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Effects and mechanisms of family-supported over-the-counter (OTC) hearing aid use behavior intervention on outcomes among older adults with subjective cognitive decline

Effects and mechanisms of family-supported over-the-counter (OTC) hearing aid use behavior intervention on outcomes among older adults at high risk of dementia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126760
Enrollment
Unknown
Registered
2026-06-15
Start date
2026-06-16
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective cognitive decline, hearing loss

Interventions

Intervention group:family-supported OTC hearing aid use behavior intervention (by online health education video courses) and patient-reported outcome (PRO) questionnaire
Control group:iFLYTEK OTC hearing aid use and without additional behavior intervention

Sponsors

Peking University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Participants should meet all of the following conditions: 1. Participants aged between 50 and 85 years old; 2. The pure-tone average (PTA) of the participants' better ear at 250, 500, 1k, 2k, and 4kHz was between 35-80db HL (excluding 80); 3. Participants were evaluated as subjective cognitive decline according to the Subjective Cognitive Decline scale-nine item (SCD-Q9>3); 4. Participants can understand the complete the intervention plan and the outcome assessment scales; 5. Participants have purchased iFLYTEK OTC hearing aids through the internet and undergone online audiometry and remote fitting based on the "iFLYTEK Hearing Health APP". Currently, they are users who have been wearing OTC hearing aids for less than 3 months; 6. Participants have support from their family caregivers and family caregivers are defined as family members who provide unpaid daily care and medical assistance to the research subjects, and have taken on the primary caregiving responsibilities for the research subjects in the past two years; 7. Participants sign an informed consent form and participated voluntarily.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following conditions will be excluded: 1. Participants with asymmetrical hearing loss (the difference in PTA between two ears was 30 db HL and above); 2. Participants have medical contraindications for hearing aid use (such as progressive or fluctuating hearing loss, sudden sensorineural hearing loss within the past three months, accompanied by otorrhea, ear pain, dizziness or headache, congenital or traumatic ear deformity, etc.); 3. Participants are engaging in another intervention project currently.

Design outcomes

Secondary

MeasureTime frame
Adherence on OTC hearing aid use;Motivation of OTC hearing aid use;OTC hearing aid skills;Subjective cognitive function;Quality of life;

Primary

MeasureTime frame
Outcome for OTC hearing aids;

Countries

China

Contacts

Public ContactYanan Luo

Department of Global Health, School of Public Health, Peking University

luoyanan@bjmu.edu.cn+86 10 8280 6537

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026