Hearing LossNCT05859568
Baseline Performance and Fitting Parameters for Sonova Products
A study testing Pinna-located microphone and Pinna-simulated microphone algorithm in people with Hearing Loss and Ear Diseases, run by Advanced Bionics at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Hearing Loss, Ear Diseases, Hearing Disorders
- What is being tested?
- Pinna-located microphone and Pinna-simulated microphone algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 17 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ability to provide Informed Consent/Assent
- Adults (age +18 years) and children (8-17 years) can be enrolled in this study
- If child is aged 8-17 years, an assent will be completed, and the subject must be accompanied by a parent or legal guardian for all study activities
- Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
- English language proficiency as determined by the investigator
Who cannot join
- Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
Read the detailed description
This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.
- Being tested
- Pinna-located microphone, Pinna-simulated microphone algorithm
- Medical subject headings
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pinna-located microphoneDevice
Sound processors using a pinna-located microphone
Pinna-simulated microphone algorithmDevice
Sound processors using a pinna-simulated algorithm
| Study group | Role | What they receive |
|---|---|---|
| Microphone Location versus Microphone Algorithm Comparison | Experimental | Comparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm. Receives: Device: Pinna-located microphone; Device: Pinna-simulated microphone algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech performance in noise
The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Measured: 1 day
Secondary outcomes (2)
Localization performance
A secondary efficacy endpoint is a front/back localization task where filtered pink noise is presented at 60dBA from one of six speakers in a 360 degree array. Scores are generated in percent correct; the scores obtained from the pinna-located microphone will be compared to the localization scores using the pinna-simulated microphone.
Measured: 1 day
Analysis of usability and preference questionnaire
Subject responses captured on a usability and preference questionnaire at the initial visit will be compared to responses on the questionnaire administered after each two-week chronic use interval. Questions will inquire about subject's ability and experience hearing and listening in different situations and wearing configuration preferences. The questions are rated on a 5-point Likert scale with varying strength, such as "It was easy to verify proper microphone function" with answers ranging from strongly disagree to strongly agree.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start17 Apr 2023
- Primary completion17 Apr 2028 (estimated)
- Study completion17 Apr 2028 (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
- Advanced Bionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859568
- Sponsor's protocol ID
- CPR2301
- Status last verified
- May 2025
- First submitted
- 5 May 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Performance and Fitting Parameters for Sonova Products
- ClinicalTrials.gov ID
- NCT05859568
- Acronym / sponsor ID
- CPR2301
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Advanced BionicsIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 17 Apr 2028 (estimated)
- Study completion
- 17 Apr 2028 (estimated)
- First posted
- 16 May 2023 (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.
The purpose of this study is to assess the effectiveness and optimization of various FDA approved products.
Detailed description
This study uses a prospective within-subjects repeated-measures design in which each subject serves as her/his own control. The purpose of this study is to assess the effectiveness and optimization of various FDA approved hardware, signal preprocessing and processing software, fitting characteristics, and service delivery methods, such as remote support and/or tele-audiology on an expanded subject demographic. The insights gained from this study will be used to optimize listening configuration recommendations, refine audiological practice, and inform future innovations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microphone Location versus Microphone Algorithm Comparison | Experimental | Device: Pinna-located microphone, Device: Pinna-simulated microphone algorithmComparing performance and subjective feedback for pinna-located microphone versus a pinna-simulated microphone algorithm. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide Informed Consent/Assent
- Adults (age +18 years) and children (8-17 years) can be enrolled in this study
- Have the functional capability to operate the controls for the device and to comply with all directions during the study as determined by the investigator conducting the consent/baseline visit
- English language proficiency as determined by the investigator
Key exclusion criteria (1 listed)
- Have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study endpoints
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 |
|---|---|---|
| Pinna-located microphoneSound processors using a pinna-located microphone | Device | Microphone Location versus Microphone Algorithm Comparison |
| Pinna-simulated microphone algorithmSound processors using a pinna-simulated algorithm | Device | Microphone Location versus Microphone Algorithm Comparison |
Primary outcome
Speech performance in noise
Time frame: 1 day
The primary efficacy endpoint is recorded AzBio sentences presented from a single loud speaker at 60 dBA. The recognition scores using the pinna-located microphone in quiet and noise captured at initial visit will be compared to the AzBio sentence recognition scores using the pinna-simulated microphone. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
2 secondary outcomes
Localization performance
Time frame: 1 day
Analysis of usability and preference questionnaire
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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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.
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 Pinna-located microphone and Pinna-simulated microphone algorithm in people with Hearing Loss and Ear Diseases, run by Advanced Bionics 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 1 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: enrolling by invitation, as of the sponsor's last update on 13 May 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?
This study is still under way. Results are not available in the source record yet.
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 performance in noise (time frame: 1 day). 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 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.