Table of Contents
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1 Introduction
This section offers you important information about:
▪
the intended use of the device
▪
indications and contraindications of use
▪
essential performance
▪
features and benefits
▪
a description of the device
1.1 Intended Use Statement
The MA 28 audiometer is designed to be a portable device for testing 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. Testing for hearing loss using this type of audiometer requires interaction
with the patient.
Indications for Use:
The MA 28 is a portable or standalone audiometer intended to be used for the
identification of hearing loss and the factors that contribute to the occurrence of the
hearing loss in the age range of children to adults. 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, healthcare facility or
other suitable quiet environment as defined in ISO 8253-1 or ANSI S3.1 or equivalent.
1.2 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.3 Description
The MA 28 is an electroacoustic test device that produces sounds through a range of
frequencies and intensities to test for hearing loss. It features pure tone audiometric
testing with or without masking for measuring audibility thresholds. MA 28 is meant to
be used with headphones that are calibrated to the specific audiometer and are not
interchangeable with other devices.
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. The testing for hearing loss using this kind of audiometer depends on the
interaction with the patient.
8506915 Rev. 5
Operation Manual MA 28
3
05/05/2021
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