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Indications for use
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Indications for use
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ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM® 5 should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.
Predicate Device Information
The ACAM® 5 Audiometer is substantially equivalent to the Siemens Unity 2 HIA and Probe,
K071462 design, function and technological characteristics. Both the ACAM and predicate are
modular systems intended for the diagnosis of hearing loss and hearing aid fitting. An outline
summary of similarities and differences is provided in the tables below.
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SIMILARITIES |
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Siemens Unity 2 with HIA and Probe (Predicate System) |
ACAM 5 |
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Provides modular components that can be used individually or in tandem to optimize the performance of a fitting aid. |
Same |
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Computer-controlled with software specific for their applications in addition to links to the NOAH™ software applications provided by the Hearing Instrument Manufacturers' Software Association (HIMSA™). |
Same |
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Utilize Real Ear Measurement (REM) fitting protocols. |
Same |
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Allows for the use of fitting protocols provided by the National Acoustic Laboratory (NALNL1) and by Dr Richard Seewald (DLS-IO). |
Same |
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Utilizes optional visual stimuli that accompany ambient background sounds. |
Same |
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Offers ambient sound modules to optimize hearing aid performance in real life situations. |
Same |
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Offers fitting algorithms including loudness scaling, RMS, FFT and percentile analysis. |
Same |
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Has an audiometer module to measure hearing losses with pure tone and speech, meeting the requirements of ANSI S3.6. |
Same |
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Meets the requirements for electrical medical equipment safety and electromagnetic compatibility set forth in EN 60601-1-1 and EN 60601-1-2 |
Same |
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DIFFERENCES |
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Siemens Unity 2 (Predicate System) |
ACAM 5 (Applicant System) |
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Uses single tone frequency scaling over a range of 125 - 8,000 Hz (normal mode) and 125 - 16,000 Hz (high frequency mode) |
Uses single tone frequency scaling over a range of 125 - 8,000 Hz only |
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Offers ambient sounds accompanied by still pictograms (SPL O gram) of environmental surroundings and two speakers |
Employs video sequences (real life fitting, or RLF sequence) with up to 12 speakers |
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The Siemens Unity 2 Probe and HIA can be used to program Siemens hearing aids |
Measures, but does not program, hearing aids |
Summary of Testing
The ACAM 5 was subjected to electrical safety and electromagnetic compatibility testing and
was found to be in compliance with the requirements of the consensus standards EN 60601-1- 1:2001 (FDA Recognition #5-30), EN 60601-1-2:2001 (FDA Recognition #5-35), ANSI S3.6 “Specifications for Audiometers (FDA Recognition # 4-123), ANSI S3.22-2003 Specification of Hearing Aid Characteristics (FDA Recognition # 4-124) and ANSI S3.46-1997(R2007) Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids (FDA Recognition # 4-175).
Conformity with the requirements of these standards demonstrates that the ACAM 5 Audiometer System is safe and effective and supports its substantial equivalence with the predicate device.