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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence Integrated Hearing Aid Use | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Threshold | A measurement of difference in average speech reception threshold across all groups | 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. | From enrollment in the study until completion of a one day listening test experiment. |
| Measure | Description | Time Frame |
|---|---|---|
| Preference Scores | Mean opinion scores about which device is preferred | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arun Raghavan, MD | Contact | 206-616-2598 | amraghav@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gavriel Kohlberg, MD | University of Washington | Principal Investigator |
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There will be no IPD shared with other researchers.
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Participants will be randomly assigned to groups for each hearing aid device being tested (e.g. commercial model 1, 2, vs study device)
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No masking will be performed
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| Phonak Infineo Hearing Aid | Device | 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 Aid | Device | 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. |
|
| 5 minutes |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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