Evaluation of Artificial Intelligence-Integrated Hearing Aids for Individuals with Hearing Loss

NCT ID: NCT06792110

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-07-01

Brief 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. 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.

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Artificial Intelligence Integrated Hearing Aid Use

Intervention Type: 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.

Phonak Infineo Hearing Aid

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Artificial Intelligence Integrated Hearing Aid Use

Intervention Type: 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.

Oticon Real Hearing Aid

Intervention Type: 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.

Interventions

Artificial Intelligence Integrated Hearing Aid Use

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.

Intervention Type: DEVICE

Phonak Infineo Hearing Aid

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.

Intervention Type: DEVICE

Oticon Real Hearing Aid

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Gavriel Kohlberg

Assistant Professor, School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gavriel Kohlberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

Arun Raghavan, MD

Role: CONTACT

amraghav@uw.edu

206-616-2598

Other Identifiers

STUDY00018443

Identifier Type: -

Identifier Source: org_study_id