Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)
RCT
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedNovember 29, 2023
November 1, 2023
2.6 years
April 8, 2021
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Study Arms (2)
Intervention group
EXPERIMENTALRemote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely.
Control group
ACTIVE COMPARATORTraditional hearing aid adjustment
Interventions
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.
Eligibility Criteria
You may qualify if:
- \>18 yr of age
- new hearing aid user
You may not qualify if:
- \<18 yr of age
- experienced hearing aid users
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hearing Clinic, Hearing Organization
Borås, Vastra Gotalandsregion, 501 82, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, audiologist
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 13, 2021
Study Start
February 1, 2021
Primary Completion
August 30, 2023
Study Completion
August 30, 2023
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share