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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new open-source hearing aid technology to assist people with hearing loss. Researchers aim to evaluate the effectiveness of these devices, which operate via a cloud-based system (Cloud-based OSP) or a portable setup (Portable OSP), in various settings. The goal is to make hearing aids more accessible and customizable. Suitable candidates for this trial include adults with sensorineural hearing loss (a common type affecting the inner ear) who can communicate easily in English. As an unphased trial, participants can contribute to innovative research that may improve hearing aid accessibility and customization.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this open-source speech platform is safe for hearing loss intervention?

Research shows that the Open Speech Platform (OSP) is as safe as regular hearing aids. Tests on the cloud-based OSP demonstrate performance comparable to standard hearing aids, suggesting it is likely well-tolerated by users.

For the portable OSP, studies indicate that similar over-the-counter hearing aids for mild to moderate hearing loss have been safe and easy to use. This suggests the portable OSP should also be safe for users. However, prolonged use of portable listening devices can sometimes increase the risk of hearing damage.

Overall, research supports that both the cloud-based and portable OSPs are likely as safe as other hearing aids on the market. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the open-source hearing aids for hearing loss because they offer innovative features compared to traditional hearing aids. Unlike standard options that rely on proprietary technology, these new hearing aids use open-source software, potentially leading to more affordable and customizable solutions. The cloud-based OSP allows users to adjust settings remotely, providing convenience and flexibility. The portable OSP version offers on-the-go adaptability, making it ideal for active users who need real-time adjustments. These advancements could revolutionize how people manage their hearing loss, making technology more accessible and personalized.

What evidence suggests that this trial's platforms could be effective for hearing loss?

This trial will compare two versions of the Open Speech Platform (OSP) for hearing loss: the cloud-based OSP and the portable OSP. Research has shown that the OSP can function like commercial hearing aids. Studies indicate that both the cloud-based and portable versions of OSP improve hearing. The cloud-based OSP has successfully helped people with severe hearing loss understand speech from a distance. Meanwhile, the portable OSP is praised for its user-friendly design, offering flexibility and ease of use in wearable hearing aids. Both versions promise to make advanced hearing aid features more accessible and customizable for users. ^{1 2 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05693610

NCT05693610 | Open-source Hearing Aid Platform Comparisons Experimental : Cloud-based OSP. Outcomes will be assessed with the cloud-based version of the OSP. Intervention/Treatment, Device : Cloud-based OSP. The cloud ...

2. pubs.aip.org pubs.aip.org/asa/jasa/article/153/3_supplement/A47/2885362/Comparing-outcomes-with-the-cloud-based-and?searchresult=1

Comparing outcomes with the cloud-based and portable ... This study evaluates portable and cloud-based platforms of the OSP that will enable a wide range of lab and field applications. The two platforms share common ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8900986/

Open Speech Platform: Democratizing Hearing Aid Research We evaluate the performance of OSP regarding both its hardware and software, as well as demonstrate its usefulness via a self-fitting study involving human ...

4. ctv.veeva.com ctv.veeva.com/study/open-source-hearing-aid-platform-comparisons

Open-source Hearing Aid Platform Comparisons 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 ...

5. researchgate.net researchgate.net/publication/370313313_Comparing_outcomes_with_the_cloud-based_and_portable_versions_of_an_open-source_hearing_aid

Comparing outcomes with the cloud-based and portable ... Purpose This study investigated the effects of a soft speech enhancement algorithm on distant speech perception for adults with severe-to-profound hearing loss ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11273188/

Digital Therapeutics in Hearing Healthcare: Evidence- ... Digital therapeutics (DTx) in hearing research have emerged as a new category of therapies providing evidence-based intervention via digital means.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949916X24000860

Artificial intelligence for hearing loss prevention, diagnosis, ... This paper explores the transformative impact of artificial intelligence (AI), particularly machine learning (ML), on diagnosing and treating hearing loss.

8. ui.adsabs.harvard.edu ui.adsabs.harvard.edu/abs/2023ASAJ..153A..47R/abstract

Comparing outcomes with the cloud-based and portable ... The cloud-based platform is hosted on a web server whereas the portable platform is accessed on a browser via a WiFi-enabled portable communication device.