A Comparative Clinical Investigation of Musician's Preference With Hearing Aids

NCT04939259 | Completed

• 1 other identifier: BF007-2101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

For this study, Bernafon AG will carry out testing with participants with hearing loss to compare a dedicated music program to a general listening program. The Bernafon hearing aids used for the current study are CEmarked and will be released to the market in early 2022. The goal is to determine whether musicians will perceive a difference and prefer the music program over the default listening program in real-life situations. The devices will also be validated for performance before their release to the market.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• The number of patients that prefer the music program for listening to music over the standard listening program as reported in the questionnaire that asks patients to choose a program and state the reason why it was preferred.

  A questionnaire will ask patients to choose between the music program and the standard listening program as their preferred program for listening to music. It is not a forced choice as they also have the option to choose "no preference." They are then asked to choose from a checkbox with a list of possible reasons for the preference as well as the ability to write in additional reasons.

  10 days

Secondary Outcomes (3)

• The number of patients that prefer the sound quality of the music program over the standard listening program measured with a forced choice A/B question on a touch screen.

  10 days

• The average level of decibels at which patients are able to discriminate the changes in pitch of recorded music samples as measured with a standardized test called the Adaptive Music Perception (AMP) test.

  0 days

• The average level at which patients correctly repeat sentences presented in background noise using the standardized Gottingen Sentence Test (GOSA).

  10 days

Other Outcomes (1)

• The number of patients with treatment-related adverse events as assessed by CTCAE v4.0.

  0 Days and 10 Days

Study Arms (2)

New Music Program

EXPERIMENTAL

The new hearing aid contains the new music program will be worn by all participants at the same time. The participants must switch between the two programs during use to make the comparison.

Device: New Music Program; Device: Standard Listening Program

Standard Listening Program

ACTIVE COMPARATOR

The new hearing aid also contains the standard listening program worn by all participants at the same time. The participants must switch between the two programs during use to make the comparison.

Device: New Music Program; Device: Standard Listening Program

Interventions

New Music Program DEVICE

A mini behind-the-ear hearing aid that amplifies sounds and directs them into the ear. The music program within the hearing aid will provide amplification specifically tuned for listening to music.

New Music Program; Standard Listening Program

Standard Listening Program DEVICE

A mini receiver-in-the-ear hearing aid that amplifies sounds and directs them into the ear. The standard listening program within the hearing aid will provide amplification specifically tuned for listening to speech and daily general sounds in the environment.

New Music Program; Standard Listening Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All classifications of hearing loss (sensorineural, conductive, mixed)
• If the hearing loss is conductive or mixed it must be approved for amplification by a physician
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to severe
• German speaking
• Play a musical instrument
• Both genders
• Ages 18 and older
• 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 procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
• A reduced mobility making them unable to attend weekly study appointments
• A reduced ability to describe auditory impressions and the usage of the hearing aids
• Uncooperative so that it is not possible to record a valid pure tone audiogram
• A strongly reduced dexterity
• Central hearing disorders
• Bernafon employees
• Family members of Bernafon employees

Sponsors & Collaborators

• Bernafon AG: lead

Study Sites (1)

Bernafon AG

Bern, 3018, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Barbara Simon, AuD

  Bernafon AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The order of the programs is blinded so that subjects don't know which slot (2 or 3) contains the music program or the general program. Slot 1 always has a general program for everyday speech understanding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will wear the new devices at the same time. They will have the general listening program and the new music program available in the same device. They will switch between the programs to make the comparison in multiple environments.

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 25, 2021
• Study Start: November 1, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)