Community-based hearing aid fittings by community healthcare workers using smartphone-guided and pre-set devices in low- and middle-income communities.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.