Health inequalities can’t be ignored, contributing to millions of early deaths in England alone.

Medical technologies play a part in these failings, with devices such as common pulse oximeters, reported taking inaccurate, life threatening, readings from people with darker skin.

As the UKs life science industry grows, our opportunity to reduce inequalities and provide a more inclusive future is huge and one Airquity sets out to tackle.

Airquity is an innovative core oximeter, designed as a non-invasive biometric sensor, recording medical-grade and racially inclusive health metrics from the inner ear canal, where all skin looks the same.

All campaign materials were subjected to a thorough internal agency compliance review in line with MHRA and ABHI requirements for medical device promotion before being uploaded for final sign off by the MLR signatories at Earswitch. Every care has been taken to ensure that all materials are factual, balanced and consistent with locally approved product information.

Racial disparities exist in all facets of society, including the health care system. However, African Americans still experience illness and infirmity at extremely high rates and have lower life expectancy than other racial and ethnic groups. They are also one of the most economically disadvantaged demographics in the US.

Globally the story doesn’t change.

Health care systems and health care technology has been designed for, tested on, and implemented for Caucasian populations and has not historically considered the impact or difference within marginalised groups.

The advertising of medical devices is not currently regulated by any specific UK legislation although the ABHI Code of Ethical Business Practice does set out minimum standards for a number of activities including advertising and promotion. The MHRA has enforcement powers under the Medicines and Medical Devices Act 2021.

Clinicians, health providers, clinical Regulatory bodies

African-American and African people are 3x more likely to die from respiratory conditions than white people. The tools that doctors rely on when treating these conditions have been shown to have a racial bias. We believe that they have had a role in the survival inequity that we are seeing for black people.

Traditional peripheral pulse oximeters are affected by skin tone, the more melanin you have in your skin, the more risk there is of an overestimated reading. This disparity can suggest higher oxygen levels than they actually are in black skin. Just 6-8% can be the difference between a normal O2 reading and a low O2 reading, which can result in either being sent back home or going straight to intensive care with O2 support. It has resulted in suboptimal care and contributed to deaths in a population that already distrusts the healthcare systems.

Airquity is a campaign that highlights the need for a racially inclusive diagnostic tool within healthcare systems. Be leveraging the ear canal, where all skin looks the same, we are able to identify health signs without fear of biased feedback.

Ear Switch were exploring using sensors inside the ear canal. Various use cases were being investigated including using it to control a speech system, assisted learning and gaming because the early drum can visualise and even be moved by the person using the tiny muscle inside the ear.

Another use immediately grabbed our attention - measuring vitals signs. We began collaborating with them in the area of race inequality and helped steer the development, intention and clinical trials to enable a device that delivers Airquity for all people.

Airquity, empowered by EarSwitch, is a non-invasive biometric sensor that records medical-grade, real-world, and racially inclusive health metrics from the inner ear canal.

In addition to oxygen levels, it records heart rate, heart rate variability, respiration rate and pattern, and is adding temperature, novel indicators of blood pressure, and alarm functions to alert patients and practitioners to readings outside of determined “normal” ranges.

Airquity can be integrated into a variety of in-ear devices, from earbuds to hearing aids to multi-diagnostic medical devices, to transform medical and personal health outcomes for all.

Since launching Airquity, Earswitch has been accepted onto the Innovative Devices Access Pathway programme, a scheme that accelerates life-saving medical devices into the NHS (Uk’S Healthcare system).

IDAP aims to improve patient access to innovative medical devices by helping developers to navigate key regulatory and access requirements throughout the design and development stages. The programme is a partnership between the Department of Health and Social Care (DHSC), Health Technology Wales (HTW), Medicines and Healthcare products Regulatory Agency (MHRA), National Health Service England (NHSE), National Institute for Health and Care Excellence (NICE), Office of Life Sciences (OLS), and Scottish Health Technologies Group (SHTG).