https://www.whensilence.com/changelog What changed on When Silence, and why, as trials read out and new evidence comes in. en Fri, 09 Oct 2026 00:00:00 GMT https://www.whensilence.com/knowledge/trial/NCT07032038 whensilence:2026-10-09:trial:NCT07032038:29e75d2a46 Fri, 09 Oct 2026 00:00:00 GMT Added to Clinical Trials: NCT07032038 (Rinri Therapeutics' first-in-human trial of Rincell-1 cell therapy for neural hearing loss in cochlear implant candidates, n=20, 3 UK sites), Not yet recruiting, estimated start Sep 2027. https://www.whensilence.com/knowledge/treatment/rincell1-cell-therapy whensilence:2026-10-09:treatment:rincell1-cell-therapy:c58952eb86 Fri, 09 Oct 2026 00:00:00 GMT Rincell-1's first-in-human trial has not started: the ClinicalTrials.gov record (NCT07032038, updated 1 Oct 2026) lists it as not yet recruiting, with the start moved to Sep 2027 and primary completion to May 2029. This corrects the earlier report that enrollment began in May 2026. Rinri has given no public explanation. Estimated availability moved from 2031-2033 to 2033-2035. https://www.whensilence.com/knowledge/treatment/bimodal-stimulation whensilence:2026-09-30:treatment:bimodal-stimulation:7e15bc3d65 Wed, 30 Sep 2026 00:00:00 GMT Auricle update: the fundraising round that followed TQ's Oct/25 live Q&A did not succeed, CEO Jon Pearson has departed, and no new investor has stepped in. The original lead investor, a tinnitus patient, is still overseeing the company and is weighing two paths: restructure under a new CEO, or return the licensed IP to the University of Michigan. Source: Tinnitus Quest. https://www.whensilence.com/knowledge/paper/42780685 whensilence:2026-09-30:paper:42780685:72b568e4bb Wed, 30 Sep 2026 00:00:00 GMT New paper: in rats with salicylate-induced tinnitus, a single dose of the mTOR inhibitor everolimus reduced primary auditory cortex hyperexcitability, normalized the strengthened theta-gamma coupling, lowered BDNF, PSD95 and glutamate, and improved gap detection (Fan, ..., Ma, Drug Design, Development and Therapy). An acute, reversible model with a peripheral threshold shift the authors could not fully separate from the central effect, and everolimus is an immunosuppressant, not a tinnitus candidate. Linked to Interacting Brain Networks and Central Gain. https://www.whensilence.com/knowledge/paper/42743862 whensilence:2026-09-26:paper:42743862:3f26d36432 Sat, 26 Sep 2026 00:00:00 GMT New paper: in Veterans with normal audiograms, both constant tinnitus and decreased sound tolerance came with reduced ABR wave I amplitudes, reduced envelope following responses, and reduced high frequency DPOAEs, pointing to cochlear deafferentation plus subclinical outer hair cell dysfunction (Szabo, ..., Bramhall, Hearing Research). The middle ear muscle reflex proved unreliable as a deafferentation marker. Linked to Cochlear Synaptopathy and Central Gain. https://www.whensilence.com/knowledge/trial/NCT06776705 whensilence:2026-09-22:trial:NCT06776705:82653d90ab Tue, 22 Sep 2026 00:00:00 GMT Added to Clinical Trials: NCT06776705 (Chinese University of Hong Kong pilot of MRI-guided focused low-intensity transcranial ultrasound for sleep disturbance in chronic tinnitus, n=14), Recruiting. https://www.whensilence.com/knowledge/trial/NCT07548320 whensilence:2026-09-22:trial:NCT07548320:bb6df076c1 Tue, 22 Sep 2026 00:00:00 GMT Added to Clinical Trials: NCT07548320 (Neurive's sham-controlled Soricle trial, vagus nerve plus sound stimulation, n=36), Completed Sep 2025, no results posted yet. https://www.whensilence.com/knowledge/trial/NCT07826507 whensilence:2026-09-21:trial:NCT07826507:5fbffe5097 Mon, 21 Sep 2026 00:00:00 GMT NCT07826507 (REACT: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Phase 1b/2a Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Transtympanic Injection of Paliroden (CIL001) for the Treatment of Cochlear Synaptopathy in Participants With Chronic, Constant Tinnitus): phase: Phase 1b/2a → Phase 1/Phase 2. https://www.whensilence.com/knowledge/trial/NCT07302373 whensilence:2026-09-21:trial:NCT07302373:043bedbe93 Mon, 21 Sep 2026 00:00:00 GMT NCT07302373 (Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts): completion year: 2025 → 2023. https://www.whensilence.com/knowledge/treatment/xen1101-azetukalner whensilence:2026-09-18:treatment:xen1101-azetukalner:8ddac101f4 Fri, 18 Sep 2026 00:00:00 GMT Xenon submitted its FDA NDA for azetukalner in focal epilepsy (positive Phase 2b/3 