Direct-to-Consumer Hearing Aids and Listening Effort

NCT ID: NCT05855005

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-25
• Study Completion Date: 2023-12-30

Brief Summary

The aim of this proposed project is to understand whether direct to consumer (DTC) hearing aids programmed to individual hearing losses, can reduce listening effort for effective communication. If DTC aids can provide benefits beyond amplification, then they could be an affordable option to reduce barriers to care and improve hearing aid uptake in adults with hearing loss.

Detailed Description

Hearing loss is the third most common chronic health condition in the United States, affecting individuals of any age. According to the National Institute on Deafness and Other Communication Disorders approximately 15% of all adults over age 18 in the United States have reported some trouble with their hearing, and one in eight people in the United States (about 30 million) aged 12 and older have hearing loss in both ears. However, about 28.8 million US adults who could benefit from hearing aids do not wear them. The current model of dispensing hearing aids could be a barrier to adoption by those who could benefit from amplification. Possible barriers from the current model include cost and ability to visit a hearing care professional required to purchase, adjust and repair a hearing aid.

The Food and Drug Administration (FDA) issued a proposal in 2021 to make hearing care more accessible for Americans, known as the Over-the-Counter Hearing Aid Act, part of the FDA Reauthorization Act of 2017. Unlike conventional hearing aids, these devices will not require appointments to an audiologist for adjustments. Due to their affordability and easy access, DTC hearing aids have the potential to reach more individuals with hearing loss. Despite the many potential benefits that DTC hearing aids could offer, there is little research into their use to meet unique patient listening needs and the accuracy of self-guided hearing aid fittings.

The investigators will evaluate the benefit of DTC hearing aids via questionnaires and a conversation task the participant engages in with a familiar speaker.

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DTC Hearing Aid

Group Type: EXPERIMENTAL

DTC Hearing Aids

Intervention Type: DEVICE

DTC hearing aid programmed to the individual participant.

Interventions

DTC Hearing Aids

DTC hearing aid programmed to the individual participant.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Speak English as their primary language

2. No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)

3. Bilateral mild to moderate sensorineural or mixed hearing loss

4. Pass a cognitive screener

5. Minimum Grade 10 education

6. Ability to attend all study visits

7. Eligible communication partner who can attend first study visit.

Exclusion Criteria

1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study

2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head/neck cancer

3. Diagnosis of dementia or cognitive impairment

4. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)

5. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies

6. History or current fluctuating hearing loss

7. Evidence of conductive hearing loss

8. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)

9. Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Pamela Souza

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Northwestern University

Evanston, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

STU00217791

Identifier Type: -

Identifier Source: org_study_id