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The iHearTest is not intended for use by individuals with dementia or other
cognitive impairment.
If you have any questions regarding the use of this product, please contact
iHear Medical, Inc. Customer Support Toll Free at 1 (844) iHEAR44 (1-844-
443-2744), or [email protected].
An Institutional Review Board (IRB)-approved clinical study was conducted
to assess the safety and efficacy of the iHearTest (home hearing screener)
in normal use settings. 77 subjects (154 ears), including 47 males and 30
females, ages 22-90 years, median age of 51 years, were enrolled for the
clinical study. The iHearTest scoring results were compared to the World
Health Organization (WHO) method for grading of hearing impairment
using standard practice audiometry methods. The study targeted adult
subjects who suspected or knew they had hearing loss.
The primary objective of the iHearTest clinical study was to determine a
binary (yes/no) identification of disabling hearing impairment (correspond-
ing to WHO levels 2-4), and the extent to which the iHearTest agreed with
the WHO method for determining disabling hearing impairment. The clinical
study results showed 95% agreement with the WHO method using standard
practice instruments for the assessment of disabling hearing impairment,
with high sensitivity and specificity of 89% and 97%, respectively. For the
ordinal assessment of hearing ability the iHearTest showed 86% agreement
level-by-level, relative to the WHO method using standard practice audi-
ometry, and showed 100% agreement with the WHO method using stan-
dard practice audiometry within ±1 level of WHO grading. The variability of
scoring between the iHearTest with respect to the primary standard practice
method was consistent with – and nearly identical to – the variability across
two alternate standard practice audiometry methods.
In addition to the primary objectives of determining agreement with the WHO
method using standard practice audiometry, the usability of the iHearTest
system was also evaluated in a subset of 25 subjects as an exploratory
endeavor to obtain comments on the subjective experience with the device,
packaging and setup. The iHearTest was found to be safe and effective as
an over-the-counter hearing screening device.
Clinical Summary