data), but same-day paused enrollment in its MDD/bipolar depression trials after neuropsychiatric adverse events (confusion, aphasia, ataxia) emerged in the larger Phase 3 depression population; epilepsy program unaffected. XENE shares fell ~22-30% on the news. https://www.whensilence.com/pipeline whensilence:2026-09-18:site:site:99da94116a Fri, 18 Sep 2026 00:00:00 GMT NeuroHarmonics' first human trial is now registered (ISRCTN17201632, 26 Aug 2026) and confirmed by UCL (10 Sep 2026): a safety study of transcranial ultrasound in 10 adults with essential tremor, not tinnitus. UCL describes it as about to begin; no first patient treated has been confirmed. https://www.whensilence.com/pipeline whensilence:2026-09-18:site:site:2550d9d910 Fri, 18 Sep 2026 00:00:00 GMT Nudge (Nudge Zero): confirmed directly on the company's site that its tinnitus mechanistic feasibility study, previously reported paused, has reopened and is now actively enrolling. https://www.whensilence.com/pipeline whensilence:2026-09-18:site:site:8553134c37 Fri, 18 Sep 2026 00:00:00 GMT EmayGene: a peer-reviewed preclinical paper describes a next-generation AAV capsid ("AAV-WM04") outperforming the company's existing AAV-ie vector; platform-level advance, not yet tied to a named clinical asset. https://www.whensilence.com/pipeline whensilence:2026-09-18:site:site:ec5c9826ea Fri, 18 Sep 2026 00:00:00 GMT Otovia Therapeutics: peer-reviewed Nature Medicine paper (Sep 2025) confirms the trial's core numbers (10 patients, hearing threshold 106→52 dB); clarifies that a previously-flagged '2.5 year follow-up' figure likely belonged to an unrelated, larger OTOF trial (see Hearing Loss Recovery), not to Otovia. https://www.whensilence.com/knowledge/treatment/cil001-synaptic-repair whensilence:2026-09-18:treatment:cil001-synaptic-repair:604e77c34b Fri, 18 Sep 2026 00:00:00 GMT CIL001's planned Massachusetts General Hospital chronic-tinnitus trial is now registered as NCT07826507 ("REACT"), revealing the drug's INN is paliroden; Phase 1b/2a, not yet recruiting, estimated start Jan 2027. https://www.whensilence.com/knowledge/treatment/hearing-loss-regeneration whensilence:2026-09-18:treatment:hearing-loss-regeneration:741b7cb09b Fri, 18 Sep 2026 00:00:00 GMT Zheng-Yi Chen is co-senior author on a Nature paper (Apr 2026) reporting a 42-patient multicenter human trial of AAV-delivered OTOF gene replacement therapy, 2.5-year follow-up, 90% improved, 50% reaching normal hearing. Gene replacement, not hair cell regeneration, but strong validation of Chen's delivery vectors in humans. https://www.whensilence.com/knowledge/paper/42730729 whensilence:2026-09-18:paper:42730729:1fc3ec1a76 Fri, 18 Sep 2026 00:00:00 GMT New paper: a small randomized safety/feasibility trial of sound-paired vagus nerve stimulation for tinnitus (De Ridder, University of Otago) found no effect on tinnitus loudness, but exploratory reductions in distress, anxiety, and sleep problems in the delayed-sound (parasympathetic-conditioning) group. Linked to Interacting Brain Networks. https://www.whensilence.com/pipeline whensilence:2026-09-09:site:site:06c7d7a905 Wed, 09 Sep 2026 00:00:00 GMT Added three companies to the Pipeline Watchlist: Otovia Therapeutics, EmayGene, and Salubritas Therapeutics, all working on hair cell regeneration / OTOF gene therapy for hearing loss (not tinnitus-specific), flagged as ones to watch for a first-in-human regeneration trial. https://www.whensilence.com/ai-frontier whensilence:2026-09-09:site:site:45d1f175f6 Wed, 09 Sep 2026 00:00:00 GMT Launched a new AI Frontier page tracking general-purpose AI initiatives in biology, drug discovery, and genomics (Isomorphic Labs, AlphaFold, AlphaGenome Atlas, Xaira Therapeutics, Chai Discovery, Insilico Medicine, Evo 2, Nvidia BioNeMo, GPT-Rosalind). None have a hearing loss or tinnitus program today; tracked as infrastructure that could one day accelerate treatment research. https://www.whensilence.com/knowledge/paper/42008671 whensilence:2026-09-08:paper:42008671:51354897d1 Tue, 08 Sep 2026 00:00:00 GMT New paper: a serotonergic dorsal raphe → dorsal cochlear nucleus circuit drives fusiform-cell hyperactivity and tinnitus-like behavior in mice, reversible by blocking 5-HT2A receptors (Yu, Dai, ..., Tang, Trussell, PNAS). Linked to Dorsal Cochlear Nucleus Origin. https://www.whensilence.com/knowledge/paper/42635501 whensilence:2026-09-04:paper:42635501:687f426832 Fri, 04 Sep 2026 00:00:00 GMT New