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About
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.
Full description
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). We hypothesize that amplification offered by smartphone-based in-situ hearing aid (HA) fittings and pre-set hearing aid fittings facilitated by CHWs have superior self-reported outcomes compared to minimal amplification.
To test this hypothesis, we will conduct a single-blind randomized controlled trial (RCT) where participants are assigned to either the experimental smartphone-based in-situ hearing aid fitting, pre-set hearing aid fitting, or minimal amplification fitting. A minimal amplification fitting provides only the most basic level of amplification without individualized adjustments. This level of amplification is primarily intended to prevent occlusion effects rather than to offer meaningful hearing benefits. In this study, a flat 10 dB gain will be provided across frequencies regardless of the degree of hearing loss. A placebo-controlled design is essential for assessing the true effectiveness of hearing aid interventions beyond non-specific effects such as participant expectations or the general experience of wearing a device. Comparing experimental conditions to minimal amplification ensures that any observed benefits are attributable to the intervention rather than psychological or external influences.
Outcomes will be measured by self-reported benefits, with control participants offered the smartphone-based in-situ fitting after six weeks. All participants will also receive a paper-based hearing aid acclimatization and support programme on the day of the hearing aid fitting to assist them in hearing aid use and maintenance. The participants will also be provided a contact number for the CHWs to contact if any assistance is needed.
Rationale Given the limited access to hearing care in LMICs due to prohibitive costs and scarcity of trained professionals, this study leverages mHealth solutions and task-shifting to CHWs as a sustainable and scalable approach. Preliminary studies have shown promising results for the components of these interventions, justifying the need for clinical trials to evaluate their effectiveness. By focusing on end-to-end smartphone-based in-situ hearing aid fittings and acclimatization support, this study aims to create an innovative and accessible model of hearing care that could significantly reduce the global burden of hearing loss.
Additionally, understanding the difference in outcomes between meaningful amplification and minimal amplification is crucial for guiding hearing care strategies in LMICs. If substantial benefits are observed in the experimental groups relative to minimal amplification, it strengthens the case for scaling up CHW-facilitated hearing aid provision as a cost-effective solution. Conversely, if minimal amplification yields similar self-reported outcomes, it may suggest that additional interventions (e.g., counseling, expectations management) are necessary for maximizing hearing aid benefits in these settings.
A randomized, three-arm, single-blind placebo trial (full blinding details below) with 90 participants will be used. The estimated timeline for trial completion is approximately 52 weeks post-hearing aid fitting. The clinical trial will be conducted across three sites (Khayelitsha and Drakenstein Districts in the Western Cape Province of South Africa and Atteridgeville District in the Gauteng Province of South Africa).
Randomization will be conducted before participant enrollment, ensuring that each participant is assigned to one of the three study arms (In-situ fitting, Pre-set fitting, or Minimal Gain fitting) before enrolling in the study.
After baseline assessments to determine candidacy (T0), participants will be randomly assigned and start with one of the three interventions (T1). There will be one placebo-control group with Lexie Lumen hearing aids fitted to minimal gain (i.e., 10 dB HL across the frequency range regardless of hearing loss levels) with two experimental groups: (i) In-situ hearing aid fitting using a proprietary algorithm on Lexie Lumen hearing aids that are based on the National Acoustics Laboratories Non-Linear Version 2 (NAL-NL2) algorithm (ii) Pre-set hearing aid fitting with Go Ultra hearing aids. Following fitting (T1), there will be a 6-week field trial, with follow-up visits scheduled at 6 weeks (T2). Following that, the minimal gain group (control) will be crossed over to in-situ fitting (CG-T2;), and another 6-week field trial will be conducted (follow up at CG-T3). Follow-up visits for the In-situ and Pre-set groups will occur again at 12 weeks (T3), 26 weeks (T4), and 52 weeks (T5).
The primary endpoint will be at the six-week follow-up. The primary outcome measure will be the IOI-HA. A difference of ≥3 points in the IOI-HA score is considered clinically significant based on prior research by Apple, representing a meaningful improvement in hearing aid benefit, satisfaction, and quality of life.
The secondary measures will be the RHHI-S and EQ-5D-5L. Baseline RHHI-S and EQ-5D-5L scores will be compared with scores obtained at subsequent follow-up visits.
Additionally, a questionnaire with Likert scale questions targeting functional use and meaningful life changes will be completed at all follow-up visits.
Procedure - All assessment and fitting procedures will be facilitated by the CHWs T0: Baseline assessment
T1: Hearing-aid fitting Once randomized into one of the three groups, participants will be booked for Visit 2 for hearing aid fitting. All participants will undergo otoscopy, and the participants (not the pre-set group) will undergo an in-situ hearing test via the Lumen hearing aids before the hearing aid fitting.
All groups (in-situ, control, and pre-set) will complete the baseline RHHI-S and EQ-5D-5L.
In-situ Group
Control Group
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.
T2: Follow-up #1 and cross-over for Control Group
T3: Follow-up #2 (Final follow-up for Control Group)
T4: Follow-up #3
T5: Final Review
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90 participants in 3 patient groups
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Central trial contact
Caitlin Frisby, PhD Audiology; Tersia de Kock, MA (Audiology)
Data sourced from clinicaltrials.gov
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