Hearing LossNCT07690670
WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users
A study testing Go Ultra Hearing Aids, WhatsApp-delivered AI-enabled support and Paper-Based Support Programme in people with Hearing Loss, run by University of Pretoria at 2 sites in South Africa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Go Ultra Hearing Aids, WhatsApp-delivered AI-enabled support and Paper-Based Support Programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 6 Jul 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Confirmed mild to severe (20 to < 80 dB PTA in both ears) hearing loss (determined during baseline assessments)
- Willing/available to commit to 5-week follow-up
- Must have access to their own personal WhatsApp
- Functional proficiency in English, isiXhosa, or Sepedi sufficient to provide informed consent and to self-complete the study outcome measures in one of these three languages, as judged by the recruiting CHW during the screening conversation.
Who cannot join
- 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.
- Unwilling/unavailable to commit to a 5-week follow-up.
- Unilateral hearing loss
- No access to WhatsApp/only has access via another individual's WhatsApp
- Home language other than English, isiXhosa, or Sepedi, where the individual does not have functional proficiency in any of these three languages.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa2 sites, 2 recruiting
- Recruiting
Khayelitsha Community
Cape Town, Western Cape, 7784
Tersia de Kock, MA (Audiology), +27 84 514 2086, tersia@hearxfoundation.org
Caitlin Frisby, PhD (Audiology), +27 78 300 2511, caitlin.frisby@up.ac.za
- Recruiting
Atteridgeville Community
Pretoria, Province, 0008
Caitlin Frisby, PhD Audiology, +27 78 300 2511, caitlin.frisby@up.ac.za
Tersia de Kock, MA(Audiology), +27 84 514 2086, tersia@hearxfoundation.org
About this study
Official title: A WhatsApp-Delivered AI-Enabled Support Programme Versus Paper-Based Support for First-Time Hearing Aid Users in Low-Resource Communities: A Randomized Controlled Trial
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.
Read the detailed description
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:
- 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.
- Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
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.
- Conditions
- Hearing Loss
- Being tested
- Go Ultra Hearing Aids, WhatsApp-delivered AI-enabled support, Paper-Based Support Programme
- Keywords
- hearing loss, community-based, hearing aid, service delivery model, community health workers, pre-set hearing aids, randomized controlled trial, mHealth, mHealth acclimatization, low- and middle-income
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go Ultra Hearing AidsDevice
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 supportOther
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.
Paper-Based Support ProgrammeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (WhatsApp-delivered AI-enabled support) | Experimental | 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. Receives: Device: Go Ultra Hearing Aids; Other: WhatsApp-delivered AI-enabled support |
| Control group (paper-based support) | Active comparator | Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting. Receives: Device: Go Ultra Hearing Aids; Other: Paper-Based Support Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Five-week follow-up
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: Five-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start6 Jul 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, two-arm, with blinded outcome assessment trial with 66 participants will be used. Randomization will be conducted before participant enrolment ensuring that each participant is assigned to one of the two study arms (Control or Experimental Group) before enrolling in the study. After baseline assessments to determine candidacy (T0), participants will be randomly assigned and be fitted with Go Ultra hearing aids and receive one of two interventions (T1). There will be one control group receiving paper-based support program only with one experimental group: mHealth support program only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, De Wet Swanepoel, University of Pretoria
- Investigators
- De Wet Swanepoel, PhD Audiology, Principal investigator, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690670
- Sponsor's protocol ID
- HUM011/0724
- Other IDs
- 5R33DC020134
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miola AC, Miot HA. P-value and effect-size in clinical and experimental studies. J Vasc Bras. 2021 Jul 5;20:e20210038. doi: 10.1590/1677-5449.210038. eCollection 2021. No abstract available.
PubMed 34267792Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Chadha S, Kamenov K, Cieza A. The world report on hearing, 2021. Bull World Health Organ. 2021 Apr 1;99(4):242-242A. doi: 10.2471/BLT.21.285643. No abstract available.
PubMed 33953438West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. doi: 10.1080/14992020701545898.
PubMed 18049965Stephens D. The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). Int J Audiol. 2002 Jan;41(1):42-7. doi: 10.3109/14992020209101311.
PubMed 12467369Mulwafu W, Ensink R, Kuper H, Fagan J. Survey of ENT services in sub-Saharan Africa: little progress between 2009 and 2015. Glob Health Action. 2017;10(1):1289736. doi: 10.1080/16549716.2017.1289736.
PubMed 28485648Meyer C, Hickson L, Fletcher A. Identifying the barriers and facilitators to optimal hearing aid self-efficacy. Int J Audiol. 2014 Feb;53 Suppl 1:S28-37. doi: 10.3109/14992027.2013.832420. Epub 2014 Jan 21.
