Over-the-Counter Hearing Aids for Sensorineural Hearing Loss

Recruiting at 1 trial location

Overseen By Lipika Sarangi, Doctor of Philosophy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Outer or middle ear pathologies

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether self-efficacy-based auditory rehabilitation (SEBAR) can boost confidence and satisfaction in using over-the-counter (OTC) hearing aids. It seeks to determine if this method improves users' willingness to try these aids and enhances their overall quality of life and emotional well-being. Participants will wear OTC hearing aids and provide feedback through questionnaires and an app. This trial targets individuals who developed mild-to-moderate hearing loss as adults, have no prior experience with hearing aids, and speak English as their first language. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve the accessibility and effectiveness of hearing aids for many.

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 the SEBAR process is safe for participants?

Research shows that self-efficacy-based auditory rehabilitation (SEBAR) is generally safe. Although specific data on side effects is unavailable, SEBAR focuses on boosting confidence and helping individuals manage over-the-counter hearing aids. This approach emphasizes support and education rather than new drugs or risky procedures.

The over-the-counter hearing aids used in this study have received approval from organizations like the FDA, indicating they have passed safety checks for public use. Users of these devices have not reported major safety issues.

Overall, both SEBAR and the hearing aids are expected to be well-tolerated based on current knowledge. For personalized information, discussing any concerns with the trial team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about self-efficacy-based auditory rehabilitation (SEBAR) for sensorineural hearing loss because it empowers patients to take control of their hearing health. Unlike traditional hearing aids that focus solely on amplifying sound, SEBAR emphasizes building users' confidence and skills in managing their hearing devices. This approach could lead to better long-term outcomes as individuals become more adept at using and adjusting their over-the-counter hearing aids. Additionally, SEBAR is designed to be easily accessible and user-friendly, potentially making it a game-changer for people who might otherwise struggle with standard hearing aids.

What evidence suggests that the SEBAR process is effective for improving confidence and success with OTC hearing aids?

Research has shown that self-efficacy-based auditory rehabilitation (SEBAR), which participants in this trial will receive, might help people feel more confident using over-the-counter (OTC) hearing aids. This method aims to boost users' belief in their ability to manage and benefit from their hearing aids. Early results suggest that SEBAR could increase willingness to use OTC hearing aids, enhance satisfaction, and improve quality of life. It might also positively impact emotional well-being. Although hard data remains limited, this approach appears promising for making hearing aid use more effective and satisfying. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with adult-onset, bilateral mild-to-moderate sensorineural hearing loss who have never used hearing aids and speak English as their first language. They should be in good health and have stable hearing loss with similar levels in both ears.

Inclusion Criteria

No previous experience with hearing aids

English as their first language with good self-reported health

I have adult-onset hearing loss that is mild to moderate and similar in both ears.

Exclusion Criteria

My gender or race/ethnicity does not affect my eligibility.

I have had ear problems affecting the outer or middle ear.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline Assessment

Participants complete unaided baseline outcome measures and receive SEBAR and OTC hearing aids

1 day

1 visit (in-person)

Treatment

Participants wear OTC hearing aids and use the SEBAR for at least 4 hours daily for one week

1 week

Home use with app monitoring

Follow-up Assessment

Participants return for a second appointment to complete outcome measures with OTC hearing aids

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Self-efficacy-based Auditory Rehabilitation

Trial Overview The study tests a new audiology treatment called SEBAR to see if it boosts confidence and success using over-the-counter (OTC) hearing aids. It will compare participants' willingness to adopt OTC aids, satisfaction, quality of life, and emotional state before and after the intervention.

How Is the Trial Designed?

Group I: Pre-post single arm design Experimental Treatment 1 Intervention

Participants will wear the hearing aids for a week while receiving the SEBAR. Outcomes will be assessed with and without hearing aids.

Self-efficacy-based Auditory Rehabilitation is already approved in United States for the following indications:

Approved in United States as Over-the-Counter Hearing Aids for:

• Mild to moderate hearing loss in adults 18 years or older

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Published Research Related to This Trial

The Self-Efficacy for Situational Communication Management Questionnaire (SESMQ) effectively measures perceived self-efficacy (PSE) in adults with acquired hearing loss, demonstrating high reliability and internal consistency with a test-retest reliability of 0.94.

The SESMQ revealed that participants generally felt more confident in managing communication than their actual hearing ability, indicating a potential gap that could influence their rehabilitation outcomes and suggesting that addressing self-efficacy may enhance audiologic rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric properties of the self-efficacy for situational communication management questionnaire (SESMQ). Jennings, MB., Cheesman, MF., Laplante-Lévesque, A.[2022]

In a study of 30 first-time adult hearing aid users, self-efficacy for using hearing aids was found to predict satisfaction with the devices, highlighting the importance of confidence in using hearing aids for positive outcomes.

