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Completed

NCT Number: NCT04843124

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

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.

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Key information

Conditions

Hearing Aids

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearing Clinic, Hearing Organization

Borås, Vastra Gotalandsregion, 501 82, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 yr of age
  • new hearing aid user

Exclusion criteria

  • <18 yr of age
  • experienced hearing aid users

Treatment and study plan

Remote HA adjustment

Device

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.

Traditional hearing aid

Other

Traditional hearing aid

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Sodra Alvsborgs Hospital

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 13, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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