Hearing Rehabilitation Strategies for Hearing Loss

Overseen By Kristin Montella

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Hearing aids, Cochlear implants

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with hearing loss by testing two different rehabilitation approaches. Participants will either receive counseling on using assistive listening devices or be referred to a traditional audiology care pathway. The goal is to determine which method better improves hearing experiences. Individuals who have trouble hearing, do not currently use hearing aids or cochlear implants, and can speak English or Spanish are a good fit for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods for hearing loss.

Do I need to stop my current medications for this trial?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that assistive listening devices are generally safe for people with hearing loss. These devices help users hear spoken information more clearly and are often used in schools and small settings to aid communication. No reports of serious side effects have emerged from using these devices.

In this trial, one approach involves counseling on how to use these devices. Since they are already widely used, they are considered safe and well-tolerated. Existing studies have not raised any specific safety concerns.

The other approach in this trial is the usual care audiology pathway, a standard method for managing hearing loss that many people use without safety issues.

In summary, both methods in this trial are based on treatments with a strong safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these hearing rehabilitation strategies because they offer a fresh approach to managing hearing loss. Unlike traditional audiology care, which typically focuses on hearing aids and regular audiological services, the alternative strategy emphasizes counseling and the use of accessible assistive listening devices. This approach empowers patients by providing them with tailored tools and strategies that can enhance their hearing experience in specific environments. By focusing on personalized solutions and patient education, these strategies have the potential to improve communication and quality of life for individuals with hearing loss in ways that standard methods might not fully address.

What evidence suggests that this trial's treatments could be effective for hearing loss?

This trial will compare different hearing rehabilitation strategies. Research has shown that assistive listening devices, which participants in the "Alternative Rehabilitation Strategies" arm may receive counseling on, can greatly improve hearing for people with hearing loss. Studies have found that devices like FM systems help adults understand speech better, especially in noisy places. Telehealth counseling also proves helpful, making hearing care more accessible and enhancing the recovery experience. These tools are part of a larger plan to improve hearing beyond regular hearing aids. Strong evidence supports the effectiveness of these alternative methods for those in need. Participants in the "Usual Care" arm will follow the traditional audiology care pathway. ^{1 6 7 8 9}

Who Is on the Research Team?

David Friedmann, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers who can consent to research and have hearing loss. It's not for those who already use hearing aids or cochlear implants.

Inclusion Criteria

I am able to understand and agree to participate in research.

Exclusion Criteria

Has or uses hearing aids or cochlear implants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants are randomized to either counseling on accessible assistive listening devices or referral to traditional audiology care pathway

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Counseling on accessible assistive listening devices
• Referral to traditional audiology care pathway alone

Trial Overview The study tests two ways to help with hearing loss in a primary care setting: one group gets counseling on assistive listening devices, while the other follows standard audiology care.

How Is the Trial Designed?

Group I: Alternative Rehabilitation Strategies Experimental Treatment 1 Intervention

Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.

Group II: Usual Care Active Control 1 Intervention

Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Many adults who could benefit from hearing aids do not use them, and those who do often stop using them shortly after, indicating that simply providing hearing aids is not enough for effective treatment of hearing loss.

The Audiology Practice Standards Organization has introduced evidence-based standards for hearing aid selection and fitting, emphasizing the need for thorough assessments of patients' amplification needs and measuring outcomes to improve adoption and success rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

APSO Standards: Implementing Hearing Aid Needs Assessments and Measuring Related Outcomes. Arnold, ML., Sanchez, VA.[2023]

Building a strong, patient-centered relationship during the initial evaluation is crucial for encouraging patients with hearing loss to use hearing aids effectively.

Training healthcare professionals in specific counseling skills, such as Motivational Interviewing and the Teach-Back Method, can significantly improve patient adherence to hearing aid recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Foundational Counseling Skills for Addressing Adherence Issues in Auditory Rehabilitation. Johnson, CE., Jilla, AM., Danhauer, JL.[2020]

A survey of 205 clinical supervisors in audiology graduate programs revealed that while 88% of programs require a counseling course, there is variability in how counseling skills are taught and assessed, indicating a need for more standardized training methods.

Supervisors with more experience reported greater confidence in teaching counseling skills, particularly in discussing emotional topics with clients, suggesting that mentorship and experience play a crucial role in developing effective counseling instruction for audiology students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Counseling Skills in Audiology Graduate Programs: Clinical Supervisors' Perceptions and Practices. Muñoz, K., Landon, T., Corbin-Lewis, K.[2020]

Assistive listening devices can significantly improve communication for elderly patients with hearing loss, helping to reduce feelings of isolation and enhance their quality of life.

Patients and families are encouraged to seek information and support from local audiologists and the American Speech-Language-Hearing Association to find suitable hearing aids and assistive devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nontraditional 'aids' to hearing: assistive listening devices. Rupp, RR., Vaughn, GR., Lightfoot, RK.[2004]

A survey of audiology faculty from 40 ASHA-accredited colleges revealed gaps in the aural rehabilitation training provided to graduate students, particularly in areas like cochlear implants and vestibular disorders.

