Recent Updates

Launched the When Silence YouTube channel (youtube.com/@WhenSilence) with its first video, "Why Is Severe Tinnitus Ignored? What the Data Show". Every published video now has a home on the new Videos page.

Added Attune Neurosciences to the pipeline as a focused-ultrasound watchlist entry. The company names tinnitus as a target for its wearable ultrasound headband, but none of its 8 registered studies is for tinnitus. CEO Rajiv Mahadevan told us by email (14 Oct 2026) that early, unpublished results showed substantial tinnitus reduction in over half of participants. Also renamed the Hong Kong ultrasound pilot from 'TUS' to 'CUHK'.

Ebselen (SPI-1005): at the AAO-HNS 2026 Annual Meeting, Sound Pharmaceuticals presented an award-winning new analysis of its Phase 3 Meniere's data. More treated ears than placebo ears gained at least 10 dB of low-to-mid frequency hearing (pure-tone and words-in-noise, p<0.01), which the company says supports a future sudden hearing loss indication. This is a hearing result from a press release with no effect sizes, not a tinnitus result.

New paper: the AAO-HNS 2026 update of the US clinical guideline on tinnitus (Adams et al., Otolaryngology-Head and Neck Surgery). Recommends CBT and hearing aids, advises against medications, supplements and rTMS, and newly lists bimodal neuromodulation as an option.

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.

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.

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.

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.

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.

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.

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.

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.

NCT07302373 (Harnessing Endogenous Brain Plasticity Systems for the Recalibration of Pathological Auditory Percepts): completion year: 2025 → 2023.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Confirmed NCT07648615 is a separate, unrelated European program (ENTIC), not the same device as TINIS.

Added to Clinical Trials: NCT03988699 (Mayo Clinic 'Novel Tinnitus Implant System' feasibility study), now Completed, no results posted yet.

NCT07777549 updated (Aug 20, 2026) with estimated primary completion Aug 2027; still not yet recruiting.

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.

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.

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.

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.

New paper: human EEG study finds distinct brain-network signatures for acute vs. chronic tinnitus (Gong et al., iScience). Linked to Interacting Brain Networks.

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).

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.

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.

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.

Added NEU-002 (NeuDirection) to the pipeline and knowledge base, plus sponsor company entries linking treatments to the companies developing them.