WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users

NCT07690670 | Recruiting

• 2 other identifiers: HUM011/07245R33DC020134
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Hearing Loss

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

Outcome Measures

Primary Outcomes (1)

• 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

  Five-week follow-up

Secondary Outcomes (4)

• International Outcome Inventory for Hearing Aids (IOI-HA)

  Five-week follow-up

• Revised Hearing Handicap Inventory and Screening Tool (RHHI-S)

  Baseline and five-week follow-up

• Berkman-Syme Social Network Index (SNI)

  Baseline and five-week follow-up

• Hearing Aid Skills and Knowledge Inventory (HASKI-Clin)

  Five-week follow-up

Study Arms (2)

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.

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.

Device: Go Ultra Hearing Aids; Other: Paper-Based Support Programme

Interventions

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.

Control group (paper-based support); Experimental group (WhatsApp-delivered AI-enabled support)

WhatsApp-delivered AI-enabled support OTHER

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.

Experimental group (WhatsApp-delivered AI-enabled support)

Paper-Based Support Programme OTHER

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.

Control group (paper-based support)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pretoria: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Atteridgeville Community

Pretoria, Province, 0008, South Africa

RECRUITING

Khayelitsha Community

Cape Town, Western Cape, 7784, South Africa

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• De Wet Swanepoel, PhD Audiology

  University of Pretoria

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Frisby, PhD Audiology

CONTACT

+27 78 300 2511; caitlin.frisby@up.ac.za

Tersia de Kock, MA (Audiology)

CONTACT

+27 84 514 2086; tersia@hearxfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor De Wet Swanepoel

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)