This section offers you important information about:
▪ the intended use of the device
▪ indications and contraindications of use
▪ features and benefits
▪ a description of the device
1.1 Intended Use Statement
Screening audiometers are designed for determine hearing thresholds levels. The
instrument is intended for all patient populations over 3 years age and able to respond
to test signal in a rational way.
1.2 Indications for Use Statement
The MA 25/MA 25e/MA 27/MA 27e 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.
1.3 Contraindications of Use
The patient is too young, sick or uncooperative to perform the tasks.
1.4 Features and Benefits of the MA 25/MA 25e and MA 27/MA 27e
1.4.1 General Information About the MA 25/MA 25e and MA 27/MA 27e
The MA 25/MA 25e and the MA 27/MA 27e gives you the benefit of:
• Portable audiometer
• Multiple transducer options
• Air Conduction
• Pure, Pulse and Warble Tone
• Built-in handle and storage compartment – MA 27 and MA 27e version
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