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

Not Applicable

Completed

• Conditions: Hearing Aids
• Interventions: Device: Remote HA adjustment; Other: Traditional hearing aid

• Registration Number: NCT04843124
• Lead Sponsor: Sodra Alvsborgs Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-13
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• >18 yr of age
• new hearing aid user

Exclusion Criteria

• <18 yr of age
• experienced hearing aid users

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Remote HA adjustment	Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely.
Control group	Traditional hearing aid	Traditional hearing aid adjustment

Primary Outcome Measures

Name	Time	Method
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)	Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.	Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome.

Secondary Outcome Measures

Name	Time	Method
The Abbreviated Profile of Hearing Aid Benefit (APHAB)	Change" is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.	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)

Trial Locations

Locations (1)

Hearing Clinic, Hearing Organization; 🇸🇪 Boras, Vastra Gotalandsregion, Sweden