Direct-to-Consumer Hearing Aids and Listening Effort

Not Applicable

Completed

Conditions: Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral

Interventions: Device: DTC Hearing Aids

Registration Number: NCT05855005

Lead Sponsor: Northwestern University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

Inclusion Criteria

Speak English as their primary language
No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)
Bilateral mild to moderate sensorineural or mixed hearing loss
Pass a cognitive screener
Minimum Grade 10 education
Ability to attend all study visits
Eligible communication partner who can attend first study visit.

Exclusion Criteria

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
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
Diagnosis of dementia or cognitive impairment
Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)
Co-enrolled in other intervention studies targeting hearing, language, or communication strategies
History or current fluctuating hearing loss
Evidence of conductive hearing loss
Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day for most days within the past year)
Current active hearing aid wearer within 30-day trial period of purchased hearing aids from a licensed provider

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DTC Hearing Aid	DTC Hearing Aids	-

Primary Outcome Measures

Name	Time	Method
Diapix Conversation Task: Average Time Per Correctly Identified Difference	Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.	Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone. Primary measurement is average time for each correctly identified difference. A decrease in time indicates improved efficiency in the task.

Secondary Outcome Measures

Name	Time	Method
Pupillometry and Recall Repeat Task (RRT)	Task will be completed at second study visit (about one hour). second visit usually takes place 1-2 weeks after first visit.	Participant completes the RRT, a measure of memory and reported listening effort where the listener repeats pre-recorded sentences as they are presented and is then asked to recall them 15 seconds later.