Hearing LossNCT06792110
Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss
A study testing Artificial Intelligence Integrated Hearing Aid Use, Phonak Infineo Hearing Aid and Oticon Real Hearing Aid in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Washington.
Trial summary
The goal of this clinical trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are: 1. How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural
- What is being tested?
- Artificial Intelligence Integrated Hearing Aid Use, Phonak Infineo Hearing Aid and Oticon Real Hearing Aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum Age of 18 yo
- Bilateral sensorineural hearing loss amenable to hearing aids
- Able to give informed consent
- Native English speaker
- Able to wear a standard pair of hearing aids
Who cannot join
- Unable to participate in informed consent
- Use of a cochlear implant
- Hearing loss not amenable to hearing aid use
- Conductive hearing loss
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are:
- How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise.
- How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.
Read the detailed description
Hearing loss is a leading cause of disability globally. Undertreated hearing loss has been associated with several deleterious sequelae, including social isolation, decreased quality of life, and cognitive decline. For a large portion of individuals with hearing loss, hearing aids remain the intervention of choice for improving communication, decreasing social isolation, and enhancing quality of life. Yet, less than 20% of hearing aid candidates choose to use them2. This is partly due to a perceived lack of benefit from hearing aids. Individuals who use hearing aids continue to report difficulty with speech perception in noisy environments with multiple speakers, such as parties, restaurants, and other complex auditory settings.
The investigators have developed a neural network that runs on-device to achieve real-time target speech hearing in realistic multi-talker environments. Using our neural network, the wearer can focus on speech from a target speaker by learning their unique speech cues while ignoring all interfering speech and noise in complex acoustic environments. The wearer is additionally able to use distance to separate sounds from the environment from target sounds to be amplified. Finally the wearer is also able to specificy categories of sound that will be amplified in environment.
This study will prospectively study a hearing aid implementing these algorithms on individuals with hearing loss. Participants will be randomized to utilizing one of two commercial hearing aids vs the experimental device. Participants will participate in listening tests in which they must identify the words spoken by a specific voice in multi-talker babble noise. The investigators will measure performance with the primary and secondary outcome measures listed elsewhere.
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural
- Being tested
- Artificial Intelligence Integrated Hearing Aid Use, Phonak Infineo Hearing Aid, Oticon Real Hearing Aid
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence Integrated Hearing Aid UseDevice
Participants in this arm will use the study-designed artificial intelligence-integrated hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.
Phonak Infineo Hearing AidDevice
Participants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.
Oticon Real Hearing AidDevice
Participants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls.
| Study group | Role | What they receive |
|---|---|---|
| Oticon Hearing Aid vs Experimental Hearing Aid | Experimental | Participants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks. Receives: Device: Artificial Intelligence Integrated Hearing Aid Use; Device: Phonak Infineo Hearing Aid |
| Phonak Hearing Aid vs Experimental Hearing Aids | Experimental | Participants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks. Receives: Device: Artificial Intelligence Integrated Hearing Aid Use; Device: Oticon Real Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Reception Threshold
A measurement of difference in average speech reception threshold across all groups
Measured: From enrollment in the study until completion of a one day listening test experiment.
Awareness of Environmental Marker
During certain listening tasks, an environmental sound of concern (e.g. a siren, or alarm) will be played while the participant is tasked with identifying speech. Awareness of these sounds will be tested by reaction time to the sound and identification of the sound.
Measured: From enrollment in the study until completion of a one day listening test experiment.
Secondary outcomes (2)
Preference Scores
Mean opinion scores about which device is preferred
Measured: From enrollment in the study until completion of a one day listening test experiment.
Sound quality
Mean opinion scores about subjective sound quality of respective devices
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion1 Jul 2026 (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.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to groups for each hearing aid device being tested (e.g. commercial model 1, 2, vs study device)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gavriel Kohlberg, University of Washington
- Investigators
- Gavriel Kohlberg, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792110
- Sponsor's protocol ID
- STUDY00018443
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There will be no IPD shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss
- ClinicalTrials.gov ID
- NCT06792110
- Acronym / sponsor ID
- STUDY00018443
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Jan 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 trial will be to evaluate the efficacy of artificial intelligence-integrated hearing aids in individuals with hearing loss. The main questions to answer are:
- How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise.
- How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.
Detailed description
Hearing loss is a leading cause of disability globally. Undertreated hearing loss has been associated with several deleterious sequelae, including social isolation, decreased quality of life, and cognitive decline. For a large portion of individuals with hearing loss, hearing aids remain the intervention of choice for improving communication, decreasing social isolation, and enhancing quality of life. Yet, less than 20% of hearing aid candidates choose to use them2. This is partly due to a perceived lack of benefit from hearing aids. Individuals who use hearing aids continue to report difficulty with speech perception in noisy environments with multiple speakers, such as parties, restaurants, and other complex auditory settings.
The investigators have developed a neural network that runs on-device to achieve real-time target speech hearing in realistic multi-talker environments. Using our neural network, the wearer can focus on speech from a target speaker by learning their unique speech cues while ignoring all interfering speech and noise in complex acoustic environments. The wearer is additionally able to use distance to separate sounds from the environment from target sounds to be amplified. Finally the wearer is also able to specificy categories of sound that will be amplified in environment.
This study will prospectively study a hearing aid implementing these algorithms on individuals with hearing loss. Participants will be randomized to utilizing one of two commercial hearing aids vs the experimental device. Participants will participate in listening tests in which they must identify the words spoken by a specific voice in multi-talker babble noise. The investigators will measure performance with the primary and secondary outcome measures listed elsewhere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to groups for each hearing aid device being tested (e.g. commercial model 1, 2, vs study device)
| Arm | Type | Receives |
|---|---|---|
| Oticon Hearing Aid vs Experimental Hearing Aid | Experimental | Device: Artificial Intelligence Integrated Hearing Aid Use, Device: Phonak Infineo Hearing AidParticipants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks. |
| Phonak Hearing Aid vs Experimental Hearing Aids | Experimental | Device: Artificial Intelligence Integrated Hearing Aid Use, Device: Oticon Real Hearing AidParticipants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Minimum Age of 18 yo
- Bilateral sensorineural hearing loss amenable to hearing aids
- Able to give informed consent
- Native English speaker
- Able to wear a standard pair of hearing aids
Key exclusion criteria (4 listed)
- Unable to participate in informed consent
- Use of a cochlear implant
- Hearing loss not amenable to hearing aid use
- Conductive hearing loss
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 |
|---|---|---|
| Artificial Intelligence Integrated Hearing Aid UseParticipants in this arm will use the study-designed artificial intelligence-integrated hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls. | Device | Oticon Hearing Aid vs Experimental Hearing Aid, Phonak Hearing Aid vs Experimental Hearing Aids |
| Phonak Infineo Hearing AidParticipants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls. | Device | Oticon Hearing Aid vs Experimental Hearing Aid |
| Oticon Real Hearing AidParticipants in this arm will use a fitted commercial hearing aid in the listening tasks. Participants will also perform the listening tasks without hearing aids to act as controls. | Device | Phonak Hearing Aid vs Experimental Hearing Aids |
Primary outcome
Speech Reception Threshold
Time frame: From enrollment in the study until completion of a one day listening test experiment.
A measurement of difference in average speech reception threshold across all groups
Awareness of Environmental Marker
Time frame: From enrollment in the study until completion of a one day listening test experiment.
During certain listening tasks, an environmental sound of concern (e.g. a siren, or alarm) will be played while the participant is tasked with identifying speech. Awareness of these sounds will be tested by reaction time to the sound and identification of the sound.
2 secondary outcomes
Preference Scores
Time frame: From enrollment in the study until completion of a one day listening test experiment.
Sound quality
Time frame: 5 minutes
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 24 Jan 2025.
- Individual participant dataSharing planned: No. There will be no IPD shared with other researchers.
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Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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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.
Gavriel Kohlberg, MD principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Integrated Hearing Aid Use, Phonak Infineo Hearing Aid and Oticon Real Hearing Aid in people with Hearing Loss and Hearing Loss, Sensorineural, run by University of Washington.
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 4 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: opening soon, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Arun Raghavan, MD (206-616-2598, amraghav@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Reception Threshold (time frame: From enrollment in the study until completion of a one day listening test experiment.). 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 24 Jan 2025.