December 14, 2018 -- Tri-county graduates launch medical device startups
An employee of Westlake Village-based CDG Biotech works with one of the company’s diagnostic test kits for clinical labs.
Hoping to build on the success of biotech giant Amgen in Thousand Oaks and portable oxygen-maker Inogen in Goleta, regional universities are working to embrace medical technology as part of the tri-county startup tech culture.
Westlake Village-based CDG Biotech, which makes diagnostic test kits for clinical labs, is one startup joining the biotech hub in the Conejo Valley region. The company was founded in 2015 by CEO Noel Silva, who moved to the area from Venezuela, along with his wife Llume, to attend a master’s dual-degree program in business and biotechnology at CSU Channel Islands.
The Silvas had already built a successful company in Latin America that manufactured and distributed devices, but made the decision to expand into the U.S. when they faced business difficulties during growing unrest in Venezuela in 2013.
Noel Silva said the program allowed him to further his education in biotech and business as well as network and plug into the business community within the region.
“The information was great, but I would put at the top my experience interacting with students, professors, peers and other members of the community,” Silva said.
In addition to the program at CSUCI, California’s reputation for innovation, proximity to Los Angeles, nice weather and a “biotech hub-like environment” in Westlake Village are other reasons Silva said he selected the region for the biotech startup.
Although the company is still in its incubation period, financing from Silva’s company in Venezuela as well as a distribution partnership and $500,000 investment from a European company with a similar product have contributed to its financial outlook.
“Our expectation for next year is to have $1 million in sales, and in three to five years between $4 million to $5 million in revenue per year,” he said, based on product sales in international markets.
Meanwhile, a new medical device company brewing in The SLO HotHouse in downtown San Luis Obispo and the Cal Poly Center for Innovation and Entrepreneurship has raised about $200,000 in seed money.
De Oro Devices incorporated in September and is currently in a pre-seed fundraising round, said founder and CEO Sidney Collin, who is working full time at De Oro and finishing her bachelor’s degree in biomedical engineering at Cal Poly.
The device helps treat freezing of gait, a symptom commonly experienced by people with Parkinson’s disease that impairs their ability to walk.
“We didn’t necessarily invent a new technology to treat this symptom. We took the research and gave people a device they can use,” Collin said. Along with her two teammates, both Cal Poly connections who run business operations, Collin is working on testing and research.
The group has created prototypes and tested the device on about 10 patients at conferences, associations and support groups for people with Parkinson’s across the Tri-Counties, Collins said.
Funding has trickled in from The Parkinson Alliance, Cal Poly’s HotHouse accelerator program and national grants. On Dec. 14, the group will compete for thousands of dollars in funding from an Arizona State University innovation competition.
The concept of De Oro Devices started as a school project for Collin when she met a local veteran named Jack who was experiencing freezing of gait. When he came to Cal Poly for help, she helped create the device for him.
“At the time, that’s all I thought it was,” she said, but after attending Jack’s support group she realized the need was much bigger. Physical therapists and large companies were asking for a prototype.
Collin said the device doesn’t need FDA approval and the team hopes to get it out to patients within the next six to 12 months.
In Santa Barbara County, hearing aid device company iHear Medical was created by UC Santa Barbara graduates. Although the business is now located in the Bay Area and the original founder is no longer with the company, two executives and an engineer are UCSB grads.
iHear developed an FDA-approved iHeartest kit that can be purchased online or over-the-counter and is especially beneficial for people with diabetes who often experience hearing loss but don’t have it tested regularly, CEO John Luna said.
The test also recommends specific hearing aids based on the severity of hearing loss.
The American Diabetes Association announced a partnership with iHear in November, and the company has signed distribution agreements with major pharmacy distributers, including Amerisource Bergen, Cardinal Health, CVS Pharmacy and Rite Aid.
“Having home hearing assessment available over-the-counter is something that is of high interest to retailers and consumers,” Luna said.
With 25 patents pending, iHear is currently in a Series D round of financing for product marketing and distribution, he said. It plans on raising $25 million in financing in the current round.
“I’m fortunate to be one of the grads from UCSB that has been able to use his degree and experience from UCSB throughout my entire professional career,” said Luna, who graduated from the university with a bachelor’s degree in audiology in 1992.
August 30, 2018 -- iHEAR® Medical, first to create FDA-cleared home hearing assessment kit, a breakthrough for home diagnostics
The FDA-cleared iHEARtest™ gives consumers control of their hearing health in the convenience and privacy of their own home, with affordable and innovative technology.
