An interventional study of Go Ultra Hearing Aids and WhatsApp-delivered AI-enabled support in Hearing Loss, sponsored by University of Pretoria. Recruiting at 2 sites in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Pretoria · Not applicable, Interventional, and Treatment
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 evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme for adults receiving preset hearing aids in low-resource community settings. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push programme of 16 voice notes and images delivered over four weeks, and (ii) an on-demand artificial-intelligence (AI) conversational support agent available throughout the four-week intervention period. The primary objective is to determine whether this WhatsApp-delivered AI-enabled programme results in superior hearing aid self-efficacy compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting. By comparing hearing aid self-efficacy, hearing aid outcomes, and user engagement between the intervention (WhatsApp AI-enabled) and control (paper-based) groups, this study seeks to establish whether AI-enabled digital delivery provides superior support and leads to better self-efficacy for first-time hearing aid users compared to traditional paper-based methods.
This study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme, compared to traditional paper-based support, for adults receiving preset hearing aids in community-based settings in South Africa. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push component consisting of 16 voice notes and images sent over four weeks, covering hearing aid use, maintenance, troubleshooting, and communication strategies; and (ii) an on-demand AI conversational support agent available throughout the four-week intervention period, enabling participants to ask free-text questions and receive individualized, educationally-bounded responses. The two components are conceived as complementary: structured content delivers a planned curriculum at the right pace for acclimatization, while the AI agent answers ad-hoc questions and addresses individual concerns as they arise. We hypothesize that this WhatsApp-delivered AI-enabled intervention will result in superior hearing aid self-efficacy at five weeks post-fitting compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting.
To test this hypothesis, we will conduct a two-arm randomized controlled trial with blinded outcome assessment, in which all participants receive preset hearing aids fitted by trained community healthcare workers (CHWs). Participants will be randomly assigned to one of two groups:
This design compares two delivery models for hearing aid support information, a WhatsApp-delivered AI-enabled programme versus traditional paper-based provision, for first-time hearing aid users in low-resource community settings. Follow-up occurs one week after completion of the 4-week intervention. Therefore, follow-up visits to complete outcome measures will be conducted at five weeks post-fitting to ensure all experimental group participants have completed the intervention.
The primary outcome will be hearing aid self-efficacy, assessed using the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) global score at five weeks post-fitting. Secondary outcomes will include self-reported average daily use assessed using an open-ended question, self-reported hearing aid benefit, use, and satisfaction as measured by the International Outcome Inventory for Hearing Aids (IOI-HA), perceived hearing handicap assessed using the Revised Hearing Handicap Inventory - Screening (RHHI-S), hearing aid skills and knowledge assessed using the Hearing Aid Skills and Knowledge Inventory (HASKI), and social connectedness assessed using the Berkman-Syme Social Network Index (SNI). Device retention and any device-related issues will also be recorded as additional secondary outcomes. All participants will be provided with a contact number for CHWs should they require additional assistance.
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 demonstrated the feasibility of CHW-facilitated hearing aid fittings and the potential of digital support programmes to improve user outcomes. However, there is a lack of evidence from randomized controlled trials comparing digital versus traditional paper-based support in LMICs. By evaluating differences in hearing aid self-efficacy, hearing aid benefit, use, satisfaction, perceived handicap, and practical device skills, this study will provide evidence on whether mHealth-delivered support offers superior support compared to standard paper-based information.
If mHealth support demonstrates superior outcomes, it would justify scaling up digital acclimatization programmes as part of community-based hearing care models, leveraging widely available platforms such as WhatsApp to improve hearing aid success in underserved populations.
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's planned enrollment of 66 is above the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →University of Pretoria is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental group (WhatsApp-delivered AI-enabled support): receives the AI-enabled support and acclimatization programme delivered exclusively via WhatsApp, comprising (i) 16 structured voice notes and images delivered over four weeks and (ii) on-demand access to the AI conversational support agent throughout the four-week intervention period.
Device: Go Ultra Hearing Aids · Other: WhatsApp-delivered AI-enabled support
Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
Device: Go Ultra Hearing Aids · Other: Paper-Based Support Programme
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.
