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Not yet recruiting NCT07699146

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

No phase Interventional Hearing Loss Hearing Impairment Age Related Hearing Loss Age-related Hearing Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HEARS MD Device, HEARS MD Program.
Who it may be relevant to
Registry conditions: Hearing Loss, Hearing Impairment, Age Related Hearing Loss, Age-related Hearing Impairment. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • 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.

Primary outcome measures

  • Intervention feasibility (enrollment rate) [Time frame: 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]
Secondary outcome measures (2)
  • Change in Hearing Handicap Inventory for the Elderly (HHIE-S) [Time frame: 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07699146 · IRB00281367 · 1R21DC020149-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