HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship (HEARS MD)

July 7, 2026 updated by: Johns Hopkins University
This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact Backup

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

Yes

Description

Inclusion Criteria:

  • Age 60 years or older
  • English-speaking
  • Aural-oral verbal communication as primary communication modality
  • Post-lingual hearing loss (Audiometric pure tone averages [0.5-2kHz] in better ear >25 dB)

Exclusion Criteria:

  • Current self-reported use of hearing aid or amplification device
  • Medical contraindication to use hearing aids (e.g. draining ears)

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
HEARS Intervention
Device: HEARS MD Device
Tailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.
Behavioral: HEARS MD Program
Tailored aural rehabilitation for participant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention feasibility (enrollment rate)
Time Frame: Baseline, 1-week, 3-months, and 6-months post-intervention
Percentage of eligible individuals who enroll in the trial
Baseline, 1-week, 3-months, and 6-months post-intervention
Intervention feasibility (intervention retention)
Time Frame: Baseline, 1-week, 3-months, and 6-months post-intervention
Percentage of participants who complete the Hearing Handicap Inventory for the Elderly (HHIE-S)
Baseline, 1-week, 3-months, and 6-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: Baseline, 1-week, 3-months, and 6-months post-intervention
Scoring: 0-8 suggests no hearing handicap; 10-24 suggests mild-moderate hearing handicap; 26-40 suggests significant hearing handicap. Score range 0-40, an increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Baseline, 1-week, 3-months, and 6-months post-intervention
International Outcome Inventory for Hearing Aids (IOI-HA)
Time Frame: Baseline, 1-week, 3-months, and 6-months post-intervention
The hearing inventory survey is used to evaluate the effectiveness of alternative interventions such as assistive devices and communication strategies. The total score ranges from 7-35, where higher scores indicate a better outcome.
Baseline, 1-week, 3-months, and 6-months post-intervention

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Hae-Ra Han, PhD, RN, Johns Hopkins 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 (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

July 7, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00281367
  • 1R21DC020149-01 (U.S. NIH Grant/Contract)

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

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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