Welch Allyn OAE Hearing Screener - User Manual - Manual (Page 6)

Welch Allyn OAE Hearing Screener Directions for Use 705353 Rev F 5
Chapter 1: Introduction
The Welch Allyn OAE Hearing Screener performs otoacoustic emissions tests. Using a
combination of hardware and software, the Welch Allyn OAE Hearing Screener produces a
controlled acoustic signal in the ear canal and measures the resulting evoked emission that is
generated by outer hair cells in the cochlea. The system collects and averages data samples until
specified measurement parameters are achieved. For distortion product otoacoustic emissions
(DPOAEs), the DP and noise floor amplitudes appear on the LCD. A pass or refer result is
assigned at the end of the test based on comparison of the test measures to the active protocol
criteria. Users can view and analyze the results for further evaluation of the test outcomes.
The Welch Allyn OAE Hearing Screener is a medical device that produces information about the
auditory system of a patient. This information is then available for medical diagnosis or screening.
Therefore:
The Welch Allyn OAE Hearing Screener is intended for use
by a health care professional or a technician who is trained
and supervised by a health care professional or accredited
organization.
Indications for use
The Welch Allyn OAE Hearing Screener produces controlled acoustic signals in the ear canal and
measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair
cells of the inner ear as a result of normal peripheral hearing processes. The Welch Allyn OAE
Hearing Screener performs distortion product otoacoustic emissions (DPOAE) tests that can be
utilized in hearing screening and diagnostic test environments.
As an OAE based screening tool, Welch Allyn OAE Hearing Screener is indicated for use by any
personnel (nurses, technicians, volunteers) who are trained to operate the device for the purpose
of performing an objective, automated physiologic screening measure with pass/refer result
requiring no further clinical interpretation. Additionally, as a tool that can provide diagnostic
information, the device is indicated for use by trained health care professionals (audiologists,
physicians) to further assess cochlear function for the purpose of diagnosis and treatment of
hearing disorders, since additional information may be obtained by viewing the details of the
performed otoacoustic emissions test.
The device can be used for patients of all ages, from newborn infants through adults, to include
geriatric patients. The otoacoustic emissions test is especially indicated for use in testing
individuals for whom behavioral results are deemed unreliable, such as infants, young children,
and cognitively impaired adults.