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

NCT06792110 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00018443
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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. 1.How effective is an artificial intelligence integrated hearing aid in improving speech perception in noise.
2. 2.How does an artificial intelligence integrated hearing aid compare to currently available commercial hearing aids.

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• Preference Scores

  From enrollment in the study until completion of a one day listening test experiment.

• Sound quality

  5 minutes

Study Arms (2)

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.

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.

Device: Artificial Intelligence Integrated Hearing Aid Use; Device: Oticon Real Hearing Aid

Interventions

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.

Oticon Hearing Aid vs Experimental Hearing Aid; Phonak Hearing Aid vs Experimental Hearing Aids

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 Hearing Aid vs Experimental Hearing Aid

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.

Phonak Hearing Aid vs Experimental Hearing Aids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to participate in informed consent
• Use of a cochlear implant
• Hearing loss not amenable to hearing aid use
• Conductive hearing loss

Sponsors & Collaborators

• University of Washington: lead

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavriel Kohlberg, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arun Raghavan, MD

CONTACT

206-616-2598; amraghav@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Model Details: Participants will be randomly assigned to groups for each hearing aid device being tested (e.g. commercial model 1, 2, vs study device)

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 24, 2025
• Study Start: February 1, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share