About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lexie Lumen Hearing Aids
- Go Ultra Hearing Aids
Treatment groups
Sponsors and collaborators
University of Pretoria
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator