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The Purpose of the study is to show that the performance of the new feedback cancellation system is better than the feedback system used in the currently marketed hearing aids. Speech understanding should not be negatively affected by the new system, ad there should be no consequential artifacts or unwanted noises caused by the new system.
The amplification of sounds with a hearing aid is the most common treatment for hearing loss. Benefits of amplification and accessories used with it outweigh any risks in mild to profound hearing-impaired subjects. Hearing aids provide a benefit for people with only a mild sensorineural hearing loss. However, often people are counselled to wait to purchase hearing aids until their hearing loss becomes more significant. The benefits are obtainable for both unilateral and bilateral fittings and are both short term and durable on long term.
Acoustic feedback is a critical problem to all hearing aids. The acoustic coupling between the hearing aid receiver and the microphone occurs when an endless loop is formed so that the microphone is re-amplifying sound from its own receiver. The higher the amplification of the system, the more unstable it becomes and the more likely an acoustic feedback will occur. When this happens the hearing aid user and those around them hear a loud whistling noise. A common method used to combat this problem is feedback cancellation, more specifically adaptive feedback cancellation. The goal of feedback cancellation is to quickly identify feedback path changes and make adjustments to preserve the stability of the system while maintaining a high sound quality and still providing a high stable gain compared to the gain achieved without an active feedback reduction.
For this study, the Sponsor will carry out testing with participants who have hearing loss to validate the performance of the new feedback cancelling algorithm. Studies have investigated the advantages and disadvantages of different feedback cancellation techniques. However, it is accepted by professionals that having a feedback system is better than not using feedback cancellation. The Sponsor has used an adaptive feedback cancellation algorithm since 2010. For the current study the new adaptive algorithm will be compared to the current algorithm implemented in the hearing aids that are certified by the European Conformity and sold on the market. The aim is to determine if less feedback is experienced using the new system in comparison to the old system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hearing loss current Mermaid first, then new | Active Comparator | Participants were randomized to wear the current Mermaid hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Mermaid Hearing aid for another 10 days. |
|
| Moderate Hearing loss new Mermaid first, then current | Active Comparator | Participants were randomized to wear the new Mermaid hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Mermaid Hearing aid for another 10 days. |
|
| Severe hearing loss current Power first, then new | Active Comparator | Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days. |
|
| Severe hearing loss new Power first, then current | Active Comparator | Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid Mermaid Current | Device | The current hearing aid used to treat hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Live Feedback Test Scores From Day 10 to Day 20 | In the lab, subjects will have the hearing aid placed in their ear. They will rate on a visual analogue scale whether feedback occurs and if so, how much annoyance it causes. The scale has a minimum of 0 and a maximum of 10. A lower score is a better answer. It will be tested in two conditions, aided with the current Hearing aid, and aided with the new Hearing aid at 10 and 20 days. The difference between the scores from day 10 and day 20 was calculated by subtracting day 20 ("new hearing aid") from day 10 ("current hearing aid") after both sessions of testing were completed and reported as the mean difference for the group. Regardless of the arm assignment, participants wore the same hearing aids for the lab test on days 10 and 20. | 10 days, 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Word Recognition - Aided | Subjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the aided condition with the current Hearing aid and with the new Hearing aid. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting an Adverse Event | The safety of the hearing aids will be rated by the number of adverse events reported by subjects. The minimum score is Zero and the maximum is not defined but is likely not more than 20. A lower number of adverse Events indicates a better outcome. The Outcome will be reported as the sum of Adverse Events reported across time frames. | 0, 10, and 20 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babara Simon, AuD | Sponsor/Bernafon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernafon | Bern | 3018 | Switzerland |
33 participants were randomized. 22 met the inclusion criteria for moderate Hearing loss and 11 for severe Hearing loss.
