Regulatory & standards
Regulatory status, standards and claims
The Kuduwave is a medical device, so what we say about it matters. Every regulatory, standards, evidence and statistical statement on this website comes from one register - here is all of it, in one place.
Regulatory and quality system
Registration of the device and the quality system it is made under.
FDA registered
Registration and device listing with the US Food and Drug Administration. See “What FDA registered means” below.
Manufactured under a quality management system implemented to ISO 13485
Standards and instrument type
The standards the Kuduwave is designed and calibrated to, and its instrument classification.
Designed and calibrated to the IEC, ANSI and SANS standards for audiometry
- SANS 10083 (South Africa)
Meets the audiometric testing requirements of SANS 10083
Type 1 clinical audiometer (IEC 60645-1)
Type 1 clinical immittance instrument (IEC 60645-5)
Clinical evidence
What the published research shows - always read with the conditions of the studies.
Validated against sound-booth audiometry in peer-reviewed studies
The results apply within the ambient-noise limits and the populations the studies examined.
Read the research
Use and recognition
Who uses the Kuduwave, and awards it has received.
Used aboard the International Space Station by NASA astronauts
NASA used a modified Kuduwave for audiometry and tympanometry aboard the ISS. This is use, not an endorsement.
The ISS storyUsed by service providers for the U.S. Department of Veterans Affairs (VA)
- MDR-TB programme
Telemedicine testing of more than 100,000 patients for MDR-TB ototoxicity
- Awards
2015 GAP Awards (Gauteng Accelerator Programme), 2nd place; 2019 Gauteng Disability Rights Excellence Awards, Innovation, Silver - won by eMoyo, the company that made the Kuduwave before GeoAxon
Figures
Numbers we quote about the Kuduwave.
- Kuduwave hearing tests performed
3 million+
- Kuduwave audiometers sold
3,000+
Warranty
What we promise when you buy a Kuduwave.
3-year "Repair or Replace" warranty
The audiometer: 3 years. The response button: 1 year. The headband, the bone conductor, tubes and cables are not covered.
Warranty terms
Seen a statement about the Kuduwave - on this site, in a brochure or from a distributor - that is not in this register? Please tell us.
Plain language
What “FDA registered” means
Companies that make or distribute medical devices for the United States register their establishment with the US Food and Drug Administration and list the devices they sell. That is what “FDA registered” means.
Registration and listing tell the agency who makes a device and where. They are not an approval, a clearance or a certification of the device, and they do not mean the agency has reviewed its performance. Under the FDA’s own rules (21 CFR Part 807), presenting registration as an official approval is misleading - which is why you will only ever see “FDA registered” on this website.
FDA: device registration and listingThe words we use, and the ones we don’t
- We say “FDA registered”
- We don’t say FDA “approved”, “cleared” or “certified”
- We say “used aboard the International Space Station by NASA astronauts”
- We don’t say that NASA “approved” or endorsed the Kuduwave
- We say “validated against sound-booth audiometry in peer-reviewed studies”, and link the studies
- We don’t claim booth-level accuracy without stating the conditions of the studies
Safety
How to report a problem with a device
If a Kuduwave or its software has caused or may have caused harm, gave a result you do not trust, or does not perform as described, please tell us as soon as possible.
Report it to GeoAxon
Our complaints and feedback page explains what to include (serial number, software version, what happened and when) and how to send it.
Complaints & feedbackIn the United States
You can also report to the FDA through MedWatch, its safety information and adverse event reporting programme.
FDA MedWatchElsewhere, your national medical-device regulator accepts reports too.
Questions about our regulatory status?
Ask us for the documents behind any statement on this page - we usually reply within one working day.