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OTC Hearing Aids and Communication Strategies for Hearing Loss and Mild Cognitive Impairment

This study is looking at whether Over-the-Counter (OTC) hearing aids can improve communication for people aged 60 to 90 who have mild to moderate hearing loss and also experience mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD). It also wants to see if the benefits depend on how severe someone's cognitive issues are, and if communication strategies alone offer similar help. You would need to have a communication partner willing to participate. The study will measure improvements in communication using a tool called the Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT) after 4 weeks of using either OTC hearing aids or communication strategies. The goal is to understand which approach is most helpful.

Study design
This is a single-blind, cross-over study with 50 participants, comparing OTC hearing aids to communication strategies. Participants and a communication partner will be randomly assigned to receive one intervention first, then the other.
What's involved
You would receive OTC hearing aids with typical directions and have one remote visit with an audiologist one week later. Communication strategies information would also be provided. The primary endpoint is measured after 4 weeks of using each intervention.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured after 4 weeks of using each intervention.

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NCT06112860

OTC Hearing Aid and MCI

Recruiting
NAAges 60–90InterventionalTreatment
Northwestern University
~50 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Over the counter hearing aidCommunication Strategies Information/Counseling

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
Measured over Baseline at enrollment, then after 4 weeks of using each intervention

Conditions

Hearing Loss
Mild Cognitive Impairment
Alzheimer Disease and Related Dementias (ADRD)

Explore related trials

Alzheimer's DiseaseHearing LossMild cognitive disorder

Where it's being run

3 sites across 2 states
Wisconsin2
Illinois1

Study leadership

  • Pamela Souza, PhD · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Kendra Marks
[email protected]
8474670897
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Over 60 years of age
Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).
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.
No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
Able to provide own consent as evaluated by the Consent Assessment

What this trial measures

  • Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)Baseline at enrollment, then after 4 weeks of using each intervention

    A questionnaire completed by the communication partner of the individual with MCI and hearing loss. On this scale, higher scores reflect more frequent and more problematic conversation difficulties; item possible scores range from 0 (not problematic) to 7 (.very problematic)