Hearing LossNCT06712693
Venting Effects on Speech Performance
A study testing Phonak Audeo Infinio Hearing Aid in people with Hearing Loss, run by Sonova AG at 1 site in United States.
Trial summary
This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- 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
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 23 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:
- 18-85 years of age
- Experienced hearing aid users
- N3-N4 hearing loss
- Fluent in English; ability to read and write in English
- Able to complete complex tasks
- Willing and able to provide informed consent
- Available for the data collection period
The presence of any one of the following exclusion criteria will lead to the exclusion of the subject:
- Self-reported active ear-related pathology (otorrhea, dizziness, sudden hearing loss or worsening of hearing, otalgia)
- Visible deformity of the ear
- Chronic, severe tinnitus
- Unilateral hearing loss
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Phonak Audiology Research Center
Aurora, Illinois, 60504
About this study
This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.
- Conditions
- Hearing Loss
- Being tested
- Phonak Audeo Infinio Hearing Aid
- 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
Receiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All participants will be tested using all three types of domes: Power, Vented, Open. Receives: Device: Phonak Audeo Infinio Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
AZ Bio Sentences
Sentences will be presented at a pre-determined Signal-to-Noise Ratio (SNR). The SNR will be the same for all three conditions (Power dome, Vented dome, Open dome). Percent correct will be calculated for all conditions. A higher percentage indicates better performance.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start11 Nov 2024
- Primary completion23 Jan 2025
- Study completion23 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
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be fit with the investigational devices under three conditions: Power dome, Vented dome, and Open dome. Participant will complete the same tests under each condition. All participants will complete the same conditions.
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT06712693
- Sponsor's protocol ID
- SRF-26765
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venting Effects on Speech Performance
- ClinicalTrials.gov ID
- NCT06712693
- Acronym / sponsor ID
- SRF-26765
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 2 Dec 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.
This study aims to gather behavioral data on the effect of earmold venting on speech performance in noise with a new noise reduction feature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be fit with the investigational devices under three conditions: Power dome, Vented dome, and Open dome. Participant will complete the same tests under each condition. All participants will complete the same conditions.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Phonak Audeo Infinio Hearing AidAll participants will be tested using all three types of domes: Power, Vented, Open. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 AidReceiver-In-Canal hearing aid type that is coupled with either a custom earmold or a dome. | Device | Experimental |
Primary outcome
AZ Bio Sentences
Time frame: 1 day
Sentences will be presented at a pre-determined Signal-to-Noise Ratio (SNR). The SNR will be the same for all three conditions (Power dome, Vented dome, Open dome). Percent correct will be calculated for all conditions. A higher percentage indicates better performance.
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 4 May 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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, 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?
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 4 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?
AZ Bio Sentences (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 4 May 2025.