NCT07255586

Brief Summary

This project investigates how self-monitoring of hearing aids through an AI-based mobile app can complement physical and digital healthcare visits. The aim is to increase patient involvement in rehabilitation, enable hearing aid adjustments in everyday sound environments, and improve access to hearing care.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Jul 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 24, 2026

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

September 30, 2025

Last Update Submit

April 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hearing Handicap Inventory for the Elderly-Screening

    Evaluates self-perceived psychosocial and emotional effects of hearing loss. Min 0 to max 100 points. Higher points equal greater self-perceived hearing problems.

    From enrollment to the end of treatment at 6 months

Secondary Outcomes (2)

  • Client Oriented Scale of Improvement

    From enrollment to the end of treatment at 6 months

  • Communication Strategies Scale of the Communication Profile for the Hearing Impaired

    From enrollment to the end of treatment at 6 months

Other Outcomes (1)

  • International Outcome Inventory for Hearing Aids

    At the end of treatment at 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Self-monitoring of hearing aids. ALl participants in this group are offered self-monitoring of hearing aids.

Device: Self-monitoring of hearing aids using artificial intelligence

Standard care

OTHER

All participants in this group are offered traditional hearing care.

Other: Traditional hearing care at our clinics.

Interventions

Self-monitoring of hearing aids using artificial intelligence

Intervention group

Traditional hearing care at our clinics

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who are eligible for a new or renewed hearing rehabilitation process at four of the Hearing organizations audiology clinics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Milijana M Malmberg, PhD

    Habilitering & Hälsa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 30, 2025

First Posted

December 1, 2025

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

April 24, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share