EMO-TOS FIH (EarMetrics Oximeter Validation Device)
Research type
Research Study
Full title
EarMetrics® Oximeter- a Targeted Oxygenation Observation Study: A Controlled Desaturation Study to establish the safety & performance of the EarMetrics®-Oximeter Validation Device
IRAS ID
353410
Contact name
Dhruv Parekh
Contact email
Sponsor organisation
EarSwitch Ltd
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
EarSwitch Ltd. has developed a prototype device (oximeter) to detect oxygen levels from the inner ear-canal; EarMetrics Oximeter. The advantage of the inner ear-canal is that it is the same colour for everyone irrespective of skin colour. Other oximeters have been shown to be inaccurate when assessing oxygen levels for people with brown or black skin, which is dependent on the level of skin pigment (melanin). The EarMetrics-Oximeter, in theory, will not be affected by skin colour.
The EarMetrics-Oximeter consists of an earpiece containing a sensor (a camera with LEDs) and single user disposable earbuds connected via a lapel clip, to a display unit. The earpiece is worn in the user’s ear like a consumer audio earbud.
In order to develop EarMetrics-Oximeter to medical grade device, this study seeks to determine its safety and performance by comparing the EarMetrics-Oximeter oxygen levels (derived from colour of image data from the inner ear-canal), with the gold standard for oxygen levels; arterial blood gas analysis/ co-oximetry.The investigational device: the EarMetrics®-Oximeter Validation Device will be studied during controlled desaturation. International standardised testing protocols (ISO) will be employed to carry this out with healthy participants who will be breath reducing oxygen levels through a mask. Participants will be monitored with an independent pulse oximeter and regular testing of blood from an arterial line, whilst data is gathered synchronously from the EarMetrics-Oximeter ear-bud. This data will be compared to demonstrate the accuracy (ARMS) of EarMetrics-Oximeter Validation Device oxygen level estimation to the gold standard; co-oximetry from arterial blood. This is a standard protocol in keeping with established guidance as outlined in ISO 80601-2- 61:2017, Corrected version 2018-02 Annex EE. The study will also monitor and report on safety, including through adverse event reporting, and comfort.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0038
Date of REC Opinion
21 Mar 2025
REC opinion
Further Information Favourable Opinion