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

Sponsor
Sodra Alvsborgs Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04843124
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
17.9
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Remote HA adjustment
  • Other: Traditional hearing aid
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely.

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.
Active Comparator: Control group

Traditional hearing aid adjustment

Other: Traditional hearing aid
Traditional hearing aid

Outcome Measures

Primary Outcome Measures

  1. 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

  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.]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 18 yr of age

  • new hearing aid user

Exclusion Criteria:

  • <18 yr of age

  • experienced hearing aid users

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hearing Clinic, Hearing Organization Boras Vastra Gotalandsregion Sweden 501 82

Sponsors and Collaborators

  • Sodra Alvsborgs Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Milijana Malmberg, PhD, audiologist, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier:
NCT04843124
Other Study ID Numbers:
  • Remote HA-fitting new
First Posted:
Apr 13, 2021
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2022