PubMed 24447235Kelly-Campbell RJ, McMillan A. The Relationship Between Hearing Aid Self-Efficacy and Hearing Aid Satisfaction. Am J Audiol. 2015 Dec;24(4):529-35. doi: 10.1044/2015_AJA-15-0028.
PubMed 26650773Jorbonyan A, Abolfathi Momtaz Y, Foroughan M, Mehrkian S. Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Persian Version of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (P-MARS-HA). Audiol Res. 2025 Mar 15;15(2):31. doi: 10.3390/audiolres15020031.
PubMed 40126279Johnson CE, Jilla AM, Danhauer JL, Sullivan JC, Sanchez KR. Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. Semin Hear. 2018 May;39(2):158-171. doi: 10.1055/s-0038-1641742. Epub 2018 Jun 15.
PubMed 29915453Hall DA, Zaragoza Domingo S, Hamdache LZ, Manchaiah V, Thammaiah S, Evans C, Wong LLN; International Collegium of Rehabilitative Audiology and TINnitus Research NETwork. A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures. Int J Audiol. 2018 Mar;57(3):161-175. doi: 10.1080/14992027.2017.1393565. Epub 2017 Nov 21.
PubMed 29161914Fuentes-Lopez E, Fuente A, Valdivia G, Luna-Monsalve M. Does educational level predict hearing aid self-efficacy in experienced older adult hearing aid users from Latin America? Validation process of the Spanish version of the MARS-HA questionnaire. PLoS One. 2019 Dec 19;14(12):e0226085. doi: 10.1371/journal.pone.0226085. eCollection 2019.
PubMed 31856164Frisby C, Eikelboom RH, Mahomed-Asmail F, Kuper H, Moore DR, de Kock T, Manchaiah V, Swanepoel W. Mobile Health Hearing Aid Acclimatization and Support Program in Low-Income Communities: Feasibility Study. JMIR Form Res. 2023 Aug 23;7:e46043. doi: 10.2196/46043.
PubMed 37610802Ferguson MA, Woolley A, Munro KJ. The impact of self-efficacy, expectations, and readiness on hearing aid outcomes. Int J Audiol. 2016 Jul;55 Suppl 3:S34-41. doi: 10.1080/14992027.2016.1177214. Epub 2016 Jun 7.
PubMed 27266542Chen J, Shen Y, Lin Q, Feng Y, Li H. Translation of Chinese version of the measure of audiologic rehabilitation self-efficacy for hearing aids and the self-efficacy among hearing aid users in China: Application of the questionnaire. PLoS One. 2025 Aug 20;20(8):e0330163. doi: 10.1371/journal.pone.0330163. eCollection 2025.
PubMed 40834003
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A WhatsApp-Delivered AI-Enabled Support Programme Versus Paper-Based Support for First-Time Hearing Aid Users in Low-Resource Communities: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07690670
- Acronym / sponsor ID
- HUM011/0724
- Conditions
- Hearing Loss
- Keywords
- hearing loss, community-based, hearing aid, service delivery model, community health workers, pre-set hearing aids, randomized controlled trial, mHealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- Control group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, two-arm, with blinded outcome assessment trial with 66 participants will be used. Randomization will be conducted before participant enrolment ensuring that each participant is assigned to one of the two study arms (Control or Experimental Group) before enrolling in the study. After baseline assessments to determine candidacy (T0), participants will be randomly assigned and be fitted with Go Ultra hearing aids and receive one of two interventions (T1). There will be one control group receiving paper-based support program only with one experimental group: mHealth support program only.
| Arm | Type | Receives |
|---|---|---|
| Experimental group (WhatsApp-delivered AI-enabled support) | Experimental | Device: Go Ultra Hearing Aids, Other: WhatsApp-delivered AI-enabled supportExperimental 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. |
| Control group (paper-based support) | Active comparator | Device: Go Ultra Hearing Aids, Other: Paper-Based Support ProgrammeControl group (paper-based support): receives the equivalent core support information delivered exclusively in a printed pamphlet at the time of fitting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and older
- Confirmed mild to severe (20 to < 80 dB PTA in both ears) hearing loss (determined during baseline assessments)
- Willing/available to commit to 5-week follow-up
- Must have access to their own personal WhatsApp
- Functional proficiency in English, isiXhosa, or Sepedi sufficient to provide informed consent and to self-complete the study outcome measures in one of these three languages, as judged by the recruiting CHW during the screening conversation.
Key exclusion criteria (8 listed)
- 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.
