OTC Hearing Aid and MCI

September 15, 2025 updated by: Pamela Souza, Northwestern University

Over-the-counter Hearing Aids and Mild Cognitive Impairment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single blind cross-over study comparing OTC Hearing Aids to communication strategies information/counseling and their impact on communication between a person who has hearing loss and MCI and a communication partner. Due to the nature of the study, it will not be possible to blind the participants to which arm they are in, but the scorers will be blinded.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Enrolling by invitation
        • La Crosse Mayo Clinic
      • Madison, Wisconsin, United States, 53706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. 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.
  2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer
  3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
  4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
  5. History or current fluctuating hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: OTC Hearing Aid First
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.
Device: Over the counter hearing aid
An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Other Names:
  • OTC hearing aid
Behavioral: Communication Strategies Information/Counseling
Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Other Names:
  • Communication Strategies
Other: Communication Strategies First
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.
Device: Over the counter hearing aid
An over the counter hearing aid is a device that provides amplification appropriate for individuals with mild to moderate hearing loss. Participants will receive the devices with typical directions and have one scheduled remote visit one week after receiving devices with an audiologist.
Other Names:
  • OTC hearing aid
Behavioral: Communication Strategies Information/Counseling
Communication Strategies provide information meant to help an individual compensate for hearing loss. The information provides tips both for the individual with hearing loss and for those communicating. People who choose not to pursue hearing aids will typically be given communication strategies information to help them manage their hearing loss. Participants will receive the counseling information in the mail and then have a 1 week follow-up appointment with an audiologist.
Other Names:
  • Communication Strategies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
Time Frame: 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)
Baseline at enrollment, then after 4 weeks of using each intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Handicap Inventory for the Elderly (HHIE)
Time Frame: Baseline at enrollment, then after 4 weeks of using each intervention
Questionnaire has 25 items with subscales for social and emotional impacts and is scored from 0-100, with 100 representing least handicap.
Baseline at enrollment, then after 4 weeks of using each intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversation Analysis
Time Frame: 4 weeks after first intervention
The Diapix conversation task where participant and communication partner find the differences in two very similar pictures by discussing them.
4 weeks after first intervention
Adherence
Time Frame: 4 weeks after each intervention
Reported Use (hours per day)
4 weeks after each intervention
Usability
Time Frame: 4 weeks after OTC intervention
We will use a modification of the Systematic Usability Scale to query the patient's experience with the OTC aids.
4 weeks after OTC intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Pamela Souza, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00219514

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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