Medical devices & diagnostics · Hearing restoration
Auricle
A two person medical device company building an implant that stimulates the hearing nerve from outside the cochlea, so patients can gain back high frequency hearing without gambling the hearing they still have. Six years on it has one federal grant, one registered study and no product.
The man who would not choose
A man in his early sixties came back to the Stanford audiology clinic, as he had for years, with his wife beside him. Two Biodesign fellows were shadowing that day.
“From the moment he was called in to the consulting room, it was obvious that he had real difficulty understanding speech and even communicating with his wife,” Francis Wong recalled.
The clinic had one thing left to offer. “His best option was a cochlear implant, but that comes with some risk of losing residual hearing, and he was struggling with the decision because he knew there would be no turning back,” Wong said.
So he kept coming back, and kept not deciding. That stalemate is the whole company.
Hear the voice, miss the words
Sensorineural hearing loss takes the high frequencies first, and the high frequencies carry the consonants. The result is a patient who can hear that someone is speaking and cannot tell what was said. Hearing aids make the sound louder, not clearer.
The grant abstract Auricle filed with the National Institutes of Health sets the population at 3.3 million US adults and states the dead end without hedging: “Hearing aids cannot provide benefit for these patients, and the only available treatment is a cochlear implant.” An implant threads an electrode array inside the cochlea. It works, and it cannot be undone. The same abstract says of those implants: “These are irreversible and come with a 50% risk of residual hearing loss”. Faced with that trade, most eligible patients decline.
Auricle proposes to stay outside. Place electrodes on the cochlear promontory, the bony wall between middle ear and inner ear, and stimulate the cochlear nerve through it. Nothing enters the cochlea, so nothing inside it is damaged, and the device can come out.
Two fellows and a shelved idea
Francis Wong and Jay Dhuldhoya met in the 2019 to 2020 Stanford Biodesign Innovation Fellowship. Wong is the clinician: “I’m Francis, a UK-trained surgeon who worked in the National Health Service as a surgeon for 5 years.” Dhuldhoya is the engineer: “I am a medical device engineer and entrepreneur with a BA from Columbia and an MS from Rice in biomedical engineering.” That year the fellowship’s clinical focus was ear, nose and throat, and the pair logged more than 200 unmet needs, Fogarty Innovation reported, before settling on this one.
The physics was not new. Promontory stimulation was tried in the late 1980s and never turned into a product. “Many of the limitations of this previous work can be overcome with the technological advancements made in the last 30 years,” Wong told Fogarty. Dhuldhoya said the find itself was the thrill: “When we ‘rediscovered’ this forgotten technology, we were very excited because we felt confident we could push it forward and make it work for a vast number of patients.”
Stanford, then an awake ear in Cleveland
In August 2020 Fogarty Innovation wrote that “The team’s next steps include an upcoming clinical study at Stanford and a fundraising push.” Both landed. By February 2021 Stanford Biodesign reported that, working with otolaryngology faculty, “the team recently started a clinical study and completed several proof-of-concept cases.” Auricle went through Y Combinator that same winter.
Then the public trail goes quiet for three years. It picks up in August 2024, when the National Institute on Deafness and Other Communication Disorders awarded Auricle Health Inc. an SBIR Phase I grant of $275,371 to refine the electrode and test it in animals. The end date was later pushed from July 31, 2025 to July 31, 2026.
On June 2, 2025 the company started its first registered human study. TONES, NCT07402941, runs at the Cleveland Clinic and plans to enroll 18 adults already booked for awake middle ear surgery. The surgeon exposes the middle ear, the team stimulates the promontory, and the patient says out loud whether two pulses sounded the same or different. The registry listed the study as recruiting when the record was last verified in February 2026.
Three companies, one word
Auricle is the anatomical name for the outer ear, so it is a crowded label. A University of Michigan spinout called Auricle, Inc. is developing a bimodal stimulation system for tinnitus, and its chief executive is Jonathan T. Pearson. A Copenhagen earphone startup uses the name too. Databases have merged the first two, and the merge matters: the lone SEC Form D that surfaces for the name, and a 2025 NIH tinnitus award, both belong to Pearson’s company rather than this one.
