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NCT Number: NCT07699146

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

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.

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Key information

Conditions

Hearing Loss Age Related Hearing Loss Age-related Hearing Impairment Ear Diseases Hearing Disorders Hearing Impairment Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Presbycusis Sensation Disorders Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HEARS MD Device

Device

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

HEARS MD Program

Behavioral

Tailored aural rehabilitation for participant.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carrie L Nieman, MD, MPH

CONTACT

[email protected]

410-502-6965

Jalisa Bass

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: HEARS MD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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