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NCT Number: NCT07255586

Self-monitoring of Hearing Aids Using Artificial Intelligence

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not fullfilling the inclusion criteria

Treatment and study plan

Self-monitoring of hearing aids using artificial intelligence

Device

Self-monitoring of hearing aids using artificial intelligence

Traditional hearing care at our clinics.

Other

Traditional hearing care at our clinics

Primary outcomes

  1. Hearing Handicap Inventory for the Elderly-Screening

    Time frame: From enrollment to the end of treatment at 6 months

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

Secondary outcomes

  1. Client Oriented Scale of Improvement

    Time frame: From enrollment to the end of treatment at 6 months

    Not reporting score on a scale.

  2. Communication Strategies Scale of the Communication Profile for the Hearing Impaired

    Time frame: From enrollment to the end of treatment at 6 months

    The CSS includes three subscales: the Maladaptive Behaviours, nine questions addressing strategies that complicate communication, and Verbal Strategies and Nonverbal Strategies, both of which address 16 items related to strategies that can improve communication. The scoring for all three subscales reflects how frequently a specific strategy occurs in different situations.

Other outcomes

  1. International Outcome Inventory for Hearing Aids

    Time frame: At the end of treatment at 6 months

    The IOI-HA measures seven different variables where higher points equal better outcomes. The variables are use, benefit, activity limitation, satisfaction, participation restriction, impact on environment, and quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Milijana M Malmberg, PhD

CONTACT

[email protected]

+46703803663

Sponsors and collaborators

Lead sponsor

Sodra Alvsborgs Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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