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

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ClinicalTrials.gov Identifier: NCT04843124
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Milijana Malmberg, 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.


Condition or disease Intervention/treatment Phase
Hearing Aids Device: Remote HA adjustment Other: Traditional hearing aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

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




Primary Outcome Measures :
  1. Hearing Handicap Inventory for the Elderly/Adults (HHIE/A) [ Time Frame: 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) [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >18 yr of age
  • new hearing aid user

Exclusion Criteria:

  • <18 yr of age
  • experienced hearing aid users

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843124


Locations
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Sweden
Hearing Clinic, Hearing Organization
Boras, Vastra Gotalandsregion, Sweden, 501 82
Sponsors and Collaborators
Sodra Alvsborgs Hospital
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Responsible Party: Milijana Malmberg, PhD, audiologist, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier: NCT04843124    
Other Study ID Numbers: Remote HA-fitting new
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No