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)

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 21, 2025

Primary Completion Date

December 1, 2026

Study Completion Date

December 15, 2026

Conditions
Hearing Loss
Interventions
DEVICE

Lexie Lumen Hearing Aids

The Lexie Lumens (Lexie Hearing) are self-fitting wireless air conduction hearing aids consisting of 16 channels, wide-dynamic-range compression technology, feedback reduction, Bluetooth connectivity and programming, digital noise reduction, and a directional microphone array. These hearing aids will be sourced at a cost of $240 USD per pair as this study will be conducted in low-income settings. The hearing aids allow for Bluetooth in-situ hearing aid fitting using the Lexie proprietary fitting algorithm that is based on the NAL/NL2 algorithm from a smartphone application (Lexie Hearing) based on the four hearing thresholds tested. These digital hearing aids were designed for use by adults over the age of 18 years with known or self-perceived mild-to-moderate hearing loss. The Lexie Lumens are behind-the-ear (BTE) hearing aids powered by replaceable batteries. Individuals can conduct an in-situ hearing test via the hearing aids for customized amplification or select a minimal gain.

DEVICE

Go Ultra Hearing Aids

Go Ultras (GoHearing) are rechargeable, BTE pre-set hearing aids with advanced audio features, digital sound processing and Bluetooth-streaming capabilities. Designed for adults with mild-to-moderate hearing loss, these hearing aids have four unique programs that the user can manually change to ensure optimal listening comfort. These devices have both program and volume memory functions, as well as noise and wind noise reduction. Go Ultras will be sourced at a cost of less than $130 USD per pair, as this study will be conducted in low-income settings.

Trial Locations (3)

7646

RECRUITING

Paarl Valley, Paarl

7784

RECRUITING

Khayelitsha Community, Cape Town

0008

RECRUITING

Atteridgeville Community, Pretoria

All Listed Sponsors
collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

lead

University of Pretoria

OTHER