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 awaiting FDA review), 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): Meta-analysis (28 studies, N=853): THI −14.0, loudness VAS −3.1.

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.