Hearing LossNCT05067751
Asymmetrical Directionality With Bimodal Systems.
An observational study of Hearing Loss, run by GN Hearing A/S.
Trial summary
Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. 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 with directionality
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2021to 31 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects, male/female with diagnosed hearing loss that have been treated with Cochlear implants in one ear.
Who may be able to join
- Subjects must meet the inclusion criteria described below to be eligible for this clinical investigation.
- Adults who are English speaking and aged 18 years and older.
- Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
- New and experienced bimodal users (cochlear implant + hearing aid).
- Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
- Individuals able to complete test measures as outlined in the informed consent and protocol.
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- Individuals with access to a Smart Phone/device that is either iOS 7.0 or Android 4.0 and later who are willing to utilize their personal Smart Phone/device for participation in the trial.
- Individuals willing to use their personal email account for participation in the trial.
- -
Who cannot join
- Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.
- Individuals using sound processors in the Hybrid mode.
- Bilateral cochlear implant users.
- Unable or unwilling to comply with the requirements of the study as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational device.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.
Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.
Read the detailed description
The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.
- Conditions
- Hearing Loss
- Being tested
- hearing aid with directionality
- 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 with directionalityDevice
Hearing directionality allows users the ability to focus on voices and other signals of interest, reducing background noises that are unimportant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing loss assessed by the SSQ 12 hearing related questionnaire
Speech Spatial and Qualities of hearing questionnaire is designed to measure of range of hearing disabilities across several domains. Specific attention is given to hearing speech in a host of competing contexts, and to the directional, distance and movement components of spatial hearing.
Measured: 2 weeks
Secondary outcomes (1)
Hearing loss assessed by the AZ Bio sentence test in the presence of noise
AZ Bio sentence in noise test comprised of 15 lists of 20 sentences each and is a measure of speech perception ability by individuals that mimics real life conditions with the presence of background noise.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start6 Oct 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GN Hearing A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Megan Quilter, Principal investigator, GN Hearing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067751
- Sponsor's protocol ID
- Parker
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Asymmetrical Directionality With Bimodal Systems.
- ClinicalTrials.gov ID
- NCT05067751
- Acronym / sponsor ID
- Parker
- Conditions
- Hearing Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- GN Hearing A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Oct 2021 (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.
Research supports that bimodal stimulation includes improvements in auditory performance and daily living over using a cochlear implant (CI) or hearing aid (HA) alone. Although bimodal users continue to achieve high levels of satisfaction, speech perception in noise continues to be highly problematic. The aim of this field study is to identify which directionality schemes in a bimodal solution are preferred by users using an ecological momentary assessment tool.
Detailed description
The primary purpose of this research trial is to evaluate asymmetrical directionality in bimodal users for hearing speech in noise in the sound field and in daily life using an EMA tool. The aim is to collect information regarding hearing for speech in background noise as well as end-user insights, testimonials, and communication content.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects, male/female with diagnosed hearing loss that have been treated with Cochlear implants in one ear.
Key inclusion criteria (9 listed)
- Subjects must meet the inclusion criteria described below to be eligible for this clinical investigation.
- Adults who are English speaking and aged 18 years and older.
- Individuals with a mild sloping to severe/profound hearing loss in the hearing aided ear.
- New and experienced bimodal users (cochlear implant + hearing aid).
- Experienced Nucleus 7 or Kanso 2 cochlear implant users with minimum experience using electrical hearing for 6 months.
Key exclusion criteria (7 listed)
- Subjects who meet any of the exclusion criteria described below will not be eligible for this clinical investigation.
- Individuals using sound processors in the Hybrid mode.
- Bilateral cochlear implant users.
- Unable or unwilling to comply with the requirements of the study as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
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 with directionalityHearing directionality allows users the ability to focus on voices and other signals of interest, reducing background noises that are unimportant. | Device | – |
Primary outcome
Hearing loss assessed by the SSQ 12 hearing related questionnaire
Time frame: 2 weeks
Speech Spatial and Qualities of hearing questionnaire is designed to measure of range of hearing disabilities across several domains. Specific attention is given to hearing speech in a host of competing contexts, and to the directional, distance and movement components of spatial hearing.
1 secondary outcome
Hearing loss assessed by the AZ Bio sentence test in the presence of noise
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
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Enrolling by invitation
Self-monitoring of Hearing Aids Using Artificial Intelligence
Hearing Loss
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
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.
Megan Quilter principal investigator
GN Hearing
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by GN Hearing A/S.
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 9 inclusion and 7 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Megan E Quilter (13124157270, mquilter@gnresound.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing loss assessed by the SSQ 12 hearing related questionnaire (time frame: 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 5 Oct 2021.