- Unwilling/unavailable to commit to a 5-week follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Go Ultra Hearing AidsGo 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. | Device | Control group (paper-based support), Experimental group (WhatsApp-delivered AI-enabled support) |
| WhatsApp-delivered AI-enabled supportWhatsApp-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. | Other | Experimental group (WhatsApp-delivered AI-enabled support) |
| Paper-Based Support ProgrammePrinted 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. | Other | Control group (paper-based support) |
Primary outcome
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)
Time frame: Five-week follow-up
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
4 secondary outcomes
International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: Five-week follow-up
Revised Hearing Handicap Inventory and Screening Tool (RHHI-S)
Time frame: Baseline and five-week follow-up
Berkman-Syme Social Network Index (SNI)
Time frame: Baseline and five-week follow-up
Hearing Aid Skills and Knowledge Inventory (HASKI-Clin)
Time frame: Five-week follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 34267792Miola AC, Miot HA. P-value and effect-size in clinical and experimental studies. J Vasc Bras. 2021 Jul 5;20:e20210038. doi: 10.1590/1677-5449.210038. eCollection 2021. No abstract available.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Background: PubMed 33953438Chadha S, Kamenov K, Cieza A. The world report on hearing, 2021. Bull World Health Organ. 2021 Apr 1;99(4):242-242A. doi: 10.2471/BLT.21.285643. No abstract available.
- Background: PubMed 18049965West RL, Smith SL. Development of a hearing aid self-efficacy questionnaire. Int J Audiol. 2007 Dec;46(12):759-71. doi: 10.1080/14992020701545898.
- Background: PubMed 12467369Stephens D. The International Outcome Inventory for Hearing Aids (IOI-HA) and its relationship to the Client-oriented Scale of Improvement (COSI). Int J Audiol. 2002 Jan;41(1):42-7. doi: 10.3109/14992020209101311.
- Background: PubMed 28485648Mulwafu W, Ensink R, Kuper H, Fagan J. Survey of ENT services in sub-Saharan Africa: little progress between 2009 and 2015. Glob Health Action. 2017;10(1):1289736. doi: 10.1080/16549716.2017.1289736.
- Background: PubMed 24447235Meyer C, Hickson L, Fletcher A. Identifying the barriers and facilitators to optimal hearing aid self-efficacy. Int J Audiol. 2014 Feb;53 Suppl 1:S28-37. doi: 10.3109/14992027.2013.832420. Epub 2014 Jan 21.
- Background: PubMed 26650773Kelly-Campbell RJ, McMillan A. The Relationship Between Hearing Aid Self-Efficacy and Hearing Aid Satisfaction. Am J Audiol. 2015 Dec;24(4):529-35. doi: 10.1044/2015_AJA-15-0028.
- Background: PubMed 40126279Jorbonyan A, Abolfathi Momtaz Y, Foroughan M, Mehrkian S. Translation, Cross-Cultural Adaptation, and Psychometric Properties of the Persian Version of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (P-MARS-HA). Audiol Res. 2025 Mar 15;15(2):31. doi: 10.3390/audiolres15020031.
- Background: PubMed 29915453Johnson CE, Jilla AM, Danhauer JL, Sullivan JC, Sanchez KR. Benefits from, Satisfaction with, and Self-Efficacy for Advanced Digital Hearing Aids in Users with Mild Sensorineural Hearing Loss. Semin Hear. 2018 May;39(2):158-171. doi: 10.1055/s-0038-1641742. Epub 2018 Jun 15.
- Background: PubMed 29161914Hall DA, Zaragoza Domingo S, Hamdache LZ, Manchaiah V, Thammaiah S, Evans C, Wong LLN; International Collegium of Rehabilitative Audiology and TINnitus Research NETwork. A good practice guide for translating and adapting hearing-related questionnaires for different languages and cultures. Int J Audiol. 2018 Mar;57(3):161-175. doi: 10.1080/14992027.2017.1393565. Epub 2017 Nov 21.
- Background: PubMed 31856164Fuentes-Lopez E, Fuente A, Valdivia G, Luna-Monsalve M. Does educational level predict hearing aid self-efficacy in experienced older adult hearing aid users from Latin America? Validation process of the Spanish version of the MARS-HA questionnaire. PLoS One. 2019 Dec 19;14(12):e0226085. doi: 10.1371/journal.pone.0226085. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
De Wet Swanepoel, PhD Audiology principal investigator
University of Pretoria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Go Ultra Hearing Aids, WhatsApp-delivered AI-enabled support and Paper-Based Support Programme in people with Hearing Loss, run by University of Pretoria at 2 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caitlin Frisby, PhD Audiology (+27 78 300 2511, caitlin.frisby@up.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA) (time frame: Five-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07690670, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.