iHear Medical gains FDA approval for OTC hearing test
SAN LEANDRO, Calif. - iHear Medical announced Monday that it has received FDA clearance for the iHearTest, a hearing screener approved for sale over-the-counter.
"The iHearTest is a disruptive new technology and cost saving method that can expand hearing care significantly," stated Randy Pozos, president and healthcare technology analyst with Advanced Knowledge Resources. "Less than one-third 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."
"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," added Adnan Shennib, iHear Medical CEO.
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.
iHear Medical plans to retail the iHearTest kit for $49, which includes testing for two family members. The iHearTest is protected by four U.S. and international patent applications.
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, a premiere Beijing-based hearing solution provider.