Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)

Study Overview
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Brief Summary
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Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist. The purpose of this project is to offer remote hearing aid adjustment as an additional support for new hearing aid users.

Official Title
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Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial

Conditions
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Hearing Aids

Intervention / Treatment
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* Device: Remote HA adjustment
* Other: Traditional hearing aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 yr of age new hearing aid user Exclusion Criteria: <18 yr of age experienced hearing aid users

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely. | Device: Remote HA adjustment<br>* The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.<br>|
| Active Comparator: Control group<br>Traditional hearing aid adjustment | Other: Traditional hearing aid<br>* Traditional hearing aid<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/Adults (HHIE/A) | Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome. | Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Abbreviated Profile of Hearing Aid Benefit (APHAB) | Measures subjective hearing loss in four typical hearing situations (subscales). There are six items for each subscale. Each item is answered for without my hearing aid and with my hearing aid. Each item is a statement associated with a percentage of occasions (1%_Never, 12%_Seldom, 25%_Occasionally, 50%_Half-the-time, 75%_Generally, 87%_Almost Always, 99%_Always) | Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post. |