Evaluation of the eAdjust Application

Study Overview
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Brief Summary
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Despite being effective, the majority of people who would benefit from using hearing aids do not access them. For those who do obtain hearing aids, around 20% do not wear them regularly. People often do not use their hearing aids because they continue to experience difficulties when listening to and understanding speech in noisy situations. Conventional hearing aids must be programmed and adjusted by a trained audiologist with specialist equipment and therefore provide limited user-control over the hearing aid's functionality. In comparison to conventional hearing aids, Smartphone-connected hearing aids enable patients to adjust their programmes themselves in different situations using a Smartphone application. Smartphone-connectivity can supplement clinical practices, as patients can adjust their hearing aids without the need to visit the clinic. This has the potential to empower patients to be actively involved in their own hearing healthcare. A systematic review assessing the effectiveness of alternative listening devices showed that there is no published high-quality research assessing the clinical effectiveness of Smartphone-connected hearing aids. Furthermore, a usability research study has shown that patients want to personalise and adjust their own HA programmes to meet their individual needs. Having carried out the early development work, the next step would be to carry out a study to evaluate smartphone-connected hearing aids, in accordance with the MRC guidelines on developing and evaluating complex interventions. This study will assess the benefits of a smartphone application, eAdjust that has been developed for use with Phonak Audeo B90-Direct hearing aids. The eAdjust app connects to the hearing aid via Bluetooth, and enables hearing aid users to fine-tune their hearing aids via their smartphone. The benefits of the eAdjust app will be assessed in the real-world as well as in the laboratory. A mixed methods approach will be taken, using both behavioural and patient reported outcomes.

Official Title
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Evaluation of the eAdjust Application to Provide Benefits in Users of Smartphone-connected Hearing Aids

Conditions
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Hearing Loss, Bilateral, Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: eAdjust 0.2 hearing aid smartphone application (or app)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged ≥18 years. With hearing loss type: symmetric (not more than 20 dB difference) and sensorineural. With mild to severe hearing loss in the categories: N2, N3, N4, N5, S2 and S3. No disturbing tinnitus. No contraindications against wearing hearing aids (e.g. ear disease or motor impairment). Hearing aid user: First-time (using hearing aids < 3 months) Existing (using hearing aids > 6 months) Owns an iPhone (v5 and IOS 10 or higher) and uses functions of her/his smartphone which exceed calling and writing text messages. Willing to wear test hearing aids, to use the eAdjust App, to take notes about experiences and to perform various tasks during the study period. English as a first spoken language or a good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected. Exclusion Criteria: - Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| First-time hearing aid user<br>Using hearing aids less than or equal to three months. | Device: eAdjust 0.2 hearing aid smartphone application (or app)<br>* The app connects to the Audeo B-90 Direct hearing aids via Bluetooth. The intended use for the app to enable hearing aid users to fine-tune their hearing aids. The app contains a series of sound modifiers, factory presets, sound modifier presets.<br>|
| Existing hearing aid user<br>Using hearing aids for 6 months or more. | Device: eAdjust 0.2 hearing aid smartphone application (or app)<br>* The app connects to the Audeo B-90 Direct hearing aids via Bluetooth. The intended use for the app to enable hearing aid users to fine-tune their hearing aids. The app contains a series of sound modifiers, factory presets, sound modifier presets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing Handicap Inventory for the Elderly | 25-item self-reported questionnaire assessing the effects of hearing loss on the emotional and social/situational adjustment. Scored using a three-point scale. | Change from Baseline following 7-weeks of intervention use. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Hearing Aid Benefit Profile | Assesses self-reported hearing disability and handicap (Part I), as well as hearing aid use, benefit, residual disability and satisfaction (Part II). Each domain is measured on a five-point scale. | Baseline (Part I) and following 7-weeks of intervention use (Part II). | 
| Vanderbilt Fatigue Scale for Adults with Hearing Loss | A 40-item self-report measure of listening effort and fatigue. Scored using a five-point scale. | Change from Baseline following 7-weeks of intervention use. | 
| Device-Orientated Subjective Outcome scale | Self-report questionnaire suitable for quantifying subjective hearing aid outcomes. Scored using a seven-point response scale. | Change from Baseline following 7-weeks of intervention use. | 
| Glasgow Hearing Aid Difference Profile (existing hearing aid users only) | Assesses self-reported use and residual disability with 'old' hearing aids (Part I), as well as use and residual disability with 'new' hearing aids, and the difference in benefit and and satisfaction between 'old and 'new' hearing aids (Part II). Each domain is measured on a five-point scale. | Change from Baseline following 7-weeks of intervention use. | 
| Auditory Lifestyle and Demands Questionnaire | Self-report measure of auditory lifestyle. | Following 1-week of intervention use. | 
| Clarity and Comfort Questionnaire | Self-report measure of hearing aid preferences concerning sound clarity and comfort. | Following 1-week of intervention use. | 
| Hearing aid datalogging | Hearing aid use in hours, internal to the hearing aid. | Following 1-week and 7-weeks of intervention use. | 
| Montreal Cognitive Assessment | Validated screening tool for mild cognitive impairment. | Following 1-week of intervention use. | 
| BKB Speeh-In-Noise Test | Behavioural measure of speech intelligibility in the presence of background noise. | Following 1-week and 7-weeks of intervention use. | 
| eAdjust 0.2 app datalogging | Usage data, internal to the app. | Following 2-week and 6-weeks of intervention use. | 
| App real-world use questionnaire | Self-report questionnaire of app usage. Consists of closed- and open-ended questions. | Following 2-week and 6-weeks of intervention use. | 
| Hearing aid tasks | Self-report questionnaire of app functionality in different environments. | Following 2-week and 6-weeks of intervention use. |