Hearing Loss, SensorineuralNCT05072457
Benefit of Assistive Listening Device for Lateralization
A study testing Roger On microphone and Roger Select microphone in people with Hearing Loss, Sensorineural, run by Sonova AG at 1 site in United States.
Trial summary
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Roger On microphone and Roger Select microphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2021to 2 Jul 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Experienced hearing aid users, age 18 or older
- Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
- Good understanding of the English language
- Health outer ear as confirmed by otoscopy
- Informed consent as documented by signature
Who cannot join
- Contraindications to the medical device noted upon otoscopy
- Known hypersensitivity or allergies to materials of the investigations device or comparator
- Inability to produce reliable test results
- Known psychological problems
- Self reported symptoms of vertigo or dizziness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit of Assistive Listening Device for Lateralization and Spatial Hearing
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Roger On microphone, Roger Select microphone
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roger On microphoneDevice
Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
Roger Select microphoneDevice
Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. Receives: Device: Roger On microphone; Device: Roger Select microphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateralization Hearing Ability
Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Measured: Day 1 of 1 day study
Spatial Hearing Ability
Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)
Measured: Day 1 of 1 day study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start18 Oct 2021
- Primary completion13 Dec 2021
- Study completion2 Jul 2022
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 Loss, SensorineuralStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hearts for Hearing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072457
- Sponsor's protocol ID
- SRF-387
- Status last verified
- May 2023
- First submitted
- 28 Sep 2021
- Last updated
- 15 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Assistive Listening Device for Lateralization and Spatial Hearing
- ClinicalTrials.gov ID
- NCT05072457
- Acronym / sponsor ID
- SRF-387
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Hearts for Hearing
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 11 Oct 2021 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Roger On microphone, Device: Roger Select microphoneAll participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Experienced hearing aid users, age 18 or older
- Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
- Good understanding of the English language
- Health outer ear as confirmed by otoscopy
- Informed consent as documented by signature
Key exclusion criteria (5 listed)
- Contraindications to the medical device noted upon otoscopy
- Known hypersensitivity or allergies to materials of the investigations device or comparator
- Inability to produce reliable test results
- Known psychological problems
- Self reported symptoms of vertigo or dizziness
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 |
|---|---|---|
| Roger On microphoneRoger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids | Device | Experimental |
| Roger Select microphoneRoger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids | Device | Experimental |
Primary outcome
Lateralization Hearing Ability
Time frame: Day 1 of 1 day study
Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Spatial Hearing Ability
Time frame: Day 1 of 1 day study
Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
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 Roger On microphone and Roger Select microphone in people with Hearing Loss, Sensorineural, run by Sonova AG at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 15 Jun 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 United States. 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 18 May 2023). 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?
Lateralization Hearing Ability (time frame: Day 1 of 1 day study). The study lists 2 primary outcomes in all. 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 15 Jun 2023.