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Open-Source Hearing Aids for Hearing Loss (COSP-1 Trial)

N/A
Waitlist Available
Led By Varsha H Rallapalli, AuD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sensorineural hearing loss with pure-tone thresholds between 25-85 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz
Normal or corrected-to-normal vision
Must not have
Evidence of conductive hearing loss or middle ear issues
Clinically significant unstable or progressive medical conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-intervention (1 day)
Awards & highlights
No Placebo-Only Group

Summary

This trial seeks to bridge the gap between commercial hearing aids and research, creating an open-source platform. It will be evaluated to enable lab and field applications, and all activities will take place at Northwestern University.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-invasive technology rather than medication, traditional side effects are not expected. However, participants may experience discomfort from wearing the device or fatigue during testing procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have hearing loss within a specific range.
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My vision is normal or corrected to normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have hearing loss or problems with my middle ear.
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I do not have any worsening or serious health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-intervention (1 day)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-intervention (1 day) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Word-identification ability
Secondary study objectives
Phoneme confusions
Response time

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Portable OSPExperimental Treatment1 Intervention
Outcomes will be assessed with the portable version of the OSP.
Group II: Cloud-based OSPExperimental Treatment1 Intervention
Outcomes will be assessed with the cloud-based version of the OSP.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,649 Previous Clinical Trials
958,741 Total Patients Enrolled
Nadi, LLCUNKNOWN
Varsha H Rallapalli, AuD, PhDPrincipal InvestigatorNorthwestern University
~1 spots leftby Feb 2025
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