NCT06982716 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)
| NCT ID | NCT06982716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pretoria |
| Condition | Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-05-21 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-05-21 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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
Contact & Investigator
Professor De Wet Swanepoel, PhD Audiology
PRINCIPAL INVESTIGATOR
University of Pretoria
Frequently Asked Questions
Who can join the NCT06982716 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06982716 currently recruiting?
Yes, NCT06982716 is actively recruiting participants. Contact the research team at caitlin.frisby@up.ac.za for enrollment information.
Where is the NCT06982716 trial being conducted?
This trial is being conducted at Pretoria, South Africa, Cape Town, South Africa, Paarl, South Africa.
Who is sponsoring the NCT06982716 clinical trial?
NCT06982716 is sponsored by University of Pretoria. The principal investigator is Professor De Wet Swanepoel, PhD Audiology at University of Pretoria. The trial plans to enroll 90 participants.