paper: sex-adjusted ABR Wave I amplitude norms flag likely cochlear deafferentation in living patients, catching 51% of a high-risk veteran sample (Kampel, Bramhall et al., American Journal of Audiology). Linked to Cochlear Synaptopathy. https://www.whensilence.com/knowledge/treatment/tinis-cochlear-implant whensilence:2026-08-27:treatment:tinis-cochlear-implant:4c5de609cd Thu, 27 Aug 2026 00:00:00 GMT Confirmed NCT07648615 is a separate, unrelated European program (ENTIC), not the same device as TINIS. https://www.whensilence.com/knowledge/trial/NCT03988699 whensilence:2026-08-27:trial:NCT03988699:d2d22e18da Thu, 27 Aug 2026 00:00:00 GMT Added to Clinical Trials: NCT03988699 (Mayo Clinic 'Novel Tinnitus Implant System' feasibility study), now Completed, no results posted yet. https://www.whensilence.com/knowledge/treatment/trtl913-gaba-a-pam whensilence:2026-08-27:treatment:trtl913-gaba-a-pam:fd264fa2a7 Thu, 27 Aug 2026 00:00:00 GMT NCT07777549 updated (Aug 20, 2026) with estimated primary completion Aug 2027; still not yet recruiting. https://www.whensilence.com/knowledge/treatment/opakalim-bhv7000 whensilence:2026-08-27:treatment:opakalim-bhv7000:bbe2358783 Thu, 27 Aug 2026 00:00:00 GMT Biohaven out-licensed opakalim and its Kv7 platform to SK Biopharmaceuticals for up to $795M plus royalties; still epilepsy-only, no tinnitus relevance. Note: puts Biohaven behind XEN1101 (Xenon targeting Q3 2026 NDA) while opakalim awaits RISE3 results. https://www.whensilence.com/knowledge/trial/NCT07777549 whensilence:2026-08-24:trial:NCT07777549:18c74e9c5d Mon, 24 Aug 2026 00:00:00 GMT NCT07777549 (A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)): phase: Phase 2a → Phase 2. https://www.whensilence.com/knowledge/treatment/trtl913-gaba-a-pam whensilence:2026-08-21:treatment:trtl913-gaba-a-pam:11472129b3 Fri, 21 Aug 2026 00:00:00 GMT Registered Phase 2a trial found for TRTL-913 (NCT07777549): a 7-day double-blind safety/PK study in healthy volunteers plus a 14-day open-label efficacy study in adults with chronic tinnitus, measuring TFI, THI, and loudness/annoyance VAS. Not yet recruiting, estimated start Sep 2026, site in Auckland, NZ. https://www.whensilence.com/knowledge/paper/42573663 whensilence:2026-08-18:paper:42573663:0f3e2029f5 Tue, 18 Aug 2026 00:00:00 GMT New paper: blood RNA-seq and a mouse model share the same inflammatory signature, and blocking TNF-alpha/microglia reduces tinnitus-like behavior in mice (Cheng et al., Neuroscience Bulletin). Linked to Central Neuroinflammation. https://www.whensilence.com/knowledge/paper/42571416 whensilence:2026-08-18:paper:42571416:bfe6e9c738 Tue, 18 Aug 2026 00:00:00 GMT New paper: human EEG study finds distinct brain-network signatures for acute vs. chronic tinnitus (Gong et al., iScience). Linked to Interacting Brain Networks. https://www.whensilence.com/knowledge/paper/42507681 whensilence:2026-08-18:paper:42507681:ca82a58eea Tue, 18 Aug 2026 00:00:00 GMT New paper: national VA cohort of 267,395 veterans finds tinnitus in 47%, more common with TBI, anxiety, or depression (Clifford et al., Ear and Hearing). https://www.whensilence.com/knowledge/paper/42585331 whensilence:2026-08-18:paper:42585331:0193157da5 Tue, 18 Aug 2026 00:00:00 GMT New paper: synaptic zinc plasticity in auditory cortex explains both adaptive recovery and maladaptive hyperactivity after cochlear injury (Kumar et al., Science Advances). Linked to Central Gain and PV Interneuron Dysfunction. https://www.whensilence.com/knowledge/treatment/cil001-synaptic-repair whensilence:2026-08-08:treatment:cil001-synaptic-repair:52ba58a7ba Sat, 08 Aug 2026 00:00:00 GMT Added Cilcare's planned CIL001 interventional program: three Phase 1b/2a studies (type 2 diabetes, chronic tinnitus, mild cognitive impairment) and their target start dates. https://www.whensilence.com/knowledge/treatment/cil001-synaptic-repair whensilence:2026-08-08:treatment:cil001-synaptic-repair:382aaf8bfa Sat, 08 Aug 2026 00:00:00 GMT CIL001 entry revised to align strictly with details from Cilcare's TinnitusTalk podcast appearance, trial design, timelines, and the DIAMONT/SAFIER observational studies that shaped it. https://www.whensilence.com/knowledge/treatment/neu002-cck-agonist whensilence:2026-08-01:treatment:neu002-cck-agonist:c3dd5d1800 Sat, 01 Aug 2026 00:00:00 GMT Added NEU-002 (NeuDirection) to the pipeline and knowledge base, plus sponsor company entries linking treatments to the companies developing them.