
WHAT IS THE TECHNOLOGY?
Impacted cerumen (ear wax) is a common recurring condition that affects many individuals. It can occur at any age, but is more common in older individuals where it causes pain and difficulty hearing. Some people get relief with over the counter ear drops that help to soften wax, however for others treatment for wax impaction involves visits to the doctor where a provider (or member of their staff) uses different tools to wash out the ear canal. Since ear wax is continually being formed in the ear canal, this is an annoying recurring problem. While there are some new devices that help to spray water into the ear canal, largely the tools used in primary care or elder care settings to remove ear wax are quite crude.
SafKan has developed a new wearable device, shaped like a pair of headphones, that the user places over their ears, and circulates water in and out of each ear canal, removing wax. Initial evaluation suggests that users found this effective and easy to use, however it has not been evaluated in a large clinical trial.

WHAT IS THE TECHNOLOGY’S POTENTIAL IMPACT ON PRIMARY CARE?
Impacted earwax is a common and recurring complaint that causes pain and difficulty hearing in many older individuals. A new technology that individuals could use themselves to remove earwax, could help to reduce the burden of this condition and reduce the need for visits to a clinician.
Evidence from a clinical trial will provide evidence for the efficacy, safety and usability of this new device among older individuals. If results are encouraging, this would support wider implementation efforts.

WHAT IS PCI-Lab Doing?
We will be leading the analysis and reporting out of the results of the clinical trial of this new device.