OTC Hearing Aid for Cognitive Impairment

Recruiting at 2 trial locations

Overseen By Kendra Marks

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Unstable medical conditions, Stroke, Schizophrenia, others

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

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Communication Strategies Information/Counseling and Over the counter hearing aid for cognitive impairment?

Research shows that communication education programs for older adults with hearing impairment can lead to significant improvements in communication skills and knowledge. Additionally, counseling on hearing aid use and adherence can enhance the effectiveness of hearing aids, suggesting that combining these strategies may help improve cognitive function by addressing communication challenges. ^{1 2 3 4 5}

How does the OTC hearing aid treatment for cognitive impairment differ from other treatments?

The OTC hearing aid treatment is unique because it combines affordable, direct-to-consumer hearing aids with communication strategies and counseling, aiming to improve communication and independence in individuals with cognitive impairment. Unlike traditional hearing aids that require professional fitting, OTC devices are more accessible and can be used without a prescription, making them a novel option for those with mild cognitive issues. ^{3 6 7 8 9}

What is the purpose of this trial?

The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids: 1. improve communication 2. Whether the magnitude of benefit depends on the patient's level of cognitive disability, 3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits. Participants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.

Research Team

Pamela Souza, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for individuals over 60 with mild dementia or mild cognitive impairment and mild to moderate hearing loss who don't currently use a hearing aid. They must have a partner to communicate with during the study, be able to consent, and not have severe vision impairments.

Inclusion Criteria

Mild to moderate bilateral hearing loss and no current hearing aid use

A communication partner who is able and willing to participate in the study

I am over 60 years old.

Exclusion Criteria

Co-enrolled in other intervention studies targeting hearing, language, or communication strategies

My hearing loss comes and goes.

Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Phase 1

Participants receive either OTC hearing aids or communication strategies for 4 weeks

4 weeks

1 visit (in-person) at baseline, 1 visit (in-person) after 4 weeks

Intervention Phase 2

Participants switch to the alternate intervention (OTC hearing aids or communication strategies) for another 4 weeks

4 weeks

1 visit (in-person) after 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after both interventions

4 weeks

Treatment Details

Interventions

• Communication Strategies Information/Counseling
• Over the counter hearing aid

Trial Overview The study aims to see if Over-the-Counter (OTC) hearing aids help improve communication in patients with cognitive challenges and whether targeted communication strategies offer similar benefits. Participants will try either the OTC hearing aid or communication strategies first, then switch.

Participant Groups

Group I: OTC Hearing Aid First Experimental Treatment 2 Interventions

Participants will be provided a pair of OTC hearing aids (experimental) with typical directions and use for 4 weeks before outcome measures will be assessed. After which, participants will then receive the communication strategies information/counseling (control) and have outcome measures assessed after 4 weeks.

Group II: Communication Strategies First Experimental Treatment 2 Interventions

Participants will receive the communication strategies information/counseling intervention (control) first. Outcome measures will be assessed at 4 weeks. After which, participants will then be given a pair of OTC hearing aids (experimental) with typical directions and use for four weeks before having outcome measures assessed.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Findings from Research

A communication education program for older adults with hearing impairment, involving 96 participants over five weeks, showed positive outcomes and high satisfaction, as measured by the International Outcome Inventory--Alternative Interventions (IOI-AI).

The results from this program were comparable to other audiological interventions, suggesting that the IOI-AI and its version for significant others (IOI-AI-SO) are effective tools for assessing the impact of alternative communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring outcomes of a communication program for older people with hearing impairment using the International Outcome Inventory. Hickson, L., Worrall, L., Scarinci, N.[2019]

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]

The 'Keep on Talking' program significantly improved communication knowledge and skills among older adults, with 45% of participants taking action to enhance their communication abilities after one year, compared to only 10% in the control group.

Communication education programs, like 'Active Communication Education,' are valuable supplements to traditional hearing aid fittings, helping older adults develop practical strategies for better communication in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond hearing aid fitting: improving communication for older adults. Hickson, L., Worrall, L.[2015]

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]

A study involving 656 hearing aid users found no significant difference in overall satisfaction and benefit between those using over-the-counter (OTC) hearing aids and those using conventional hearing care professional (HCP) services.

While HCP users reported longer daily use of their hearing aids, OTC users experienced less difficulty in hearing situations where they wanted to hear better, suggesting that OTC hearing aids can provide comparable outcomes to traditional models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. Swanepoel, W., Oosthuizen, I., Graham, MA., et al.[2023]

Adults with mild cognitive impairment or Alzheimer's disease face significant cognitive barriers that affect their ability to use hearing aids effectively, as revealed through interviews with 10 participants aged 75-86.

Despite recognizing the benefits of hearing aids, participants expressed ambivalence towards their use, indicating a need for targeted strategies to enhance hearing aid adoption and support in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. Gregory, S., Billings, J., Wilson, D., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Measuring outcomes of a communication program for older people with hearing impairment using the International Outcome Inventory. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Developing Foundational Counseling Skills for Addressing Adherence Issues in Auditory Rehabilitation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Beyond hearing aid fitting: improving communication for older adults. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Experienced hearing aid users' perspectives of assessment and communication within audiology: a qualitative study using digital methods. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

APSO Standards: Implementing Hearing Aid Needs Assessments and Measuring Related Outcomes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Experiences of hearing aid use among patients with mild cognitive impairment and Alzheimer's disease dementia: A qualitative study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Older adult performance on the communication profile for the hearing impaired. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Over-the-Counter Hearing Aids: A Lost Decade for Change. [2018]