Hearing Aids for Hearing Loss

Overseen By Research Audiologist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Normal hearing, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how different features of hearing aids (also known as hearing instruments) perform in various environments for adults with hearing loss. The study will explore which features users prefer during their daily activities. Participants will wear hearing aids and provide feedback through questionnaires. It suits adults with N4 hearing loss who have previously used hearing aids. As an unphased trial, this study allows participants to contribute to the development of more effective hearing aids tailored to real-world needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on hearing aids, so it's unlikely to require changes to your medication, but you should confirm with the study team.

What prior data suggests that these hearing instruments are safe for users?

Research has shown that hearing aids are generally safe for use. They have been available for a long time and assist many people with hearing loss. The FDA states that these devices are designed to be safe and effective.

It is important to know that hearing aids do not harm hearing over time. One study examined their long-term effects and found they do not worsen hearing loss. This indicates that most people can use hearing aids without issues. There are no major reports of negative effects solely from their use.

Overall, hearing aids are a safe choice for those needing assistance in hearing better in various situations. Participants in this study will wear hearing aids in their daily lives, a common method to evaluate how these devices function in real-world settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these hearing instruments because they aim to provide a more personalized listening experience for individuals with hearing loss. Unlike traditional hearing aids, which often use a one-size-fits-all approach, these new instruments focus on adapting to the user's specific environment and personal preferences. By gathering detailed feedback through user questionnaires, these devices may offer improved sound quality and comfort, potentially leading to a more satisfying and effective hearing experience.

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

Studies have shown that hearing aids can significantly improve the lives of people with hearing loss. They help users communicate more easily and boost social and emotional well-being. Research suggests that regularly using hearing aids might even lower the risk of early death by 24% compared to those who don't use them. While hearing aids don't completely restore normal hearing, they effectively reduce the negative effects of hearing loss. This effectiveness makes them a popular first-choice treatment for many with hearing difficulties. Participants in this trial will wear hearing instruments and provide feedback on their experiences. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-95 with N4 hearing loss who have used hearing aids before and can speak, read, and write English fluently. They should be able to complete complex listening tasks without cognitive impairments. People with normal hearing or outside the specified range, no experience with hearing aids, or any condition that affects study participation are excluded.

Inclusion Criteria

Experienced hearing aid user

English fluency

I have severe hearing loss.

Exclusion Criteria

No hearing aid experience

Unable to speak, read, or write English fluently

Cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are fit with hearing instruments and wear them in their home environment

6 weeks

Initial fitting visit (in-person), ongoing home use

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Instrument

Trial Overview

The trial is testing how different features of a new hearing instrument perform in various environments. Adults with hearing loss will use these instruments at home and provide feedback through questionnaires about their preferences and the performance of the device's features.

How Is the Trial Designed?

Group I: Hearing Aid Users Experimental Treatment 1 Intervention

Participants will wear hearing instruments for the duration of the study period. They will be asked to complete questionnaires about their environment and experience.

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

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions - NCBI - NIH

Sound localization of listeners with normal hearing, impaired hearing, hearing aids, bone-anchored hearing instruments, and cochlear implants: A review.

2.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/2833823

Hearing Aid Service Models, Technology, and Patient ...

Hearing aids (HAs) can improve communication ability, quality of life, and social and emotional function and may potentially reduce cognitive ...

3.

news.keckmedicine.org

news.keckmedicine.org/hearing-aids-may-help-people-live-longer/

Hearing aids may help people live longer

We found that adults with hearing loss who regularly used hearing aids had a 24% lower risk of mortality than those who never wore them.

4.

thelancet.com

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

Association between hearing aid use and mortality in ...

Hearing aids are a first-line intervention for most individuals with hearing loss and their use has been shown to improve perceived disability ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165032724010176

Association between the hearing aid and mental health ...

While hearing aids do not fully restore normal auditory function or address the underlying causes of hearing loss, they significantly aid in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11150995/

Deterioration of Hearing Due to Hearing Aids - PMC

This study examined the long-term effects of HAs on standard audiometric changes in individuals with sensorineural hearing loss.

7.

cdc.gov

cdc.gov/niosh/noise/about/noise.html

Noise-Induced Hearing Loss

Workers who are exposed to noise at or above the NIOSH REL are at risk of developing significant hearing loss over their working lifetime.

8.

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).

9.

fda.gov

fda.gov/medical-devices/consumer-products/hearing-aids

Hearing Aids

This site provides general information on hearing aids including benefit and safety information, types and styles, how to get and buy a ...

10.

hopkinsmedicine.org

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

The Hidden Risks of Hearing Loss

In a study that tracked 639 adults for nearly 12 years, Johns Hopkins experts found that mild hearing loss doubled dementia risk. Moderate loss tripled risk, ...