Hearing LossHEARS MDNCT07699146
HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
A study testing HEARS MD Device and HEARS MD Program in people with Hearing Loss and Hearing Impairment, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Hearing Impairment, Age Related Hearing Loss
- What is being tested?
- HEARS MD Device and HEARS MD Program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Current self-reported use of hearing aid or amplification device
- Medical contraindication to use hearing aids (e.g. draining ears)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jalisa Bass contact
About this study
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.
- Conditions
- Hearing Loss, Hearing Impairment, Age Related Hearing Loss, Age-related Hearing Impairment
- Being tested
- HEARS MD Device, HEARS MD Program
- Medical subject headings
- Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEARS MD DeviceDevice
Tailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.
HEARS MD ProgramBehavioural
Tailored aural rehabilitation for participant.
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment | Experimental | HEARS Intervention Receives: Device: HEARS MD Device; Behavioral: HEARS MD Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility (enrollment rate)
Percentage of eligible individuals who enroll in the trial
Measured: Baseline, 1-week, 3-months, and 6-months post-intervention
Intervention feasibility (intervention retention)
Percentage of participants who complete the Hearing Handicap Inventory for the Elderly (HHIE-S)
Measured: Baseline, 1-week, 3-months, and 6-months post-intervention
Secondary outcomes (2)
Change in Hearing Handicap Inventory for the Elderly (HHIE-S)
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.
Measured: Baseline, 1-week, 3-months, and 6-months post-intervention
International Outcome Inventory for Hearing Aids (IOI-HA)
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.
Measured: Baseline, 1-week, 3-months, and 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699146
- Sponsor's protocol ID
- IRB00281367
- Other IDs
- 1R21DC020149-01
- Acronym
- HEARS MD
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship
- ClinicalTrials.gov ID
- NCT07699146
- Acronym / sponsor ID
- HEARS MD / IRB00281367
- Conditions
- Hearing Loss, Hearing Impairment, Age Related Hearing Loss, Age-related Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment | Experimental | Device: HEARS MD Device, Behavioral: HEARS MD ProgramHEARS Intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Current self-reported use of hearing aid or amplification device
- Medical contraindication to use hearing aids (e.g. draining ears)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEARS MD DeviceTailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component. | Device | Immediate treatment |
| HEARS MD ProgramTailored aural rehabilitation for participant. | Behavioural | Immediate treatment |
Primary outcome
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
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)
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jalisa Bass contact
Hae-Ra Han, PhD, RN principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing HEARS MD Device and HEARS MD Program in people with Hearing Loss and Hearing Impairment, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carrie L Nieman, MD, MPH (410-502-6965, cnieman1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention feasibility (enrollment rate) (time frame: Baseline, 1-week, 3-months, and 6-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.