Auricle bisensory stimulation (Susan Shore device) for Tinnitus: What Does the Evidence Show?

Current evidence

The only treatment with rigorous randomized evidence of making tinnitus quieter — still stuck in the lab.

Evidence strength: Moderate (3/5) · Tier 2 — promising · Evidence independence: Mixed.

A home-use device from Susan Shore's University of Michigan lab that pairs precisely timed sound (matched to your tinnitus spectrum) with mild electrical stimulation of the face or neck, 30 minutes a day. Licensed to Auricle Inc. Not for sale anywhere.

Did tinnitus loudness improve?

Moderate. Loudness was a CO-PRIMARY endpoint, measured by psychoacoustic loudness matching (dB SL): within-participant change −7.2 dB per-protocol (p=.03) at week 6, deepening to −14.1 dB by week 12 of the second active phase — the strongest percept-level result of any tinnitus RCT. These are changes during treatment, not active-minus-control differences.

Did tinnitus distress improve?

Moderate. TFI (the other co-primary): −12.0 ITT / −13.2 per-protocol after active treatment, at the clinically meaningful threshold; the control block produced no clinically significant decrease. ≥13-point responders: 65% per-protocol / 53% ITT vs 25%/20% control.

Loudness means the tinnitus percept itself became quieter (psychoacoustic matching or loudness ratings). Distress means questionnaire scores such as THI/TFI, sleep, anxiety or quality of life improved — the sound may be unchanged. A THI/TFI improvement is never evidence the tinnitus got quieter.

How strong is the evidence?

A rigorous NIH-funded double-blind crossover with percept-level benefit earns a 3/5; independent replication, a pivotal trial, and regulatory progress would raise it.

Has the result been independently replicated?

Same group/sponsor only. Both trials come from the inventor's own lab (Univ. of Michigan/Auricle); no independent replication yet.

Independence: Trials were NIH-funded, but run by the device inventors, who co-founded the company commercializing it (Auricle).

What are the limitations?

• Single-center evidence; per-protocol n=56
• Somatic tinnitus only
• No registered pivotal trial, no FDA submission, and company silence since 2023 — commercial timeline unknown

Conflicts of interest: NIH funded the trials, but Shore and Martel cofounded Auricle and hold equity and patent interests (disclosed).

What should patients know about safety?

Safety evidence: Moderate. No serious adverse events reported in trials; mild, well-tolerated stimulation.

Is it available?

Regulatory status: Investigational. No FDA authorization of any kind; only one device (Lenire) has ever been authorized in the bimodal tinnitus class (QVN). Claims of Breakthrough Device designation could not be verified. No trial sponsored by Auricle Inc is registered on ClinicalTrials.gov as of Sept 2026 (don't confuse it with 'Auricle Health Inc', an unrelated company running a hearing-restoration study, NCT07402941).

Availability: Not available — investigational only · Europe: Not available · Cost (approx.): N/A — no commercial pricing exists

What the studies found

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