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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Self-monitoring of hearing aids using artificial intelligence; Other: Traditional hearing care at our clinics.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Milijana M Malmberg, PhD; Phone Number: +46703803663; Email: milijana.lundberg.malmberg@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; Self-monitoring of hearing aids using artificial intelligence
Other: Standard care; All participants in this group are offered traditional hearing care.	Other: Traditional hearing care at our clinics.; Traditional hearing care at our clinics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Oriented Scale of Improvement	Not reporting score on a scale.	From enrollment to the end of treatment at 6 months
Communication Strategies Scale of the Communication Profile for the Hearing Impaired	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.	From enrollment to the end of treatment at 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Outcome Inventory for Hearing Aids	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.	At the end of treatment at 6 months

Collaborators and Investigators

• Sponsor: Sodra Alvsborgs Hospital
• Investigators: Principal Investigator: Milijana M Malmberg, PhD, Habilitering & Hälsa

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: Self-monitoring of HAs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No