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Clinical Trials/NCT05465564
NCT05465564
Active, Not Recruiting
N/A

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

WSAUD A/S1 site in 1 country40 target enrollmentFebruary 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Impairment
Sponsor
WSAUD A/S
Enrollment
40
Locations
1
Primary Endpoint
overall hearing aid satisfaction
Status
Active, Not Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2022
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
WSAUD A/S
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

overall hearing aid satisfaction

Time Frame: 6 months

minimum: 1, maximum: 10 ; the higher value indicates a better outcome

IOI-HA

Time Frame: 6 months

minimum: 7, maximum: 35; the higher value indicates a better outcome

hearing aid satisfaction (Hearing-Related Lifestyle scale)

Time Frame: 6 months

minimum: 1, maximum: 5; the higher value indicates a better outcome

Study Sites (1)

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