Technical Evaluation of Earswitch Phase B

Summary

The Earswitch is a demonstrated proof-of-concept that detects the voluntary contraction of a small muscle in the ear, called the tensor tympani (TT) muscle, which can be effectively used as an input switch. The voluntary activation of the TT makes the eardrum move, and such movement can be detected using a small camera inserted into the ear canal. A previously funded NIHR 'i4i Connect' research project showed how the Earswitch may be advantageous to populations with severe neuro-disabilities, where other communication methods are limited.

This project aims to realise the EarSwitch's potential as an assistive communication device and provide supporting evidence towards regulatory approval of the medical device.

The robustness and usability of the device will be tested on participants with mild-to-moderate neuro-disabilities and healthy participants. This complements data collected from assistive technology users following the same protocol but will provide additional data to train and understand the underlying detection algorithms for the Earswitch.

The ease of which an assistive technology device can be installed and calibrated independently (without guidance from the researcher) so that it is ready to use is also an important consideration for its potential adoption. Participants will have the opportunity to interactively use the Earswitch daily at home, over a prolonged period of 4 weeks. Interviews and questionnaires will be used to gather information on usability and comfort of the device, whilst data from the interactive tasks will provide feedback of engagement and performance.

Overall, this will provide crucial insights into how viable the Earswitch is as an assistive technology device and how accurately and reliably the current detection algorithm can detect contraction of the TT muscle. This data will be analysed to inform the final design of the Earswitch ready for commercial production.

Conditions

• Motor Neuron Disease

Interventions

DEVICE

EarSwitch device

The Earswitch™ device consists of an earpiece made from silicon or similar bio-compatible material and incorporates a miniature camera. The earpiece sits within the ear canal and is not in direct contact with the eardrum and the camera is not in contact with the ear-canal. The camera detects voluntary movement from the tensor tympani muscle as presented at the eardrum and the Earswitch system translates this movement to an external virtual keypad or similar to allow the patient to communicate nonverbally.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Earswitch Ltd.

  collaborator UNKNOWN

• University of Bath

  lead OTHER

Principal Investigators

• Dario Cazzola, MEng,PhD · University of Bath

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-30

Primary Completion

2025-04-30

Completion

2025-04-30