FDA Approves First Consumer Hearing Test The iHearTest, the first over-the-counter hearing screening test marketed to consumers, has received clearance from the Food and Drug Administration (FDA). According to the test’s manufacturer, iHear Medical, the screener profiles hearing ability based on World Health Organization (WHO) guidelines. It is targeted to adults who suspect they have hearing ... News in Brief
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News in Brief  |   March 2016
FDA Approves First Consumer Hearing Test
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Hearing Disorders / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   March 2016
FDA Approves First Consumer Hearing Test
The ASHA Leader, March 2016, Vol. 21, 6. doi:10.1044/leader.NIB1.21032016.6
The ASHA Leader, March 2016, Vol. 21, 6. doi:10.1044/leader.NIB1.21032016.6
The iHearTest, the first over-the-counter hearing screening test marketed to consumers, has received clearance from the Food and Drug Administration (FDA).
According to the test’s manufacturer, iHear Medical, the screener profiles hearing ability based on World Health Organization (WHO) guidelines. It is targeted to adults who suspect they have hearing loss or are reluctant to seek a professional hearing assessment.
The company says that FDA approval of the iHearTest was based on extensive technological development and clinical research to demonstrate safety and efficacy. In a clinical study of 96 participants, iHearTest results were compared to WHO grading of hearing impairment using standard practice audiometry. According to iHear Medical, results showed 96.4 percent 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 percent level-by-level agreement and 100 percent agreement within ±1 level with respect to WHO grading using standard practice instruments.
Online and mobile apps for hearing tests available to consumers are unregulated. They rely on uncalibrated headphones, speakers and sound cards that may result in unpredictable test signals that may produce inaccurate results.
The iHearTest kit includes a handheld USB device that connects to a personal computer and factory-calibrated earphones. The user downloads the testing software, which provides instructions on how to administer the test. Using secure online access to a HIPAA-compliant server, the user can review test results at any time. The system periodically checks earphone calibration to ensure continued test signal accuracy.
The company notes that the system 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 hearing health issue.
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March 2016
Volume 21, Issue 3