Tuned App Self-Fitting vs. Professional Fitting

Tuned Ltd.

Status: Completed

Conditions: Hearing Loss

Treatments: Device: professional fitting vs. self fitting

Study type: Interventional

Funder types: Industry

Identifiers

NCT05869266

TU1-PLN-111

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Professional-fitting

Active Comparator group

Description:

Subject receives hearing aids and a licensed professional performs the hearing aid fitting using professional programing tools, and the thresholds that were obtained from the traditional audiometry. Subject uses the professionally fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

Treatment:

Device: professional fitting vs. self fitting

Self-fitting

Active Comparator group

Description:

Subject receives hearing aids, downloads the Tuned self fitting App and performs self-fitting of the hearing aids including a self-hearing test. Subject uses the self fitted hearing aids for two weeks then completes COSI and the IOI-HA questionnaires.

Treatment:

Device: professional fitting vs. self fitting