Open-Source Hearing Aids for Hearing Loss

(COSP-1 Trial)

Overseen By Kendra Marks, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Unstable conditions, Cognitive issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Varsha Rallapalli, Au.D, Ph.D

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with sensorineural hearing loss, who speak English as their primary language and have normal or corrected vision. They should be in good health overall. People with unstable medical conditions, cognitive impairment (scoring below 23 on a specific test), conductive hearing loss, or significant ear/neurological disorders cannot participate.

Inclusion Criteria

I have hearing loss within a specific range.

My vision is normal or corrected to normal.

I consider myself to be in good health.

Exclusion Criteria

You have a history of ear or brain disorders that are important.

I have hearing loss or problems with my middle ear.

You scored lower than 23 on a test that checks how well you can think and remember things.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are tested with the cloud-based and portable versions of the open-source hearing aid using the Modified Rhyme Test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects or feedback post-intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cloud-based OSP
• Portable OSP

Trial Overview The study is testing two versions of an open-source speech platform (OSP) designed to improve research into hearing aids: one that's portable and another that's cloud-based. The goal is to see how these platforms can support lab and field work in audiology research at Northwestern University.

How Is the Trial Designed?

Group I: Portable OSP Experimental Treatment 1 Intervention

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

Group II: Cloud-based OSP Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Nadi, LLC

Collaborator

Trials

1

Recruited

10+

Nadi LLC

Industry Sponsor

Trials

1

Recruited

10+