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

Hearing Loss Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280808
• Other study ID #: SRF-385
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: November 29, 2022

Study information

• Verified date: February 2022
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 29, 2022
• Est. primary completion date: November 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
Australia	Melbourne Support Office and Clinic/Teleaudiology	Carlton	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Sonova Audiological Care Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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