Introduction; About This Manual; Intended Use - Interacoustics Affinity2.0 Instructions For Use Manual

1 Introduction

1.1

About this manual

This manual is valid f or the Af f inity2.0/Equinox2.0. These products are manuf actured by:
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 f or f urther testing procedures and/or the f itting of hearing
aid devices.
The Af f inity2.0/Equinox2.0 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 Af f inity2.0/Equinox2.0 with REM440 is intended to be used f or Real-Ear Measurement that takes care of
all clinical verif ication needs during hearing aid f itting. The process is such that ref erence 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 prof essional, 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 qualif ied 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 f rom 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 perf ormance and to also detect any deviations f rom
manuf acturer specif ications. This ensures the subject is always in receipt of ef fectively functioning hearing
instruments.
D-0004578-R – 2022/05
Affinity2.0/Equinox2.0 - Instructions for Use - US
Interacoustics A/S
Audiometer Allé 1
5500 Middelf art
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: inf o@interacoustics.com
Web: www.interacoustics.com
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