33 patients were screened for eligibility from the list of contacts at the Bernafon Hearing clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Hearing Loss Current Mermaid, Then New | Participants first used the current Mermaid hearing aid with the current feedback cancellation system for 10 days. Then they used the new Mermaid Hearing aid with the new feedback system for 10 days. |
| FG001 | Moderate Hearing Loss New Mermaid, Then Current | Participants first used the new Mermaid hearing aid with the new feedback cancellation system for 10 days. Then they used the current Mermaid Hearing aid with the current feedback system for 10 days. |
| FG002 | Severe Hearing Loss Current Power, Then New | Participants first used the current power hearing aid with the current feedback cancellation system for 10 days. Then they used the new power Hearing aid with the new feedback system for 10 days. |
| FG003 | Severe Hearing Loss New Power First/Current Second | The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
The Mermaid group included Hearing impaired with a mild to severe Hearing loss and a mean age of 67. The Power group included Hearing impaired with a moderate to profound Hearing loss and a mean age of 67.
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| ID | Title | Description |
|---|---|---|
| BG000 | Current Mermaid First, Then New | Participants were randomized to wear the current hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new Hearing aid for another 10 days. |
| BG001 | New Mermaid First, Then Current |
| 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 | Change in Live Feedback Test Scores From Day 10 to Day 20 | In the lab, subjects will have the hearing aid placed in their ear. They will rate on a visual analogue scale whether feedback occurs and if so, how much annoyance it causes. The scale has a minimum of 0 and a maximum of 10. A lower score is a better answer. It will be tested in two conditions, aided with the current Hearing aid, and aided with the new Hearing aid at 10 and 20 days. The difference between the scores from day 10 and day 20 was calculated by subtracting day 20 ("new hearing aid") from day 10 ("current hearing aid") after both sessions of testing were completed and reported as the mean difference for the group. Regardless of the arm assignment, participants wore the same hearing aids for the lab test on days 10 and 20. | Posted | Mean | Standard Deviation | units on a scale | 10 days, 20 days |
|
6 weeks
The Definition is the same. The participants are asked at every Appointment about any Events that may have occurred during the time since the last Appointment.
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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 | Moderate Hearing Loss Current Mermaid Hearing Aid | The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the current feedback system regardless of the randomization order. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Infections and infestations | Systematic Assessment | Common cold that did not Need Treatment. |
No limitations or caveats
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Simon | Bernafon AG | +41 31 998 15 15 | 1664 | bsim@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 | Sep 13, 2018 | Oct 10, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 20, 2018 | Oct 10, 2019 | 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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The participants will wear hearing aids with the current feedback system and the new feedback system each for 10 +/- 5 days. Some will wear the current hearing aids first and some will wear the new Hearing aids first.
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The participants are masked during the lab testing. They will not know which device they are testing because the Investigator will place it on their ear without letting them see it.
| Hearing Aid Mermaid New | Device | The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system. |
|
| Power Hearing Aid Current | Device | The current power hearing aid used to treat strong hearing loss. |
|
| Power Hearing Aid New | Device | The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system. |
|
| 20 days |
| Sound Quality Rating | The subjects will complete a questionnaire that asks them to rate the quality of different aspects of the hearing aid including sound quality, own voice quality, and the sound quality when in a noisy environment. The scale is from 1 to 5 with 1 being the minimum and 5 being the maximum. A higher score indicates better quality. The questionnaire will be answered for two conditions, aided with the current Hearing aid and aided with the new Hearing aid. The difference between the scores for each condition will be calculated and reported as the mean difference across both arms (moderate hearing loss and severe hearing loss). The difference is not calculated over time points but at the end of the field trial and the assignment order of the hearing aid (new first or current first) does not bear an impact. | 20 days |
| Word Recognition - Unaided | This measurement is made without any hearing aids. Subjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the unaided condition. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score. The scores are not dependent on the assignment order of the hearing aids (new or current first) as the measurement is made without hearing aids and a score calculated for each group (moderate or severe hearing loss) and not for each arm.- | 10 days |
| COMPLETED |
|
| NOT COMPLETED |
|
