Hearing LossNCT06564701
A Pediatric Comparison of Remote Microphone Technologies
A study testing Phonak Roger TouchScreen Microphone and Phonak Partner Mic in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Phonak Roger TouchScreen Microphone and Phonak Partner Mic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2024to 16 Jan 2025
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy middle and outer ear
- Mild, moderate or moderate-severe binaural sensorineural hearing loss
- Minimum AZ Bio score of 70% at 60 dB in quiet
- Experienced hearing aid users (6+ months)
- Able to read and follow directions
- English speakers with ability to communicate easily
Who cannot join
- Active middle ear infection
- Temporary or unilateral hearing loss
- Unable to follow verbal directions
- Unable to communicate easily
- Unable to tolerate the physical fit of the hearing aids
Trial locations and contacts
1 site in 1 country.
About this study
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.
Read the detailed description
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. The simulated classroom environment will include a teacher condition, in which speech is presented from a distance in front of the participant, and a small-group condition, in which speech is presented randomly from three different speakers around the participant. Both conditions will have diffuse background noise, and the various SNR (Signal to Noise Ratio) levels will be tested.
Subjective preference and fatigue questionnaires will also be collected from the participants after the use of each transmitter.
- Conditions
- Hearing Loss
- Being tested
- Phonak Roger TouchScreen Microphone, Phonak Partner Mic
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phonak Roger TouchScreen MicrophoneDevice
Transmitter microphone system operating on the 2.4 GHz band, which allows for low-delay and reliable long-range broadcast to a compatible Roger receiver, designed to be used in educational settings. It features six microphones and adaptive technology in which speech signals are increased when background noise increases to ensure that the speech signal is always above the noise level.
Phonak Partner MicDevice
Wireless microphone that uses Phonak proprietary AirStream technology to connect to Phonak hearing aids. It uses a fixed directional microphone, and is paired to the hearing aids such that the hearing aid microphones are attenuated at a fixed level when the microphone is in use.
| Study group | Role | What they receive |
|---|---|---|
| Lab and Home Trial | Experimental | Participants who complete the lab testing, and who are able to use both devices during a field trial period in school Receives: Device: Phonak Roger TouchScreen Microphone; Device: Phonak Partner Mic |
| Experimental No Field Trial | Experimental | Participants who are only able to complete the lab testing Receives: Device: Phonak Roger TouchScreen Microphone; Device: Phonak Partner Mic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition
Sentences are presented from a front speaker located 8.5 feet away from participant. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.
Measured: One day (Visit 1)
Speech Intelligibility score using the AZ Bio Sentence Test- small group condition
Sentences are presented randomly from three different speakers, located around a small table with the participant, simulating a small group at a table. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.
Measured: One day (Visit 1)
Secondary outcomes (2)
Listening Fatigue using the Vanderbilt Fatigue Scale for Children
Ten questions related to fatigue, answers rank from 1 (never) to 5 (almost always). Total scores can range from 10 to 50, with higher scores indicating more self-perceived fatigue.
Measured: Two days (Visit 2 and Visit 3)
Subjective Preferences of participants
Participants will be asked to rank their preference for the microphone systems using a Likert type of rating scale (1-5), where a lower score (<3) would indicate preference for the partner mic and a higher score (>3) will indicate preference for the Roger Touchscreen.
Measured: Two days (Visit 1 following the lab testing, and Visit 3, following the field trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start5 Aug 2024
- Primary completion30 Nov 2024
- Study completion16 Jan 2025
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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Speech intelligibility testing will be conducted on a single group of participants, first using one remote mic system, and then the other. The order of devices will be counter-balanced across participants.
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT06564701
- Sponsor's protocol ID
- SRF-22936
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pediatric Comparison of Remote Microphone Technologies
- ClinicalTrials.gov ID
- NCT06564701
- Acronym / sponsor ID
- SRF-22936
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- Hearts for Hearing
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 16 Jan 2025 (actual)
- First posted
- 21 Aug 2024 (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.
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone.
Detailed description
Speech intelligibility will be evaluated for school age children with hearing loss in a simulated classroom environment, using Phonak hearing aids and receivers and two different microphone transmitters: a Roger Touchscreen mic and a fixed directional microphone. The simulated classroom environment will include a teacher condition, in which speech is presented from a distance in front of the participant, and a small-group condition, in which speech is presented randomly from three different speakers around the participant. Both conditions will have diffuse background noise, and the various SNR (Signal to Noise Ratio) levels will be tested.
Subjective preference and fatigue questionnaires will also be collected from the participants after the use of each transmitter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Speech intelligibility testing will be conducted on a single group of participants, first using one remote mic system, and then the other. The order of devices will be counter-balanced across participants.
| Arm | Type | Receives |
|---|---|---|
| Lab and Home Trial | Experimental | Device: Phonak Roger TouchScreen Microphone, Device: Phonak Partner MicParticipants who complete the lab testing, and who are able to use both devices during a field trial period in school |
| Experimental No Field Trial | Experimental | Device: Phonak Roger TouchScreen Microphone, Device: Phonak Partner MicParticipants who are only able to complete the lab testing |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy middle and outer ear
- Mild, moderate or moderate-severe binaural sensorineural hearing loss
- Minimum AZ Bio score of 70% at 60 dB in quiet
- Experienced hearing aid users (6+ months)
- Able to read and follow directions
Key exclusion criteria (5 listed)
- Active middle ear infection
- Temporary or unilateral hearing loss
- Unable to follow verbal directions
- Unable to communicate easily
- Unable to tolerate the physical fit of the hearing aids
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 |
|---|---|---|
| Phonak Roger TouchScreen MicrophoneTransmitter microphone system operating on the 2.4 GHz band, which allows for low-delay and reliable long-range broadcast to a compatible Roger receiver, designed to be used in educational settings. It features six microphones and adaptive technology in which speech signals are increased when background noise increases to ensure that the speech signal is always above the noise level. | Device | Experimental No Field Trial, Lab and Home Trial |
| Phonak Partner MicWireless microphone that uses Phonak proprietary AirStream technology to connect to Phonak hearing aids. It uses a fixed directional microphone, and is paired to the hearing aids such that the hearing aid microphones are attenuated at a fixed level when the microphone is in use. | Device | Experimental No Field Trial, Lab and Home Trial |
Primary outcome
Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition
Time frame: One day (Visit 1)
Sentences are presented from a front speaker located 8.5 feet away from participant. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.
Speech Intelligibility score using the AZ Bio Sentence Test- small group condition
Time frame: One day (Visit 1)
Sentences are presented randomly from three different speakers, located around a small table with the participant, simulating a small group at a table. Diffuse background noise is presented from four corner speakers. Various Signal to Noise Ratios (SNR) will be tested: +4 dB, +2 dB, and -2 dB. The number of words correctly repeated will be calculated and expressed as a percentage for each SNR level. A higher score is better.
2 secondary outcomes
Listening Fatigue using the Vanderbilt Fatigue Scale for Children
Time frame: Two days (Visit 2 and Visit 3)
Subjective Preferences of participants
Time frame: Two days (Visit 1 following the lab testing, and Visit 3, following the field trial)
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 13 Mar 2025.
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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.
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 Phonak Roger TouchScreen Microphone and Phonak Partner Mic in people with Hearing Loss, 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 6 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 13 Mar 2025. 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?
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?
Speech Intelligibility score using the AZ Bio Sentence Test-teacher condition (time frame: One day (Visit 1)). 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 13 Mar 2025.