A Standard Music Program Compared to an Optimized Music Program

NCT ID: NCT04147442

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-09
• Study Completion Date: 2019-12-20

Brief Summary

The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. The trial seeks to investigate the benefit received by musicians that regularly play an instrument and belong to an organized music group or orchestra instead of people that listen to music.

Detailed Description

The initial goal of hearing aids is to amplify speech and facilitate speech understanding especially in noise. Besides speech difficulty, people with hearing loss also report a reduced enjoyment of music. The hearing aid settings used for amplifying speech often have adverse effects on music.

For this study, the sponsor will carry out testing with participants with hearing loss to compare dedicated music programs. The current study will compare the standard music program available in the software to one that is fine-tuned for each subject. The hearing aids that will be used for the study are certified by the European Conformity and have been on the market for almost one year. The goal is to determine whether musicians will perceive a difference and prefer a fine-tuned music program over the default music program in real-life situations.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Music program fine-tuned and standard

The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it.

Group Type: EXPERIMENTAL

Hearing aid with fine-tuned and standard programs

Intervention Type: DEVICE

A digital, wireless hearing aid is programmed specifically to each subject's hearing loss and fitted with both a program that is fine-tuned for their specific music playing as well as the standard music program that uses pre-determined settings.

Interventions

Hearing aid with fine-tuned and standard programs

A digital, wireless hearing aid is programmed specifically to each subject's hearing loss and fitted with both a program that is fine-tuned for their specific music playing as well as the standard music program that uses pre-determined settings.

Intervention Type: DEVICE

Other Intervention Names

Viron 9 mini receiver-in-the-ear hearing aid

Eligibility Criteria

Inclusion Criteria

• All classifications of hearing loss (sensorineural, conductive, mixed)
• If conductive or mixed, approval for amplification by a physician is needed
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to profound
• German or French speaking
• Play a musical instrument
• Ability and willingness to sign the consent form

Exclusion Criteria

• Normal hearing
• Contraindications for amplification
• Active ear disease
• Don't play an instrument
• Inability to follow the study procedures due to language problems, psychological disorders, dementia, or other cognitive problems
• Unable to attend study appointments due to reduced mobility
• Reduced ability to describe auditory impressions and usage of hearing aids
• Uncooperative so that it is ot possible to record a valid audiogram
• Severely reduced dexterity
• Central hearing disorders
• Sponsor employees
• Family members of employees of the Sponsor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bernafon AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Simon, AuD

Role: PRINCIPAL_INVESTIGATOR

Bernafon AG

Locations

Bernafon AG

Bern, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BF006-1902

Identifier Type: -

Identifier Source: org_study_id