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Completed

NCT Number: NCT05280808

Evaluation of Software for Self-Fitting of Hearing Aids by People With Hearing Loss

The purpose of the study is to evaluate the efficacy of a prototype app for the self-fitting of hearing aids.

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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

Primary location

Melbourne Support Office and Clinic/Teleaudiology

Carlton, Victoria, 3053, Australia

About this study

After being informed about the study and potential risks, clients giving written informed consent will be enrolled as participants. Each participant will use the app to self-fit and fine-tune the study aids over 30 days. Outcome measures include speech perception tests, questionnaires and the need for support with using the app. Own-aid performance is the reference, while unaided performance is the baseline.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Online client
  • Daily aid use
  • Bilateral aid use
  • Uses P70-R or P90-R aids (same model both ears)
  • Does not use earmolds
  • Uses same soft tip on both aids
  • Owns iPhone7/iOS12 or later
  • Willing to install prototype app on own phone and use it in study
  • Willing to participate in study for 30 days

Exclusion criteria

  • Dexterity or cognitive issues that would be problematic for using the app in the study

Treatment and study plan

Experimental phone app used for self-fitting of hearing aids

Device

This software allows participants to set up hearing aids as appropriate for their hearing loss

Primary outcomes

  1. Change in speech perception after 30 days

    Time frame: Day 1 and Day 30

    The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception.

  2. Change in self-rated hearing ability after 30 days

    Time frame: Day 1 and Day 30

    An expanded version of the Client Oriented Scale of Improvement questionnaire will be used to assess the effect of the intervention on self-rated hearing ability in different listening situations.

  3. Softest sounds that can be heard

    Time frame: Day 1

    The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.

Secondary outcomes

  1. Change in preferences for fitted settings and fitting method over 30 days

    Time frame: Day 1, Day 10, Day 20 and Day 30.

    A custom questionnaire will be used to assess preferences for the fitted settings and fitting method of the intervention as these preferences evolve over time.

  2. Change in experimental self-fitting phone app use over 30 days

    Time frame: Days 1-30

    The use of the experimental self-fitting phone app will be automatically logged every day to assess changes in how the app is used over time.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Sonova Audiological Care Australia Pty Ltd

Registry information

Official study title

Device Clinical Trial of the Efficacy of Using Novel Remote Self-fitting Software Compared With Standard Remote Fitting Software in the Customisation of Hearing-aid Settings for Adults With Hearing Loss

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 15, 2022
Registry last updated
Feb 6, 2023

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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