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

Hearing Aids Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843124
• Other study ID #: Remote HA-fitting new
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hearing Aids

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.