Hearing Loss, Bilateral or UnilateralNCT06957730
A Comparison of Hearing Aid Noise Programs on Speech Intelligibility
A study testing Phonak Audeo Infinio Hearing Aid in people with Hearing Loss, Bilateral or Unilateral, run by Sonova AG at 1 site in United States.
Trial summary
Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral
- What is being tested?
- Phonak Audeo Infinio Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2025to 1 May 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral moderate to severe hearing loss (N3-N4)
- Experienced hearing aid user
- Fluent in English
- Cognitively able to complete complex listening tasks
Who cannot join
- Unilateral hearing loss
- New hearing aid user
- Unable or unwilling to complete complex listening tasks
Trial locations and contacts
1 site in 1 country.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
About this study
Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.
Read the detailed description
Program 1 is the current default in the commercially available devices. Programs 2 and 3 are being tested against the current default.
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Being tested
- Phonak Audeo Infinio Hearing Aid
- Keywords
- Hearing Loss
- 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 Audeo Infinio Hearing AidDevice
Commercially available receiver-in-canal (RIC) style hearing aid manufactured by Sonova.
| Study group | Role | What they receive |
|---|---|---|
| Phonak Audeo RIC | Experimental | All participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three settings. Receives: Device: Phonak Audeo Infinio Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZBio Speech in noise testing
A list of 20 sentences is presented from a speaker located in front of the participant. At the same time, background noise is presented from the same speaker at various SNR (Signal to Noise Ratio) levels. That is, speech may be presented 5 dB lower/softer than the noise up to 5 dB higher/louder than the noise. The number of words correct is counted and a percentage from the total number of words presented is calculated. A higher percentage is better and indicates better speech intelligibility. This test will be conducted for all three hearing aid program settings.
Measured: Day 1 of 1 day study
Secondary outcomes (1)
Subjective ratings of sound quality
Participants will be asked to choose between two of the hearing aid programs using an A/B comparison, on the following dimensions: clarity, speech naturalness, speech volume, noise intrusion, listening effort, overall sound quality, and preference. Participants will compare program setting 1 to program setting 2 and choose their preference for each above mentioned dimension. Additionally, participants will compare program setting 1 to program setting 3 and choose preference for each dimension. There is no better or worse, but a count will be taken of preferences for each program. Program 2 and 3 are not compared against each other as the objective of the measure is to compare programs 2 and 3 against the current default program (program 1).
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 posted4 May 2025
- Study start22 Apr 2025
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies 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
- Model description
- All participants will be tested with the same three hearing aid programs, but the order of the programs will be randomized for each participant.
- Masking
- None (open label)
- Enrolment
- 17 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
- NCT06957730
- Sponsor's protocol ID
- SRF-29404
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data collected in this study will only be available to Sonova researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Hearing Aid Noise Programs on Speech Intelligibility
- ClinicalTrials.gov ID
- NCT06957730
- Acronym / sponsor ID
- SRF-29404
- Conditions
- Hearing Loss, Bilateral or Unilateral
- Keywords
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 4 May 2025 (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.
Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.
Detailed description
Program 1 is the current default in the commercially available devices. Programs 2 and 3 are being tested against the current default.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be tested with the same three hearing aid programs, but the order of the programs will be randomized for each participant.
| Arm | Type | Receives |
|---|---|---|
| Phonak Audeo RIC | Experimental | Device: Phonak Audeo Infinio Hearing AidAll participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three settings. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bilateral moderate to severe hearing loss (N3-N4)
- Experienced hearing aid user
- Fluent in English
- Cognitively able to complete complex listening tasks
Key exclusion criteria (3 listed)
- Unilateral hearing loss
- New hearing aid user
- Unable or unwilling to complete complex listening tasks
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 Audeo Infinio Hearing AidCommercially available receiver-in-canal (RIC) style hearing aid manufactured by Sonova. | Device | Phonak Audeo RIC |
Primary outcome
AZBio Speech in noise testing
Time frame: Day 1 of 1 day study
A list of 20 sentences is presented from a speaker located in front of the participant. At the same time, background noise is presented from the same speaker at various SNR (Signal to Noise Ratio) levels. That is, speech may be presented 5 dB lower/softer than the noise up to 5 dB higher/louder than the noise. The number of words correct is counted and a percentage from the total number of words presented is calculated. A higher percentage is better and indicates better speech intelligibility. This test will be conducted for all three hearing aid program settings.
1 secondary outcome
Subjective ratings of sound quality
Time frame: Day 1 of 1 day study
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 30 May 2025.
- Individual participant dataSharing planned: No. Data collected in this study will only be available to Sonova researchers
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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 Audeo Infinio Hearing Aid in people with Hearing Loss, Bilateral or Unilateral, 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 4 inclusion and 3 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 30 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?
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?
AZBio Speech in noise testing (time frame: Day 1 of 1 day study). 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 30 May 2025.