The US Food and Drug Administration (FDA) has given the green light for marketing of an over-the-counter testing system for hearing loss, reports MedDeviceOnline.
San Leandro, California-based company iHear Medical has announced that it has received FDA clearance for sale of its iHearTest. The system is to be used at home to accurately and quickly determine the user’s hearing ability, and will cost USD 49.
“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,” said iHear Medical founder and CEO, Adnan Shennib. Other companies have developed and marketed online hearing tests and mobile apps, but iHear Medical claims that these unapproved products are consistently inaccurate since they do not use calibrated earphones or soundcards.
The kit includes a USB device for connection to a personal computer, powered by the computer, and factory-calibrated earphones, along with a background noise sensing system to ensure the accuracy of the results. The associated software application is downloaded online and provides instructions on how to use iHearTest. Test results are stored on a web-based server and customers can connect anytime using secure online access.
iHear Medical warns potential customers that the iHearTest is not a diagnostic test to clinically assess hearing health, nor to treat, cure, or prevent disease. The company reminds customers that they should consult with a hearing health professional for a medical evaluation of their ears and hearing health.
Source: MedDeviceOnline;