SilenEar™ is a multi-modal, HRV-guided closed-loop neuromodulation platform that combines acoustic therapy, vagus nerve stimulation, and real-time biofeedback to treat tinnitus and autonomic dysfunction.
Tinnitus is a constant, debilitating ringing in the ears — affecting sleep, focus, and mental health. Current treatments mask symptoms. None address the neural root cause.
Sound masking and hearing aids provide temporary relief but do not adapt to the patient's changing physiology.
Existing neuromodulation devices deliver one-size-fits-all stimulation without real-time feedback loops.
Fixed-protocol therapies lose effectiveness over time as the brain adapts, reducing long-term clinical benefit.
A closed-loop platform that combines vagus nerve stimulation, personalized sound therapy, and HRV-guided biofeedback.
Ear-level vagus nerve stimulation paired with personalized sound therapy and real-time physiological sensors — capturing your body's response as treatment unfolds.
Closed-loop biofeedback engine tracks nervous system response in real time, dynamically adjusting therapy parameters to prevent habituation and maximize efficacy.
Up to 2× parasympathetic activation compared to acoustic therapy alone — measurable via HRV shift from sympathetic dominance to vagal recovery.
Wearable sensors capture HRV, skin conductance, and autonomic state in real time.
On-device algorithms assess stress–calm balance and neural adaptation risk.
Therapy parameters — frequency, amplitude, timing — adjust automatically each session.
Clinical outcomes (TFI, HRV trends) logged continuously for patients and clinicians.
Objective physiological data — not just self-reported outcomes.
Measurable nervous system shift from sympathetic stress to parasympathetic calm.
Tinnitus Functional Index reduction target exceeding clinically significant threshold.
Consistent outcomes across engineering validation trials with objective data protocols.
FDA 510(k) pathway confirmed — 24 months faster than De Novo.
Ethics clearance for clinical study
30-patient efficacy validation study
Full regulatory submission
Commercial market rollout
Product development, IP strategy, and regulatory pathway. Chemistry background (NTU), DBA (Grenoble EM).
Acoustic and wearable system development. Leading hardware integration.
Psychiatry Chief, Tri-Service General Hospital. President, Taiwan Society of Clinical TMS. Leading IRB and clinical study.
Vice Dean, Business School, NYCU. Commercialization strategy and industry partnerships.
One platform. Multiple modalities. Multiple conditions. Billions in reach.
Beachhead market. FDA 510(k) pathway validated. Clinical pilot underway.
Same adaptive platform, expanded to adjacent neuromodulation indications with larger addressable markets.
Expanding the platform across therapeutic modalities — device, digital, and beyond — for multiple neurological and autonomic conditions.
We're seeking partners, clinical collaborators, and investors who believe tinnitus patients deserve better.
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