Osicus User Guide V8
09/09/2021
Page
12
of
46
4. Introduction
The Osicus Audiometer is a medical device used to screen subjects for noise induced
hearing loss.
It is intended that the Osicus will be used as part of a hearing screening program in
industrial and corporate environments. The hearing screening will measure the hearing
threshold of a test subject and indicate the need for further clinical analysis and
treatment. The Osicus is a stand-alone product and is not intended to be used with other
medical devices.
The operator of the Osicus is expected, as a minimum, to be a competent person.
Competent persons have completed courses with syllabi determined by the British Society
of Audiology. These courses familiarise them with audiology, the methods of performing
hearing testing and how to operate and maintain audiometers. Other users may be more
skilled experts in audiology, such as Occupational Health nurses and audiologists.
The subject, upon whom the hearing testing is performed, is expected to be an employee
working in high noise environments being screened in line with the Health and Safety
Executive’s regulations on noise
at work, or being routinely screened as a part of a
workplace health programme. Subsequently, they come from all walks of life and are of
working age.
The Osicus audiometer is expected to be used in an environment suitable for the
conduction of hearing testing. Most likely a quiet office or a room fitted out with a
hearing test booth.
The process follows the British Society of Audiology approved procedures for the
determination of Pure Tone thresholds, using the Hughson Westlake technique. The
headphones rest on the outside of the head of the test subject and shall transfer sound
energy to the subject by air conduction. The subject holds the remote switch and presses
it when tones are heard.
Once thresholds have been determined for both ears on selected frequencies, and the
age and gender of the subject being tested has been input, the audiogram is
categorised according to the Health & Safety Executive categorisation scheme.
