Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

PCORI has identified hearing loss as an important research topic. Patients, caregivers, clinicians, and others want to learn: How do treatments for mild to moderate age-related hearing loss, such as hearing aids and other supports, compare? To help answer this question, PCORI launched an initiative in 2019 on Treatment Options for Age-Related Hearing Loss. The initiative funded this research project and others.

What is the research about?

Age-related hearing loss affects more than 40 percent of adults over age 60 in the United States. Hearing aids are an effective way to treat hearing loss. But few adults with hearing loss use hearing aids. Until recently, people with hearing loss could only get hearing aids from a healthcare professional with a license to fit hearing aids, such as an audiologist. In 2017, a federal law was passed that allows people buy hearing aids over the counter without seeing an audiologist. Once regulations based on this law are published, people should be able to get hearing aids over the counter.

Researchers have tested ways for people to get hearing aids over the counter and found them to be effective. In this study, the research team is comparing two of these over-the-counter, or OTC, ways for people to get hearing aids with usual care from an audiologist.

Who can this research help?

Once regulations permitting OTC hearing aids are published, results may help

  • People with hearing loss decide how to get hearing aids
  • Healthcare professionals decide what advice to give their patients

What is the research team doing?

The research team is enrolling 591 people with age-related hearing loss from Chicago, Illinois, and Galveston, Texas, who have never used hearing aids. The team is assigning people by chance to one of the three ways to get a hearing aid.

In the first way, usual care, an audiologist helps the person pick the color and fit of the hearing aids; then they adjust the settings to match the person’s hearing loss. This way doesn’t involve getting hearing aids over the counter.

In the second and third ways, people get hearing aids over the counter, without help from an audiologist. The person uses a tablet computer to select the color and fit of the hearing aids. The person then compares different settings on the hearing aids while playing different sounds through the tablet. The tablet guides the person to choose the setting they like the most. In the second way, the person can compare different volume settings. In the third way, the person can compare settings for both volume and pitch.

People in the study are filling out surveys six weeks and six months after they start using hearing aids. The surveys ask people how well they hear in different settings and how much hearing loss affects their quality of life. The research team is comparing these outcomes for people in the three groups.

People with hearing loss, audiologists, and representatives from the hearing industry are giving the research team feedback on the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 350 adults ages 50–79 with age-related hearing loss
  • Brief consumer decides model
  • Efficient fit model
  • Usual care from an audiologist

Primary: hearing aid effectiveness, hearing-related quality of life, hearing aid self-efficacy

Secondary: ability to use hearing aid

Timeframe 6-week follow-up for primary outcomes

Project Information

Sumitrajit Dhar, PhD, MS
Northwestern University
Comparison of Direct-to-Consumer Treatments Using Hearing Devices and Behavioral Training

Key Dates

November 2019
June 2024

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 28, 2024