Operation Manual MA 1
8100216 Rev. 5
2
09/03/2023
1 Introduction
This section offers you important information about:
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the intended use of the device
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indications and contraindications of use
▪
features and benefits
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a description of the device
1.1 Intended Use
The MA 1 is a device designed to perform a hearing screening. The instrument is
intended for all patient populations over 3 years old and able to respond to test signals
in a rational way
1.2 Indications for Use Statement
The MA 1 is a portable or hand-held device intended to be used for the identification of
hearing loss and the factors that contribute to the occurrence of hearing loss. It is used
as part of a total test battery to determine hearing acuity by audiologists, ENTs, hearing
healthcare professionals, or other trained technicians in a hospital, clinic, or healthcare
facility.
1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Features and Benefits
The MA 1 gives you the benefit of
•
Compact handheld portable device
•
Multiple transducer options
•
Air Conduction
•
Battery operation
1.5 Description
The MA 1 screening device is designed for screening of hearing loss. Output and
specificity of this type of device are based on the test characteristics defined by the
user, and may vary depending on environmental and operating conditions. Screening
for hearing loss using this kind of device depends on the interaction with the patient.
As with any type of hearing screening, a “pass” result should not overrule any additional
concerns regarding hearing ability. A full audiologic evaluation should be administered
if concerns about hearing sensitivity persist.
