A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid

Bernafon

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Successor hearing aid to Juna

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086018

BF001-1611

Details and patient eligibility

About

The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market.

The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.

Full description

The reason for this study is to evaluate a new hearing aid. The goal is to evaluate the audiological performance and usability as well as features and functions in comparison to the hearing aid already CE marked. Furthermore, it is important to identify unexpected or unwanted behavior from the devices. This clinical investigation is a validation testing and is designed to evaluate the new hearing instrument system. As human subjects are involved, this validation test falls under the definition of a clinical investigation. The validation addresses the performance of the device with new functionality, and additionally addresses whether the end user can understand speech as well as with the current marketed device.

End users will be tested in the lab with speech tests and usability tests. They will also participate in field tests after which they will answer questionnaires concerning their experience with the instruments. Evaluating the overall performance of the hearing instrument is important to verify that the end user is satisfied with the device and that all user requirements are fulfilled. Many of the features available in the new device have already been validated and are used in devices currently on the market.

The purpose of this research is to show that the performance of the new device is as good as or better than the current device. Furthermore, speech should not be negatively affected with the addition of new features, the usability of the devices (that end users are able to handle the devices) should be as good as the current device, and there should be no artifacts or unwanted noises. Some measurements serve as quality control prior to product launch.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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
• Ability and willingness to sign the consent form

Exclusion criteria

• Contraindications for amplification
• Active ear disease
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Successor hearing aid to Juna

Experimental group

Description:

The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. The will wear the intervention device for approximately two weeks.

Treatment:

Device: Successor hearing aid to Juna