Participants were randomized to wear the new Hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current Hearing aid for another 10 days. |
| BG002 | Current Power First, Then New | Participants were randomized to wear the current power hearing aid that uses the current feedback cancellation first for 10 days. Then they wore the new power Hearing aid for another 10 days. |
| BG003 | New Power First, Then Current | Participants were randomized to wear the new power hearing aid that uses the new feedback cancellation first for 10 days. Then they wore the current power Hearing aid for another 10 days. |
| BG004 | Total | Total of all reporting groups |
| 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 Threshold | The threshold is the lowest/softest tone measured in decibels (dB) that a Person can hear during the testing and it measured at various frequencies from 250 to 8000 Hertz (Hz). The louder that the tone Needs to be in order to hear it, the more Hearing loss that a Person has. | Mean | Standard Deviation | decibels |
|
| OG001 | Moderate Hearing Loss New Mermaid First/Current Second | The new Mermaid Hearing aid with the new feedback system will be worn first for this group.The current hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second. |
| OG002 | Severe Hearing Loss Current Power First/New Second | The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn first by this group. The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn second. |
| OG003 | Severe Hearing Loss New Power First/Current Second | The new power hearing aid that is not yet sold and uses the new feedback cancellation system will be worn first by this group. The current power hearing aid that is sold and uses the current feedback cancellation system will be used as a comparator and worn second. |
|
|
| Secondary | Word Recognition - Aided | Subjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the aided condition with the current Hearing aid and with the new Hearing aid. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score. | Posted | Mean | Standard Deviation | percentage of words correct | 20 days |
|
|
|
| Secondary | Sound Quality Rating | The subjects will complete a questionnaire that asks them to rate the quality of different aspects of the hearing aid including sound quality, own voice quality, and the sound quality when in a noisy environment. The scale is from 1 to 5 with 1 being the minimum and 5 being the maximum. A higher score indicates better quality. The questionnaire will be answered for two conditions, aided with the current Hearing aid and aided with the new Hearing aid. The difference between the scores for each condition will be calculated and reported as the mean difference across both arms (moderate hearing loss and severe hearing loss). The difference is not calculated over time points but at the end of the field trial and the assignment order of the hearing aid (new first or current first) does not bear an impact. | Posted | Mean | 95% Confidence Interval | units on a scale | 20 days |
|
|
|
| Other Pre-specified | Number of Participants Reporting an Adverse Event | The safety of the hearing aids will be rated by the number of adverse events reported by subjects. The minimum score is Zero and the maximum is not defined but is likely not more than 20. A lower number of adverse Events indicates a better outcome. The Outcome will be reported as the sum of Adverse Events reported across time frames. | Posted | Count of Participants | Participants | 0, 10, and 20 days |
|
|
|
| Secondary | Word Recognition - Unaided | This measurement is made without any hearing aids. Subjects will indicate on a touch screen which word that they heard through the loud speaker. The touch screen will give 5 possible answer choices that includes the correct choice and 4 other words that rhyme with the actual word. The test is run in the unaided condition. The test is scored by the percentage of words that they answer correctly. 0 percent is the lowest score possible and 100 percent is the highest. A higher percentage indicates a better score. The scores are not dependent on the assignment order of the hearing aids (new or current first) as the measurement is made without hearing aids and a score calculated for each group (moderate or severe hearing loss) and not for each arm.- | Posted | Mean | Standard Deviation | percentage of words correct | 10 days |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 5 |
| 22 |
| EG001 | Moderate Hearing Loss New Mermaid Hearing Aid | The number of participants with a moderate hearing loss to report an AE while wearing the Mermaid hearing aid with the new feedback system regardless of the randomization order. | 0 | 22 | 0 | 22 | 3 | 22 |
| EG002 | Severe Hearing Loss Current Power Hearing Aid | The number of participants with a severe hearing loss to report an AE while wearing the current Power hearing aid regardless of the randomization order. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG003 | Severe Hearing Loss New Power Hearing Aid | The number of participants with a severe hearing loss to report an AE while wearing the new Power hearing aid regardless of the randomization order. | 0 | 11 | 0 | 11 | 3 | 11 |
|
| Bodily harm | Injury, poisoning and procedural complications | Systematic Assessment | Subjects suffered an accident and injured a part of the body but required no Treatment. |
|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment | Subjects had a skin irritation that required no treatment |
|
| Pain | Product Issues | Systematic Assessment | Subjects reported pain that required no treatment |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| New hearing aid |
|