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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04843124
Other study ID # Remote HA-fitting new
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date August 30, 2023

Study information

Verified date November 2023
Source Sodra Alvsborgs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - >18 yr of age - new hearing aid user Exclusion Criteria: - <18 yr of age - experienced hearing aid users

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Remote HA adjustment
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.
Other:
Traditional hearing aid
Traditional hearing aid

Locations

Country Name City State
Sweden Hearing Clinic, Hearing Organization Boras Vastra Gotalandsregion

Sponsors (1)

Lead Sponsor Collaborator
Sodra Alvsborgs Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
See also
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Active, not recruiting NCT04618315 - Patient-Centered Hearing Aid Trial N/A
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Not yet recruiting NCT06377215 - Understanding Aided Speech Perception in Noise