Self-monitoring of Hearing Aids Using Artificial Intelligence

NCT ID: NCT07255586

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Considering the growing population, healthcare is increasingly focusing on integrating digital solutions into care. Such solutions typically require active patient participation and have the potential to positively impact person-centered care.

The purpose of this project is to investigate the outcomes of complementing physical and/or digital hearing care visits with patient self-monitoring of hearing aids. Participants will undergo the standard steps of the hearing rehabilitation process. In addition, the intervention group will be offered the opportunity to self-monitor their hearing aids between physical and/or digital appointments using artificial intelligence (AI) integrated into a mobile application provided by a hearing aid supplier.

The focus is to increase patient involvement in the rehabilitation process, utilize adjustment possibilities in everyday sound environments, and improve access to hearing care for the target population.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Self-monitoring of hearing aids using artificial intelligence

Intervention Type DEVICE

Self-monitoring of hearing aids using artificial intelligence

Standard care

All participants in this group are offered traditional hearing care.

Group Type OTHER

Traditional hearing care at our clinics.

Intervention Type OTHER

Traditional hearing care at our clinics

Interventions

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Self-monitoring of hearing aids using artificial intelligence

Self-monitoring of hearing aids using artificial intelligence

Intervention Type DEVICE

Traditional hearing care at our clinics.

Traditional hearing care at our clinics

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sodra Alvsborgs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Milijana Malmberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milijana M Malmberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Habilitering & Hälsa

Central Contacts

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Milijana M Malmberg, PhD

Role: CONTACT

+46703803663

Other Identifiers

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Self-monitoring of HAs

Identifier Type: -

Identifier Source: org_study_id

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