Tuned App Self-Fitting vs. Professional Fitting

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05869266
• Other study ID #: TU1-PLN-111
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 15, 2023

Study information

• Verified date: October 2023
• Source: Tuned Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss
• Seizures

Intervention

Device:
• professional 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.

Locations

Country	Name	City	State
Israel	Ozen-Kashevet Hearing Clinic	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Tuned Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of self fitting and professional fitting by COSI scores	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.	4 weeks
Secondary	Comparison of self fitting and professional fitting by IOI-HA scores	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.	4 weeks