New Tinnitus Treatments and Research

The short answer

The most consequential recent developments are bimodal neuromodulation devices (Lenire's FDA De Novo authorization; the Shore/Auricle device, investigational and not commercially available, with its regulatory status not publicly verified), large head-to-head and sound-therapy trials (UNITI; the MOST trial, N=440), and a small pipeline of drug programs. "New" does not mean "better" — several heavily promoted approaches have failed their trials, and this page reflects the evidence as of our latest weekly review.

Recent developments from the evidence timeline (2024–2026)

• 2026 — Lenire (bimodal tongue stimulation): Second US real-world chart review published (AJA).
• 2026 — Digital CBT & app-based therapeutics: First double-blind sham-controlled app RCT published in JAMA Otolaryngology (Japan).
• 2026 — SPI-1005 (ebselen): Open-label Phase 3 safety study completes enrollment (July); primary completion December 2026.
• 2026 — TRTL-913 (GABA-A modulator): Tortugas Neuroscience launches with $106M (April); Phase 2 tinnitus trial registered.
• 2026 — tDCS / tACS / tRNS (transcranial electrical stimulation): WHITBY home-based tDCS feasibility trial (Nottingham) due to complete.
• 2026 — TrueSilence / digital polytherapeutic (Searchfield): TrueSilence Therapeutics spinout announced (August).
• 2026 — Venous sinus stenting (pulsatile tinnitus): Dedicated stent (BosSTENT) 90-patient trial registered.
• 2026 — Levo System (sleep-time sound matching): Levo Gen 2 cleared (K260413, Levo Medical Corp., August).
• 2026 — Transcranial focused ultrasound (emerging): Tinnitus Quest funds Oxford TUS project; study starting after ethics approval.
• 2025 — Cognitive Behavioral Therapy (CBT): UNITI-RCT (N=461): CBT among the largest single-treatment effects; combinations add little.
• 2025 — Auricle bisensory stimulation (Susan Shore device): Auricle declines to comment on timing; no pivotal trial registered.
• 2025 — Digital CBT & app-based therapeutics: Oto RCT published (Flinders); DEFINE trial completes.
• 2025 — Hearing aids (with hearing loss): UNITI-RCT strengthens the case: hearing aids among the top single treatments.
• 2025 — Mindfulness-Based Cognitive Therapy (MBCT): Online iMBCT trial (Warsaw) underway (NCT07183826).
• 2025 — SPI-1005 (ebselen): FDA Breakthrough Therapy designation (December).
• 2025 — rTMS (repetitive transcranial magnetic stimulation): Meta-analysis of 16 RCTs: short-term benefit only.
• 2025 — Off-label oral drugs (antidepressants, benzodiazepines, gabapentin, betahistine): Network meta-analysis of 60 RCTs: no approved drug, weak evidence base.
• 2025 — Hair-cell regeneration & inner-ear gene therapy: DB-OTO CHORD results published in NEJM; Rinri first-in-human approved.
• 2024 — Lenire (bimodal tongue stimulation): TENT-A3 pivotal published in Nature Communications — subgroup benefit only.
• 2024 — Cochlear implants (for qualifying hearing loss): CINGLE reports 24-month tinnitus outcomes (120 randomized): the implant group improved on THI, TQ and VAS; differences versus the device groups were significant for VAS, not for THI and TQ.

What's in trials now

See the 21 registered clinical trials we track, verified weekly against ClinicalTrials.gov. For weekly research updates, see This Week in Tinnitus Research.