Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remote Hearing Aid Adjustment for Experienced Hearing Aid Users (RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04840277
Recruitment Status : Recruiting
First Posted : April 9, 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 experienced hearing aid users.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Hearing Aid Adjustment for Experienced Hearing Aid Users; a Randomised Controlled Trial
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

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 hearing aid 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.

No Intervention: Control group
Traditional hearing aid adjustment



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; minimum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • experienced hearing aid user

Exclusion Criteria:

  • <18 yr of age
  • new 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): NCT04840277


Contacts
Layout table for location contacts
Contact: Milijana Malmberg, PhD +46703803663 milijana.lundberg.malmberg@vgregion.se
Contact: Jennie Hagberg, audiologist 031-342 24 94 jennie.hagberg@vgregion.se

Locations
Layout table for location information
Sweden
Hearing Clinic, Hearing Organization Recruiting
Boras, Vastra Gotalandsregion, Sweden, 501 82
Contact: Milijana Malmberg, PhD    +46703803663    milijana.lundberg.malmberg@vgregion.se   
Sponsors and Collaborators
Sodra Alvsborgs Hospital
Investigators
Layout table for investigator information
Principal Investigator: Milijana Malmberg, PhD Hearing Organization, Sweden
Layout table for additonal information
Responsible Party: Milijana Malmberg, PhD, audiologist, Sodra Alvsborgs Hospital
ClinicalTrials.gov Identifier: NCT04840277    
Other Study ID Numbers: Remote HA-fitting
First Posted: April 9, 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No