Hearing Instruments for Hearing Loss

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Normal hearing, Vulnerable populations, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different hearing aids can improve speech understanding and reduce listening effort for individuals with hearing loss. Researchers aim to determine if certain hearing aids perform better than others. Participants will try three different hearing aid models and engage in lab activities to assess their speech comprehension and listening ease. Individuals with significant hearing loss (N3 or N4) who already use hearing aids may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance hearing aid technology for future users.

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.

What prior data suggests that these hearing instruments are safe for use in adults with hearing loss?

Research shows that hearing aids are generally safe for people with hearing loss. Studies have found that older adults using hearing aids often communicate better and express high satisfaction with their devices, indicating that hearing aids are usually well-accepted.

Major reports of problems directly caused by these devices have not emerged. This likely results from the non-invasive nature of hearing aids, as they do not involve surgery or enter the body. They simply amplify sounds, aiding in speech comprehension and making listening easier, without any known serious health risks.

For those considering joining a trial for hearing aids, current research suggests they are safe and can significantly improve hearing and communication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these hearing instruments because they aim to offer a more personalized and effective solution for individuals with hearing loss. Unlike traditional hearing aids, which often rely on a one-size-fits-all approach, this trial is exploring three different models of hearing instruments to tailor the experience to individual needs. By testing these models without users knowing which one they're using, the goal is to identify subtle differences in performance that could enhance user satisfaction and auditory outcomes. This approach could lead to more precise fitting and better hearing experiences for those with hearing impairments.

What evidence suggests that hearing instruments are effective for hearing loss?

Studies have shown that hearing aids can greatly enhance communication for people with hearing loss. Research indicates that the methods of providing hearing aids and the technology used can influence their effectiveness, with some options yielding better results. One study found that regular hearing aid users tend to live longer than non-users. Additionally, users report greater satisfaction and improved hearing with hearing aids. Overall, hearing aids help people hear and communicate more effectively in their daily lives. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with bilateral hearing loss are eligible for this trial. They will test different hearing instruments to see if they help understand speech better and reduce the effort needed to listen. Participants must be willing to wear various models and engage in lab activities.

Inclusion Criteria

Experienced hearing aid user

English fluency

I have severe to profound hearing loss.

Exclusion Criteria

I am not within the specified age range for the trial.

Hearing within normal limits or otherwise not appropriate for hearing instruments under study

I struggle with understanding complex instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants are fitted with varying models of hearing instruments and participate in lab-based activities to evaluate speech understanding, listening effort, and subjective preference

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Instruments

Trial Overview The study is testing how well different hearing instruments improve speech understanding and listening effort in adults with hearing loss. It involves wearing these devices during lab tasks that measure their effectiveness.

How Is the Trial Designed?

Group I: Hearing instrument users Experimental Treatment 1 Intervention

Individuals with hearing impairment will be fit with three different models of hearing instruments. They will all be fit with the same hearing instruments, although they will not be aware which model they are using at the time of testing.

Who Is Running the Clinical Trial?

Sonova AG

Lead Sponsor

Trials

84

Recruited

2,000+

Arnd Kaldowski

Sonova AG

Chief Executive Officer since 2018

MBA from INSEAD, MSc in Mechanical Engineering from ETH Zurich

Stefan Launer

Sonova AG

Chief Medical Officer since 2016

PhD in Natural Sciences from ETH Zurich

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4925253/

Impact of Hearing Aid Technology on Outcomes in Daily Life I This research was designed to explore reported differences in hearing abilities for adults using premium-feature and basic-feature hearing aids in their daily ...

2. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2833823

Hearing Aid Service Models, Technology, and Patient ... The trial results suggest that while the lower-cost OTC service models are effective, the best outcomes were achieved with the best practice service model.

3. thelancet.com thelancet.com/journals/lanhl/article/PIIS2666-7568(23)00232-5/fulltext

Association between hearing aid use and mortality in ... Regular hearing aid use was associated with lower risks of mortality than in never users in US adults with hearing loss when accounting for age, hearing loss, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925000598

Effects on health outcomes following a nurse-led hearing ... Conclusions. Significant improvements were seen in communication abilities and hearing aid satisfaction for older adults in the intervention group after ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2022_AJA-22-00130

Comparing Hearing Aid Outcomes in Adults Using Over- ... This study compared hearing aid outcomes reported by clients from OTC and conventional hearing care professional (HCP) service delivery models.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7586498/

Characteristics and Health Outcomes Associated With ... This study recruited older adults to explore physical and psychosocial conditions and other health outcomes associated with hearing loss (HL) and hearing aid ...

7. who.int who.int/news-room/fact-sheets/detail/deafness-and-hearing-loss

Deafness and hearing loss Over 5% of the world's population – or 430 million people – require rehabilitation to address their disabling hearing loss (including 34 million children).

8. hopkinsmedicine.org hopkinsmedicine.org/health/wellness-and-prevention/the-hidden-risks-of-hearing-loss

The Hidden Risks of Hearing Loss Moderate loss tripled risk, and people with a severe hearing impairment were five times more likely to develop dementia.

9. research.va.gov research.va.gov/topics/hearing.cfm

Hearing Loss Early results found that the prevalence of hearing loss in the sample was 8% for low frequencies (0.25 to 2 kHz), 20% for high frequencies (3 to 8 kHz), and 39% ...