WhatsApp-delivered AI-enabled support and acclimatization programme: A pre-defined sequence of 16 voice notes and images, designed to provide clear and accessible information on the key aspects of hearing aid use, maintenance, troubleshooting, and communication strategies. Messages are delivered on a fixed schedule, sent every second day from the time of fitting over a 30-day period, to promote engagement and to support participants during the early acclimatization period. The voice notes and images are produced in English, isiXhosa, and Sepedi; participants receive content in the language they select at onboarding. On-demand access to an AI-assisted conversational support agent integrated into the same WhatsApp channel. The agent enables participants to ask free-text questions about hearing aid use, maintenance, troubleshooting, and communication strategies, and to receive individualized, educationally grounded responses.
Printed pamphlet. The pamphlet covers the same content domains as Component 1 of the experimental intervention: hearing aid use, maintenance, troubleshooting, and communication tips, presented in clear and concise language with supporting illustrations. The pamphlet includes information in English, isiXhosa, and Sepedi; participants can read the version in their preferred language. This approach reflects current community-based fitting practice, in which information is typically provided once during the fitting session, with no structured follow-up support. Participants retain the pamphlet and may refer to it at any time.
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (West \& Smith, 2007) is a 24-item self-report instrument measuring four factors: (1) Basic Handling, (2) Advanced Handling, (3) Adjustment, \& (4) Aided Listening. Each item is rated on a 0-100% confidence scale in 10% increments (0% = no confidence at all, 100% = full confidence). The global score is the arithmetic mean of the 24 item responses \& ranges from 0 to 100, with higher scores indicating greater hearing aid self-efficacy. Subscale scores are calculated as the mean of the items contributing to each factor. A global score of 80% or higher is conventionally interpreted as high self-efficacy; scores below 80% indicate low to moderate self-efficacy. The MARS-HA has been translated into isiXhosa and Sepedi for use in this study; both translations underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018). Participants can complete in English , isiXhosa, or Sepedi
Time frame: Five-week follow-up
International Outcome 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, (iv) satisfaction, (v) residual participation restrictions, (vi) impact on others, and (vii) quality of life. Each item has five response choices, from worst to best outcome (Appendix V). The IOI-HA has been translated into the languages most commonly used in these communities, namely isiXhosa and Sepedi. All translated instruments underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018). The participants will have the option to complete the IOI-HA in either of these languages or in English. The IOI-HA total score (range 7-35; higher scores indicate better hearing-aid outcomes, including use, benefit, satisfaction, and quality of life) will be measured at 5 weeks post-fitting.
Time frame: Five-week follow-up
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). Each question has three possible responses: yes, sometimes, or no. The RHHI-S has been translated into the languages most commonly used in these communities, namely isiXhosa and Sepedi. All translated instruments underwent forward-backward translation and pilot testing for cultural equivalence (Hall et al., 2018). The participants will have the option to complete the RHHI-S in either of these languages or in English. RHHI-S total score (range 0-40; higher scores indicate greater perceived hearing handicap) will be measured at baseline and 5 weeks post-fitting (Appendix VI)
Time frame: Baseline and five-week follow-up
Berkman-Syme Social Network Index (SNI)
The SNI is a well-established tool used to assess the extent of an individual's social connections. The SNI examines the relationship between social networks and health outcomes. The SNI evaluates social integration by assessing four key domains: Marital status - Whether the individual is married or in a committed partnership. Contacts with close friends and relatives - Frequency of social interactions with family and friends. Religious group membership - Whether the individual is part of a church or religious group and attends regularly. Participation in voluntary or community organizations - Involvement in social or civic groups outside of family and work. The SNI assigns points based on the individual's responses to the above components. Scores range from 0 to 4, with higher scores indicating greater social integration. The SNI can be completed by the participants in English, isiXhosa or Sepedi
Time frame: Baseline and five-week follow-up
Hearing Aid Skills and Knowledge Inventory (HASKI-Clin)
The HASKI is a clinician-administered questionnaire designed to evaluate the practical skills \& knowledge of hearing aid users. It covers key areas such as basic handling (insertion, removal, cleaning, \& battery management), operational knowledge (using settings, adjusting controls, \& troubleshooting), communication strategies (effective use in different environments), self-management (accessing resources \& scheduling appointments), \& care \& maintenance (routine care \& recognizing when professional servicing is needed). This tool helps audiologists identify areas where users may need additional training or support, ultimately improving hearing aid outcomes \& user satisfaction. Scoring is calculated by summing the total number of items identified as competent (not problematic), dividing this by the number of items for which a response was given (i.e., excluding the "Not Applicable responses), and multiplying by 100 to give a percentage of competency. Items are equally weighted.
Time frame: Five-week follow-up
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