My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

December 19, 2023 updated by: WSAUD A/S
The primary purpose of this study is to investigate how personality, motivation & auditory lifestyle relate to hearing aid satisfaction & acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • DK
      • Lynge, DK, Denmark, 3540
        • Dina Lelic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

First-time hearing aid users

Description

Inclusion Criteria:

  • 18-85 years of age
  • Sensorineural hearing loss within the hearing aid's fitting range
  • Fluency in local language
  • First-time hearing aid user
  • Experienced smartphone and app user
  • Must sign the informed consent

Exclusion Criteria:

  • Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP)
  • Inability for the TPs to travel to the clinic during the study period
  • Complex hearing disorders such as Ménière's

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall hearing aid satisfaction
Time Frame: 6 months
minimum: 1, maximum: 10 ; the higher value indicates a better outcome
6 months
IOI-HA
Time Frame: 6 months
minimum: 7, maximum: 35; the higher value indicates a better outcome
6 months
hearing aid satisfaction (Hearing-Related Lifestyle scale)
Time Frame: 6 months
minimum: 1, maximum: 5; the higher value indicates a better outcome
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

WSAUD A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

July 15, 2022

First Submitted That Met QC Criteria

July 15, 2022

First Posted (Actual)

July 20, 2022

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hear_101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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