Positive expectations about hearing aids and a readiness to improve hearing were significant predictors of satisfaction and perceived benefit from the devices, suggesting that these psychological factors should be assessed in audiology clinics to identify individuals who would benefit most from hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of self-efficacy, expectations, and readiness on hearing aid outcomes. Ferguson, MA., Woolley, A., Munro, KJ.[2017]

Tinnitus can significantly impact individuals through disabilities like distorted auditory perception and emotional distress, with personal factors such as chronic depression influencing the severity of the experience.

Cochlear implants improve sound detection for those with prelingual hearing loss and enhance speech recognition for those with postlingual loss, but their effectiveness can vary based on the age of implantation and the quality of auditory input received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reports about tinnitus and about cochlear implants. Noble, W.[2019]

The Swedish Hearing Handicap Inventory for the Elderly (HHIE-S) demonstrated good reliability and internal consistency, making it a useful tool for assessing hearing difficulties in individuals with hearing loss.

In a study of 69 participants, the HHIE-S effectively evaluated the impact of hearing aid rehabilitation, showing a significant reduction in reported hearing difficulties after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Swedish Hearing Handicap Inventory for the Elderly (Screening Version) and Evaluation of Its Effect in Hearing Aid Rehabilitation. Öberg, M.[2019]

Audiologists are increasingly required to provide evidence of the effectiveness of their rehabilitative interventions, such as hearing aids, in reducing the communicative and psychosocial challenges faced by individuals with hearing loss.

Self-assessment questionnaires are valuable tools that help predict a person's suitability for hearing aids and their treatment outcomes, highlighting the importance of client engagement in the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Handicap versus impairment: an important distinction. Weinstein, BE., Richards, AM., Montano, J.[2020]

The study introduces the HEARRING graph, which effectively combines audiological data and patient-reported outcomes into a single visual representation, allowing for a comprehensive evaluation of hearing rehabilitation benefits.

This innovative approach enables clinicians to track individual or cohort performance over time, highlighting correlations between different measures and identifying patients who may need additional support based on their performance metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Representation of Audiological and Subjective Findings for Acoustical, Bone Conduction and Direct Drive Hearing Solutions. Sprinzl, GM., Magele, A., Schoerg, P., et al.[2023]

A qualitative study involving five older adults with high hearing aid self-efficacy (HASE) revealed that their success with hearing aids was largely due to intrinsic motivation and confidence in their health decisions.

Participants emphasized the importance of positive expectations and personal attributes, suggesting that internal factors play a more significant role in achieving successful outcomes with hearing aids than external influences or advice from others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared experiences among successful hearing aid users with high hearing aid self-efficacy. Johnson, J., Sarangi, L.[2023]

Wearing hearing aids significantly improves listening self-efficacy in older adults with mild to moderately severe sensorineural hearing loss, regardless of the communication environment.

Factors such as lower levels of neuroticism, longer duration of hearing aid use, and the severity of hearing loss are associated with greater improvements in listening self-efficacy, suggesting that personalized aural rehabilitation could enhance the benefits of hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Amplification on Listening Self-Efficacy in Adults With Sensorineural Hearing Loss. Kawaguchi, L., Wu, YH., Miller, C.[2020]

The multimedia educational program (C2Hear reusable learning objects) significantly improved self-efficacy and knowledge about hearing aids in first-time users compared to a printed booklet, based on a study of 56 adults.

Participants who received the RLOs also showed a borderline increase in readiness for hearing rehabilitation, suggesting that this educational approach can help users better manage their hearing aids before they start using them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving self-efficacy for hearing aid self-management: the early delivery of a multimedia-based education programme in first-time hearing aid users. Gomez, R., Ferguson, M.[2021]

Citations

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Benefits from, Satisfaction with, and Self-Efficacy for ... Little evidence is available regarding outcomes of advanced digital technology (ADT) hearing aid wearers with mild sensorineural hearing loss (MSNHL).

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Self-efficacy-based Auditory Rehabilitation With Over-the- ... This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation ( SEBAR ) can improve confidence ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06560918/self-efficacy-based-auditory-rehabilitation-with-over-the-counter-hearing-aids

Self-efficacy-based Auditory Rehabilitation with Over-the- ... This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve confidence ...

4. withpower.com withpower.com/trial/phase-hearing-loss-9-2024-9dc9e

Over-the-Counter Hearing Aids for Sensorineural Hearing Loss This goal of this study is to learn if a new audiology treatment process called the self-efficacy-based auditory rehabilitation (SEBAR) can improve ...

5. healthprofessions.uams.edu healthprofessions.uams.edu/research/funding/seed-grant/awardees/

Seed Grant Awardees | UAMS Research Office The proposed pilot study will aim at estimating the impacts of a self-efficacy-based auditory rehabilitation protocol on these individuals' HASE and other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6003813/

Disruptive Hearing Technologies and Mild Sensorineural ... Benefits from, satisfaction with, and self-efficacy for advanced digital hearing aids in users with mild sensorineural hearing loss. Semin Hear. 2018;39(02): ...