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)

ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pretoria

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

90 Participants
are divided into 3 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