Back to resultsTuned App Self-Fitting vs. Professional Fitting
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
professional fitting vs. self fitting
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss focused on measuring self fitting
Eligibility Criteria
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.
Sites / Locations
- Ozen-Kashevet Hearing Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Professional-fitting
Self-fitting
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05869266
Brief Title
Tuned App Self-Fitting vs. Professional Fitting
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tuned Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
Keywords
self fitting
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Professional-fitting
Arm Type
Active Comparator
Arm 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.
Arm Title
Self-fitting
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
professional fitting vs. self fitting
Other Intervention Name(s)
Tuned App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of self fitting and professional fitting by COSI scores
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Comparison of self fitting and professional fitting by IOI-HA scores
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Kriksunov
Organizational Affiliation
Ozen-Kashevet Hearing Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ozen-Kashevet Hearing Clinic
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tuned App Self-Fitting vs. Professional Fitting
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