Personalized Hearing Aid Settings for Hearing Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if hearing aids adjusted to fit a person’s unique listening habits improve speech comprehension more than standard settings. Researchers will test two hearing aid settings: one tailored to personal listening habits and one that is not. Participants with sensorineural hearing loss, a common type of permanent hearing loss, will compare these settings by listening to and repeating sentences in a noisy environment. As an unphased study, this trial allows participants to contribute to innovative research that could enhance personalized hearing aid technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these hearing aid settings are safe for use?

Research has shown that personalized hearing aid settings are generally safe. Although specific safety data for these settings is lacking, the technology appears promising. These personalized settings are part of digital therapeutics, which use proven methods to enhance hearing. Studies indicate that many individuals with mild to moderate hearing loss prefer these personalized settings over standard ones, suggesting they are well-tolerated.

As this is neither a medication nor a surgery, it likely poses low risk. Personalized hearing aid settings aim to improve hearing without causing harm, making them a safe choice for those considering this option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these personalized hearing aid settings because they go beyond the traditional approach of programming hearing aids based solely on pure-tone thresholds. Unlike standard hearing aids, which provide a general setting based on hearing tests, these customized settings are tailored to match the individual listening strategies of the user. This means that users may experience improved sound clarity and comfort in various listening environments. By focusing on personal listening preferences, this approach has the potential to significantly enhance the overall hearing experience and satisfaction for individuals with hearing loss.

What evidence suggests that customized hearing aid settings are effective for better speech understanding?

Research has shown that customizing hearing aid settings can help people with hearing loss understand speech better. In this trial, participants will experience two different approaches: one group will first use hearing aid settings customized to match their listening strategy, while the other group will start with general settings based on pure-tone thresholds. Studies have found that hearing aids adjusted by users themselves can work just as well as those set by professionals. Additionally, new technologies can use data to suggest personalized settings, enhancing the effectiveness of hearing aids. People using advanced hearing aids often notice better results than those with basic models. This evidence suggests that adjusting hearing aid settings to fit individual needs can greatly improve understanding of speech in noisy environments. ^{3 6 7 8 9}

Who Is on the Research Team?

Pamela Souza, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals with sensorineural hearing loss who are interested in testing whether customized hearing aid settings improve speech understanding. Participants must be willing to visit a lab, wear hearing aids, and perform listening tasks. Specific eligibility criteria were not provided.

Inclusion Criteria

I have hearing loss that is not due to earwax or an ear infection.

Exclusion Criteria

Montreal Cognitive Assessment < 23 points

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear hearing aids and listen to sentences in noise with two different settings during a 2-hour lab visit

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any feedback or additional assessments post-intervention

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Customized Hearing Aid Settings

Trial Overview The study tests if personalized hearing aid settings based on individual listening strategies provide better speech comprehension than standard settings based only on an audiogram. It involves comparing the effectiveness of these two approaches during a laboratory visit.

How Is the Trial Designed?

Group I: Customized to match listening strategy First Active Control 2 Interventions

Participants in this arm will listen to hearing aid settings programmed to match their listening strategy first, then the general setting

Group II: Not customized to match listening strategy First Active Control 2 Interventions

Participants will listen to hearing aid settings based only on their pure-tone thresholds first (general hearing aid settings), then ones programmed to match their listening strategies.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A study analyzing adverse event reports for cochlear implants found that most incidents involved patient injury (16,736 cases) and device malfunction (10,760 cases), highlighting areas for potential safety improvements.

Using machine learning algorithms, researchers achieved high prediction accuracy (up to 88.6%) in identifying the cochlear implant manufacturer and type of adverse event based on the descriptions, suggesting that data analysis can enhance understanding of device performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. Crowson, MG., Hamour, A., Lin, V., et al.[2021]

A study of 56 participants with mild sensorineural hearing loss showed that advanced digital technology (ADT) hearing aids significantly improved user satisfaction and outcomes, with users wearing them for an average of 10.5 hours per day.

Despite achieving good overall satisfaction and self-efficacy, users reported challenges with managing background noise and advanced device handling, highlighting the need for ongoing support from hearing health care providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. Johnson, CE., Jilla, AM., Danhauer, JL., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12082484/

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.

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

Artificial intelligence for hearing loss prevention, diagnosis, ... ML algorithms can analyze data from tele-audiology tools to provide personalized recommendations for hearing aid settings and other treatments, ...

3. frontiersin.org frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2024.1397604/full

Evaluation of outcomes in a clinical trial: comparing self-fit ... The study aimed to determine whether a self-fitting algorithm for hearing aids could produce outcomes comparable to those achieved with professionally fitted ...

4. 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 ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2024_JSLHR-24-00423

A Multisite Randomized Controlled Trial Comparing the ... These RCTs have further demonstrated that adults can self-fit hearing aids and achieve outcomes comparable to those attained with audiology best practices. The ...

6. withpower.com withpower.com/trial/phase-hearing-loss-sensorineural-3-2025-97363

Personalized Hearing Aid Settings for Hearing Loss Is it safe to use personalized hearing aid settings for hearing loss? The research does not provide specific safety data for personalized hearing aid settings ...

7. 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.

8. mdpi.com mdpi.com/1424-8220/24/5/1546

A Review of Machine Learning Approaches for the ... The results demonstrated that participants with mild to moderate hearing loss preferred the personalized DSLv5 settings over the reference DSLv ...

9. humanfactors.jmir.org humanfactors.jmir.org/2025/1/e65142/PDF

Evaluating the Safety and Usability of an Over-the-Counter ... Hearing loss is associated with an increased risk for falls [3] and may lead to cognitive decline [4] and dementia [5]. Yet, only 1 in 3 older ...