Open-source Hearing Aid Platform Comparisons (COSP-1)

Northwestern University

Status: Terminated

Conditions: Hearing Loss; Hearing Loss, Sensorineural

Treatments: Device: Cloud-based OSP; Device: Portable OSP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05693610

Pro00062688

Details and patient eligibility

About

New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source speech platform (OSP) was developed to bridge the gap between audiology research and commercial hearing aid features, to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. All human subjects-related activities will be conducted at Northwestern University (single-site study).

Full description

New discoveries for hearing loss intervention are often impeded by the proprietary nature of commercial hearing aids and their use in scientific research as "black boxes". An open-source hearing aid (open-source speech platform or OSP) was developed to bridge the gap between audiology research and the commercialization of hearing aid technologies and to promote innovative solutions to meet the needs of the hearing loss community. The OSP can replicate functions found in commercial hearing aids, and provides tools to researchers and listeners to access those functions. The purpose of this study is to evaluate portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications by measuring speech perception abilities with the open-source hearing aid in quiet and in noise for adults with and without hearing loss.

The study is a within-subjects design that allows for the comparison of outcomes within the same participant. The study will compare performance with two platforms of the open-source hearing aid (portable and cloud-based) for adults with hearing loss and normal hearing. The study will measure performance using tests of word identification. We will test aided performance with clinically validated hearing aid settings in quiet and in noise. Each participant will be presented with all the test conditions, and the order of presentation of the test conditions will be randomized across participants. Statistical analyses will use a repeated measures model to control for correlation between outcomes for the same participant.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• >= 18 years of age; any sex
• Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
• Speak English as their primary language
• Normal or corrected-to-normal vision
• Participants will be in good health (self-report)

Exclusion criteria

• Clinically significant unstable or progressive medical conditions
• Participants who score < 23 on the cognitive screening test (Montreal Cognitive Assessment)
• Evidence of conductive hearing loss or middle ear issues
• Significant history of otologic or neurologic disorders
• Non English-speaking or non-native English speaking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Portable OSP

Experimental group

Description:

Outcomes will be assessed with the portable version of the OSP.

Treatment:

Device: Portable OSP

Cloud-based OSP

Experimental group

Description:

Outcomes will be assessed with the cloud-based version of the OSP.

Treatment:

Device: Cloud-based OSP