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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Over-the-Counter (OTC) hearing aids can enhance communication for individuals with mild to moderate hearing loss who also have mild cognitive impairment or Alzheimer's. Researchers aim to determine if the effectiveness of hearing aids varies with the level of cognitive issues and whether communication strategies (information and counseling) can be equally effective. Participants will begin with either OTC hearing aids or communication strategies. This trial suits those over 60 with mild dementia, mild cognitive issues, and hearing loss, who do not currently use hearing aids, and have a partner willing to participate. As an unphased trial, it offers a unique opportunity to contribute to understanding how hearing aids and communication strategies can improve quality of life.

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.

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

Research has shown that over-the-counter (OTC) hearing aids are generally safe for users. In one study, users reported no medical problems that would render these devices unsafe, suggesting they are well-tolerated. Another study found that people using OTC hearing aids were typically younger and had milder hearing loss than those using prescription hearing aids, but this did not raise safety concerns.

Some hearing health professionals express concern about the effectiveness of OTC hearing aids compared to traditional ones, but no strong evidence indicates major safety risks. Overall, for those considering joining a trial for OTC hearing aids, current research suggests they are safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring over-the-counter (OTC) hearing aids and communication strategies for cognitive impairment because they offer a more accessible and potentially cost-effective alternative to traditional hearing aids, which often require professional fitting and can be expensive. Unlike standard hearing aids, OTC options can be purchased directly by consumers, making them easier to obtain. Additionally, the trial is investigating how communication strategies can complement hearing aids to improve cognitive function, which is a relatively new approach. This combination could lead to new strategies for managing cognitive impairment, providing a holistic way to support individuals who may not have access to specialized hearing care.

What evidence suggests that this trial's treatments could be effective for cognitive impairment?

This trial will compare the effects of over-the-counter (OTC) hearing aids with communication strategies information and counseling for individuals with mild to moderate hearing loss and mild cognitive impairment (MCI) or Alzheimer's. Research has shown that OTC hearing aids can improve communication, offering benefits similar to professionally fitted hearing aids. Evidence suggests that hearing aids might slow cognitive decline by 19%, making them a promising option for those facing both hearing and cognitive challenges. Initial findings indicate that older adults can effectively manage OTC hearing aids, making them a practical solution. ^{6 7 8 9 10}

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 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

My hearing loss comes and goes.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11713560/

A randomized trial of over‐the‐counter hearing aids for ... Results of this trial will provide important evidence to guide treatment recommendations in community‐dwelling older adults with MCI or early ADRD.

2. hopkinsmedicine.org hopkinsmedicine.org/news/articles/2024/12/how-does-hearing-loss-link-to-cognitive-decline

How Does Hearing Loss Link to Cognitive Decline? Results were promising, with participants showing improvements in communication similar in impact to that from hearing aids fitted by ...

3. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2833823

Hearing Aid Service Models, Technology, and Patient ... Although OTC+ and OTC had poorer outcomes compared with AUD, their mean EMA-GHABP global scores were close to 4 points (Table 2 and Figure 2), ...

4. pubs.asha.org pubs.asha.org/doi/10.1044/2025_AJA-25-00013

Usability of Over-the-Counter Hearing Aids in Older Adults This study aimed to identify individual factors associated with older adults' ability to manage commercially available over-the-counter (OTC) hearing aids ...

5. academic.oup.com academic.oup.com/ageing/article/54/1/afaf004/7965371

Early detection and management of hearing loss to reduce ... A recent meta-analysis estimates that hearing aid use may reduce the rate of cognitive decline by 19% [6]. ... However, in a pre-specified ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10037636/

Hearing Healthcare Professionals' Views about Over-The- ... Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10801511/

First Experiences with Over-the-Counter Hearing Aids for ... The patient reported no “red flag” medical conditions that would preclude him from safely using an OTC hearing aid device.

8. frontiersin.org frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2024.1347437/full

Over-the-counter hearing aids: implementations and ... When compared to new prescription hearing aid users, new OTC hearing aid users, on average, were 2 years younger (64 vs. 62) and have milder hearing loss, but ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06112860

Study Details | NCT06112860 | OTC Hearing Aid and MCI This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication.

10. pubs.asha.org pubs.asha.org/doi/10.1044/2023_JSLHR-23-00306

Over-the-Counter Hearing Aids Challenge the Core Values ... The results of this study indicate that the OTC hearing aids model challenges the values of the traditional audiology model, which may provide an alternative ...