An interventional study of HEARS MD Device and HEARS MD Program in Hearing Loss, Hearing Impairment and Age Related Hearing Loss, sponsored by Johns Hopkins University. Not yet recruiting. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
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.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 300 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HEARS Intervention
Device: HEARS MD Device · Behavioral: HEARS MD Program
Tailored fitting and programming of an over the counter hearing device accompanied by an aural rehabilitation component.
Tailored aural rehabilitation for participant.
Intervention feasibility (enrollment rate)
Percentage of eligible individuals who enroll in the trial
Time frame: 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)
Time frame: Baseline, 1-week, 3-months, and 6-months post-intervention
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.
Time frame: 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.
Time frame: Baseline, 1-week, 3-months, and 6-months post-intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Mar 2029, 26 months later.
Of 196 non-industry interventional studies with no phase under Hearing Loss, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 26 months is below that.
Counting every sponsor, half of 321 studies reached it within 19 months; a quarter within 5 and three quarters within 42.
Start moved once since we started tracking on Sep 25, 2026: Nov 2026 → Jan 2027, on Nov 9, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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