NCT07677748

Brief Summary

This study aims to optimize music listening quality for 66 hearing aid users (33 musicians and 33 non-musician music enthusiasts) by developing a dedicated "Music Program" based on individual frequency preference profiles. We will evaluate the program's efficacy by comparing listening quality and emotional response scores against standard settings, while also investigating correlations with music reward sensitivity. We hypothesize that the customized program will yield significant improvements, with a more pronounced benefit observed in the musician group.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1.7 years

First QC Date

June 16, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of scores obtained using the Davies-Venn validated quality ranking questionnaire between the Main Program and the Music Program.

    scale from 0 (bad listening quality) to 10 (best listening quality)

    for 4 months

Secondary Outcomes (6)

  • Comparison of listening improvement scores on the Davies-Venn validated quality ranking questionnaire between hearing aid users categorized as "musicians" and "non-musicians."

    for 4 months

  • Comparison of Filtering Patterns (PFP) obtained during the preference test between Session 1 and Session 2 for the same musical excerpt.

    for 4 months

  • Comparison of Filtering Patterns across two musical excerpts of different styles.

    Day 2

  • Comparison of scores on the Davies-Venn validated quality ranking questionnaire between two musical excerpts of different styles.

    Day 2

  • Determination of a correlation between the improvement associated with the Music Program and Barcelona Music Reward Questionnaire (BMRQ) scores, analyzed separately for musicians and non-musicians.

    for 4 months

  • +1 more secondary outcomes

Study Arms (2)

Hearing-impaired musicians

Other: Musical listening quality preference test

music enthusiasts who have been using hearing aids

Other: Musical listening quality preference test

Interventions

Preference test to determine their Preferred Frequency Profile (PFP). The gain characteristics of the PFP will be added to the hearing aids' Main Program, thereby creating a dedicated Music Program.

Hearing-impaired musiciansmusic enthusiasts who have been using hearing aids

Eligibility Criteria

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

Hearing-impaired musicians or music enthusiasts who have been using hearing aids for at least 6 months.

You may qualify if:

  • For all participants:
  • Aged 18 years or older,
  • Fitted with hearing aids for at least 6 months,
  • Reporting dissatisfaction with music listening while using their hearing aids.
  • For musician participants:
  • Defined as instrumentalists or knowledgeable music enthusiasts engaging in daily music practice for a minimum of 4 hours.
  • For non-musician participants:
  • Defined as individuals without formal musical training who listen to music for at least one hour per day

You may not qualify if:

  • Asymmetric hearing loss (pure-tone audiometry showing a difference between the two ears \> 15 dB)
  • Irregular use of hearing aids: \< 4 hours per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

July 1, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

July 1, 2026

Record last verified: 2026-06