Hearing LossNCT04167735
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_33
A study testing Hearing Aid without Reverberation Canceller (RevC). and Hearing Aid Reverberation Canceller enabled (RevC_1) in people with Hearing Loss, run by Sonova AG at 1 site in Switzerland.
Trial summary
Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing Aid without Reverberation Canceller (RevC). and Hearing Aid Reverberation Canceller enabled (RevC_1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Oct 2019to 12 Dec 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Mild-Moderate/Severe (N2-N4) hearing loss
Who cannot join
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. While listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. Participants are asked to repeat back the sentences loud. At fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. Two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. The same conditions will be re-tested once after a minimum of one day. A pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid without Reverberation Canceller (RevC)., Hearing Aid Reverberation Canceller enabled (RevC_1)
- 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 without Reverberation Canceller (RevC).Device
Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is without Reverberation Canceller principle enabled.
Hearing Aid Reverberation Canceller enabled (RevC_1)Device
Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The experimental condition applies the Reverberation Canceller and is predicted to provide a benefit in reverberant room simulations.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid without Reverberation Canceller (no_RevC) | Active comparator | Hearing Aid without Reverberation Canceller (RevC) Receives: Device: Hearing Aid without Reverberation Canceller (RevC). |
| : Hearing Aid Reverberation Canceller enabled (RevC_1) | Experimental | Hearing Aid Reverberation Canceller enabled (RevC_1) Receives: Device: Hearing Aid Reverberation Canceller enabled (RevC_1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Event-related-pupil-dilations (ERPDs)
Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations.
Measured: 4 weeks
Secondary outcomes (2)
Oldenburg sentence test
- Words recalled correctly: words repeated back by participants are logged and the percentage of words recalled correctly calculated.
Measured: 4 weeks
subjective rating
Subjective ratings: using a game controller, participants rate the difficulty of the sentences and listening effort on a visual analog scale. The scale is continuous and ranges from minimal to maximal difficulty/effort. The position of the cursor on the scale is then used to calculate a percentage from 0-100% difficulty/effort.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start22 Oct 2019
- Primary completion12 Dec 2019
- Study completion12 Dec 2019
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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167735
- Sponsor's protocol ID
- Sonova2019_33
- Status last verified
- Dec 2019
- First submitted
- 15 Nov 2019
- Last updated
- 16 Dec 2019
- 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 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
- ClinicalTrials.gov ID
- NCT04167735
- Acronym / sponsor ID
- Sonova2019_33
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 19 Nov 2019 (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.
Participants will complete a listening task in a simulated reverberant environment. Participants are seated and instructed to look at a fixation cross while a sentence is played. Sentences are varied with respect to their speech rate. While listening to the sentences participant's pupil dilation is measured by means of pupillometry which is a non-invasive physiological measurement. Participants are asked to repeat back the sentences loud. At fixed intervals, subjective ratings are collected by asking participants to move an on-screen slider using a game controller. Two hearing aid programs will be compared, one intended for speech perception in quiet and the other to reduce reverberation in reverberant environments. The study is designed as factorial, with 2 speech rates, 2 room simulations and 2 hearing aid programs. The same conditions will be re-tested once after a minimum of one day. A pilot study will determine appropriate speech rates by applying a different factorial, with 4 speech rates, 2 room simulations and 1 hearing aid program. Participants complete all conditions (within-subjects) in one experimental sessions that lasts around 1 hour.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid without Reverberation Canceller (no_RevC) | Active comparator | Device: Hearing Aid without Reverberation Canceller (RevC).Hearing Aid without Reverberation Canceller (RevC) |
| : Hearing Aid Reverberation Canceller enabled (RevC_1) | Experimental | Device: Hearing Aid Reverberation Canceller enabled (RevC_1)Hearing Aid Reverberation Canceller enabled (RevC_1) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- Mild-Moderate/Severe (N2-N4) hearing loss
Key exclusion criteria (7 listed)
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
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 without Reverberation Canceller (RevC).Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is without Reverberation Canceller principle enabled. | Device | Hearing Aid without Reverberation Canceller (no_RevC) |
| Hearing Aid Reverberation Canceller enabled (RevC_1)Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The experimental condition applies the Reverberation Canceller and is predicted to provide a benefit in reverberant room simulations. | Device | : Hearing Aid Reverberation Canceller enabled (RevC_1) |
Primary outcome
Changes in Event-related-pupil-dilations (ERPDs)
Time frame: 4 weeks
Pupil dilations will be recorded from the participant during the performance of the auditory tasks. Analyses will be carried out relative to the pre-trial baseline (measured one second prior to the onset of the stimulus), in order to account for differences in baseline physiological activity. It is planned to analyze event-related-pupil-dilations.
2 secondary outcomes
Oldenburg sentence test
Time frame: 4 weeks
subjective rating
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
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 without Reverberation Canceller (RevC). and Hearing Aid Reverberation Canceller enabled (RevC_1) in people with Hearing Loss, run by Sonova 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 4 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: finished, as of the sponsor's last update on 16 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Event-related-pupil-dilations (ERPDs) (time frame: 4 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 16 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.