A Standard Music Program Compared to an Optimized Music Program

NCT04147442 | Completed Results

• 1 other identifier: BF006-1902
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Preference Rating

  Subjects will answer a questionnaire that asks them to choose which program that they preferred. The questionnaire gives Program 1 or Program 2 as the choices as well as a no Preference option for those that did not notice a difference between the two. The percentage of subjects that chose each Program will be calculated to determine if more preferred the optimized music program.

  20 days

Secondary Outcomes (7)

• Sound Perception Test - Pitch

  0,10, and 20 days

• Music Sound Quality Rating

  0,10, and 20 days

• Sound Perception Test - Duration

  0,10, and 20 days

• Sound Perception Test - Level

  0,10, and 20 days

• Sound Perception Test - Brightness

  0,10, and 20 days

Other Outcomes (1)

• Occurrence of Device Related Adverse Events

  0,10, and 20 days

Study Arms (1)

Music program fine-tuned and standard

EXPERIMENTAL

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.

Device: Hearing aid with fine-tuned and standard programs

Interventions

Hearing aid with fine-tuned and standard programs 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.

Also known as: Viron 9 mini receiver-in-the-ear hearing aid

Music program fine-tuned and standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernafon AG: lead

Study Sites (1)

Bernafon AG

Bern, 3018, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies; Sensory Aids

Results Point of Contact

• Title: Dr Barbara Simon
• Organization: Bernafon AG

bsim@bernafon.com

+41 31 998 1515

Study Officials

• Barbara Simon, AuD

  Bernafon AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The allotted program position for the music programs will be randomized. Half of the participants will have the fine-tuned program in slot 2 and half will have it in slot 3. They will not know in which position the fine-tuned program is versus the standard program.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: November 1, 2019
• Study Start: October 9, 2019
• Primary Completion: November 30, 2019
• Study Completion: December 20, 2019
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)