A Comparative, Controlled, Clinical Investigation & Quality Control of a

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hearing Loss

Clinical Trial Details

NCT number	NCT03086018
Study type	Interventional
Source	Bernafon AG
Contact
Status	Completed
Phase	N/A
Start date	March 13, 2017
Completion date	June 28, 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms