Hearing Aid Fitting for Alzheimer's Disease

No longer recruiting at 1 trial location

Overseen By Elizabeth Stangl, AuD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yu-Hsiang Wu

Disqualifiers: Non-native English speaker

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different approaches to fitting hearing aids can assist people with Alzheimer's Disease and related dementias. Researchers will divide participants into three groups to test various fitting styles: one with full audiologist support, one with minimal support, and one focusing solely on the device. The trial aims to assess how these methods impact hearing, daily life, and caregiver stress six weeks after receiving the hearing aids. It is suitable for individuals with mild to moderate cognitive issues and adult-onset hearing loss who have never used hearing aids before. As an unphased trial, it offers a unique opportunity to explore innovative hearing aid solutions for those with cognitive challenges.

Do I have to stop taking my current medications for this trial?

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

What prior data suggests that these hearing aid interventions are safe for individuals with Alzheimer's Disease?

Research has shown that hearing aids are generally safe for individuals with both dementia and hearing loss. Studies indicate that using hearing aids can reduce the risk of developing dementia. While most people use them without issues, some may find handling and operating the device challenging, which can affect its effectiveness.

Hearing aids have been available for many years, providing extensive information about their safety. They might cause minor issues like discomfort or feedback noise, but they do not cause serious side effects. Overall, hearing aids offer a safe and effective way to improve hearing in individuals with cognitive impairments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring hearing aid fittings for Alzheimer's disease because they aim to determine the best method to improve both hearing and cognitive function in affected individuals. This trial compares three different approaches: audiologist-based fittings, service-only fittings with minimal amplification, and device-only fittings with minimal audiologist involvement. Each method offers a unique way to potentially enhance communication and daily functioning, which could significantly improve quality of life. Unlike typical Alzheimer's treatments that focus on slowing cognitive decline, these approaches are looking at how improved hearing can directly impact brain health and cognitive engagement. This could open new avenues for managing Alzheimer's symptoms beyond conventional medications.

What evidence suggests that this trial's hearing aid interventions could be effective for Alzheimer's Disease?

Research has shown that using hearing aids benefits brain health, particularly in older adults with hearing loss. A review of several studies found that hearing aid users have a 19% lower risk of mental decline over time. Specifically, one study found that these individuals performed better on thinking and memory tests even three years after obtaining their hearing aids. Hearing loss might accelerate mental decline, so improving hearing could help slow it down. This trial will compare different approaches to hearing aid fitting: the Audiologist-Based approach, the Service-Only approach, and the Device-Only approach. Hearing aids thus present a promising option for individuals with Alzheimer's and similar memory issues. ^{6 7 8 9 10}

Who Is on the Research Team?

Yu-Hsiang Wu, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for older adults with mild or moderate cognitive disorders like Alzheimer's, who also have adult-onset mild-to-moderate hearing loss and haven't used hearing aids before. Participants must speak English natively.

Inclusion Criteria

You have never used a hearing aid before.

I have adult-onset hearing loss that is not severe.

I have been diagnosed with mild or moderate Alzheimer's disease.

Exclusion Criteria

You do not speak English as your first language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to three intervention groups: Audiologist-Based Intervention, Service-Only Group, and Device-Only Group. Hearing aid interventions are provided.

6 weeks

Multiple visits as per intervention group requirements

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome data collected on hearing loss impact and caregiver burden.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Aid

Trial Overview The study tests three ways of fitting hearing aids: by an audiologist, service-only without an audiologist's fine-tuning, and device-only without additional services. It aims to see how these affect the lives of patients with cognitive impairments and their caregivers after 6 weeks.

How Is the Trial Designed?

Group I: Service-Only Experimental Treatment 1 Intervention

In this group, hearing aids that have minimum amplification will be fitted by audiologists.

Group II: Device-Only Experimental Treatment 1 Intervention

In this group, hearing aids will be provided with minimum services from audiologists.

Group III: Audiologist-Based Active Control 1 Intervention

In this group, the audiologist-based fitting will be used to provide hearing aids.

Hearing Aid is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Approved in European Union as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Approved in Canada as Hearing Aid for:

• Hearing Loss
• Age-related Hearing Loss
• Sensorineural Hearing Loss

Who Is Running the Clinical Trial?

Yu-Hsiang Wu

Lead Sponsor

Trials

4

Recruited

710+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

In a study of 114,862 adults aged 66 and older with hearing loss, the use of hearing aids was associated with a reduced risk of being diagnosed with Alzheimer's disease or dementia (hazard ratio of 0.82), anxiety or depression (0.89), and injurious falls (0.87) within three years of hearing loss diagnosis.

The study highlighted significant disparities in hearing aid usage among different sexes and racial/ethnic groups, with men and white individuals using hearing aids more frequently than women and minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Hearing Aids Delay Time to Diagnosis of Dementia, Depression, or Falls in Older Adults? Mahmoudi, E., Basu, T., Langa, K., et al.[2020]

In a study involving 31 older hearing aid users and 6 young normal-hearing listeners, those with mild hearing deficits performed better in speech recognition tasks compared to those with more severe deficits, highlighting the variability in outcomes based on hearing loss severity.

The effectiveness of hearing aids in improving speech-in-noise outcomes was found to be significantly influenced by the degree of hearing loss and the specific gain settings of the devices, suggesting that current fitting strategies may not adequately address the needs of users with pronounced hearing deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Three Auditory Profiles on Aided Speech Perception in Different Noise Scenarios. Wu, M., Cañete, OM., Schmidt, JH., et al.[2021]

The prototype digital hearing aid significantly improved speech recognition in patients with sensorineural hearing loss, achieving maximum intelligibility levels of 90-100% in 6 out of 10 patients tested.

In addition to benefiting those with sensorineural hearing loss, the device also provided improvements in speech recognition for patients using conventional hearing aids, demonstrating its potential effectiveness across different types of hearing impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical design and evaluation of the prototype of a new digital audioprosthesis for profound hearing loss: speech recognition aspects. Urquiza, R., Ruiz-Rico, R., Tejero, C., et al.[2017]

In a study involving 10 patients with mixed hearing loss, both the National Acoustic Laboratories (NAL) and Desired Sensation Level (DSL) fitting algorithms for bone-anchored hearing aids produced similar audiological outcomes over an average of 7 months.

Patients with poorer hearing thresholds showed a preference for the DSL program, which provided better word recognition in quiet environments, suggesting that the DSL may be more beneficial for those with greater hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone-Anchored Hearing Aids Fitted According to NAL and DSL Procedures in Adults with Mixed Hearing Loss. Bruschini, L., Canelli, R., Guida, M., et al.[2022]

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]

A meta-analysis of six studies involving 171 Alzheimer's Disease (AD) patients and 222 age-matched controls found that individuals with AD have significantly poorer hearing, with an average increase of 2.3 dB HL at lower frequencies (0.5-2 kHz) and 4.5 dB HL at higher frequencies (0.5-4 kHz).

This study highlights the importance of quantifying hearing loss in AD patients, suggesting that hearing impairment may serve as a potential biomarker for earlier diagnosis and treatment strategies for Alzheimer's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure Tone Audiometry and Hearing Loss in Alzheimer's Disease: A Meta-Analysis. Kwok, SS., Nguyen, XT., Wu, DD., et al.[2023]

The study highlights that traditional clinical procedures for Alzheimer's Disease often overlook hearing issues, suggesting a need for innovative ways to measure treatment effectiveness, particularly through caregiver-reported behaviors.

Modeling hearing aid use as a dynamic system can predict outcomes and quantify the relationship between hearing aid intervention and changes in patient behavior, indicating a promising approach for assessing treatment efficacy in challenging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of counted behaviors in a single-subject design: modeling of hearing-aid intervention in hearing-impaired patients with Alzheimer's disease. Durrant, JD., Palmer, CV., Lunner, T.[2019]

Sensorineural hearing loss affects 30 to 50% of older adults, significantly impacting their ability to understand speech and enjoy daily activities, but it is not an unavoidable part of aging.

