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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)

RecruitingNAAges 18 Years - anyAllUniversity of Pretoria
NCT06982716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-facilit

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Lexie Lumen Hearing Aids
  • Go Ultra Hearing Aids
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Where

3 sites
Atteridgeville Community
Pretoria, South Africa
Khayelitsha Community
Cape Town, South Africa
Paarl Valley
Paarl, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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