Clinical trial NCT03086018: A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
Official title: A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid in Comparison to the Currently Marketed Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Bernafon AG
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech Intelligibility Performance
timeFrame: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Secondary outcomes:
measure: Subjective Performance of Aided Benefit
timeFrame: A 2 week time period during which they will wear the devices and answer questionnaires about the experience.
measure: Speech Intelligibility Performance With New Feature
timeFrame: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
measure: Handling/Usability Performance
timeFrame: 2 hour period of usability testing with tasks and questionnaires.
measure: Events
timeFrame: A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Bernafon AG
Study officials:
affiliation: Bernafon AG
name: Barbara Simon, AuD
role: PRINCIPAL_INVESTIGATOR
References: