Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arun Raghavan, MD
- Phone Number: 206-616-2598
- Email: amraghav@uw.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to participate in informed consent
- Use of a cochlear implant
- Hearing loss not amenable to hearing aid use
- Conductive hearing loss
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oticon Hearing Aid vs Experimental Hearing Aid
Participants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks.
|
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.
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.
|
|
Experimental: Phonak Hearing Aid vs Experimental Hearing Aids
Participants will use both one hearing aid model that is commercial and the experimental hearing aid on listening tasks.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment in the study until completion of a one day listening test experiment.
|
|
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.
|
From enrollment in the study until completion of a one day listening test experiment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preference Scores
Time Frame: From enrollment in the study until completion of a one day listening test experiment.
|
Mean opinion scores about which device is preferred
|
From enrollment in the study until completion of a one day listening test experiment.
|
|
Sound quality
Time Frame: 5 minutes
|
Mean opinion scores about subjective sound quality of respective devices
|
5 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gavriel Kohlberg, MD, University of Washington
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00018443
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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