Susan Shore’s Tinnitus Research Is Promising. Here’s Why I’m Not Telling My Patients to Wait.
By Dr. Layne Garrett, Au.D., FAAA, ABAC, CH-TM, CDP (About | YouTube | Podcast | LinkedIn)
Date Published: February 26, 2026, 3:30PM MST
“When is the Susan Shore tinnitus device coming out?” I hear that question almost every week in our Utah clinics. The research is exciting. I get why people are waiting. But here’s the part no one is talking about: waiting may be making your tinnitus harder to treat.
Quick Answer: The Auricle device developed by Dr. Susan Shore is not FDA-approved as of early 2026. The research is strong — a 2023 JAMA study showed meaningful results for a specific type of tinnitus called somatic tinnitus. But there is no confirmed release date. Meanwhile, Lenire — an FDA-approved bimodal device that uses a different approach — is available right now and is helping patients today. If you have tinnitus, you don’t have to wait for someday.
With tinnitus research accelerating — but FDA timelines remaining unpredictable — patients are increasingly stuck between hope and hesitation. Referring physician? Skip to the clinical summary.
Here’s something worth understanding before we go further. Clinical research tells us whether something can work under controlled conditions. Clinical practice tells us whether it does work for the person sitting in front of me. Those are not the same question — and tinnitus lives in that gap. I’ve followed Dr. Shore’s work for years and consider it among the most rigorous tinnitus research published in the last two decades. That’s exactly why I can say with confidence: the research is ready. The device is not.
Prefer video? I walk through this research — and who should not wait — in this short explainer: watch it here.
Table of Contents
- What Dr. Shore’s Research Actually Shows
- How the Auricle Device Works — A Clinical Perspective
- Who This Device Is (and Is Not) Designed For
- Where Things Stand With FDA Approval — and What Nobody Knows Yet
- Susan Shore Device vs. Lenire: Key Differences
- What I Recommend Patients Do Right Now
- What This Means If You’re in Utah
- Summary for Referring Clinicians
- FAQ
What Dr. Shore’s Research Actually Shows
The science behind the Auricle device is real. I want to be clear about that. Dr. Susan Shore and her team at the University of Michigan did the work correctly.
Their 2023 study in JAMA Network Open was a proper double-blind, randomized clinical trial. Ninety-nine participants. Six weeks of daily treatment. That’s not a small pilot study — that’s serious clinical research.
Here’s what they found. Over 60% of participants reported significantly reduced tinnitus symptoms after active treatment. They also saw real improvements in quality of life scores and measurable drops in tinnitus loudness. And here’s what makes this especially interesting — those results only showed up with the combined treatment. Sound therapy alone didn’t move the needle. It was the combination that made the difference.
Over 20 years of treating tinnitus, I’ve learned to pay attention to studies that show a dose-response. The Shore research showed that the longer people used the active treatment, the better they did. That pattern suggests this isn’t placebo. It suggests real neurological change.
That said, I never promise patients results based on early research. The study worked for the patients it was designed for. Whether it will work for you depends on specifics I’ll explain below.
How the Auricle Device Works — A Clinical Perspective
The Auricle device uses what’s called bimodal or bisensory stimulation. That’s a technical term for a simple idea — it stimulates two sensory systems at once.
During treatment, you’d hear sounds through headphones matched to your specific tinnitus frequency. At the same time, you’d receive mild electrical stimulation to the neck or jaw area. The two signals are precisely timed together.
Here’s the brain science behind it. Deep in your brainstem, there’s an area called the dorsal cochlear nucleus. This is where your hearing nerves and your touch nerves meet. In people with tinnitus, the neurons in this area fire too much. They also fire in sync with each other. That synchronized firing creates the phantom sound you hear.
The goal of the Shore device is to retrain those overactive neurons. The right sound combined with the right touch signal — at exactly the right timing — interrupts that synchronized firing. The aim is to bring those neurons back to normal levels.
It’s neuroplasticity at work. You’re trying to rewire how your brain responds to missing signals. That’s not a radical concept — it’s the same principle behind many evidence-based tinnitus approaches. But the precision of the timing here is what makes this device different from sound therapy alone.
Who This Device Is (and Is Not) Designed For
This is where I need to slow down, because this matters a lot.
The Shore device was specifically designed for people with somatic tinnitus. Somatic tinnitus is a form where your movements can change what you hear. Clench your jaw. Turn your head to one side. Press gently on your neck or forehead. If doing any of those things changes the pitch or loudness of your tinnitus — even slightly — you likely have some somatic component.
The American Tinnitus Association reports that nearly 70% of tinnitus sufferers have the somatic form. So this is actually a large group of people.
But if your tinnitus doesn’t change with body movements, we don’t have data yet on whether this device will help you. The study didn’t include those patients. We can’t assume the results would transfer.
