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510(k) Data Aggregation
K Number
K113831Device Name
PRIMUS HEARING INSTRUMENT TEST UNIT
Manufacturer
AUDITDATA A/S
Date Cleared
2012-04-19
(114 days)
Product Code
ETW, EWO
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
AUDITDATA A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Primus Hearing Instrument Test Unit (PHITU):
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.
- The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved.
Primus Fitting Unit (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
- The Primus Fitting Unit is intended for hearing test.
- The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments.
- The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
- Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
- The Primus Fitting Unit is indicated for use with both pediatric and adult age groups.
- The Primus Fitting Unit is not indicated as a sole means of diagnostics.
Device Description
The Primus Fitting System is a PC operated system that contains Primus Hearing Instrument Test unit (PHITU) for Hearing Instrument testing (HIT), Primus Fitting Unit (PFU) for Audiometry (AUD) and Real Ear measurement (REM). The Primus Fitting System is operated from a dedicated software application installed on a standard Windows operating system. The Primus Fitting system can either be sold individually (PHITU or PFU) or together (PHITU and PFU).
The Primus software solution operates within the NOAH framework, as well as stand-alone. On-top diagrams and control panels make it easy to use simultaneously with the proprietary hearing instrument fitting systems of your choice. The stand-alone client data files hold all historical session information, and makes fittings away from the office very easy.
Audiometry (AUD):
Primus AUD is a PC based audiometry module providing a wide range of possibilities within pure tone audiometry, bone conduction audiometry and speech audiometry including inserts probe and industry standard headsets with an option of high frequency testing.
Real Ear Measurements (REM):
Primus REM offers classic Real Ear Measurements as well as comprehensive Speech Mapping measurements, where all measurements include high frequency testing. The measurements are supported by a large sound library including technical sounds, daily life sounds, speech signals and dialogue. The Primus REM module contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear.
The classic Real Ear Measurements, which can be performed by Primus REM, include: Unaided, Occluded and Aided Response as well as Insertion Gain. Toggling between SPL and Gain shows the response measurements in gain view.
The PFU hardware is powered by a USB connection from the PC and a medical grade power supply (for extended sound pressure) and can be placed at the most convenient working place.
Hearing Instrument Testing (HIT):
Primus HIT offers full featured technical measurements for testing and troubleshooting hearing instruments. The test can be run as an automatic test sequence in accordance with European and American standards. The Primus HIT unit module contains of 2 microphones (one for measuring and one for reference) and various couplers for hearing aid testing.
The PHITU hardware is powered by a USB connection from the PC and can be placed at the most convenient working place.
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