OTC Hearing Aid and MCI
Over-the-counter Hearing Aids and Mild Cognitive Impairment
1 other identifier
interventional
50
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedStudy Start
First participant enrolled
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 19, 2025
September 1, 2025
2.4 years
October 25, 2023
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perception of Conversation Index - Dementia Alzheimer's Type (PCI-DAT)
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 Outcomes (1)
Hearing Handicap Inventory for the Elderly (HHIE)
Baseline at enrollment, then after 4 weeks of using each intervention
Other Outcomes (3)
Conversation Analysis
4 weeks after first intervention
Adherence
4 weeks after each intervention
Usability
4 weeks after OTC intervention
Study Arms (2)
OTC Hearing Aid First
OTHERParticipants 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.
Communication Strategies First
OTHERParticipants 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
- Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
- Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.
- History or current fluctuating hearing loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Northwestern University HA Lab
Evanston, Illinois, 60201, United States
La Crosse Mayo Clinic
La Crosse, Wisconsin, 54601, United States
UW Madison
Madison, Wisconsin, 53706, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Souza, PhD
Northwestern University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Those listening and scoring recorded tasks will be blinded to which group the participants are in.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Otolaryngology; Communication Sciences and Disorders
Study Record Dates
First Submitted
October 25, 2023
First Posted
November 2, 2023
Study Start
July 23, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share