapy not working.
Would have to be true: Bimodal acoustic-plus-electrical stimulation with paired timing would have to be buildable around the incumbent's patent position.
Where it stands: Never asked claim 28unconfirmed — unexamined, not clear. On a deliberate follower strategy this is the most foreseeable of the three hard gate conditions, and the incumbent's position is the obvious blocking surface. The academic trial now on record claim 29unconfirmed identifies a second assignee family worth including in any search.
What would settle it: A patent landscape on bimodal timing and on transcutaneous stimulation for tinnitus, starting from the De Novo grantee and the University of Michigan programme as assignees; expiry checks; then counsel.
If it's false: Automatic kill under the Stage 5 gate — and on a deliberate follower strategy this is the most foreseeable of the three hard conditions.
Every condition above with nothing verified behind it.
The four verified claims are regulatory and they do useful work: the category exists claim 2verified, when it was created claim 1verified, and how FDA treats fitting and labelling in the adjacent classification claim 5verified, claim 6verified. What none of them touches is the question the candidate itself calls its central risk — and thirteen new claims since the last build did not touch it either, though one now points straight at the document that would.
If only one thing from this chair could be checked: whether bimodal plasticity transfers from the predicate's tongue stimulation to a trigeminal or cervical cutaneous electrode claim 14unconfirmed.
The candidate says so itself, and the whole file arranges around it: it decides whether FDA finds substantial equivalence, which decides whether the capital number is low single-digit millions or mid-eight figures claim 15unconfirmed; it decides whether the clinical evidence for the class transfers or has to be regenerated claim 13unconfirmed; and it decides whether a follower has anything to sell but price claim 23unconfirmed — which matters more now that the incumbent is reported to hold the VA contract claim 40unconfirmed.
It survives as load-bearing and it got cheaper to attack. The last build said a literature review could narrow it. There is now something more specific: a completed randomized crossover trial of non-intraoral auditory-somatosensory bimodal stimulation in 100 participants, with results posted on ClinicalTrials.gov claim 29unconfirmed. Reading that record is free, takes an hour, and speaks directly to whether the mechanism survives leaving the tongue. Nothing else on this candidate offers that ratio.
Naming it is not a recommendation, a gate, or a kill.
_shared/plain-language.md