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Can smarter hearing aids keep aging brains sharp?

NCT ID NCT06495268

Disease control Sponsor: Kuopio University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a personalized, data-driven hearing rehabilitation program can improve hearing, thinking, and quality of life in older adults with mild to moderate hearing loss. Two hundred first-time hearing aid users will be randomly assigned to either the new personalized approach or standard care. The main goal is to see if the personalized method leads to better speech understanding in noisy environments.

What this could mean

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

Active substance
individualized data-driven hearing rehabilitation using real-ear measurements
What this could lead to
If successful, this could point toward a more effective way to treat hearing loss and potentially slow cognitive decline in older adults.
What could go wrong
This is a small, early proof-of-concept trial with 200 participants, so results may not apply broadly. The intervention is complex and may not show clear benefits over standard care.

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 200 people

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

Started

Oct 2024

Expected to finish

Feb 2028

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

65 to 84 years

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: * Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), as per Global Burden of Disease Expert Group on Hearing loss criteria) * Community-dwelling, i.e. living at home / not living in a care home or nursing home * Proficiency in Finnish language * First-time hearing aid user Exclusion Criteria: * Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutive frequencies) * Difference between hearing levels of the ears is more than 15dB (HL) in three consecutive frequencies * Hearing aid contraindication * Previously diagnosed dementia, or current use of cholinesterase inhibitors and/or memantine. If there is a current ongoing diagnostic process for suspected dementia, the decision on eligibility will be made by an experienced study physician based on medical records and clinical judgement. * Any health conditions severely impairing vision, mobility, communication, and/or ability to participate in study visits and complete study assessments, as judged by the study nurse and/or physician.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction hearing loss disorder Hearing Loss, Sensorineural sensorineural hearing loss disorder X-linked mixed hearing loss with perilymphatic gusher

As listed by the trial registrant

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

Cognitive decline Sensorineural hearing loss

Contacts and locations

Locations

  • Kuopio University Hospital

    Kuopio, 70210, Finland

More trials for these conditions

Other studies related to the condition(s) this trial covers.