Clinical trial NCT04147442: A Standard Music Program Compared to an Optimized Music Program
Official title: A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Bernafon AG
Sponsor class: INDUSTRY
First posted: 2019-11-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will have access to both music programs for 10 +/- 7 days. During this time they will use both programs and switch between them during music playing situations.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Preference Rating
timeFrame: 20 days
Secondary outcomes:
measure: Sound Perception Test - Pitch
timeFrame: 0,10, and 20 days
measure: Music Sound Quality Rating
timeFrame: 0,10, and 20 days
measure: Sound Perception Test - Duration
timeFrame: 0,10, and 20 days
measure: Sound Perception Test - Level
timeFrame: 0,10, and 20 days
measure: Sound Perception Test - Brightness
timeFrame: 0,10, and 20 days
measure: Sound Perception Test - Attack
timeFrame: 0,10, and 20 days
measure: Sound Perception Test - Spectral Irregularities
timeFrame: 0,10, and 20 days
Other outcomes:
measure: Occurrence of Device Related Adverse Events
timeFrame: 0,10, and 20 days
Locations:
city: Bern
country: Switzerland
facility: Bernafon AG
Study officials:
affiliation: Bernafon AG
name: Barbara Simon, AuD
role: PRINCIPAL_INVESTIGATOR
References: