iHear Medical Receives Landmark FDA Approval for the First Over-the-Counter Home Hearing Test
San Leandro, CA (PRWEB) January 04, 2016 -- iHear Medical announced today that it has received FDA clearance for the iHearTest™, the world’s first hearing screener approved for over-the-counter (OTC) sales. The iHearTest is a hearing screener for profiling hearing ability based on the World Health Organization (WHO) guidelines, targeting adults who suspect they have hearing loss, or those reluctant to seek professional evaluation for a basic hearing assessment.
The iHearTest and other hearing solutions developed by iHear Medical are in line with the disruptive technology that the President’s Council of Advisors on Science and Technology (PCAST) called for in the October 2015 letter to the President recommending automated online hearing tests made affordable and available to those with age-related, progressive, mild-to-moderate hearing loss.
"The iHearTest is a disruptive new technology and cost saving method that can expand hearing care significantly. Less than 1/3 of physicians include hearing screening for their patients and millions in the mild to moderate hearing loss range go untreated, which increases their risk of dementia along with losing friendships, jobs and careers. iHear's breakthrough home hearing test is a game-changer for millions of consumers seeking affordable and accessible hearing solutions," stated Randy Pozos, PhD, president and healthcare technology analyst with Advanced Knowledge Resources, Inc.
"This landmark FDA approval will allow us to reach out to millions who suspect hearing loss and conduct a basic hearing evaluation for themselves or their family members from the privacy and convenience of their home,” noted Adnan Shennib, founder and CEO of iHear Medical.
The FDA approval of the iHearTest was based on extensive technological development and clinical research to demonstrate safety and efficacy. An Institutional Review Board (IRB)-approved clinical study was conducted on 96 subjects with iHearTest results compared to WHO grading of hearing impairment using standard practice audiometry. The clinical study results showed 96.4% agreement with the WHO method using standard practice audiometry for the assessment of disabling hearing impairment. For the ordinal assessment of hearing ability, the iHearTest showed 85.9% level-by-level agreement and 100% agreement within ±1 level with respect to WHO grading using standard practice instruments.
Other manufacturers currently offer online and mobile apps for hearing tests, but these unregulated tests are notoriously inaccurate and do not comply with the accepted standards of audiometric evaluation. The reliance on uncalibrated headphones, speakers and sound cards, results in unpredictable test signals, which often produce grossly inaccurate test results. The FDA has previously intervened to remove unapproved hearing tests with unsubstantiated claims of accuracy.
The iHearTest kit includes a handheld USB device for connection to a personal computer and factory-calibrated earphones. The iHearTest software application is downloaded online and provides step-by-step instructions on how to administer the iHearTest. The iHearTest kit requires a standard personal computer running Microsoft Windows or Mac OS X. Test results are stored on a remote HIPAA-compliant server for review any time by the consumer using secure online access. The iHearTest system also conducts periodic checks of earphone calibration to ensure continued test signal accuracy. The iHearTest is not intended as a diagnostic test to evaluate hearing health or treat ear disease. The test advises consumers to seek professional evaluation for any symptoms that may indicate a health issue.
The delay in basic assessment of hearing loss presents challenges for the hearing health system, which often deals with hearing loss at the severe stages, rather than early on during the mild and moderate stages. Early symptoms of hearing loss include inability to discern speech in noisy situations, asking others to repeat words frequently, and turning the TV loud at home. Because hearing loss is typically a gradual process developing slowly over decades, self assessment is often elusive with individuals exhibiting denial or assuming others “mumble” or are not speaking clearly. Psychological and other barriers prevent many from seeking professional evaluation early on, resulting in untreated loss and communication barriers. The lack of solutions available directly to consumers or through their primary care providers results in a delay in basic hearing assessment and treatment of about 6-9 years according to industry reports.
Hearing loss is a global problem of epidemic proportion and those who are affected often exhibit denial, confusion and even personality changes. The WHO estimates about 5% of the world’s population, or approximately 360 million people, suffer from a disabling level of hearing impairment. Over 40 million people in the U.S. and over 100 million people in China and Japan are known to have a measurable degree of hearing loss, with prevalence predicted to rise significantly due to an aging population and growing use of personal listening devices. While the vast majority of people with hearing loss can be successfully treated with hearing aids, less than 10% use them globally due to persisting barriers including high cost and lack of access to hearing assessment and treatment. A disabling level of hearing impairment refers to a hearing loss of 40 decibels or more.
iHear Medical plans to retail the iHearTest kit for $49 USD which includes testing for two family members. The iHearTest is protected by four U.S. and international patent applications. To learn more about the iHearTest visit http://www.ihearmedical.com/ihear-test
iHear Medical plans to offer a range of innovative web-based hearing solutions directly to consumers and through partnerships with leading insurance and professional distribution channels. Recently, the company announced partnerships with Ameritas, a major U.S. insurance provider, and AIER(爱耳时代 ), a premiere Beijing-based hearing solution provider.
iHear Medical is a venture-backed firm dedicated to addressing the global need for affordable and accessible hearing solutions. iHear Medical's new products and business models are intended to break through persisting barriers preventing people with hearing loss from acquiring and using hearing aids. iHear Medical is pioneering web-enabled hearing solutions and was founded by Adnan Shennib, who has started and led the development at several Silicon Valley firms, including InSound Medical, which was acquired by Sonova-Phonak in 2010 in a deal totaling $169M. For more information on iHear Medical, visit http://www.ihearmedical.com.
Media Contact:
Fonea Lam
iHear Medical, Inc.
fonea (at) ihearmedical (dot) com
510 276-4437
Fonea Lam, iHear Medical, Inc., http://www.ihearmedical.com, +1 (510) 276-4437, [email protected]
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