Hearing LossNCT03086018
A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
A study testing Successor hearing aid to Juna in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Successor hearing aid to Juna
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Mar 2017to 28 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- A strongly reduced dexterity
- Central hearing disorders
- Bernafon employees
- Family members of Bernafon employees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid in Comparison to the Currently Marketed Device
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Successor hearing aid to Juna
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Successor hearing aid to JunaDevice
The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.
| Study group | Role | What they receive |
|---|---|---|
| Successor hearing aid to Juna | Experimental | 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. Receives: Device: Successor hearing aid to Juna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility Performance
Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.
Measured: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Secondary outcomes (4)
Subjective Performance of Aided Benefit
The subjective performance for the new device will be measured with the APHAB questionnaire (Abbreviated Hearing Aid Benefit Profile). The questionnaire is a list of 24 statement that the subjects must agree or disagree with using a scale of units from A to G (A being Always and G being Never). Each letter has a corresponding score used for the calculation: A receives 99, B receives 87, C receives 75, D receives 50, E receives 25, F recevies 12, and G receives 1.
An average for each subscale is calculated, and a global or overall score can be calculated by taking the mean of the three positive subscales (Ease of communication, Background noise, and Reverberation). For these three subscales a higher score indicates a better performance. The highest possible score is 99 and the lowest is 1. The fourth scale (Aversiveness) is a negative scale meaning that a higher score means a worse performance. The highest possible score is 99 and the lowest is 1.
Measured: A 2 week time period during which they will wear the devices and answer questionnaires about the experience.
Speech Intelligibility Performance With New Feature
Word recognition test scores will be measured with two signal-to-noise ratio (SNR) levels in percent correct in two conditions, with the new feature on and the new feature off.
The test is a speech test with the words stated in noise at either a 5 dB SNR or a 15 dB SNR. The subject is presented with 5 rhyming words and must choose which word they heard. It is a forced choice meaning that the test will not continue with the next word until they've made a selection. They cannot leave any blank and are not penalized for wrong answers. The score is a percentage of words correct with the maximum score being 100% and the minimum being 0%. A higher score means a better outcome.
Measured: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Handling/Usability Performance
The usability of the new device will be measured with a 3-point rating scale used by the tester to evaluate tasks performed by the end user as well as questionnaires and interviews.
The questionnaire asks subjects to perform tasks, and the clinician rates the ease with which they complete the tasks. 2 is the highest score meaning that they could complete without help, 1 means that they required some assistance, and 0 means that they could not complete the task. A higher score means a better outcome.
Measured: 2 hour period of usability testing with tasks and questionnaires.
Events
Events will be measured by the reporting of unexpected sounds or behavior of the device through questionnaires, diaries, and interviews. The number of events reported including AEs related to the device will be used to measure the outcome. Less events is a better outcome.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start13 Mar 2017
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernafon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Simon, AuD, Principal investigator, Bernafon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086018
- Sponsor's protocol ID
- BF001-1611
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2017
- Last updated
- 6 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid in Comparison to the Currently Marketed Device
- ClinicalTrials.gov ID
- NCT03086018
- Acronym / sponsor ID
- BF001-1611
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bernafon AGIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.
| Arm | Type | Receives |
|---|---|---|
| Successor hearing aid to Juna | Experimental | Device: Successor hearing aid to JunaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Successor hearing aid to JunaThe participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device. | Device | Successor hearing aid to Juna |
Primary outcome
Speech Intelligibility Performance
Time frame: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.
4 secondary outcomes
Subjective Performance of Aided Benefit
Time frame: A 2 week time period during which they will wear the devices and answer questionnaires about the experience.
Speech Intelligibility Performance With New Feature
Time frame: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.
Handling/Usability Performance
Time frame: 2 hour period of usability testing with tasks and questionnaires.
Events
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Simon, AuD principal investigator
Bernafon AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Successor hearing aid to Juna in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Intelligibility Performance (time frame: 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.