New Approach to Objectively Measure Social Engagement in Older Adults With Hearing Loss

The goal of this clinical trial is to learn if hearing devices, like hearing aids, affect social and cognitive function of older adults. The main questions the researchers want to answer are:

• How social are older adults with hearing loss before and after using hearing devices?
• How well do older adults with hearing loss think before and after using hearing devices?
• For older adults who have hearing loss and use hearing devices, do changes in social interaction explain changes in how well they think (cognitive function)?
• Do brainwaves (EEGs) in older adults with hearing loss change after using hearing devices?
• Are there differences in how social older adults with hearing loss are compared to older adults without hearing loss?

What Participants Will Do:

• Participants will take questionnaires for around 60 minutes. Questionnaires will ask participants about their background, health, hearing, and how social they are. Another set of questionnaires will check their thinking ability or cognition.
• Participants will wear an audio sensor (TILES Audio Recorder on Jelly Mobile phone) for 2 weeks. The sensor will collect and store information about a participant's voice during conversations. Once the device has information about a participant's voice such as pitch and tone it will store this information and delete the audio recording. Words spoken during conversations will be deleted.
• (Optional) Participants can choose to participate in a 45-60-minute EEG (electroencephalogram) recording session. Participants will have sensors placed on top of their heads. Sensors will record the participants' brainwaves. Sounds will be played to see how participants' brainwaves change when they hear sounds. Eligible participants will be invited to participate in 4-month follow-up study.

Study Overview

• Status: Recruiting
• Conditions: Hearing Loss, Bilateral (Causes Other Than Tumors)
• Intervention / Treatment: Device: Hearing aid use

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Janet Choi, MD, MPH; Phone Number: 323-442-5790; Email: janet.choi@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles General Medical Center
      • Contact: Janet Choi, MD, MPH; Phone Number: 323-442-5790; Email: janet.choi@med.usc.edu
    • Los Angeles, California, United States, 90066
      • Recruiting
      • University of Southern California
      • Contact: Janet Choi, MD, MPH; Phone Number: 323-442-5790; Email: janet.choi@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals meeting the inclusion criteria will be recruited from the affiliated tertiary hospitals and hearing aid centers. Both individuals with audiometry-measured bilateral hearing loss who are clinically indicated for hearing aid fitting and healthy volunteers without hearing loss will be recruited to participant in the study.

Description

Inclusion Criteria:

• Age >= 60 years
• English or Spanish speaking
• Group 1- older adults with normal hearing defined as speech frequency PTA <25dB HL in bilateral ears
• Group 2- older adults with bilateral hearing loss who are not using hearing aids
• Group 3- older adults with bilateral hearing loss, who are currently using hearing aids

Exclusion Criteria:

• Age <60 years
• Unable to complete questionnaires in English or Spanish

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults without hearing loss; Hearing loss defined as speech-frequency pure-tone average >=25 dB HL bilaterally
Adults with bilateral hearing loss (hearing aid users); Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and currently using hearing aids.	Device: Hearing aid use; Hearing aid use will be discussed with all eligible participants with hearing loss and will be encouraged to pursue hearing aid fitting through standard clinical indications via participants' insurance and audiologists.
Adults with hearing loss (non-hearing aid users); Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average >=25 dB HL bilaterally) and not currently using hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Audio sensor- speech arousal	The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech arousal measures include the percentage of strong arousals, serving as a proxy of enhanced engagement in conversations.	Baseline, 4-month after hearing aid use
Audio sensor- speech activity	The audio sensor employs deep-learning-based multimodal speech pattern modeling of participants' own voice activities to extract speech arousal and speech activities. Speech activity measures include the intersession time (the interval between speech sessions, representing the frequency of conversation engagement).	Baseline and 4-month after hearing aid use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Measures	EEG Event Related Potentials (ERPs) are measures of cortical activities in response to auditory stimuli and provide information about cognitive processing, memory, and attention. Participants will complete auditory oddball tasks during EEG measurements and ERPs including P1, N1, P2, MMN, P3 will be recorded.	Baseline, 4-month after hearing aid use
Cognitive test- MoCA	Montreal Cognitive Assessment (MoCA) The MoCA is a brief cognitive screening tool assessing multiple domains including memory, attention, executive function, language, visuospatial skills, and orientation. The standard MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function (better outcomes).	Baseline and 4-month after hearing aid use
UCLA Loneliness Scale	The UCLA Loneliness Scale is a 20-item self-report measure assessing subjective feelings of loneliness and social isolation. Total scores range from 20 to 80, with higher scores indicating greater loneliness and worse outcomes. Minimum score: 20; maximum score: 80. Higher scores represent worse outcomes.	Baseline, optional 4 months follow-up
Lubben Social Network Scale (LSNS-6)	The Lubben Social Network Scale (LSNS-6) is a 6-item self-report measure assessing social engagement and perceived social support from family and friends. Total scores range from 0 to 30, with higher scores indicating larger and more supportive social networks (better outcomes). Minimum score: 0; maximum score: 30. Higher scores represent better outcomes.	Baseline, optional 4 months follow-up
Duke Social Support Index (DSSI-11)	The Duke Social Support Index (DSSI-11) is an 11-item self-report measure assessing social support across social interaction and subjective support domains. Total scores range from 10 to 30, with higher scores indicating greater perceived social support (better outcomes). Minimum score: 10; maximum score: 30. Higher scores represent better outcomes.	Baseline, optional 4 months follow-up
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S)	The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes.	Baseline, optional 4 months follow-up
Generalized Anxiety Disorder 7-item (GAD-7) Scale	The GAD-7 is a 7-item self-report questionnaire assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity and worse outcomes. Minimum score: 0; maximum score: 21. Higher scores represent worse outcomes.	Baseline, optional 4 months follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D is a 20-item self-report questionnaire assessing depressive symptoms in the general population over the past week. Total scores range from 0 to 60, with higher scores indicating greater depressive symptom severity and worse outcomes. Minimum score: 0; maximum score: 60. Higher scores represent worse outcomes.	Baseline, optional 4 months follow-up
Short Form Health Survey - 12 Item (SF-12)	The SF-12 is a 12-item self-report measure assessing overall health-related quality of life across physical and mental domains. Scores are typically summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. When reported as a combined or transformed total score ranging from 0 to 200, higher scores indicate better health-related quality of life (better outcomes). Minimum score: 0; maximum score: 200. Higher scores represent better outcomes.	Baseline, optional 4 months follow-up
Short Assessment of Health Literacy (SAHL)	The SAHL is an 18-item word recognition and comprehension test assessing health literacy. Total scores range from 0 to 18, with higher scores indicating better health literacy (better outcomes). Minimum score: 0; maximum score: 18. Higher scores represent better outcomes.	Baseline, optional 4 months follow-up

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: January 8, 2025
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: dementia; cognition; hearing loss; hearing aids
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dementia; Hearing Loss
• Other Study ID Numbers: UP-24-01177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No