Introduction; About This Manual; Intended Use - Interacoustics Affinity Compact Instructions For Use Manual

1 Introduction

1.1 About this manual

This manual is valid f or the Af f inity Compact. This product is manuf actured by:

1.2 Intended use

Indications for use
The Af f inity Compact 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 inity Compact 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 inity Compact 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 inity Compact 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 inity Compact 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 f ectively functioning hearing instruments.
The Af f inity Compact 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.
D-0123672-H – 2022/05
Affinity Compact - 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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