Advancements in hearing aid technology have made them more accessible and effective for elderly individuals, emphasizing the importance of early identification and routine screening for better management of hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Geriatric hearing loss: myths, realities, resources for physicians. Weinstein, BE.[2005]

In a study involving 51 older patients with Alzheimer's disease and hearing loss, the use of hearing aids for 6 months did not show a significant cognitive benefit compared to a placebo, with similar cognitive decline observed in both groups.

After a secondary activation phase of hearing aids in the placebo group, no significant improvement in cognitive function was noted, indicating that hearing aids may not provide cognitive advantages in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Hearing Aids on the Cognitive Status of Patients with Alzheimer's Disease and Hearing Loss: A Multicenter Controlled Randomized Trial. Nguyen, MF., Bonnefoy, M., Adrait, A., et al.[2018]

Elderly individuals experience greater difficulties in understanding speech compared to younger individuals with similar hearing loss, often due to age-related changes in the central auditory nervous system.

Improving the signal-to-noise ratio can effectively help mitigate the challenges posed by auditory processing disorders in older adults, leading to better outcomes with hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Special hearing aid considerations in elderly patients with auditory processing disorders. Stach, BA., Loiselle, LH., Jerger, JF.[2019]

This study highlights the often-overlooked issue of hearing impairment in Alzheimer's disease patients, showing that addressing hearing deficits can significantly reduce caregiver-reported problem behaviors related to communication.

In a small group of 8 participants, the use of hearing aids led to a notable reduction in problem behaviors, with participants wearing their devices for 5 to 15 hours daily, demonstrating both compliance and efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction in caregiver-identified problem behaviors in patients with Alzheimer disease post-hearing-aid fitting. Palmer, CV., Adams, SW., Bourgeois, M., et al.[2019]

Out of 312 patients fitted with hearing aids over 16 months, only 35.5% were optimally supplied, indicating a significant need for better fitting processes and follow-up assessments.

A substantial 71.8% of fitting reports were inadequately completed, which likely contributed to the need for complete refitting in 33% of patients, highlighting the importance of thorough documentation in hearing aid fittings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The importance of hearing-aid testing by the otorhinolaryngologist]. Schorn, K.[2006]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9856596/

Association of Hearing Aids and Cochlear Implants With ... This systematic review and meta-analysis evaluates data for patients with hearing loss from studies of the association of hearing interventions ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084262/

Hearing impairment and dementia: cause, catalyst or ... In principle, hearing impairment could cause (directly promote), catalyze (amplify) or be a consequence of neurodegenerative pathology and cognitive decline.

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2799139

Association of Hearing Aids and Cochlear Implants With ... In this meta-analysis, the usage of hearing restorative devices by participants with hearing loss was associated with a 19% decrease in hazards of long-term ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02294513

NCT02294513 | Hearing Instruments in Alzheimer's Disease There is a strong connection between hearing loss and cognitive impairment, particularly dementia, in old age. Worldwide, dementia affects approximately 5% ...

5. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2023.1302185/full

ENHANCE: a comparative prospective longitudinal study of ... Conclusion: Hearing aid users demonstrated significantly better cognitive performance to 3 years post-fitting, suggesting that hearing intervention may delay ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9197139/

Hearing Assessment and Rehabilitation for People Living ... The aim of this review was to outline best practice recommendations for the assessment and rehabilitation of hearing impairment for PwD with reference to the ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1525861022005527

Systematic Review of Factors Associated With Hearing Aid ... Hearing aid use for people living in the community with dementia and hearing loss is influenced by (1) degree of hearing aid handling proficiency, (2) positive ...

8. evidence.nihr.ac.uk evidence.nihr.ac.uk/alert/what-impact-does-hearing-loss-have-on-dementia-risk/

What impact does hearing loss have on dementia risk? A 2022 systematic review found that people with hearing loss who use hearing aids or cochlear implants have a reduced risk of developing dementia.

9. medrxiv.org medrxiv.org/content/10.1101/2025.03.25.25324637v1.full.pdf

Hearing aid interventions to mitigate cognitive impairment NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. Page 2 ...

10. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12248

The impact of hearing impairment and hearing aid use on ... We assessed the association of self-reported hearing impairment and hearing aid use with cognitive decline and progression to mild cognitive ...