Hearing Loss, BilateralNCT07116135
Speech Understanding and Listening Effort Benefits of Hearing Instruments
A study testing hearing instruments in people with Hearing Loss, Bilateral, run by Sonova AG at 1 site in United States.
Trial summary
The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are: Does hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Hearing Loss, Bilateral
- What is being tested?
- hearing instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2025to Dec 2025
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18-95 years
- N3 or N4 hearing loss
- Experienced hearing aid user
- English fluency
- Cognitively able to complete complex listening tasks
Who cannot join
- Outside of specified age range
- Vulnerable populations
- Hearing within normal limits or otherwise not appropriate for hearing instruments under study
- Inability to read, write, or speak English
- Inability to complete complex listening tasks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of South Florida Auditory Neurosciences & Technology Lab
Tampa, Florida, 33612
Study Coordinator, 813-974-4148, ant-lab@usf.edu
About this study
Official title: Speech Understanding and Listening Effort Benefits of Infinio Sphere
The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are:
Does hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of hearing instruments to see how speech understanding and listening effort are impacted.
Participants will be asked to wearing varying hearing instruments and participate in lab-based activities to evaluate their speech understanding, listening effort, and subjective preference.
- Conditions
- Hearing Loss, Bilateral
- Being tested
- hearing instruments
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing instrumentsDevice
Also called hearing aids
Participants will be fit with three different models of hearing instruments.
| Study group | Role | What they receive |
|---|---|---|
| Hearing instrument users | Experimental | Individuals with hearing impairment will be fit with three different models of hearing instruments. They will all be fit with the same hearing instruments, although they will not be aware which model they are using at the time of testing. Receives: Device: hearing instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task
During the CRM task (Bolia et al., 2000), participants are presented with a phrase detailing the following identifiers: target, color, and digit.
They must listen for a target name and respond with the corresponding color and digit. Speech intelligibility performance is assessed based on accuracy, or percent correct across all trials conducted in a given condition.
Measured: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.
Secondary outcomes (1)
Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)
The ACALES is an adaptive measure of listening effort where the target and interfering background signals are adapted according to participant feedback. Following the target presentation, participants rate listening effort on a 14-point scale
Measured: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start5 Feb 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, BilateralStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sonova AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116135
- Sponsor's protocol ID
- SRF-22934 STUDY7873
- Status last verified
- Jan 2025
- First submitted
- 28 Jul 2025
- Last updated
- 11 Aug 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Understanding and Listening Effort Benefits of Infinio Sphere
- ClinicalTrials.gov ID
- NCT07116135
- Acronym / sponsor ID
- SRF-22934 STUDY7873
- Conditions
- Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sonova AGIndustry (pharma, biotech, devices)
- Collaborators
- University of South Florida
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Aug 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.
The goal of this clinical study is to investigate the benefits of hearing instrument use in adults with hearing loss. The main questions it aims to answer are:
Does hearing instrument use improve speech understanding and listening effort amount people with hearing loss? Researchers will compare varying models of hearing instruments to see how speech understanding and listening effort are impacted.
Participants will be asked to wearing varying hearing instruments and participate in lab-based activities to evaluate their speech understanding, listening effort, and subjective preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing instrument users | Experimental | Device: hearing instrumentsIndividuals with hearing impairment will be fit with three different models of hearing instruments. They will all be fit with the same hearing instruments, although they will not be aware which model they are using at the time of testing. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult 18-95 years
- N3 or N4 hearing loss
- Experienced hearing aid user
- English fluency
- Cognitively able to complete complex listening tasks
Key exclusion criteria (5 listed)
- Outside of specified age range
- Vulnerable populations
- Hearing within normal limits or otherwise not appropriate for hearing instruments under study
- Inability to read, write, or speak English
- Inability 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 |
|---|---|---|
| hearing instrumentsAlso: hearing aidsParticipants will be fit with three different models of hearing instruments. | Device | Hearing instrument users |
Primary outcome
Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task
Time frame: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.
During the CRM task (Bolia et al., 2000), participants are presented with a phrase detailing the following identifiers: target, color, and digit. They must listen for a target name and respond with the corresponding color and digit. Speech intelligibility performance is assessed based on accuracy, or percent correct across all trials conducted in a given condition.
1 secondary outcome
Listening Effort as assessed by the Adaptive Categorical Listening Effort Scaling (ACALES)
Time frame: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.
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 11 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hearing instruments in people with Hearing Loss, Bilateral, 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: looking for participants now, as of the sponsor's last update on 11 Aug 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?
Contact Study Coordinator (813-974-4148, ant-lab@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech intelligibility as assessed by the Coordinate Response Measure (CRM) Task (time frame: Data is collected during the second lab visit for each participant, approximately 2 weeks after study enrollment. The duration of the study visit including testing is approximately 2.5 hours.). 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 11 Aug 2025.