Optimisation of Hearing Aid Fitting

Study Overview
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Brief Summary
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This study aims to explore if objective brain responses to speech stimuli (words and running speech) can be used to evaluate hearing aid fitting in adults. Objective brain responses would be beneficial, as they could be used to evaluate hearing with people who are incapable or unwilling to provide subjective responses. The study aims to determine if EEG responses to speech sounds are sensitive to the effects of hearing aids for hearing aid users. Secondary, the study will look into the need for using speech stimuli in order to obtain more robust responses compared to current clinical standards.

Detailed Description
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The research questions addressed are as follows Are speech-evoked objective brain responses sensitive to hearing aid amplification? Are speech-evoked brain responses sensitive to distortions in speech and can hearing aid amplification resolve issues with brain responses to distorted speech? Which tests are optimal for detection of objective brain responses to speech? Are realistic speech stimuli (words or running speech) able to robustly detect brain responses compared to current clinical standards (clicks and tones)? The study will be carried out on a group of mildly to moderately hearing impaired subjects between the age of 18 and 70. Subjects will be recruited from the Royal Berkshire NHS Foundation Trust, where the research will be conducted. Participants will have their hearing function and hearing aid fitting checked as described in the design and methodology section of this proposal. During the experiment, participants will be asked to listen to speech sounds presented from a loudspeaker at comfortable listening levels. The responses will be measured with the participant wearing and not wearing hearing aids. Additionally, participants will perform a behavioural task for perception of speech. Participants will be asked to attend 2 sessions of 2 hours. Data collection will run over 1 year.

Official Title
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Objective Response Detection to Natural Speech Stimuli for Optimisation of Hearing Aid Fitting Evaluation

Conditions
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Hearing Loss, Hearing Abnormality

Intervention / Treatment
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* Diagnostic Test: Objective speech response detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects are between 18 and 70 years old Native English speakers Have mild to moderate hearing loss in their better ear measured using current clinical standards Routine hearing aid users Exclusion Criteria: Clinical observation indicates the presence of ear infections or an occluded ear canal on the day of testing Subjects with recent ear surgery (within a month before the day of testing) Subjects who are taking substances that could affect brain responses (e.g. medication for the treatment of depression)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hearing Impaired<br>Participants will be asked to wear an electro-encephalography (EEG) cap for measurement of brain activity whilst listening to speech stimuli. The speech stimuli will be presented through a loudspeaker positioned 1 meter in front of the participant. Participants will be asked to listen to the speech stimuli when using and without using their hearing aid. They will be asked to pay attention to the speech stimuli. This will be assured by asking them to answer questions related to the speech stimulus at random intervals. Subjects will also go through standard clinical procedures for assessing their hearing function and hearing aid setup. | Diagnostic Test: Objective speech response detection<br>* Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response detection | Detection success rate and time for obtaining a brain response to the sound stimuli. | Immediate | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved statistical test | Hotelling's T2 test to objectively determine the presence of a response compared to background noise. | Immediate | 
| Stimulus reconstruction | Correlation test to determine the accuracy of the estimated speech stimulus using the decoder compared to the presented speech stimulus for running speech. Detection of auditory brainstem and auditory steady state potential characteristic peaks and troughs for responses to click and tone stimuli, respectively. | Immediate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Hearing Abnormality