D-0004578-R – 2022/05 Page 1
Affinity2.0/Equinox2.0 - Instructions for Use - US
1 Introduction
1.1 About this manual
This manual is valid for the Aff inity2.0/Equinox2.0. These products are manuf actured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: inf o@interacoustics.com
Web: www.interacoustics.com
1.2 Intended use
Indications for use
The Af f inity2.0/Equinox2.0 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 further testing procedures and/or the fitting of hearing
aid devices.
The Aff inity2.0/Equinox2.0
with HIT440 is intended to be used for 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 Af f inity2.0/Equinox2.0 with REM440 is intended to be used for Real-Ear Measurement that takes care of
all clinical verification 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 performed in the REM440 module. Data sets are then gathered to validate and verify 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 Af f inity2.0/Equinox2.0 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 qualified operator to prescribe hearing instruments and f urther support any
additional/ongoing otological management.
The Af f inity2.0/Equinox2.0
with HIT440 provides objective measurements from hearing aids and assistive
hearing devices which can be compared against local standard protocols or hearing aid manuf acturer
specif ications to ensure consistency in quality and performance and to also detect any deviations from
manufacturer specif ications. This ensures the subject is always in receipt of ef fectively functioning hearing
instruments.
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