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

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

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Experimental phone app used for self-fitting of hearing aids

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Melbourne Support Office and Clinic/Teleaudiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental phone app; Experimental phone app for self-fitting of hearing aids	Device: Experimental phone app used for self-fitting of hearing aids; This software allows participants to set up hearing aids as appropriate for their hearing loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in speech perception after 30 days	The online Speech Perception Test developed by Blamey Saunders Hearing will be used to assess the effect of the intervention on speech perception.	Day 1 and Day 30
Change in self-rated hearing ability after 30 days	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.	Day 1 and Day 30
Softest sounds that can be heard	The intervention will be used to measure the softest sounds that can be heard at different tone frequencies.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in preferences for fitted settings and fitting method over 30 days	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.	Day 1, Day 10, Day 20 and Day 30.
Change in experimental self-fitting phone app use over 30 days	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.	Days 1-30

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Sonova Audiological Care Australia Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2022
• Primary Completion (ACTUAL): November 29, 2022
• Study Completion (ACTUAL): November 29, 2022

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (ACTUAL): March 15, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: SRF-385

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
• product manufactured in and exported from the U.S.: No