EarLens - 2014 Fierce 15

CEO: William Facteau
Based: Menlo Park, CA
Founded: 2005
Website: www.earlenscorp.com

The scoop: EarLens is working to create the world's first hearing device that uses light to transmit sound. Most existing hearing aids are simply tiny speakers that turn up the volume on air-conducted sound. That means they are subject to the same problems as any type of speakers: They get disruptive feedback when turned up too loud, and they have a difficult time conducting sound in the upper frequency ranges.

The EarLens Contact Hearing Device uses a distinct method of improving hearing. It turns the user's own eardrum into a speaker, thereby enabling an ultrawide frequency range from 125 to 10,000 hertz and a higher maximum gain margin than typical hearing aids.

Improving hearing aid technology could transform the whole category. It's already a $7 billion market, most of which is self-pay. But only about one-quarter of people who need hearing aids have them. Aging and exposure to loud noise are both only growing trends, likely to expand the market need. And some research has shown that leaving aging patients without the hearing aids they need can exacerbate associated conditions such as Alzheimer's disease, dementia and social isolation.

What makes EarLens Fierce: EarLens has a pair of serial entrepreneurs at the helm: The duo each have a history of creating med tech startups that sell. So, don't be surprised to see EarLens follow a similar path.

Its founder and CMO, Rodney Perkins, is an otologic surgeon and has launched a series of healthcare technology startups, some of which have sold. He also founded the California Ear Institute at Stanford and is a clinical professor of surgery at Stanford University School of Medicine.

EarLens' Contact Hearing Device--Courtesy of EarLens

EarLens Chairman, President and CEO William Facteau was sales director at vessel closure company Perclose, which sold to Abbott Laboratories ($ABT) for $683 million. He then became the head of Acclarent, which was sold to Johnson & Johnson ($JNJ) for $800 million. He was also chairman of Cabochon Aesthetics, which sold to Ulthera last year. Most recently, he was vice chairman of medical device accelerator ExploraMed and an entrepreneur-in-residence with New Enterprise Associates.

Facteau joined the company about a year ago.

"What really attracted me to it were a number of things. It is truly proprietary and differentiated; all the other hearing aids generally use air," he said in an interview with FierceMedicalDevices. "The benefits address an unmet need in the hearing aid world. It's a $7 billion established market, but grossly underpenetrated at about 25%. That speaks to some of the shortcomings of the existing technology."

He expects the EarLens product will retail at $3,000 to $3,500, on par with existing, high-end hearing aids, and that the company will avoid reimbursement issues, because the category is largely self-pay. With the exception of the Veterans Administration, very few large payers reimburse for the devices--in part because of the deficiencies of the existing tech.

Early proof-of-concept data show that the system produces sufficient output for as much as 60 dBHL of hearing impairment for up to 8 kHz in 86% of the study population and up to 11.2 kHz in 50% of the population. This was a 16-person study of people with normal hearing to moderately hearing-impaired for up to a 10-month period.

"We believe this could be a real game-changer for hearing-impaired individuals," Facteau concluded. Its backers agree; this year it pulled in $28.5 million in new venture money from investors including New Enterprise Associates, Aisling Capital and Lightstone Ventures.

What to look for: EarLens is pursuing a 510(k) pathway and hopes to have a product with FDA and CE-mark approval by mid-2015.

The company is in the midst of a pivotal trial, which it expects to report this year. The trial, a 50-patient study at four U.S. sites, is looking at safety and efficacy at 30 days and four months.

Facteau said the EarLens device isn't randomized against any other technologies in the trial, but part of the criteria for patient enrollment is that they have had an air-conduction hearing aid. So, surveys will be done in parallel with the study to examine the difference in patient experience between the two kinds of devices.

The startup is already working on the next-generation product, which Facteau said will include cosmetic improvements, as well as a more efficient battery and audio streaming for the iPhone via low-energy Bluetooth technology. The existing battery works for 12 to 14 hours, but EarLens is aiming for more than 18 hours with a rechargeable battery. Most existing hearing aids use a disposable battery. -- Stacy Lawrence (email | Twitter)

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EarLens - 2014 Fierce 15