DeafnessNCT05943509
Hearing Program in Primary Care
A study testing Alternative rehabilitation strategies in people with Deafness, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deafness
- What is being tested?
- Alternative rehabilitation strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2024to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- speaks English or Spanish;
- capacity to consent to research
Who cannot join
- has or uses hearing aids or cochlear implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Deafness
- Being tested
- Alternative rehabilitation strategies, Usual Care
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative rehabilitation strategiesBehavioural
Counseling intervention.
Usual CareBehavioural
Usual care audiology pathway.
| Study group | Role | What they receive |
|---|---|---|
| Alternative Rehabilitation Strategies | Experimental | Patients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm. Receives: Behavioral: Alternative rehabilitation strategies |
| Usual Care | Active comparator | Patients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Potential Participants Approached
Measured: Up to Month 3
Number of Potential Participants Screened
Measured: Up to Month 3
Percentage of Screened Participants with Hearing Loss
Measured: Up to Month 3
Secondary outcomes (3)
Percentage of Intervention Arm Participants who Complete Counseling Session
Measured: Up to Month 3
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
Measured: Up to Month 3
Percentage of Participants who Respond to 3-Month Follow-Up
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start15 Feb 2024
- Primary completion18 Aug 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DeafnessStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Friedmann, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943509
- Sponsor's protocol ID
- 23-00648
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Friedmann DR, Diminich LN, Spitzer ER, Ajmal S, Weinstein B, Dickson V, Goldfeld KS, Chodosh J. Study protocol: feasibility of a hearing program in primary care for underserved older adults. Pilot Feasibility Stud. 2026 Feb 24;12(1):68. doi: 10.1186/s40814-026-01773-2.
PubMed 41736137
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Hearing Program in Primary Care for Underserved Older Adults
- ClinicalTrials.gov ID
- NCT05943509
- Acronym / sponsor ID
- 23-00648
- Conditions
- Deafness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 13 Jul 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Rehabilitation Strategies | Experimental | Behavioral: Alternative rehabilitation strategiesPatients who screened positive for hearing loss and were randomized into the counselling on alternative rehabilitation strategies intervention arm. |
| Usual Care | Active comparator | Behavioral: Usual CarePatients who screened positive for hearing loss and were randomized into the usual care audiology pathway control arm alone. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- speaks English or Spanish;
- capacity to consent to research
Key exclusion criteria (1 listed)
- has or uses hearing aids or cochlear implants
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 |
|---|---|---|
| Alternative rehabilitation strategiesCounseling intervention. | Behavioural | Alternative Rehabilitation Strategies |
| Usual CareUsual care audiology pathway. | Behavioural | Usual Care |
Primary outcome
Number of Potential Participants Approached
Time frame: Up to Month 3
Number of Potential Participants Screened
Time frame: Up to Month 3
Percentage of Screened Participants with Hearing Loss
Time frame: Up to Month 3
3 secondary outcomes
Percentage of Intervention Arm Participants who Complete Counseling Session
Time frame: Up to Month 3
Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
Time frame: Up to Month 3
Percentage of Participants who Respond to 3-Month Follow-Up
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Derived from this study: PubMed 41736137Friedmann DR, Diminich LN, Spitzer ER, Ajmal S, Weinstein B, Dickson V, Goldfeld KS, Chodosh J. Study protocol: feasibility of a hearing program in primary care for underserved older adults. Pilot Feasibility Stud. 2026 Feb 24;12(1):68. doi: 10.1186/s40814-026-01773-2.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
David Friedmann principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative rehabilitation strategies in people with Deafness, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Potential Participants Approached (time frame: Up to Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05943509, which also lists 1 linked publication.
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 2 Oct 2026; AzTrials last refreshed its copy on 28 Oct 2026.