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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Successor hearing aid to Juna | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Simon, AuD | Bernafon AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernafon AG | Bern | 3018 | Switzerland |
Individual data will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Successor Hearing Aid to Juna | The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Field Testing |
| |||||||||||||
| Final Testing for End of Trial |
|
For this study all data gathered had to be included in the analysis. This means that some data is analyzed from 30 participants and some from only 28 for any data not gathered after the two participants dropped from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: Successor Hearing Aid to Juna | The intervention is the new hearing aid which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | dB SNR | 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks. |
|
4 months
All Cause Mortality is not a separate item in the definition of adverse events used in the study. This is considered part of the serious adverse events definition. We identified two categories, Serious adverse events and Adverse Events. All events fall into one of these categories, so when it is not considered a serious adverse event, it is an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental: Successor Hearing Aid to Juna | The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. They will wear the intervention device for approximately two weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to accident | Social circumstances | Non-systematic Assessment | Was hospitalized after an accident at home, in which the back was injured requiring surgery. Participant could not continue in trial. No causality to IMD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | General disorders | Non-systematic Assessment | Two participants reported colds during the study. One of the two participants reported it twice (on two separate Occasions). No causality to IMD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Tantau | Bernafon AG | +41 31 998 1646 | juta@bernafon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 2, 2017 | Nov 16, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 14, 2016 | Aug 21, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.
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The hardware will be obviously different from the control devices and impossible to blind.
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| 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. | 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. | 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. | 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. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hearing Instrument Experience | Count of Participants | Participants |
|
|
|
| Secondary | 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. | For this questionnaire, two participants had left the study and data was not collected. | Posted | Median | Standard Deviation | Units on a scale | A 2 week time period during which they will wear the devices and answer questionnaires about the experience. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent correct out of 100% | 2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks. |
|
|
|
| Secondary | 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. | Posted | Number | percentage of tasks scored with 2 | 2 hour period of usability testing with tasks and questionnaires. |
|
|
|
| Secondary | 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. | Posted | Number | Units of AEs related to device | 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. |
|
|
|
| 0 |
| 0 |
| 1 |
| 30 |
| 11 |
| 30 |
|
|
| Tore Meniscus | General disorders | Non-systematic Assessment | Participant tore left meniscus when the foot was twisted while walking. No causality to IMD |
|
| Scratch on ear canal | General disorders | Non-systematic Assessment | Participant reported discomfort in ear. Upon inspection, a small scratch was found on the ear canal. |
|
| Dome in Ear | Product Issues | Non-systematic Assessment | Dome fell off in the ear canal. |
|
| Headache | General disorders | Non-systematic Assessment | Participant reported getting a headache after being in too much noise |
|
| Irritation in ear | General disorders | Non-systematic Assessment | Participant reported irritation and pain in ear after wearing the domes for a few days. Removed device till problem resolved. |
|
| Sore Concha | Product Issues | Non-systematic Assessment | Sore spot in concha, which resolved overnight after removing the device for the evening. |
|
| Back Pain | General disorders | Non-systematic Assessment | Trouble with lower back pain. No causality to IMD |
|
| Pressure point | General disorders | Non-systematic Assessment | Pressure point in ear when device not in ear correctly. Problem resolved after removal of device. |
|
| Tore Groin muscle | General disorders | Non-systematic Assessment | Tore groin muscle on the right side after picking up grandchild. No causality to IMD |
|
| Leg problem | General disorders | Non-systematic Assessment | Leg problems caused by spinal cord compression. No causality to IMD |
|
| Face Swelling | General disorders | Non-systematic Assessment | Face swelling caused by allergic reaction to eye drops. No causality to IMD |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Aversiveness |
|
| Global Score |
|
| Title | Measurements |
|---|---|
|
| +15 SNR WAKO Feature off |
|