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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05280808
Enrollment
27
Registered
2022-03-15
Start date
2022-03-18
Completion date
2022-11-29
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Brief summary

The purpose of the study is to evaluate the efficacy of a prototype app for the 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.

Interventions

DEVICEExperimental phone app used for self-fitting of hearing aids

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

Sponsors

Sonova Audiological Care Australia Pty Ltd
CollaboratorUNKNOWN
Sonova AG
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in preferences for fitted settings and fitting method over 30 daysDay 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.
Change in experimental self-fitting phone app use over 30 daysDays 1-30The 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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026