D-0101246-Q – 2022/05
Callisto™ Instructions for Use - US Page 1
1. Introduction
1.1 About this manual
This manual is valid for the Callisto™. The product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: info@interacoustics.com
Web: www.interacoustics.com
1.2 Intended use
Indications for use
The Callisto™ with AC440 is intended to be used f or the detection and diagnosis of suspected hearing loss.
The outcomes of which can be used for f urther testing procedures and/or the fitting of hearing aid devices.
The Callisto™
with HIT440 is intended to be used f or hearing instrument testing; a way to produce an
objective indication of the characteristics of hearing instruments inside an enclosed test chamber using a
coupler.
The Callisto™ with REM440 is intended to be used for Real-Ear Measurement that takes care of all clinical
verif ication needs during hearing aid f itting. The process is such that reference microphones sit outside of
the ears whilst a small probe tube microphone is placed in each canal close to the subjects’ ear drum. Sound
pressure levels are measured to generate graphs which correspond to various tests that can be perf ormed in
the REM440 module. Data sets are then gathered to validate and verif y hearing instrument settings.
Intended operator
Trained operators like audiologist, hearing healthcare professional, or trained technician
Intended population
No restrictions
Contraindications
None known
Clinical Benefits
The Callisto™ with AC440 uses tonal and speech stimuli to provide the user with a representation of whether
there is a hearing loss present and the degree of any hearing loss. In turn, this allows the relevant qualif ied
operator to prescribe hearing instruments and further support any additional/ongoing otological
management.
The Callisto™ with HIT440 provides objective measurements from hearing aids and assistive hearing
devices which can be compared against local standard protocols or hearing aid manufacturer specif ications
to ensure consistency in quality and perf ormance and to also detect any deviations f rom manufacturer
specifications. This ensures the subject is always in receipt of effectively functioning hearing instruments.
The Callisto™ with REM440 provides the recipient of hearing instruments with objectively validated and
verif ied devices. It considers the unique quality of a subjects’ external auditory canal, thereby the operator
can accurately prescribe the device to targeted audibility levels.
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