The findings aim to highlight deficiencies in current training programs, which could help improve the education and preparedness of future audiologists working with hearing-impaired patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aural rehabilitation and graduate audiology programs. Sykes, S., Tucker, D., Herr, D.[2020]

A study involving 33 audiology professionals from 5 countries identified 64 key competencies necessary for effective audiologic counseling, emphasizing the importance of knowledge, skills, and attitudes in this field.

The findings highlight a gap in current practice guidelines for audiology education, suggesting that these competencies should be integrated into graduate training programs to enhance counseling practices for patients with ear-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counseling Competencies in Audiology: A Modified Delphi Study. Meibos, A., Muñoz, K., Twohig, M.[2019]

A survey of 209 clinical audiologists revealed that many frequently encounter normal-hearing patients who experience significant communication difficulties, yet few have established protocols for managing these cases.

Counseling is the most common rehabilitation method used, but audiologists are also beginning to fit these patients with mild-gain hearing aids, despite a lack of research supporting the efficacy of such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Questionnaire Survey of Current Rehabilitation Practices for Adults With Normal Hearing Sensitivity Who Experience Auditory Difficulties. Koerner, TK., A Papesh, M., Gallun, FJ.[2022]

A randomized controlled trial will assess the effectiveness of an internet-based counseling program using a 'patient journey' model for 158 participants with self-reported hearing disability, focusing on outcomes like hearing disability, depression, and anxiety.

If successful, this counseling approach could provide a cost-effective and time-efficient method for managing hearing disabilities, enhancing the support for individuals navigating their hearing loss journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the 'patient journey' model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial. Manchaiah, VK., Stephens, D., Andersson, G., et al.[2021]

A study involving 106 veterans showed that while hearing aids significantly improved self-perception of communication performance in both short- and long-term, there were no additional benefits from a counseling-oriented audiological rehabilitation (AR) program in the long run.

However, the AR program did provide short-term benefits in communication strategy usage, leading to better interaction and reaction scores, suggesting that it may help users adjust to hearing aids initially.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term outcomes of adult audiological rehabilitation. Chisolm, TH., Abrams, HB., McArdle, R.[2019]

In 2011, the Israeli government significantly increased subsidies for adult hearing aids, which led to a reduction in prices and increased demand, making hearing aids more accessible to the public.

However, this shift towards affordability risks diminishing the role of professional audiologists in the rehabilitation process, highlighting the need for a balance between cost reduction and the importance of professional care in hearing rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Price reductions in hearing aids and access to audiologists, Israel. Lavie, L., Bar-Moshe, T.[2022]

Participation in counseling and communication strategy-oriented group aural rehabilitation programs significantly reduces self-perception of hearing handicap in adults with hearing impairment, based on a systematic review of 12 studies.

While these programs may enhance the use of communication strategies and hearing aids in the short term, it remains uncertain if these benefits last longer than the initial period after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of counseling-based adult group aural rehabilitation programs: a systematic review of the evidence. Hawkins, DB.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12285927/

Technologies and Auditory Rehabilitation Beyond Hearing Aids Telehealth significantly improves auditory rehabilitation outcomes by providing flexible and timely access to care and facilitating better self- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4111410/

Evidence for the Use of Hearing Assistive Technology by ... The studies reviewed provide strong evidence that the use of FM devices by adults with hearing loss results in better speech understanding in noise performance ...

3. nationaldeafcenter.org nationaldeafcenter.org/resources/access-accommodations/assistive-listening-systems/

Assistive Listening Systems Assistive listening systems (ALS) provide deaf students with direct auditory access to spoken information. ALS can be used with or without personal devices.

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

Artificial intelligence for hearing loss prevention, diagnosis, ... This paper explores the transformative impact of artificial intelligence (AI), particularly machine learning (ML), on diagnosing and treating hearing loss.

5. asha.org asha.org/practice-portal/professional-issues/hearing-aids-for-adults/?srsltid=AfmBOoqu99dNKzq3Cb94ZIEddwK7w5BPYqblmpXdqUdS9FQV39CteQed

Hearing Aids For Adults Hearing aids for adults is a complex process that includes fitting and verification. It represents a part of a comprehensive aural rehabilitation plan.

6. hearingloss.org hearingloss.org/find-help/hearing-assistive-technology/

Hearing Assistive Technology Assistive listening devices (ALD) include any device, except hearing aids, that support communication for those with hearing loss in small settings and one-on- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9802570/

Reframing Our Health Care System for Patients With Hearing ... Nearly 20% of U.S. Americans report a hearing loss, yet our current health care system is poorly designed and equipped to effectively care ...

8. research.aota.org research.aota.org/ajot/article/78/Supplement%201/7810410130/26031/Assistive-Technology-Devices-and-Services-in

Assistive Technology Devices and Services in Occupational ... This AOTA Position Statement describes how assistive technology (AT) fits within the occupational therapy scope of practice.

9. quizlet.com quizlet.com/554679057/aural-rehab-final-exam-flash-cards/

aural rehab final exam Flashcards A child with a mild hearing loss is likely to be diagnosed later than a child with a profound loss. true.