Device for Hearing Loss

Overseen By Giulia Cuccato

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Luxottica Group S.p.A.

Disqualifiers: Children, No hearing loss, Pacemakers, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a new device helps individuals with mild to moderate hearing loss understand speech in noisy environments. Participants will assess their ability to hear words in various noisy settings and rate the listening effort required with and without the device. Ideal participants are adults with mild to moderate hearing loss in both ears who speak English as their first language. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance hearing assistance technology.

Do I need to stop taking 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 ask the trial coordinators for more details.

What prior data suggests that this device is safe for adults with mild to moderate hearing loss?

Research has shown that noise reduction features in hearing aids can help people with hearing loss understand speech better in noisy environments. A study on a new hearing aid technology found it helped individuals with severe hearing loss. Although this study focused on a different level of hearing loss, it provides insight into the potential safety and effectiveness of similar devices.

These devices are generally well-tolerated regarding safety. They assist with hearing without requiring medication or surgery, reducing the risk of side effects. However, users might occasionally experience discomfort while wearing the device or adjusting to new sounds. Overall, these devices are considered safe when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to improve hearing in noisy environments using a specialized device. Unlike traditional hearing aids that amplify all sounds, this device focuses on enhancing speech recognition in noise, which is a common challenge for those with hearing loss. The trial aims to evaluate how well users can understand speech in busy environments and how much effort it takes to listen with and without the device. By specifically targeting speech-in-noise intelligibility, this device could offer a more tailored solution for those struggling with hearing in social settings.

What evidence suggests that this device is effective for hearing loss?

This trial will evaluate a device designed to improve speech-in-noise intelligibility and reduce listening effort for individuals with hearing loss. Research has shown that hearing aids with special noise reduction features can enhance speech understanding in noisy environments. For those with hearing loss, hearing conversations in such settings can be challenging. Studies have found that these devices can reduce listening fatigue, enabling easier focus on conversations in busy settings. Using a hearing aid has been linked to improved speech recognition in various noisy situations. These benefits help individuals with hearing loss communicate more effectively in everyday life. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate hearing loss. Specific eligibility criteria are not provided, but typically participants would need to meet certain hearing thresholds and be able to complete the required tests.

Inclusion Criteria

I am 18 years old or older.

I have mild to moderate hearing loss in both ears.

I am a native English speaker.

Exclusion Criteria

Those who are not native speakers of English

Those who have pacemakers, other implantable devices, or insulin pumps

Those without hearing loss

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-lab Evaluation

Participants undergo in-lab testing for speech recognition in noise using the Matrix test and the Connected Speech Test, both with and without the device.

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any changes in hearing or device performance post-evaluation.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Evaluation of speech-in-noise intelligibility and listening effort

Trial Overview The study is testing how well a device helps people understand speech in noisy environments. It measures both the clarity of speech they can hear and how much effort it takes them to listen.

How Is the Trial Designed?

Group I: A prospective in-lab within-subjects design with repeated measures Experimental Treatment 1 Intervention

Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device.

Who Is Running the Clinical Trial?

Luxottica Group S.p.A.

Lead Sponsor

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11301946/

Influences of noise reduction on speech intelligibility ... This study aimed to evaluate the influences of a novel hearing aid NR algorithm on individuals with severe-to-profound hearing loss.

2. journals.lww.com journals.lww.com/ear-hearing/fulltext/2025/09000/relationships_between_subjective_and_objective.8.aspx

Relationships Between Subjective and Objective Measures ... Data were analyzed using Bayesian statistical methods. Results: Hearing loss and age were associated with speech-in-noise outcomes. Specifically, we ...

3. pubs.asha.org pubs.asha.org/doi/abs/10.1044/2017_AJA-16-0136

Relation Between Listening Effort and Speech Intelligibility ... Listeners with hearing impairment showed higher rated listening effort compared with listeners with normal hearing. For listeners with hearing impairment, the ...

4. arxiv.org arxiv.org/html/2405.07641v2

Evaluating Speech Enhancement Systems Through ... In this study, we propose a simple method to evaluate speech intelligibility and LE simultaneously without additional strain on subjects or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07074769

Evaluation of In-lab Benefit for Speech-in-noise ... Study Overview. Brief Summary. Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0378595516303513

Effects of noise on speech recognition: Challenges for ... Some studies suggest approximately 12 dB SNR is required for speech understanding in the presence of background noise levels ranging from 35 to 110 dB SPL ( ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352569/

Relationships Between Subjective and Objective Measures of ... Hearing loss and age were associated with speech-in-noise outcomes. Specifically, we observed lower intelligibility (objective and subjective), ...

8. audiologyonline.com audiologyonline.com/articles/beyond-speech-intelligibility-expanding-clinician-29406

Beyond Speech Intelligibility: Expanding the Clinician's ... Research shows that hearing loss affects more than just the ability to understand speech—it also impacts listening effort and fatigue (Pichora- ...