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)

Sponsor
University of Pretoria
Study ID
NCT06982716
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lexie Lumen Hearing Aids — DEVICE
    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.
  • Go Ultra Hearing Aids — DEVICE
    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.

Study Details

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.

Key Dates

First listed
May 21, 2025
Start date
May 21, 2025
Status verified
Aug 2025
Primary completion
Dec 1, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: In-situ Group
    * The CHW will fit each participant in the in-situ group with the Lumens programmed using the smartphone-based in-situ (proprietary algorithm based on the NAL-NL2) fitting. * Participants will select the listening environment they feel most comfortable with.
  • Other: Control Group
    * Participants in the control group will be fitted with Lumens programmed using minimal gain (10 dB gain across frequencies regardless of degree of HL). This will be conducted by the CHW. * Participants will select the listening environment they feel most comfortable with.
  • Experimental: Pre-set Group
    ● The CHW will fit each participant in the pre-set group with Go Ultra hearing aids on one of the four pre-set programs. Participants will select the program they feel most comfortable with.

Primary Outcome Measure

International Inventory for Hearing Aids (IOI-HA) [ Time Frame: The primary endpoint will be at the six-week follow-up. However, data will be collected at the 6 week, 12 week, 26 week and 52 week follow-up. ]

Central Contacts

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