An observational study in Hearing Loss, Bilateral (Causes Other Than Tumors), sponsored by University of Southern California. Recruiting at 2 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Southern California · Observational
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:
What Participants Will Do:
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 100 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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 loss defined as speech-frequency pure-tone average \>=25 dB HL bilaterally
Participants with bilateral hearing loss (defined as those with speech-frequency pure-tone average \>=25 dB HL bilaterally) and not currently using hearing aids.
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.
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).
Time frame: Baseline and 4-month after hearing aid use
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.
Time frame: Baseline, 4-month after hearing aid use
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, optional 4 months follow-up
Plan to share: No
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University of Southern California