There’s also a hearing loss component. The study only enrolled people with normal to moderate hearing loss. If you have severe or profound hearing loss, this research doesn’t speak to your situation.
To be blunt: if you see someone marketing the Shore device as a universal tinnitus cure, they’re getting ahead of the science. This treatment was designed for a specific type of tinnitus in people with specific hearing profiles. That doesn’t make it less exciting. It makes it more honest.
If you’re unsure what type of tinnitus you have, that uncertainty alone is reason not to wait. Getting a proper diagnosis now means you’re not losing months guessing.
Where Things Stand With FDA Approval — and What Nobody Knows Yet
Here’s the straight answer: the Auricle device has not been approved by the FDA as of early 2026. There is no confirmed release date.
Dr. Shore and her co-author Dr. David Martel founded Auricle Inc. to bring this device to market. The company has stated they’re working toward FDA regulatory clearance. But they have not made public statements about where they are in that process. They declined to answer questions about a release date as recently as October 2025.
The FDA approval process for a new medical device takes time — for good reasons. Safety, manufacturing quality, efficacy — all of these need verification. Even under the best circumstances, that process typically takes 12 to 18 months from submission. We don’t know for certain that submission has occurred.
I’ve seen online speculation about a 2026 release. That may be wishful thinking. Nobody outside of Auricle and the FDA knows the timeline.
Here’s the uncomfortable truth: you could wait another year, two years, or longer — and still not be able to get this device. In the meantime, your tinnitus keeps running. Your brain keeps reinforcing those firing patterns. The longer tinnitus goes untreated, the harder it often becomes to shift.
I see this pattern in our clinic more than I’d like. Patients hear about a promising new treatment and put everything else on hold. They come back 18 months later with tinnitus that has become more entrenched. That delay has a real cost.
If you want to understand why tinnitus medications and supplements haven’t delivered a cure, that context is worth reading. It explains why pinning your hopes on any single device is a risky strategy.
Susan Shore Device vs. Lenire: Key Differences
Both devices use bimodal stimulation — pairing sound with a second sensory input. But they differ in important ways.
| Auricle (Shore Device) | Lenire | |
|---|---|---|
| FDA Status | Not yet approved | FDA De Novo approved (March 2023) |
| Tinnitus Type Required | Somatic tinnitus | No somatic requirement |
| Stimulation Site | Neck or jaw | Tongue |
| Availability | Not available to public | Available by prescription |
| Evidence Base | 2023 JAMA RCT (99 participants) | 3 large clinical trials + real-world data |
The key practical difference: Lenire is here now and works for a broader range of tinnitus patients. The Shore device may eventually offer an additional option. That’s especially true for patients with strong somatic involvement who don’t respond to other approaches.
What I Recommend Patients Do Right Now
Hope is not a treatment plan. And waiting for the “perfect” tinnitus treatment is often the fastest way to make tinnitus harder to treat. So let’s talk about what actually works today.
Lenire: The FDA-Approved Bimodal Device Available Now
There is a bimodal stimulation device that is FDA-approved for tinnitus treatment. It’s called Lenire, and we offer it here at Timpanogos Hearing & Tinnitus.
Lenire received FDA De Novo approval in March 2023. It pairs specially designed audio tones through wireless headphones with mild electrical stimulation delivered to the tongue. The tongue stimulation activates the trigeminal nerve. That nerve connects into the same central auditory pathways the Shore device targets — just through a different entry point.
The clinical evidence for Lenire is strong. The TENT-A3 controlled pivotal trial was published in Nature Communications. It showed that patients with moderate or worse tinnitus were significantly more likely to improve with bimodal treatment than with sound therapy alone. In a 2025 retrospective study of 220 real-world patients, 91.5% of eligible patients who completed the treatment protocol experienced clinically significant improvement after about 12 weeks.
A key difference from the Shore device: Lenire doesn’t require somatic tinnitus. You don’t need to be able to change your tinnitus with jaw movements. That opens this treatment to a much broader group of patients.
Hearing Aids
If you have measurable hearing loss, hearing aids belong in your treatment plan — regardless of what else you’re doing. When your brain isn’t getting enough sound input, it compensates by turning up its internal volume. That compensation is a major driver of tinnitus. Hearing aids restore the signal and reduce the contrast that makes tinnitus feel so loud.
Many modern hearing aids also include sound therapy features specifically designed for tinnitus management. Our post on whether hearing aids can help tinnitus walks through what the research shows.
CBT and TRT
Cognitive behavioral therapy is the gold standard for tinnitus-related anxiety and sleep disruption. It doesn’t change the sound itself. But it changes how your brain responds to it. That shift in response is often where the most meaningful relief comes from.
