N/A
N=30
Direct-to-Consumer Hearing Aids and Listening Effort
Hearing Loss · Hearing Loss, Sensorineural · Hearing Loss, Bilateral
Bottom Line
View on ClinicalTrials.gov: NCT05855005 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
May 2024
Primary outcome: Primary: Diapix Conversation Task: Average Time Per Correctly Identified Difference — 2.47; 2.45 Minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DTC Hearing Aids (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diapix Conversation Task: Average Time Per Correctly Identified Difference |
2.47; 2.45 | — |
| SECONDARY Pupillometry and Recall Repeat Task (RRT) |
23; 18; 21 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05855005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.