(San Leandro, CA) The availability of, and demand for, at-home diagnostic products is on the rise – the market for point-of-care diagnostics is projected to reach $37 billion by the end of 2021. Consumers are seeking options to assess their own health through affordable, technologically advanced yet simple to use self-monitoring solutions. The first Food and Drug Administration-cleared home hearing assessment kit, called the iHEARtest™, has been introduced by iHEAR® Medical to give consumers control of their own hearing health.
The Center for Hearing and Communication reports that 48 million Americans have a significant hearing loss, yet only 16% of physicians routinely screen for hearing loss. For the first time, consumers now have FDA-cleared technology allowing them to screen and monitor their own hearing from the convenience and privacy of their home. Consumers can take the 6 minute iHEARtest™ assessment and immediately learn what their Hearing Number™ is on a scale from 1 to 5 (from profound hearing loss to good hearing in each ear).
Hearing loss is on the rise. From 2000 to 2015, the number of Americans with hearing loss has doubled, according to the Hearing Health Foundation. Hearing loss may result from genetic causes, complications at birth, certain infectious diseases, chronic ear infections, exposure to excessive noise, and aging. The American Speech-Language Hearing Association recommends adults have their hearing checked at least once every 10 years up to the age of 50, then every three years.
“Millions of Americans suffer from a reduced quality of life due to their hearing loss. Our vision was to develop technology that empowers and informs consumers who want to monitor their own wellbeing. People with hearing loss can definitely benefit from early identification,” said John Luna, CEO of iHEAR® Medical, Inc. “The future of screening diagnostics is being driven by consumers who want to take many routine assessments in the privacy and convenience of their home. With the iHEARtest we’re making it possible for more people to incorporate hearing health into their wellness routine.”
iHEAR® Medical has made the iHEARtest™ accessible and available over-the-counter at independently owned pharmacies, national drugstore chains, and now online (including CVS.com, FSAStore.com and Walmart.com.) The iHEARtest™ kit includes a proprietary USB device that connects to a personal computer and factory-calibrated earphones. The user downloads the screening software and follows the instructions to administer the iHEARtest™. Using secure online access to a HIPAA-compliant server, the user can review their results at any time.
For more information on iHEAR® Medical, visit: www.ihearmedical.com
About iHEAR® Medical
What’s your hearing number?™ The future of better hearing technology has arrived with iHEAR® Medical. Dedicated to affordable and accessible hearing solutions, featuring state-of-the-art technology with an intuitive and elegant design, iHEAR® Medical has a list of firsts. Founded in 2010, iHEAR® Medical continues to shape the future of hearing solutions with the first FDA-cleared over-the-counter iHEARtest™ home screener, and its hearing aid solutions, iHEARhd®, iHEARmax™, Eva™ by iHEAR®, and the personal sound amplification product TReOTM by iHEAR® 3-in-1 Amplifier. iHEAR® holds more than 50 U.S. and international patents for its products and services.
August 28, 2018 -- Denver ABC 7 Interviews John Luna, CEO About Hearing Loss and the iHEARtest
July 18, 2018 -- New hearing test to be available over-the-counter
New hearing test to be available over-the-counter
First-ever FDA-cleared test to be sold at drugstores and pharmacies nationwide
ORLANDO, Fla. - Approximately 48 million Americans report some degree of hearing loss, with less than 20 percent of them actually getting the help they need.
Numbers show that hearing loss is the third-most common physical condition, behind arthritis and heart disease, affecting people of all ages.
John Luna, the CEO of iHearMedical, joins News 6 at Nine to talk about the new at-home hearing test the company has developed that will be available nationwide this month.
Q&A with John Luna about iHearTest
What is it?
iHearTest is the only FDA-cleared home screener available direct to consumers for home use. For the first time ever, the public will be able to walk into their local independently owned pharmacy and purchase the iHearTest that they can use at home to evaluate their hearing. Having the Food and Drug Administration clearance means consumers are protected knowing the FDA has approved the efficacy and safety of how this home screener checks hearing and determines indications of benefit from the use of a hearing aid based on the Hearing Number.
Why is it important for consumers to be able to monitor their own hearing at home?
iHEAR Medical is dedicated to affordable and accessible hearing solutions, featuring superior sound quality and innovative online tools. Our self-administered hearing screener iHearTest is an integral part of the future of better, more accessible hearing products. Your own iHearTest results can be used to program your iHEAR hearing aids and amplifiers immediately, ensuring a direct and successful result.
The iHearTest is an answer for, and a boon to, the millions of people who normally wait until age 70 to treat their hearing loss by wearing hearing aids.
Who should be interested in assessing their own hearing loss?
Our goal is to bring high-quality hearing amplification to the millions of Americans who may have hesitated in the past due to cost or general uncertainty about making sure they are getting what they need. The statistics are staggering for those in need: Of adults aged 20-69 who could benefit, only 16 percent have tried hearing devices, and very likely even less have had their hearing tested in many years, or decades. In fact, the average delay between the time someone is affected by hearing loss to when they finally seek treatment is seven years. It’s recommended that adults over 40 years old monitor and screen their hearing annually.
How does it work?
Consumers can purchase the iHearTest home hearing screener, bring it home and follow the simple instructions to evaluate their own hearing in each ear. The screening takes about 5 to 6 minutes. The results are comprehensive but easy to understand, with a simple 1 through 5 scoring system, from profound hearing loss (1) to good hearing in each ear (5). People will finally know the answer to: What’s My Hearing Number?
For a video on how to use the test, click here.
For more information on how to purchase a test and to see a hearing questionnaire, click here.
Read more from News 6 at ClickOrlando.com.
July 18th, 2018 -- John Luna, CEO interview with WKMG Orlando
Mar 14, 2017 -- Do-it-yourself hearing test company offers affordable hearing aid
by: Clark Howard Updated:
ATLANTA - According to the CDC, hearing loss is the third-most chronic health condition in the United States.
Channel 2 Consumer Advisor Clark Howard says despite being so common, hearing aids are rarely covered by insurance.
Michael Rosenberg said he started noticing a problem hearing years ago.
“I can hear people talk, but the speech is not sharp enough for me,” he said “The audiologist said for some reason you lost 30 percent of your high frequencies.”
Rosenberg shopped around for hearing aids and found most hearing aids were priced just over $2,000 per ear.
“The cheapest one that I could find at Sam’s or Costco were about $635 apiece,” he said
Then Rosenberg heard Clark talk about iHear Medical, an FDA approved, do-it-yourself, home hearing test and hearing aid company.
Jan 6, 2017 -- I Hear You
By: Rick Weinberg
Jan 6, 2017
CALIFORNIA BUSINESS JOURNAL
Adnan Shennib has shaken the hearing-aid industry to its core by developing a revolutionary hearing process and device that lowers costs by a staggering 90 percent.
Greed is evident virtually everywhere you turn these days.
But don’t put Adnan Shennib in that category.
Shennib has devoted his entire professional life – more than two and a half decades — to helping people with hearing impairments. Not only did he develop Lyric, the world’s smallest hearing aid, but now he’s changed the entire landscape and direction of the industry by lowering hearing-aid costs by a staggering 90 percent – from $3,000 all the way down to $300 – with his company, iHEAR.
Oct 28, 2016 -- The quest for cheaper hearing aids
Oct 28, 2016
SF Chronicle
The quest for cheaper hearing aids
Photo: Michael Macor, The Chronicle
Sep 10, 2015 -- iHear Medical and AIER Partner to Distribute Web-Enabled Hearing Aids in China
By: iData Research
Sep 10, 2015
iData Research
iHear Medical and AIER Partner to Distribute Web-Enabled Hearing Aids in China
Hear Medical announced its plans to introduce advanced web-enabled hearing aids for the China market by partnering with Beijing-based AIER, China’s largest dedicated hearing solution provider. READ MORE from iData Research >
Nov 24, 2014 -- iHear Medical Expands C Round to $5M
(c)2011-2015
by Massinvestor, Inc.
VC News Daily
iHear Medical Expands C Round to $5M
iHear Medical, Inc. announced today the expansion of its third round of financing to $5M. The participants in this round included Brother Industries (Japan) and Ameritas Holding Company. The C-round was led earlier by Lighthouse Capital, a Shanghai-based venture capital firm with a focus on early stage investments in medical devices and IT. READ MORE from VC News Daily >
Nov 24, 2014 -- Affordable Hearing Aid Maker iHear Raises $5M Series C
Nov 24, 2014
BY CATHERINE SHU
TechCrunch
Affordable Hearing Aid Maker iHear Raises $5M Series C
iHear Medical, which makes affordable hearing aids that users can customize at home, has raised $5 million in a Series C round led by Lighthouse Capital, a Shanghai-based venture capital firm that focuses on medical devices. Japanese electronics maker Brother Industries and Ameritas Holding Company also participated. READ MORE FROM TechCrunch >
Apr 7, 2014 -- The iHEAR in Ear Hearing Device
Apr 7, 2014
By:Thomas C. Weiss
The iHEAR in Ear Hearing Device
Unfortunately, the iHEAR HD is not meant for use by everyone. The hearing device is not meant for use by people who experience severe or profound hearing loss. The benefits of the hearing device are exceptional however. For example; you can adjust your own hearing aids from home using online tools. The new approach gives people an invisible, high-quality in-the-ear hearing device at a far lower cost than prescribed hearing aids.
