Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Conditions
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.
Interventions
DEVICEDTC Hearing Aids
DTC hearing aid programmed to the individual participant.
Sponsors
Northwestern University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DTC Hearing Aid DTC Hearing Aids: DTC hearing aid programmed to the individual participant. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | DTC Hearing Aid | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 21 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | — |
| Age, Continuous | 68 years STANDARD_DEVIATION 11.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Diapix Conversation Task: Average Time Per Correctly Identified Difference
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.
Time frame: Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTC Hearing Aid | Diapix Conversation Task: Average Time Per Correctly Identified Difference | Unaided | 2.47 Minute | Standard Deviation 0.87 |
| DTC Hearing Aid | Diapix Conversation Task: Average Time Per Correctly Identified Difference | Aided | 2.45 Minute | Standard Deviation 0.85 |
Secondary
Pupillometry and Recall Repeat Task (RRT)
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.
Time frame: Task will be completed at second study visit (about one hour). second visit usually takes place 1-2 weeks after first visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DTC Hearing Aid | Pupillometry and Recall Repeat Task (RRT) | Unaided 5 dB SNR Low Context | 23 percentage of words recalled | Standard Deviation 12.7 |
| DTC Hearing Aid | Pupillometry and Recall Repeat Task (RRT) | Aided (default program per Participant's loss) 5 dB SNR Low Context | 18 percentage of words recalled | Standard Deviation 11.12 |
| DTC Hearing Aid | Pupillometry and Recall Repeat Task (RRT) | Aided (Noise program) 5 dB SNR Low Context | 21 percentage of words recalled | Standard Deviation 12.5 |