YES, the Kuduwave™ complies with all required standards as an audiometer. But lets look deeper into just how we comply to the South African National Standard (SANS) as they pertain to occupational health, thanks to a report by Dr. Anita Edwards (at the time from the CSIR)
It is important to note that ordinary audiometers wether they are screening audiometers or diagnostic, do not atttenuate sound. The combination of audiometric booths and standard audiometry headsets is what is relied upon to generate the sound blocking required and must comply with the standards related to maximum permissible ambient noise levels (MPANL) as set out by the SANS standards as much as we do.
What makes this device different is that the the soundbooth, audiometer and headset is combined creating a mix of compliance requirements unique to the KUDUwave™.
Maximum Permissible Ambient Noise Level (MPANL)
The KUDUwave's sound blocking ability means that it can test in much noisier than is available with standard audiometry headsets and in some cases audiometry booths environments as illustrated in the below table.
According to the standard, test room compliance can be determined either by objective measurement or by subjective measurement and detailed records of all verification done at sites should be kept.
Additional monitoring of noise levels in real-time adds another layer of teechnology to ensure accurate results throughout while testing and not just when the room was certified.
For more information on sound attenuation view: /ambient-noise-attenuation-the-key-to-reliable-hearing-assessment
Do we comply to the standards for use in Hearing Conservation/ hearing screening?
Yes it does. In order to comply with the standards the following conditions must be met.
Additional requirements are set out pertaining to calibration.
Calibrations, according to the standards for portable audiometers must be calibrated at least every 3 months, while we know that our devices rarely go out of calibration, it is important to reiterate the fact that compliance with the standard for ocupational health is paramount. We make every effort to ensure that devices are calibrated with as little downtime for you as possible.
Since compliance with all the above mentioned standards are requirements for SANS 10083:2012, the standard which specifies how the medical surveillance is conducted, this audiometer is fully compliant with the standards for occupational health and hearing conservation testing and able to offer portable audiology solutions to the world.
Not only do we comply, we excel!
Use of the Kuduwave in the occupational setting provides improved quality control of the audiometric test due to the built-in, real-time ambient noise level monitoring.
So the answer is a resounding YES!
In fact, compliance and quality is so important to us that we included the ability to automate testing protocols. Automation means that the same protocol is run every single time, not short cuts, no chance of stepping out of line.
Additional features such as X-check help ensure that daily calibration checks required by the standards are quick and easy to perform. The data is also stored for record keeping ( and backed up to the cloud if activated). This means that calibration checking easier than ever and that compliance with the standard is more likely to be adhered to. All while records are safely stored for later retrieval.
The software features automatic baseline, milestone, and PLH reporting specific to occupational health requirments and have also included occ health specific profiles to make testing easier, quicker and more compliant. With a fully loaded team of clinical, technical, engineering and design specialists, we are constantaly updating the both the software and hardware of our devices and welcome user suggestions and comments, who knows, your golden idea might just be the next big thing. Share it with us and help us us change the world of audiology together .
To submit a feature request or specific changes click the button below
We adhere to the strictest production standards and as such eMoyo is ISO13485 certified and the KUDUwave™ carries the CE mark for European standards ( required by South Africa law as the SABS cannot and do not certify audiometers) as well as FDA registration. We are so confident in the quality of our products that we offer a 3 year warranty as standard.
Following of the SANS standards and procedures for performing audiometric testing is a requirement and responsability of the practitioner and company performing said testing.
Looking for validation, reports and studies?
Look no further than google scholar click here