Mar 29, 2014 -- New iHear Hearing Aids Have Audiologists Anxious
Posted Mar 29, 2014
There's a new home testing device that has audiologists concerned. It’s called the IHearTest, an at-home testing unit that comes along with the iHear hearing aid and could transform hearing tests into a digital do-it-anywhere process.
The patented iHear device is the size and weight of a kidney bean. It’s claimed to be the first affordable invisible hearing aid. According to their campaign homepage, “the iHearHD device is 100% digital technology and programmable for a broad range of hearing loss types including flat, reverse slopes, high frequency, mild, moderate to moderately-severe losses.” Millions of people across the globe are able to benefit from the device, including many who avoided traditional hearing aids because of cost or bulkiness.READ MORE FROM INQUISITR >
Mar 28, 2014 -- iHear Medical Proposes a DIY Solution to Make Customized Hearing Aids More Affordable
BY DEANNA POGORELC
MedCity News
iHear Medical proposes a DIY solution to make customized hearing aids more affordable
In a bid to make customized hearing aids more accessible and less expensive to people who have a hard time hearing,iHear Medicaliscutting the Audiologist out of the equation.
The medical device startup is making mail-order hearing aids that consumers can fine-tune at home using an accompanying hearing test kit. Inside the test kit is a tool kit, USB cord and computer software.
The devices are about the size and weight of a kidney bean and fit inside the ear in a way that they are nearly invisible, iHear says. Users customize the fit using a seal tip that comes in four different sizes and calibrate the devices using the software. They’re designed to last for about 18 months, if users take them out before bed. READ MORE FROM MedCity News >
Mar 25, 2014 -- Can You Hear Me? Affordable Hearing Aid Launches From iHear Medical
MAR 25, 2014
BY TJ McCUE
Forbes.com
Can You Hear Me? Affordable Hearing Aid Launches From iHear Medical
According to the WorldHealthOrganization (WHO), 360 million people worldwide have a disabling hearing loss. Added to that, current production of hearing aids meets less than 10% of the global need. It can be argued that the production is low simply due to the affordability of these devices. iHear Medical, based in San Leandro, California, is out to change that with the world’s first web-enabled hearing aid system. READ MORE FROM FORBES >
Mar 24, 2014 -- iHear Hearing Aid can Be Calibrated Over the Internet to Keep Costs Low
MAR 24, 2014
BY NICK LAVARS
Gizmag
iHear Hearing Aid can Be Calibrated Over the Internet to Keep Costs Low
According to the Hearing Loss Association of America, 48 million Americans (around 20 percent of the population) report some degree of hearing loss. This problem is compounded by the costs associated with having the condition diagnosed and a hearing aid fitted in a clinic, causing many to allow the ailment to go untreated. iHear, an invisible hearing aid, is designed to significantly lower the cost of personalized hearing devices by enabling the user to test the extent of their condition and calibrate the hearing aid from their own home. READ MORE FROM Gizmag >
Mar 21, 2014 -- iHear Medical, Offering an Affordable Hearing Solution for Less than $1 a day
MAR 21, 2014
ERIC DYE WITH GUEST, ADNAN SHENNIB
PODCAST
iHear Medical, Offering an Affordable Hearing Solution for Less than $1 a day
- Listen to interview with host Eric Dye & guestAdnan Shennib discuss the following:
- Can you tell our listeners a little about your background and career?
- How did you come up with the idea of iHear Medical and when did you start the company?
- Can you talk about the Indiegogo crowdfunding campaign and why it’s so unique?
- How can people contribute to the crowdfunding campaign?
- Are their new products that iHear is currently developing?
Feb 24, 2014 -- Will iHear Medical’s $200 Programmable Hearing Aid Disrupt The Hearing Industry?
Will iHear Medical’s $200 Programmable Hearing Aid Disrupt The Hearing Industry?
Nov 27, 2013 -- iHear Medical Announces Plans for Product Introduction and Humanitarian Initiative
PUBLISHED NOV 27, 2013
The Hearing Review
iHear Medical Announces Plans for Product Introduction and Humanitarian Initiative
iHear Medical, San Leandro, Calif, has announced its plans to introduce what it calls the world’s first web-enabled hearing aid system, targeting tech-savvy consumers seeking alternatives to higher-priced conventional hearing aids.
The announcement was made on November 7 at the China Medtech Partnering (CMP-2013) Conference being held in Suzhou, China. The technology developed by iHear Medical—a company founded by long-time hearing industry inventor Adnan Shennib—seeks to offer advanced hearing solutions at a fraction of the cost of available hearing aids, and in smaller form-factors for invisible wear, according to the company.
