Tuned App Self-Fitting vs. Professional Fitting

October 17, 2023 updated by: Tuned Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Ozen-Kashevet Hearing Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Professional-fitting

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.
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.
Other Names:
  • Tuned App
Active Comparator: Self-fitting

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.
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.
Other Names:
  • Tuned App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of self fitting and professional fitting by COSI scores
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of self fitting and professional fitting by IOI-HA scores
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuned Ltd.

Investigators

  • Principal Investigator: Leonid Kriksunov, Ozen-Kashevet Hearing Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 15, 2023

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU1-PLN-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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