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Improving Access and Affordability of Adult Hearing Healthcare

NCT04671381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2024-10-30

No results posted yet for this study

Summary

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

Conditions

Interventions

BEHAVIORAL

Hearing Evaluation

Behavioral thresholds for pure tones will be conducted along with speech perception measures.

DEVICE

Over-the-Counter Hearing Aid (OTC HA) Fitting and Orientation

Study participants will be fitted with binaural OTC HAs in addition to receiving information on how to use and care for their devices.

BEHAVIORAL

Four Weeks of Aural Rehabilitation

Participants will receive four weeks of information sessions to help them adjust to their over-the-counter hearing aid and their hearing loss.

DEVICE

Provision of Over-the-Counter Hearing Aids

Study participants will receive binaural OTC HAs. Participants will fit their OTC HAs based on manufacturer guidelines without the help of an audiologist.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Alabama, Tuscaloosa

    lead OTHER

Principal Investigators

  • Marcia J Hay-McCutcheon, PhD · The University of Alabama, Tuscaloosa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671381 on ClinicalTrials.gov