MedPath

Tuned App Self-Fitting vs. Professional Fitting

Not Applicable
Completed
Conditions
Hearing Loss
Interventions
Device: professional fitting vs. self fitting
Registration Number
NCT05869266
Lead Sponsor
Tuned Ltd.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Professional-fittingprofessional fitting vs. self fittingSubject 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.
Self-fittingprofessional fitting vs. self fittingSubject 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.
Primary Outcome Measures
NameTimeMethod
Comparison of self fitting and professional fitting by COSI scores4 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 Outcome Measures
NameTimeMethod
Comparison of self fitting and professional fitting by IOI-HA scores4 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.

Trial Locations

Locations (1)

Ozen-Kashevet Hearing Clinic

🇮🇱

Jerusalem, Israel

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