Clinical trial NCT05855005: Direct-to-Consumer Hearing Aids and Listening Effort
Official title: Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Diapix Conversation Task: Average Time Per Correctly Identified Difference
timeFrame: Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.
Secondary outcomes:
measure: Pupillometry and Recall Repeat Task (RRT)
timeFrame: Task will be completed at second study visit (about one hour). second visit usually takes place 1-2 weeks after first visit.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Pamela Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References: