Hearing LossNCT05561335
Preference Comparisons for Algorithms to Hear Speech
A study testing hearing aid -novel program and hearing aid - standard program in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
Trial summary
Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- hearing aid -novel program and hearing aid - standard program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 21 Mar 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Including adults with sensorineural mild to moderate-severe hearing loss
- hearing aid experience (greater than 6 months)
- who are able to complete the task in English.
- Language: Can speak and understand English Fluently
- Hearing loss within the fitting ranges of the investigational products.
Show all 11Show fewer
- Healthy outer ear.
- Ability to understand instructions.
- Ability to describe listening experiences.
- Ability to fill out questionnaires.
- Informed consent as documented by signature.
Who cannot join
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
- Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
- Limited mobility and not able to attend to appointments or not able to go in a car.
- Reported symptoms of vertigo and dizziness by subject.
- Severe Tinnitus
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Western University
London, Ontario, N6G 1G9
Paula Folkeard, AuD, 519-661-2111 ext. 88936, folkeard@nca.uwo.ca
About this study
Official title: Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.
Read the detailed description
People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.
This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.
Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.
- Conditions
- Hearing Loss
- Being tested
- hearing aid -novel program, hearing aid - standard program
- 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 -novel programDevice
novel microphone configuration
hearing aid - standard programDevice
standard microphone configuration
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid use for listening to speech in a common difficult situation | Experimental | The hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences. Receives: Device: hearing aid -novel program; Device: hearing aid - standard program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall preference for a specific microphone setting/configuration
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')
Measured: 20 minutes
Secondary outcomes (3)
Rating of awareness of background noise
Scale from 0-100 with descriptors ('not at all' to 'extremely aware')
Measured: 20 minutes
Rating of Listening effort
Scale from 1 - 7 with descriptors ('not at all' to 'very')
Measured: 20 minutes
Rating of annoyance of artefacts
Rating on a scale from 0-100 with descriptors ('not at all' to 'extremely annoying')
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start21 Mar 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Western University
- Responsible party
- Sponsor
- Investigators
- Susan Scollie, PhD, Principal investigator, Western University (aka The University of Western Ontario)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561335
- Sponsor's protocol ID
- 5251
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel Algorithm to a Standard Microphone Configuration for Hearing Preference
- ClinicalTrials.gov ID
- NCT05561335
- Acronym / sponsor ID
- 5251
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Western University
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. During a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. They will provide ratings on a range of outcome measures including overall preference and awareness of background noise. Overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.
Detailed description
People with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. This is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate.
This study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. They will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. Participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. By having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences.
Of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid use for listening to speech in a common difficult situation | Experimental | Device: hearing aid -novel program, Device: hearing aid - standard programThe hearing aids will be worn in two different programs, each with a different microphone configuration. The participants will listen to speech while wearing the hearing aids and alternate programs to form their opinions about these programs; they will only know that they are rating different settings, not what the settings are. They will then rate their listening experiences via rating scales to determine their preferences. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- Including adults with sensorineural mild to moderate-severe hearing loss
- hearing aid experience (greater than 6 months)
- who are able to complete the task in English.
- Language: Can speak and understand English Fluently
Key exclusion criteria (5 listed)
- The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
- Contraindications to the MD in this study (e.g. known hypersensitivity or allergy to the investigational product).
- Limited mobility and not able to attend to appointments or not able to go in a car.
- Reported symptoms of vertigo and dizziness by subject.
- Severe Tinnitus
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 -novel programnovel microphone configuration | Device | Hearing Aid use for listening to speech in a common difficult situation |
| hearing aid - standard programstandard microphone configuration | Device | Hearing Aid use for listening to speech in a common difficult situation |
Primary outcome
Overall preference for a specific microphone setting/configuration
Time frame: 20 minutes
Rating of preference on a scale from 0-100, with descriptors ('very low' to 'very high')
3 secondary outcomes
Rating of awareness of background noise
Time frame: 20 minutes
Rating of Listening effort
Time frame: 20 minutes
Rating of annoyance of artefacts
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
Susan Scollie, PhD principal investigator
Western University (aka The University of Western Ontario)
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 -novel program and hearing aid - standard program in people with Hearing Loss, run by Sonova AG at 1 site in Canada.
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 11 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Don Hayes, PhD (519 500 3618, don.hayes@unitron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall preference for a specific microphone setting/configuration (time frame: 20 minutes). 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 7 Sep 2023.