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)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT06982716

Run by

University of Pretoria

People needed

90

Starts

2025-05-21

Expected to finish

2026-12-15

Last updated by the study team

2025-09-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atteridgeville Community — Pretoria, Gauteng, South Africa (enrolling)
• Khayelitsha Community — Cape Town, Western Cape, South Africa (enrolling)
• Paarl Valley — Paarl, Western Cape, South Africa (enrolling)

Full record on ClinicalTrials.gov

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