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Smartphone hearing aid fits by community workers could transform ear care

NCT ID NCT06982716

Symptom relief Sponsor: University of Pretoria Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether community healthcare workers can effectively fit hearing aids using a smartphone app in low- and middle-income communities. 90 adults with mild to severe hearing loss will be randomly assigned to receive either a smartphone-based fitting, a pre-set fitting, or minimal amplification. The goal is to see if these simpler methods improve hearing and quality of life as much as traditional fittings.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lexie Lumen Hearing Aids (device)
What this could lead to
If successful, this could make hearing aids more accessible and affordable for people in low- and middle-income communities, improving their hearing and daily life.
What could go wrong
This is a small, early-stage trial with only 90 participants. The fitting method may not work as well as traditional audiology, and results may not apply to all settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 at least 6- and 12-week follow-ups. * Unilateral hearing loss

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atteridgeville Community

    RECRUITING

    Pretoria, Gauteng, 0008, South Africa

  • Khayelitsha Community

    RECRUITING

    Cape Town, Western Cape, 7784, South Africa

  • Paarl Valley

    RECRUITING

    Paarl, Western Cape, 7646, South Africa

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