Hearing Program in Primary Care

Feasibility of a Hearing Program in Primary Care for Underserved Older Adults

During a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.

Study Overview

• Status: Active, not recruiting
• Conditions: Deafness
• Intervention / Treatment: Behavioral: Alternative rehabilitation strategies; Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYC H+H/Bellevue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• speaks English or Spanish;
• capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alternative Rehabilitation Strategies; Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm.	Behavioral: Alternative rehabilitation strategies; Counseling intervention.
Active Comparator: Usual Care; Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone.	Behavioral: Usual Care; Usual care audiology pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Potential Participants Approached	Up to Month 3
Number of Potential Participants Screened	Up to Month 3
Percentage of Screened Participants with Hearing Loss	Up to Month 3

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Intervention Arm Participants who Complete Counseling Session	Up to Month 3
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours	Up to Month 3
Percentage of Participants who Respond to 3-Month Follow-Up	Month 3

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: David Friedmann, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Deafness
• Other Study ID Numbers: 23-00648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.friedmann@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to David.friedmann@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No