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.
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
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.
Crossover
Lexie Lumen Hearing Aids
DeviceThe 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
DeviceGo 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.
International Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a validated seven-item questionnaire to measure the effectiveness of the hearing aid intervention (Cox and Alexander, 2002). It targets seven domains including, (i) daily use, (ii) benefit, (iii) residual activity limitations, (iii) satisfaction, (iv) residual participation restrictions, (v) impact on others, and (vi) quality of life. Each item is scored on a 5-point Likert scale, with higher scores indicating more favorable outcomes. The five response choices range from the worst (score of 1) to best (score of 5) outcome . The IOI-HA has been translated to the languages most commonly used in these communities namely isiXhosa and Sepedi. The participants will have the option to complete the IOI-HA in either of these languages or in English.
Revised Hearing Handicap Inventory and Screening Tool (RHHI-S)
The RHHI-S is a validated 10-item questionnaire that is a strong unidimensional, clinically informative measure of self-perceived hearing handicap that can be used by adults of all ages (Cassarly, Matthews, Simpson, \& Dubno, 2020). Respondents answer each item using a 3-point Likert scale: yes (4 points), sometimes (2 points), or no (0 points). The total score ranges from 0 to 40, with higher scores indicating greater self-perceived hearing handicap. The RHHI-S has been translated into the languages most commonly used in these communities, namely isiXhosa and Sepedi. The participants will have the option to complete the RHHI-S in either of these languages or in English.
EQ-5D-5L
The EQ-5D-5L is a standardized instrument used to measure generic health-related quality of life. It consists of two components: Descriptive System - This includes five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. Each dimension is rated on a 5-level Likert scale: 1 = No problems to 5 = Extreme problems / Unable to perform. The combination of responses defines a health state, which can be converted into an index value using a country-specific value set. Index scores typically range from less than 0 (health states worse than death) to 1 (perfect health). Visual Analogue Scale - A self-rated health score on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-5L has been translated into the languages most commonly used in these communities, namely isiXhosa and Northern Sotho (Sepedi). The participants will have the option to complete the EQ-5D-5L in either of these languages or in English.
Berman-Syme Social Network Index (SNI)
The Berman-Syme Social Network Index (SNI) evaluates participants' social connectedness based on four domains: (1) marital status, (2) frequency and quantity of contact with friends and relatives, (3) participation in religious meetings, and (4) involvement in community or organizational groups. Following the approach outlined by Loucks et al. (2006), responses are converted into binary scores and then summed to create a composite index ranging from 0 to 4. The total score reflects the degree of social integration, with higher scores indicating greater social connectedness.
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University of Pretoria
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Children's Hospital Medical Center, Cincinnati
Collaborator