Tinnitus retraining therapy combines sound therapy with education and counseling. It’s one of the longest-standing, research-backed approaches we have, particularly for patients whose tinnitus is tied to stress or hearing loss.
When Treatment Fails
I want to be direct about this, because it comes up often. Tinnitus treatment doesn’t work equally well for everyone. When it fails, it’s almost always for one of three reasons.
First, the underlying cause hasn’t been identified. Tinnitus from noise damage responds differently than tinnitus from hearing loss, jaw problems, or medication side effects. Treatment needs to match the cause.
Second, treatment was applied in isolation. Sound therapy alone rarely produces lasting results. Bimodal stimulation, counseling, and hearing rehabilitation often need to work together.
Third, the patient stopped too early. The brain needs repetition to rewire. The patients who see the best results in our clinic share one thing — they stayed consistent through the full treatment period.
What This Means If You’re in Utah
If you’re in Utah County — Provo, Lehi, Spanish Fork, anywhere in the valley — you don’t have to wait. Effective tinnitus treatment is available right now.
Tinnitus Treatment in Utah County
If you’re searching for tinnitus treatment in Utah County, the most important first step isn’t picking a device. It’s identifying your tinnitus type with a qualified audiologist. That diagnosis determines everything that follows — which treatments apply, which don’t, and in what order to try them.
Our clinics in American Fork and Spanish Fork specialize in tinnitus management. We’re one of only 14 Lenire Preferred Providers in the United States. Our providers hold specialty certifications (such as the CH-TM from the American Board of Audiology) and are recognized providers by the American Tinnitus Association.
We offer Lenire, hearing aid-based tinnitus management, and counseling approaches. We also do a comprehensive evaluation to figure out what type of tinnitus you have and what’s driving it. That diagnostic step matters more than most people realize. Treating somatic tinnitus looks different than treating noise-induced tinnitus. The right treatment starts with the right diagnosis.
Over 20 years, I’ve seen this pattern clearly. The patients who get the best results aren’t the ones who waited for the perfect treatment. They’re the ones who came in, got a clear picture of their situation, and started working with what was available.
When You’re Ready to Explore Your Options
Schedule your free consultation — we’ll evaluate your tinnitus type, discuss what’s driving it, and walk you through which treatments make sense for your specific situation. In our internal outcome tracking, about 9 out of 10 patients who complete a matched, multi-modal treatment plan report meaningful improvement. That means tinnitus becomes less intrusive and less distressing — not that it disappears entirely.
Or call us at (385) 332-4325 — speak with our team directly.
Want to do more research first? Visit our Learning Center for detailed information on tinnitus causes and treatment options.
Summary for Referring Clinicians
This section is written for PCPs, ENTs, and other referring clinicians. It covers trial design, patient selection criteria, regulatory status, and referral guidance. Patient-facing content begins above.
Overview of Shore et al. (2023) Trial Design
The University of Michigan trial (Jones et al., JAMA Network Open, June 2023) was a double-blind, crossover, randomized clinical trial involving 99 participants with somatic tinnitus. Treatment phases were six weeks each. Active treatment delivered precisely timed bisensory stimulation — personalized auditory tones combined with somatosensory electrical stimulation at C1/C2 — via a portable home-use device. Control treatment delivered auditory-only stimulation, previously shown to produce no residual effect.
Primary outcomes measured included Tinnitus Functional Index (TFI), Tinnitus Handicap Inventory (THI), and tinnitus loudness level. Active treatment produced statistically significant and clinically meaningful reductions across all three measures. Control treatment did not. Treatment effect persisted through the washout phase, suggesting durable neuroplastic change rather than masking. A dose-response relationship was observed — longer active treatment correlated with greater symptom reduction.
Patient Selection Criteria and Limitations
Inclusion criteria in the trial:
- Confirmed somatic tinnitus — modulation of tinnitus pitch or loudness with jaw clenching, head rotation, or cervical pressure
- Bothersome tinnitus (TFI score ≥17)
- Normal to moderate hearing loss
- No tinnitus treatment in the six months prior to enrollment
Important limitations for clinical application:
- Results should not be extrapolated to non-somatic tinnitus populations. The trial did not enroll patients unable to modulate tinnitus with somatosensory maneuvers.
- Patients with severe or profound hearing loss were excluded. Efficacy data does not exist for this population.
- Ten participants discontinued — three due to no benefit, seven due to tinnitus worsening. This is clinically relevant when counseling patients on risk.
- The trial was single-center (University of Michigan). Multi-site replication has not yet been published.
Regulatory Status and Expected Timeline
The Auricle device developed by Shore and Martel — commercialized through Auricle Inc. — has not received FDA clearance as of early 2026. The company has stated they are engaging with the FDA on regulatory clearance but has declined to provide a public timeline. As of October 2025, no release date has been confirmed.
