Tuned App Self-Fitting vs. Professional Fitting

A Prospective, Crossover Randomized Controlled Trial to Compare Subjective Outcome of a Self-fitting Process Using Tuned App to a Licensed Professional Fitting

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05869266

Enrollment

Registered

2023-05-22

Start date

2023-05-01

Completion date

2023-07-15

Last updated

2023-10-18

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

Conditions

Hearing Loss

Keywords

self fitting

Brief summary

The aim of the study is to compare the perceived outcome of the self-fitting performed by the participants using the Tuned mobile application with the traditional professional fitting as performed by a licensed professional audiologist in subjects with mild to moderate sensorineural hearing loss.

Interventions

DEVICEprofessional fitting vs. self fitting

Licensed professional fits the hearing aid fitting using professional programing tools and thresholds obtained from the traditional audiometry vs. subject performs self-fitting of the hearing aids using the Tuned App.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Intervention model description

Prospective, randomized crossover clinical study comparing two methods of fitting subjects with mild to moderate sensorineural hearing loss with hearing aids. Subjects will receive hearing aids and be assigned to professional-fitting arm or self-fitting arm, use the hearing aids for two weeks then switch to the other arm and use the hearing aids for another two weeks.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult males and females, 18 years and older. * Mild to moderate sensorineural hearing loss. * Own and able to use a smart phone (Android or iOS). * Able to read and understand Hebrew.

Exclusion criteria

* Conductive mixed hearing loss. * Unilateral hearing loss. * Any external or inner ear malformations. * Symptoms of ear disease or excessive cerumen.

Design outcomes

Primary

Measure	Time frame	Description
Comparison of self fitting and professional fitting by COSI scores	4 weeks	To compare the professional fitting and the self fitting using the Tuned App, the scores of Client Oriented Scale of Improvement (COSI) questionnaire will be used.

Secondary

Measure	Time frame	Description
Comparison of self fitting and professional fitting by IOI-HA scores	4 weeks	To compare the subjects' self-reported outcomes between professional fitting and self fitting using the Tuned App, the scores of the International Outcome Inventory for Hearing Aids (IOI-HA) questionnaires will be used.

Countries

Israel

Outcome results

None listed

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