Actively 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)
Led by University of Pretoria · Updated on 2025-09-05
90
Participants Needed
3
Research Sites
81 weeks
Total Duration
On this page
Sponsors
U
University of Pretoria
Lead Sponsor
N
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 study encompasses the following key aim: 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-income communities (LMICs). The primary goal is to determine the efficacy of CHW-facilitated smartphone-based in-situ hearing aid (HA) fittings (a proprietary fitting based on the NAL-NL2 algorithm) and pre-set HAs fittings compared to minimal amplification through a single-blind randomized controlled trial (RCT). By comparing self-reported benefits between the experimental and control groups, this aim seeks to demonstrate the superiority of the CHW-facilitated smartphone-based and pre-set hearing aid fittings compared to minimal amplification.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Confirmed mild to severe hearing loss (20 to < 80 dB PTA in both ears)
- Willing and available to attend at least 6- and 12-week follow-up visits
You will not qualify if you...
- 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 or active ear drainage
- Unwilling or unavailable to attend at least 6- and 12-week follow-up visits
- Unilateral hearing loss
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Atteridgeville Community
Pretoria, Gauteng, South Africa, 0008
Actively Recruiting
2
Khayelitsha Community
Cape Town, Western Cape, South Africa, 7784
Actively Recruiting
3
Paarl Valley
Paarl, Western Cape, South Africa, 7646
Actively Recruiting
Research Team
C
Caitlin Frisby, PhD Audiology
CONTACT
T
Tersia de Kock, MA (Audiology)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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