What is proven, and what is still claimed
| Evidence | What the record shows | Source type |
|---|---|---|
| FDA clearance | No 510(k) and no PMA record under Auricle or Auricle Health as of Sep 22, 2026. | Not found |
| TONES study | NCT07402941. Interventional, single group, basic science. Started Jun 2, 2025; first posted Feb 11, 2026; recruiting. 18 adults estimated at the Cleveland Clinic, which is also the collaborator. Primary outcome: accuracy on a same or different task across paired stimuli. Primary completion estimated May 2026. | Public record |
| Earlier human work | The company says it spun out of Stanford Biodesign having completed two acute human clinical studies. No earlier study appears in ClinicalTrials.gov under any Auricle entity, and no results have been published. | Company-stated |
| Peer-reviewed papers | None found in PubMed for the company or its founders on this technology as of Sep 22, 2026. | Not found |
| Federal grant | NIH SBIR Phase I R43DC021615, $275,371, NIDCD, awarded Aug 2024 to Auricle Health Inc. of Oakland, California. End date extended by one year. | Public record |
| Population figures | The numbers move by source. YC listing: 3.5 million US patients, $1.2B market. NIH abstract: 3.3 million adults. Wu Tsai Neurosciences Institute: 1.2 million. Stanford Biodesign in 2021: over 1 million. | Claims disagree |
| Is it still trading | PitchBook marks the company Out of Business, dated Nov 1, 2024. Against that: a grant running to Jul 2026, a trial begun Jun 2025 and verified recruiting Feb 2026, a YC entry showing Active with two staff on Sep 22, 2026, and a live website. | Vendor differs |
| Mis-attributed records | SEC Form D 0001894053-21-000001 and NIH award 1R43DC022809-01 sit under the name Auricle, Inc. Both belong to the tinnitus company led by Jonathan T. Pearson. | Wrong company |
| What it sells today | Nothing. No product on the market, no revenue reported, no customer named. Listings that file Auricle under revenue cycle software match none of the primary records. | Public record |
Read plainly: the idea is old, the physiology is credible, and almost none of it has been shown in public. Auricle has a federal grant, a registered feasibility study in live patients, and a claim of two earlier human studies that no registry or journal can confirm. The evidence it is working is the trial itself, opened at a major academic center and still recruiting in 2026. The argument for caution is that six years of effort have produced $275,371 of grant money and an 18 patient study whose endpoint is whether people can tell two electrical pulses apart.
What to watch
- TONES results. Primary completion was estimated for May 2026 and the record has not been updated since February 2026.
- An SBIR Phase II award. Phase I ended July 31, 2026, and the abstract already describes the large animal work Phase II would fund.
- Any publication covering the two acute human studies the company says it completed before spinning out.
- A first financing that leaves a public trace. There is no Form D on file for Auricle Health Inc.
In their words
“His best option was a cochlear implant, but that comes with some risk of losing residual hearing, and he was struggling with the decision because he knew there would be no turning back.”
Francis Wong, co-founder, Stanford Biodesign story, 2021 · Institution
“Many of the limitations of this previous work can be overcome with the technological advancements made in the last 30 years.”
Francis Wong, to Fogarty Innovation, 2020 · Independent
“When we ‘rediscovered’ this forgotten technology, we were very excited because we felt confident we could push it forward and make it work for a vast number of patients.”
Jay Dhuldhoya, co-founder, to Fogarty Innovation, 2020 · Independent
“As surgeons, we tend to be very needs-oriented. We see a problem and we want to fix it.”
Peter Santa Maria, MD, PhD, Stanford otolaryngology, 2021 · Institution
“The goal of this clinical trial is to learn if short electrical signals can be heard in adult subjects who are otherwise having surgery on their ear.”
TONES study record, ClinicalTrials.gov NCT07402941, 2026 · Public record
“The company was born out of Stanford Biodesign and is proud to be supported by Y Combinator, StartX and Fogarty Innovation.”
Auricle website, accessed Sep 22, 2026 · Company
Related companies
Sources
- Public recordClinicalTrials.gov NCT07402941, TONES
- Public recordNIH RePORTER 1R43DC021615-01
- Public recordGrant record R43DC021615, extended end date
- Public recordNIH RePORTER 1R43DC022809-01
- Public recordForm D, Auricle, Inc., CIK 0001894053
- Public recordEDGAR company and full text search
- Public recordPubMed searches, company and founders
- IndependentFogarty Institute Helps Advance Promising Projects from Stanford Biodesign
- InstitutionAn Innovative Partnership
- InstitutionExtracochlear neurostimulation, Auricle
- IndependentAuricle profile, Out of Business flag
- IndependentAuricle funding rounds and investors
- IndependentStudy shows promising treatment for tinnitus
- CompanyAuricle company and jobs pages
- CompanyAuricle website home page
- CompanyAuricle, Inc. tinnitus company page
- CompanyJon Pearson speaker biography
- InvestorPortfolio page listing Auricle
Profile researched and written by Healthcare Discovery. Last updated September 29, 2026.
