Hearing LossNCT04146272
A Comparison of a New Acoustic Feedback Canceller in Hearing Aids With the Current System
A study testing Hearing Aid Mermaid Current, Hearing Aid Mermaid New and Power Hearing Aid Current in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
Trial summary
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… 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?
- Hearing Aid Mermaid Current, Hearing Aid Mermaid New and Power Hearing Aid Current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Nov 2018to 7 Jul 2019
- 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)
- Conductive and mixed hearing loss must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to profound
- German speaking
- Ability and willingness to sign the consent form
Who cannot join
- Contraindications for amplification
- Active ear disease
- New hearing aid users
- Inability to follow the procedures
- Reduced mobility that makes then unable to attend study Appointments
- Uncooperative so that it's not possible to get a valid audiogram
Show all 10Show fewer
- A strongly reduced dexterity
- Central hearing disorder
- Sponsor employees
- Family members of Sponsor employees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Controlled Clinical Investigation of a New Acoustic Feedback Cancellation Strategy in Comparison With the Currently Marketed System
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.
Read the detailed description
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.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid Mermaid Current, Hearing Aid Mermaid New, Power Hearing Aid Current, Power Hearing Aid New
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid Mermaid CurrentDevice
The current hearing aid used to treat hearing loss.
Hearing Aid Mermaid NewDevice
The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
Power Hearing Aid CurrentDevice
The current power hearing aid used to treat strong hearing loss.
Power Hearing Aid NewDevice
The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hearing Aid Mermaid Current; Device: Hearing Aid Mermaid New |
| 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. Receives: Device: Hearing Aid Mermaid Current; Device: Hearing Aid Mermaid New |
| 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. Receives: Device: Power Hearing Aid Current; Device: Power Hearing Aid New |
| 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. Receives: Device: Power Hearing Aid Current; Device: Power Hearing Aid New |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days, 20 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.-
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start1 Nov 2018
- Primary completion18 Jun 2019
- Study completion7 Jul 2019
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
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernafon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Babara Simon, AuD, Principal investigator, Sponsor/Bernafon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146272
- Sponsor's protocol ID
- BF004-1901
- Status last verified
- Aug 2021
- First submitted
- 10 Oct 2019
- Last updated
- 13 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Controlled Clinical Investigation of a New Acoustic Feedback Cancellation Strategy in Comparison With the Currently Marketed System
- ClinicalTrials.gov ID
- NCT04146272
- Acronym / sponsor ID
- BF004-1901
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bernafon AGIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 7 Jul 2019 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 13 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Moderate Hearing loss current Mermaid first, then new | Active comparator | Device: Hearing Aid Mermaid Current, Device: Hearing Aid Mermaid NewParticipants 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 | Device: Hearing Aid Mermaid Current, Device: Hearing Aid Mermaid NewParticipants 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 | Device: Power Hearing Aid Current, Device: Power Hearing Aid NewParticipants 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 | Device: Power Hearing Aid Current, Device: Power Hearing Aid NewParticipants 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. |
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)
- Conductive and mixed hearing loss must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to profound
- German speaking
Key exclusion criteria (10 listed)
- Contraindications for amplification
- Active ear disease
- New hearing aid users
- Inability to follow the procedures
- Reduced mobility that makes then unable to attend study Appointments
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 |
|---|---|---|
| Hearing Aid Mermaid CurrentThe current hearing aid used to treat hearing loss. | Device | Moderate Hearing loss current Mermaid first, then new, Moderate Hearing loss new Mermaid first, then current |
| Hearing Aid Mermaid NewThe new hearing aid used to treat hearing loss with an upgraded feedback cancellation system. | Device | Moderate Hearing loss current Mermaid first, then new, Moderate Hearing loss new Mermaid first, then current |
| Power Hearing Aid CurrentThe current power hearing aid used to treat strong hearing loss. | Device | Severe hearing loss current Power first, then new, Severe hearing loss new Power first, then current |
| Power Hearing Aid NewThe new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system. | Device | Severe hearing loss current Power first, then new, Severe hearing loss new Power first, then current |
Primary outcome
Change in Live Feedback Test Scores From Day 10 to Day 20
Time frame: 10 days, 20 days
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.
3 secondary outcomes
Word Recognition - Aided
Time frame: 20 days
Sound Quality Rating
Time frame: 20 days
Word Recognition - Unaided
Time frame: 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Babara Simon, AuD principal investigator
Sponsor/Bernafon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Mermaid Current, Hearing Aid Mermaid New and Power Hearing Aid Current 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 13 Sep 2021. 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 13 Sep 2021). 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?
Change in Live Feedback Test Scores From Day 10 to Day 20 (time frame: 10 days, 20 days). 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 13 Sep 2021.