Community-based hearing aid fittings by community healthcare workers using smartphone-guided and pre-set devices in low- and middle-income communities.
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)
This project will test whether community healthcare workers using smartphone-guided and pre-set hearing aid fittings help adults with mild-to-severe hearing loss in low- and middle-income communities hear better than minimal amplification.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pretoria Academic / other |
| Locations | 3 sites (Pretoria, Gauteng and 2 other locations) |
| Trial ID | NCT06982716 on ClinicalTrials.gov |
What this trial studies
This is a single-blind randomized controlled trial conducted in South African communities that compares smartphone-based in-situ (NAL-NL2) fittings and pre-set hearing aid fittings delivered by community healthcare workers (CHWs) against a minimal amplification control (flat 10 dB gain). Adults with bilateral mild-to-severe hearing loss (20 to <80 dB PTA) will be enrolled and randomized to one of the fitting approaches, using commercially available devices (Lexie Lumen, Go Ultra). Self-reported hearing benefits will be the primary outcome with follow-up visits at about 6 and 12 weeks to capture short-term outcomes and device usage. The design uses CHWs and mHealth tools to test a scalable, community-delivered service model in low- and middle-income settings.
Who should consider this trial
Good fit: Adults aged 18 and older with confirmed bilateral mild-to-severe hearing loss (20 to <80 dB PTA), no active middle ear disease, and willingness to attend 6- and 12-week follow-ups are ideal candidates.
Not a fit: People with very severe hearing loss (≥80 dB PTA), unilateral loss, active middle ear pathology, or those unable/unwilling to attend follow-ups are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could expand affordable, locally delivered, and effective hearing aid fittings that improve hearing and daily functioning for adults in low- and middle-income communities.
How similar studies have performed: Prior pilot studies and task-shifting/mHealth projects have shown promise for CHW-delivered and smartphone-guided hearing care, but randomized controlled evidence in low- and middle-income settings is still limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pretoria, Gauteng and 2 other locations
- Atteridgeville Community — Pretoria, Gauteng, South Africa (Recruiting)
- Khayelitsha Community — Cape Town, Western Cape, South Africa (Recruiting)
- Paarl Valley — Paarl, Western Cape, South Africa (Recruiting)
Study contacts
- Principal investigator: Professor De Wet Swanepoel, PhD Audiology — University of Pretoria
- Study coordinator: Caitlin Frisby, PhD Audiology
- Email: caitlin.frisby@up.ac.za
- Phone: +27 78 300 2511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.