Status:
RECRUITING
Evaluating the Clinical Effectiveness of a Community-based Hearing Aid Fitting Service Delivery Model Facilitated by Community Healthcare Workers (CHWs) Providing Smartphone-based In-situ and Pre-set Hearing Aid Fittings in Low- and Middle-income Communities (LMICs)
Lead Sponsor:
University of Pretoria
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Children's Hospital Medical Center, Cincinnati
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This stu...
Detailed Description
This study aims to establish the effectiveness of community-based hearing aid fittings facilitated by community healthcare workers (CHWs) using mobile health (mHealth) technologies in low- and middle-...
Eligibility Criteria
Inclusion
- 18 years and older
- Confirmed mild to severe (20 to \< 80 dB PTA in both ears; (World Health Organization, 2021)) hearing loss (determined during baseline assessments)
- Willing/available to commit to at least 6- and 12-week follow-ups
Exclusion
- Younger than 18 years
- Hearing loss too severe (≥80 dB HL PTA)
- Normal hearing (\<20 dB HL PTA)
- Middle ear pathology such as otitis media; active drainage from the ears.
- Unwilling/unavailable to commit to at least 6- and 12-week follow-ups.
- Unilateral hearing loss
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06982716
Start Date
May 21 2025
End Date
December 15 2026
Last Update
September 5 2025
Active Locations (3)
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1
Atteridgeville Community
Pretoria, Gauteng, South Africa, 0008
2
Khayelitsha Community
Cape Town, Western Cape, South Africa, 7784
3
Paarl Valley
Paarl, Western Cape, South Africa, 7646