Clinical Evidence
Every claim we make about Zephyr is backed by independent testing data, regulatory certification, and clinical expertise. This is the evidence base.
University of Salford Acoustic Testing
Comprehensive acoustic analysis conducted by the University of Salford Acoustics Calibration Laboratory across 30 controlled procedures per device, using 1/32 second precision data capture.
| Measurement | Zephyr | Traditional | Difference |
|---|---|---|---|
| Overall Duration Laeq (Average) | 93.4 dB | 118.3 dB | 24.9 dB quieter |
| Phase 1: Startup Laeq | 65.0 dB | 108.5 dB | 43.5 dB quieter |
| Phase 2: Idle Laeq | 46.9 dB | 57.2 dB | 10.3 dB quieter |
| Phase 3: Active Suction Laeq | 95.2 dB | 119.0 dB | 23.8 dB quieter |
| Peak Sound Level (Cpeak Average) | 129.7 dB | 150.6 dB | 20.9 dB lower |
| Peak Sound Level (Cpeak Median) | 134.3 dB | 152.0 dB | 17.7 dB lower |
Certifications and Compliance
Zephyr meets the highest regulatory standards for medical devices and is fully aligned with the latest clinical guidance.
CE Mark / UKCA
Certified for clinical use across UK and EU markets.
Class II Medical Device
Independently classified with performance verified by the University of Salford.
ISO 13485 Manufacturing
Produced under internationally recognised quality management standards for medical devices.
ENT UK 2024 Compliant
Fully aligned with the latest clinical guidance on microsuction safety, noise, and consent requirements.
Developed with Leading ENT Specialists
Zephyr was designed from the outset with direct clinical input from practising ENT surgeons.
Patrick Axon
Consultant Otologist
Specialist expertise in middle ear and skull base surgery. Clinical input ensured Zephyr meets the precision demands of microsurgical applications.
Neil Donnelly
Consultant ENT Surgeon
Broad general ENT surgical practice. Ensured Zephyr's design meets the practical demands of high-volume outpatient clinics and theatre lists.
Clinician Case Studies
We are building a network of Key Opinion Leaders across the UK who are evaluating Zephyr in their practices. Case studies and clinical data from the programme will be published here.
Private Audiology Case Studies
Real-world data from private audiology practices trialling Zephyr. Procedure times, patient feedback, noise comparisons, and rebooking rates.
Coming SoonAggregated Clinical Data
As KOL programme data accumulates, aggregated results across practices will be published here — providing the evidence base for procurement decisions.
Coming SoonClinician Testimonials
Video and written testimonials from ENT surgeons and audiologists using Zephyr in daily practice. First-hand accounts of the clinical difference.
Coming SoonInterested in joining the KOL programme? We are looking for ENT surgeons, audiologists, and ear care practitioners across the UK.
Express InterestCompliance and Safety Resources
Detailed articles on regulatory compliance, duty of care, and clinical best practice.
ENT UK 2024 Equipment Compliance
What the updated guidance means for your microsuction equipment choices.
Noise Exposure and Duty of Care
Legal obligations for practitioners around noise exposure during microsuction.
CQC Inspection Readiness
Preparing your ear care practice for CQC inspection across all five domains.
Medicolegal Risk in Microsuction
Understanding clinical negligence, standard of care, and protecting your practice.
Is Microsuction Safe?
Evidence-based assessment of microsuction safety, including noise risks and how to mitigate them.
Microsuction Equipment Guide
What to look for when choosing a microsuction device — noise, control, ergonomics, and infection control.
Interested in Learning More?
Discover how Zephyr is redefining ear care with the first innovation in microsuction technology in over 60 years.
Contact Us