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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07699146
Acronym
HEARS MD
Enrollment
300
Registered
2026-07-13
Start date
2026-11-30
Completion date
2029-06-30
Last updated
2026-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Hearing Impairment, Age Related Hearing Loss, Hearing Impairment, Hearing Loss

Brief summary

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.

Interventions

DEVICEHEARS MD Device

Tailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.

BEHAVIORALHEARS MD Program

Tailored aural rehabilitation for participant.

Sponsors

Johns Hopkins University
Lead SponsorOTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Intervention feasibility (enrollment rate)Baseline, 1-week, 3-months, and 6-months post-interventionPercentage of eligible individuals who enroll in the trial
Intervention feasibility (intervention retention)Baseline, 1-week, 3-months, and 6-months post-interventionPercentage of participants who complete the Hearing Handicap Inventory for the Elderly (HHIE-S)

Secondary

MeasureTime frameDescription
Change in Hearing Handicap Inventory for the Elderly (HHIE-S)Baseline, 1-week, 3-months, and 6-months post-interventionScoring: 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.
International Outcome Inventory for Hearing Aids (IOI-HA)Baseline, 1-week, 3-months, and 6-months post-interventionThe 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.

Contacts

CONTACTCarrie L Nieman, MD, MPH
cnieman1@jhmi.edu410-502-6965
CONTACTJalisa Bass
jbass14@jh.edu
PRINCIPAL_INVESTIGATORHae-Ra Han, PhD, RN

Johns Hopkins University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 30, 2026