Based on standard De Novo review timelines, clearance is unlikely before late 2026 at the earliest, and that estimate assumes submission has occurred. Advising patients to defer treatment pending Auricle availability is not clinically supportable at this time.
Comparison With FDA-Cleared Bimodal Therapy
Lenire (Neuromod Devices) received FDA De Novo approval in March 2023. It delivers bimodal stimulation via auditory tones combined with transmucosal electrical tongue stimulation activating the trigeminal nerve. Unlike the Shore device, Lenire does not require somatic tinnitus for candidacy — the FDA-cleared indication covers patients with at least moderate tinnitus (THI ≥38) regardless of somatic modulation.
The TENT-A3 pivotal trial demonstrated clinically superior outcomes for bimodal treatment over sound-only stimulation in patients with moderate or worse tinnitus. Real-world data from a 2025 retrospective review of 220 U.S. patientsshowed a 91.5% responder rate at 12 weeks. Timpanogos Hearing & Tinnitus is one of 14 Lenire Preferred Providers in the United States.
Referral Guidance: When to Refer Now
Consider referral for comprehensive tinnitus evaluation when:
- Patient presents with bothersome tinnitus regardless of somatic classification
- Patient is deferring treatment while awaiting the Shore/Auricle device
- Tinnitus is accompanied by measurable hearing loss
- Tinnitus is significantly impacting sleep, concentration, or quality of life
- Patient has been told “nothing can be done” without a formal tinnitus-specific evaluation
Early intervention produces better outcomes. Prolonged untreated tinnitus is associated with increased central sensitization and reduced treatment responsiveness. We offer comprehensive evaluation, hearing assessment, tinnitus classification, and matched treatment planning including Lenire, hearing aid-based management, CBT referral coordination, and TRT.
To refer: Call (385) 332-4325 or fax at (801) 763-8282.
Can I modulate my tinnitus? How do I know if I have somatic tinnitus?
Somatic tinnitus changes when you move your jaw, neck, or face. Try clenching your jaw firmly, turning your head to each side, or pressing gently on the area just below your ear. If any of those movements change the pitch or loudness of your tinnitus — even briefly — you likely have a somatic component. This is the most common form of tinnitus, affecting roughly 70% of people who experience it.
Is the Susan Shore device the same as Lenire?
No. Both use bimodal stimulation — combining sound with a second sensory input — but they work differently. The Shore device pairs sound with electrical stimulation to the neck or jaw. Lenire pairs sound with electrical stimulation to the tongue. They also target somewhat different patient populations. Lenire is FDA-approved and available today. The Shore/Auricle device is not yet FDA-approved.
Does Lenire work if I don’t have somatic tinnitus?
Yes. Lenire’s FDA approval and clinical trials were not limited to somatic tinnitus. The device showed clinically significant results across a broader tinnitus population. This is one of the key practical differences between the two devices. If you’re unsure whether you’d be a candidate, a comprehensive evaluation can help clarify that.
Why isn’t the Shore device FDA-approved yet if the research is so good?
Good research doesn’t automatically mean fast approval. The FDA requires manufacturers to demonstrate safety, manufacturing quality, and that the device performs as claimed under controlled conditions. That process typically takes 12 to 18 months from submission — and involves significant documentation requirements beyond the clinical trial. The research is solid. The regulatory process just takes time.
What’s your success rate with tinnitus treatment at your clinic?
About 9 out of 10 patients who complete a matched, multi-modal treatment plan report meaningful improvement. That means tinnitus becomes less intrusive and less distressing — not that it disappears entirely. Success looks different for different patients. For some, tinnitus is no longer audible. For most, tinnitus no longer controls their life.
About the Author
Dr. Layne Garrett, Au.D., FAAA, ABAC, CH-TM, CDP is a board-certified audiologist and founder of Timpanogos Hearing & Tinnitus, with clinic locations in American Fork and Spanish Fork, Utah. Over 20 years, he has specialized in tinnitus management, helping thousands of patients find relief from chronic tinnitus.
Timpanogos Hearing & Tinnitus has been recognized as Best of State in Auditory Services 14 times and operates as one of only 14 Lenire Preferred Providers in the United States. Dr. Garrett holds board certifications in audiology (ABAC), tinnitus management (CH-TM), and dementia care (CDP), and is a Fellow of the American Academy of Audiology (FAAA).
His practice emphasizes patient education and honest guidance over sales-driven care. Dr. Garrett regularly publishes on tinnitus research, hearing health, and brain health through his Learning Center, YouTube channel, and podcast.
Links: About | YouTube | Podcast | LinkedIn
Reviewed/Edited by: Dr. Layne Garrett, Au.D., FAAA, ABAC, CH-TM, CDP
Date: February 26, 2026 3:30PM MST
