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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
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
|Contact: Milijana Malmberg, PhDfirstname.lastname@example.org|
|Contact: Jennie Hagberg, audiologist||031-342 24 email@example.com|
|Hearing Clinic, Hearing Organization||Recruiting|
|Boras, Vastra Gotalandsregion, Sweden, 501 82|
|Contact: Milijana Malmberg, PhD +46703803663 firstname.lastname@example.org|
|Principal Investigator:||Milijana Malmberg, PhD||Hearing Organization, Sweden|