A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System

Bernafon

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Hearing Aid Mermaid New; Device: Power Hearing Aid New; Device: Hearing Aid Mermaid Current; Device: Power Hearing Aid Current

Study type: Interventional

Funder types: Industry

Identifiers

NCT04146272

BF004-1901

Details and patient eligibility

About

The Purpose of the study is to show that the performance of the new feedback cancellation system is better than the feedback system used in the currently marketed hearing aids. Speech understanding should not be negatively affected by the new system, ad there should be no consequential artifacts or unwanted noises caused by the new system.

Full description

The amplification of sounds with a hearing aid is the most common treatment for hearing loss. Benefits of amplification and accessories used with it outweigh any risks in mild to profound hearing-impaired subjects. Hearing aids provide a benefit for people with only a mild sensorineural hearing loss. However, often people are counselled to wait to purchase hearing aids until their hearing loss becomes more significant. The benefits are obtainable for both unilateral and bilateral fittings and are both short term and durable on long term.

Acoustic feedback is a critical problem to all hearing aids. The acoustic coupling between the hearing aid receiver and the microphone occurs when an endless loop is formed so that the microphone is re-amplifying sound from its own receiver. The higher the amplification of the system, the more unstable it becomes and the more likely an acoustic feedback will occur. When this happens the hearing aid user and those around them hear a loud whistling noise. A common method used to combat this problem is feedback cancellation, more specifically adaptive feedback cancellation. The goal of feedback cancellation is to quickly identify feedback path changes and make adjustments to preserve the stability of the system while maintaining a high sound quality and still providing a high stable gain compared to the gain achieved without an active feedback reduction.

For this study, the Sponsor will carry out testing with participants who have hearing loss to validate the performance of the new feedback cancelling algorithm. Studies have investigated the advantages and disadvantages of different feedback cancellation techniques. However, it is accepted by professionals that having a feedback system is better than not using feedback cancellation. The Sponsor has used an adaptive feedback cancellation algorithm since 2010. For the current study the new adaptive algorithm will be compared to the current algorithm implemented in the hearing aids that are certified by the European Conformity and sold on the market. The aim is to determine if less feedback is experienced using the new system in comparison to the old system.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All classifications of hearing loss (sensorineural, conductive, mixed)
• Conductive and mixed hearing loss must be approved for amplification by a physician
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to profound
• German speaking
• Ability and willingness to sign the consent form

Exclusion criteria

• Contraindications for amplification
• Active ear disease
• New hearing aid users
• Inability to follow the procedures
• Reduced mobility that makes then unable to attend study Appointments
• Uncooperative so that it's not possible to get a valid audiogram
• A strongly reduced dexterity
• Central hearing disorder
• Sponsor employees
• Family members of Sponsor employees

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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33 participants in 4 patient groups

Moderate Hearing loss current Mermaid first, then new

Active Comparator group

Description:

Participants were randomized to wear the current Mermaid hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Mermaid Hearing aid for another 10 days.

Treatment:

Device: Hearing Aid Mermaid New

Device: Hearing Aid Mermaid Current

Moderate Hearing loss new Mermaid first, then current

Active Comparator group

Description:

Participants were randomized to wear the new Mermaid hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Mermaid Hearing aid for another 10 days.

Treatment:

Device: Hearing Aid Mermaid New

Device: Hearing Aid Mermaid Current

Severe hearing loss current Power first, then new

Active Comparator group

Description:

Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days.

Treatment:

Device: Power Hearing Aid Current

Device: Power Hearing Aid New

Severe hearing loss new Power first, then current

Active Comparator group

Description:

Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days.

Treatment:

Device: Power Hearing Aid Current

Device: Power Hearing Aid New