NCT05465564

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

December 20, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

July 15, 2022

Last Update Submit

December 19, 2023

Conditions

Hearing ImpairmentHearing Loss

Outcome Measures

Primary Outcomes (3)

  • overall hearing aid satisfaction

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

    6 months

  • IOI-HA

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

    6 months

  • hearing aid satisfaction (Hearing-Related Lifestyle scale)

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

    6 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First-time hearing aid users

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dina Lelic

Lynge, DK, 3540, Denmark

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 20, 2022

Study Start

February 15, 2022

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

December 20, 2023

Record last verified: 2023-12

Locations

DK(1)