Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes

Summary

Age-related hearing loss is a big problem in the United States because many people have it and it affects their quality of life. Hearing aids can help, but not many people use them. One reason is that getting hearing aids can be expensive and difficult. People usually have to visit doctors, like audiologists, many times to get their hearing tested and have the hearing aids fitted and adjusted. This process is called the AUD service model in this study. Hearing aids come with different technologies and features, like directional microphones and noise reduction algorithms. These features can make hearing aids work better but also make them more expensive, which can be another barrier for people who need them.

Recently, over-the-counter (OTC) hearing aids have become available. These hearing aids are cheaper and easier to get because people can buy them directly and fit them on their own without seeing a doctor. This is called the OTC service model in this study. Another service model that could be great is a "hybrid" service model, where professionals help fit the OTC hearing aids. This hybrid model can make hearing aids both affordable and high quality.

Studies have shown that the OTC service model works as well as the AUD service model. Additionally, other research has found no big differences in how well high-end and low-end hearing aids work for patients. However, no one has studied the different service models and technology levels together in one study, and no one has looked at how well the hybrid service model (called the OTC+ service model in this study) works.

The goal of this study is to find out how the different ways of fitting hearing aids (AUD, OTC+, and OTC) and the different technology levels (high-end and low-end) affect patient outcomes. The study will take place at two sites and will be a randomized controlled trial. Participants will be randomly assigned to one of six groups, which are combinations of the three service models and two technology levels. Measurements will be taken before the hearing aids are fitted and again six to seven weeks after fitting to see how well the hearing aids are working for the patients.

Conditions

• Presbycusis

Interventions

OTHER

AUD fitting

Prescription hearing aids will be fitted by audiologists using established procedures.

OTHER

OTC+ fitting

Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.

OTHER

OTC fitting

In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.

DEVICE

High-end HA

High-end hearing aids will be used.

DEVICE

Low-end HA

Low-end hearing aids will be used.

Sponsors & Collaborators

• Vanderbilt University Medical Center

  collaborator OTHER

• National Institute on Deafness and Other Communication Disorders (NIDCD)

  collaborator NIH

• Yu-Hsiang Wu

  lead OTHER

Principal Investigators

• Yu-Hsiang Wu, PhD · University of Iowa

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-22

Primary Completion

2023-12-22

Completion

2023-12-22

FDA Device

Yes

Countries

• United States

Study Locations